Category Archives: Anti-vaxers

The Pandemic is Over

This is my prediction that by the end of February or maybe March, as more and more of the population gets infected. However, due to the confusion promoted by the news reporters, as well as social media and changes seen in most pandemics the population has become confused.
All of a sudden there is the push to use N95 and KN95 masks as the effective face protection.
But listen here, the use of N95 and KN95 masks were always the most effective, but the scientists were “silenced” and as long as you were wearing some sort of face masks or facial coverings “everyone” was satisfied. But listen carefully, the cloth and paper masks never were and protection from any virus. Remember that viruses are measured in microns, not inches or millimeters, etc.
Also, as Omicron takes over, we are seeing the effects and power of the portion of the vaccinated. Yes, they will get sick, but many will be asymptomatic and therefore will never be counted as infected. Which is my biggest problem with the Administration sending out millions of home self-tests. So, they are going to send out 500 million to a population of about 400 million people, which means that you can use the test once. Many times, the tests will be read as negative due to the timing of the infection and then what.
Also, with self-testing, if your tests are positive, who will report their positive tests? Therefore, will our future data on which we make decisions be accurate? Actually, No and we are already seeing this happen with all the home self-tests already being sold. And then the “sick” patients should self-quarantine, that if they are honest and care about those around them and those who matter to them, or just care about society.
This new variant/mutation is more contagious, and our population is exhausted. If you don’t believe me just review the New Year’s Eve celebration from Nashville or New York city. The crowds were huge and there were very few masks being worn!
Omicron not peaking nationally yet, surgeon general says. COVID-19 is sending mixed messages. The U.S. is recording over 800,000 cases a day for the first time since the beginning of the pandemic, and hospitalizations are also setting records.
But New York State recorded only about 48,000 cases on Friday, almost a 47% drop from the previous week’s case count, Gov. Kathy Hochul said Saturday.
“We are turning the corner on the winter surge, but we’re not through this yet,” the governor said in a statement.
Minnesota also saw declining intensive-care hospitalizations for COVID-19, and cases have been falling in Washington D.C. and other cities in the eastern half of the country.
But New York’s declining trend is not indicative of the national COVID-19 portrait, Surgeon General Vivek Murthy warned on Sunday.
“The entire country is not moving at the same pace,” he told CNN host Jake Tapper.
Oklahoma and Georgia both saw over a 100% rise in weekly COVID-19 cases, a USA TODAY analysis of Johns Hopkins University data shows, while Colorado saw a 90% increase.
“We shouldn’t expect a national peak in the next coming days,” he said. “The next feel weeks will be tough.”
Also in the news:
The United States has reported its 850,000+ deaths, Johns Hopkins University data shows. The U.S. averaged 1,776 reported deaths per day over the last week.
The Biden administration on Wednesday will launch a website where Americans can order up to four free COVID-19 testing kits per person.
U.S. Rep. David Trone of Maryland announced that he has tested positive for COVID-19. Trone said he has received a booster and is experiencing “only minor symptoms,” according to The Washington Post.
Navajo Nation President Jonathan Nez has signed an executive order requiring all government workers on the tribe’s vast reservation to receive a booster shot.
Today’s numbers: The U.S. has recorded more than 65 million confirmed COVID-19 cases and more than 850,000 deaths, according to Johns Hopkins University data. Global totals: More than 326 million cases and over 5.5 million deaths. More than 208 million Americans – 62.9% – are fully vaccinated, according to the Centers for Disease Control and Prevention.
What we’re reading: Omicron is closing daycare centers in droves. Parents are “just trying to stay afloat.” USA TODAY’s Alia Wong explains.
US now averaging 800,000 new cases each day and stated that the total deaths are now over 900,000.
The United States is reporting more than 800,000 cases a day for the first time, even amid signs that America’s omicron wave is slowing down. The country reported 5.65 million cases in the week ending Saturday, a USA TODAY analysis of Johns Hopkins University data shows. The rapid acceleration of case reports continues despite a shortage of tests. Still, in just the last week the country has reported more cases than it did in March, April, May and June 2021 – combined.
About 158,500 Americans were reported hospitalized on Saturday. Hospitals in 46 states report rising numbers of patients; 34 states report rising death rates.
Mike Stucka noted that we continue to push mask mandates, social distancing, vaccinations, and possible additional lockdowns.
With the majority of really sick hospitalized patients, actually about 72%, were non-vaccinated.
I just had a young lady with four children who notified me earlier in the week that because she had a few home self-tests she tested her sons with two of the boys just having sniffles or a minor sore throat. And three tested positive. And I believe that this is going to be the majority of COVID positive patients, that is minimal or no symptoms and therefore, not self-quarantining and therefore becoming super-spreaders.
COVID Vaccines Are a Scientific Feat, but ‘Prevention’ Is a Misnomer
— In public messaging, semantics matter
Rossi A. Hassad, PhD reported that especially since the advent of the COVID-19 Omicron variant, and the increasing incidence of infection and reinfection among those fully vaccinated and boosted, I have heard from a number of people whose concerns reflect the following sentiment, “You recommended the vaccine to prevent COVID-19, I took it, and this is what I got (infected).”
Undoubtedly, these COVID-19 vaccines are a gift of life and continue to be safe and effective. Nonetheless, this sentiment is understandable, and in my assessment, it signals an urgent need for more precise labeling and messaging about the COVID-19 vaccines from the FDA.
On Dec. 10, 2020, at the invitation of the FDA, I gave a brief oral presentation at the open public session of the Vaccines and Related Biological Products Advisory Committee (VRBPAC) meeting for emergency use authorization (EUA) of the Pfizer-BioNTech COVID-19 vaccine. I ended my remarks as follows:
“In conclusion, the potential benefits of this vaccine outweigh the identified risks. Therefore, I support the issuance of an EUA with the stipulation that the vaccine can protect against symptomatic disease. But at this time, it is not known if it prevents infection and transmission.”
The COVID-19 vaccine clinical trials and the resulting evidence show that the vaccines significantly reduce the risk of severe illness, hospitalization, and death. Nonetheless, in the labeling of the vaccines, and messaging to healthcare providers and the general public, the FDA specified that the Pfizer-BioNTech, Moderna, and Janssen vaccines are indicated for the “prevention of COVID-19” — this may have fostered an unrealistic expectation of absolute protection or immunity against COVID-19. By scientific convention, a vaccine is generally characterized as a primary prevention measure for a specific disease: that is, “you can be exposed to it without becoming infected.”
Over the summer, on Aug. 2, 2021, I emailed FDA’s Acting Commissioner Janet Woodcock, MD, regarding the word prevention, which the FDA has used to characterize the scope of protection provided by the three COVID-19 vaccines in use in the U.S. I noted that the word prevention in this context seems to be a misnomer and can contribute to public confusion and vaccine hesitancy. In particular, in light of the increasing number of breakthrough cases, the public may be inclined to believe that the COVID-19 vaccines are losing effectiveness. I also urged the FDA to provide clarification to the public in this regard. Woodcock responded the same day as follows:
“Thank you for writing. We will take your suggestions into account. I agree that the expected results of vaccination are confusing for most people. It is very likely that vaccination prevents acquisition of infection in some people but not all vaccinated people and that some get symptomatic infection and rarely, severe disease, and this may be related in part to their overall immune system response, the variant they were exposed to, and the actual amount of exposure and the time since their last vaccination, among other things.”
Notably, in September 2021, the CDC tempered its definition of vaccination to reflect that vaccines produce “protection from a specific disease,” rather than “immunity to a specific disease.” (In either case, immunity was defined on the same CDC page as “protection from an infectious disease.”)
Woodcock’s response continues to reflect the performance of the COVID-19 vaccines. Prevention of COVID-19 is not the intended primary benefit of these vaccines. In fact, Woodcock and Anthony Fauci, MD, director of the National Institute of Allergy and Infectious Diseases, recently made the point that most people will get COVID eventually. These vaccines continue to significantly reduce the risk of severe illness, hospitalization, and death — and that’s an amazing scientific feat amidst a deadly pandemic. Attention to timely and effective messaging to healthcare providers and the general public should be a top priority for the FDA. Semantics matter.
(When) to Boost or Not to Boost, That Is the Question
— Countless complex questions remain
John P. Moore, PhD noted that for several months, America has been in the vaccine-booster phase of the COVID-19 pandemic. Various aspects of booster policy have been controversial and/or confusing, and the public response to the need for boosters has been mixed. But what is the best way to continue to provide the sensible majority who trust in the lifesaving COVID-19 vaccines with the best protection in the coming months to years? At times, it seems as if some folks believe “a dose a day keeps the doctor away.” And a meme is now circulating of a “Pfizer Loyalty Card,” offering a free pizza after dose nine. While droll, might that actually happen? (Dose nine, that is).
While the strong protective efficacy of the mRNA vaccines was certainly not predicted early on in the global vaccine program, a basic understanding of vaccine immunology allowed us to predict that protective antibody titers would inevitably wane over a 6-month period and could be restored with a booster dose.
The Early Booster Debates
In summer 2021, data from Israel triggered discussions among policymakers, scientists, and company executives about the need for boosters in the U.S. The vaccine booster concept wasn’t — or shouldn’t have been — inherently controversial, particularly for individuals at high risk for COVID-19 complications. However, there were doubts about the arguably premature timing of, and rationale for, a broadly based boosting program. Arguments were also raised about using those doses in under-vaccinated countries instead, both on moral grounds and to prevent the emergence of even more troubling variants (e.g., Omicron…). Other debates centered on whether the goal was to protect against mild infections (which vaccines typically don’t do) or severe disease and death. These discussions generally faded away once it became clear that protection against severe infections was diminishing significantly for older individuals, and that fully vaccinated people could still transmit their infections to others. In addition, anxious members of the vaccine-embracing public, including members of the media, put pressure on the Biden administration. A vaccine boost became something that Jane Public and Ronnie Reporter wanted, and, frankly, expected.
Americans can now be boosted 5 months after their initial two mRNA vaccine doses of Moderna or Pfizer. The far fewer recipients of the Johnson & Johnson (J&J) vaccine are also being boosted, most opting for an mRNA dose as that provides a stronger antibody response.
But what’s next? Already, Israel is rolling out a fourth Pfizer dose and is therefore well on the way to handing over a slice of pizza. Should we do the same here, and if so, when? In the hope that any policy decisions will be science-based, I will review some of the knowns and unknowns. Whatever knowledge I possess has been significantly boosted by helpful discussions with world-class immunologist colleagues.
Determining the Right Booster Schedule
Most agree that dose three (i.e., the first boost) should not be given too early. The period between the second and third dose is critical to the maturation of the immune response and establishment of immunological memory. As the quantity of antibodies in the blood declines, their quality increases, including their ability to counter variants. While there is no “magic moment” for dose three, the original CDC recommendation for a 6-month gap for both mRNA vaccines and the recent revisions to 5 months are both about right.
But what about dose four and onwards? Is there a point when it is certainly needed? Here, we don’t have hard data, although there are early indications from Israel that the antibody responses to Pfizer dose three are now dropping. That should not be a surprise, based in part on decades of experience with attempts at an HIV-1 vaccine. As but one illustrative example, an HIV-1 “spike protein” vaccine was given seven times to humans over a 30-month period. After the first two immunizations, every subsequent one triggered a rapid rise in antibody levels, followed by a gradual decline at a similar rate each time. The titer pattern over time looked like saw teeth. In the period between boosts, the antibody levels didn’t disappear, but the boosted peak levels weren’t much higher each time — there were ever diminishing returns to the potency of each booster dose.
Perhaps we will see something different with the SARS-CoV-2 spike protein, and maybe the mRNA delivery method will be the charm — but I wouldn’t bet the farm on a dramatically different outcome to our experiences with the HIV-1 spike protein. In other words, boosting is likely to increase protective antibody levels in the short term but probably won’t be truly sustained (T-cell responses, which help to prevent severe disease, also wane but more slowly). If the pandemic persists, fairly regular boosting may therefore be needed, akin to the annual flu vaccines.
However, this scenario also invites more questions about the intervals between doses: the HIV-1 vaccine study discussed above used a 6-month interval between the later doses, probably because prior experience showed that was when the boosted titers dropped back to near baseline. The Israelis, however, are now giving the fourth Pfizer vaccine dose about 4 months after the third. Is that too soon for comfort? Well, for sure, it should be no sooner than that…and most immunologists I talked to favor a longer interval. Given the cost and logistics, some important decisions will need to be made soon.
Our political and public health leaders have much to consider and will need to decide whether there is a need to sustain a high level of protection against SARS-CoV-2 infection and mild COVID-19.
Will We Keep Boosting…Forever?
What about the future? There is nothing inherently problematic with giving regular, sensibly spaced vaccine doses from an immunology perspective. Different COVID-19 vaccines can clearly be mixed when given sequentially. A recent HIV-1 vaccine study in monkeys involved nine doses of mRNAs, proteins, and protein-nanoparticles over a ~14-month period in a heroic attempt to broaden the neutralizing antibody response (the major obstacle to a successful HIV-1 vaccine). Next-generation, more potent COVID-19 vaccines may eventually play an important role. We’ll also need to explore alternative ways to deliver vaccines, whether based on immunology or emerging technology. What happens should be dictated by the trajectory of the pandemic, including the evolution of yet more variants. So far, despite vaccine manufacturers going ahead with their own plans, the case for variant-specific vaccines has been weak. Although, it’s possible the need for them may change in the coming months as Omicron continues to spread; and now what about the new variant, Deltacron?
Boosting J&J Vaccine Recipients
Additional complications are at play too: What’s the right approach to boosting J&J vaccine recipients? They can receive a second dose 2 months after the first, but in most cases that dosing interval is many months longer (and, as noted, most opted for an mRNA boost at that point). When should they receive a third dose? For the mRNA vaccines, the critical period for immunological quality improvements is the ~6-month interval between doses two and three (see above), but when does that happen for the J&J vaccine? In the long and rather random interval between doses one and two? After dose two? Or both? Could a third dose in the near future be too soon for comfort? Having more data would help.
Factoring in Natural Immunity
We also need to consider how to — or whether to — factor in immune responses induced by vaccine breakthrough infections, which are becoming increasingly common. Although breakthrough Omicron infections are generally not severe, the viral antigens will surely trigger a boosting effect in vaccine-primed immune systems — some members of the public are now embracing this idea. And we know that vaccinating previously infected people generates particularly strong immune responses (“hybrid immunity”). We can expect a lot of data on this topic in the next month or so, but for now we have to speculate.
But what happens when vaccination precedes infection? Should a two-dose vaccine recipient who is then Omicron-infected receive a further vaccine dose and, if so, when? Similarly, what happens if a triply vaccinated person becomes infected? Given how mutated the Omicron spike-protein is, an infection with this variant is likely to trigger the production of antibodies that have a lesser impact on new variants that more closely resemble the ones that circulated in 2020-2021. They would, however, be better poised to counter any variants that emerge from the Omicron lineage, as would Omicron-based vaccine boosters. In short, we need to determine how to factor in the combination of vaccination and infection history, and also how the pandemic may further evolve, to devise an optimal boosting approach. There are important scenarios that policymakers and serious immunologists must ponder soon. Otherwise, far-reaching decisions will be taken on the fly, which is never ideal.
The U.S. is blessed with an abundance of COVID-19 vaccines and world-class scientists. Our complex scenarios merit the most qualified experts to figure out the best paths forward. I, for one, look forward to reading what might emerge. I need that guidance to answer with greater confidence the questions I am frequently asked by friends, colleagues, and random members of the public. “Winging it” is becoming as tiresome as it is tiring.
Now that we have two antiviral medications that can be taken after a patient gets infected, I predict that all will change and that by the middle of February the pandemic will be declared over and be classified as an endemic. That will mean that we will be” instructed” to simply get our “up-dated shots” yearly with our updated flu vaccinations.
Infact, Moderna is already working on a combined vaccine to include updated influenza and COVID vaccines, which would be “offered” yearly.
So, can we get back to normal? Maybe! We still have to continue to assess the use of vaccines to those under the age of 5 years old. Once we have critically evaluated and cleared vaccines and antiviral medications for these young potential patients, we will have a safer healthcare system to “return to normal”.
As nations decide to live with the virus, some disease experts warn of surrendering too soon. The coronavirus isn’t going away, but that doesn’t mean resistance is futile, scientists say.
Joel Achenbach wrote that Nations around the planet are making a subtle but consequential pivot in their war against the coronavirus: Crushing the virus is no longer the strategy. Many countries are just hoping for a draw.
It’s a strategic retreat, signaled in overt and subtle ways from Washington to Madrid to Pretoria, South Africa, to Canberra, Australia. Notably, few countries today outside of China — which is still locking down cities — cling to a “zero-covid” strategy.
The phrase often heard now in the United States and many other nations is “live with the virus.” That new stance is applauded by some officials and scientists and welcomed by people exhausted with the hardships and disruptions of this global health emergency entering its third year.
But there are also disease experts who fear the pendulum will swing too far the other way. They worry that many world leaders are gambling on a relatively benign outcome from this omicron variant surge and sending messages that will lead people who are normally prudent to abandon the social distancing and mask-wearing known to limit the pathogen’s spread. Epidemiologists say the live-with-it strategy underestimates the dangers posed by omicron.
“This notion of learning to live with it, to me, has always meant a surrendering, a giving up,” World Health Organization epidemiologist Maria Van Kerkhove said.
Virologist Angela Rasmussen of the University of Saskatchewan likewise fears that people are relaxing sensible precautions prematurely: “I understand the temptation to say, ‘I give up, it’s too much.’ Two years is a lot. Everybody’s sick of it. I hate this. But it doesn’t mean actually the game is lost.”
The WHO officially declared a public health emergency of international concern on Jan. 30, 2020, when there were 7,711 confirmed cases of covid-19 and 170 deaths in China, and another 83 cases scattered across 18 other countries — and no deaths.
Two years later, the virus has killed more than 5.5 million people, and the pandemic is ongoing. But the global health emergency has evolved — reshaped by the tools deployed to combat it, including vaccines. The virus itself and the disease it causes are now so familiar, they have lost some of their early spookiness.
No national leader would ever say that it’s time to quit the struggle, but the tone of the contest has changed, with little talk of beating, crushing, defeating the virus. SARS-CoV-2 is part of the world now, a “pantropic” virus that can infect people, deer, minks, rats and all sorts of mammals.
Many nations continue to impose mask requirements, vaccination mandates and travel restrictions. But few leaders in democratic societies have the political capital to take harsh measures to suppress transmission. Even the arrival of the ultra-transmissible omicron variant did not throw the world back into winter 2021, when the paramount goal remained stopping viral spread at all costs — much less back to spring 2020, when people were told to stay home, wipe down their groceries and not touch their face.
Even officials in Australia, long a fortress nation that sought to suppress the virus at all costs, have chosen to ease some mandates in recent weeks.
Tennis superstar Novak Djokovic — shown at a training session Jan. 11 in Melbourne, Australia — has been in a pitched battle with health authorities because he lacks required coronavirus vaccination credentials. (AP)
The country has gained global headlines for its treatment of unvaccinated tennis champion Novak Djokovic, who flew in for the Australian Open and immediately ran afoul of the government’s virus protocols, spending the better part of a week in a detention hotel. On Friday, Australia’s immigration minister canceled the player’s visa a second time.
But the other national story in Australia is a debate over the relaxed restrictions. National and state leaders had an agreement that strict measures would end when vaccination reached 80 percent of the eligible population. That threshold was reached months ago, and now more than 90 percent of the eligible population is vaccinated. Masks are still required in some indoor settings, and there are capacity limits, but opposition leaders and some experts have decried what they call the “let it rip” strategy.
“The decision to remove restrictions just as Omicron surged has cost us dearly,” declared a report from an independent group of experts called OzSAGE. “The ‘let it rip’ strategy and defeatist narrative that ‘we are all going to get it’ ignores the stark lived reality of the vulnerable of our society.”
In South Africa, where officials first sounded the alarm about omicron, the government in December eased protocols, betting that previous encounters with the virus have given the population enough immunity to prevent significant levels of severe illness. The omicron wave there subsided quickly with modest hospitalizations, and scientists think one reason is that so many people — close to 80 percent — had previously been infected by earlier variants.
Omicron also appears to be less virulent — less likely to cause disease. This heavily mutated coronavirus variant stiff-arms the front-line defense of antibodies generated by vaccines and previous infection but does not seem to be adept at invading the lungs or escaping the deeper defenses of the immune system.
In the ideal scenario, omicron’s alarming wave of infections will spike quickly, leaving behind a residue of immunity that will keep a broad swath of the population less vulnerable to future infections. This would be the last major, globally disruptive wave of the pandemic. The virus would still be around but would no longer be in a special category apart from other routinely circulating and typically nonfatal viruses such as influenza.
There are other scenarios less attractive. Scientists are quick to point out that they don’t know how long omicron-induced immunity lasts. The virus keeps mutating. Slippery variants packing a more powerful punch could yet emerge, and virologists say that contrary to what has sometimes been conjectured, viruses do not inexorably evolve toward milder strains.
But humans change, too. Outside of locked-down China, most people are no longer immunologically naive to the coronavirus. Scientists believe that’s a factor in omicron’s relatively low severity for individual patients. In the long term, humans and viruses tend to reach something like a stalemate. Only one disease-causing virus, smallpox, has ever been eradicated.
In the short term, experts believe omicron is essentially unstoppable but of limited threat to individuals even as it causes societal chaos. Ali Mokdad, an epidemiologist at the University of Washington’s Institute for Health Metrics and Evaluation, said he believes that about half of the U.S. population will be infected with omicron during the next three months, with most cases asymptomatic.
“There’s no way to stop its spread — unless we do measures like China is doing, and you and I know very well that’s not possible in the United States,” Mokdad said.
‘New normal’
There is no unified global response to the pandemic. Despite calls to “follow the science,” scientific research cannot dictate the best policy for some of the stickiest issues — such as when to open schools to in-person learning, or who should be prioritized for vaccines, or whether people who have no symptoms should be regularly tested.
The national strategies typically reflect elements of a country’s culture, wealth, government structure, demographics and underlying health conditions. Also, geography: New Zealand has managed to record only a few dozen deaths from covid-19, one of the lowest per capita death tolls on the planet, by leveraging its isolation in the South Pacific.
Japan, Singapore and South Korea, nations with a long history of mask-wearing and aggressive measures to suppress epidemics, have managed to keep the virus largely in check without draconian lockdowns or major sacrifices to their economies.
Peru, hammered by the variants dubbed lambda and gamma before the delta and omicron waves arrived, has had the deadliest pandemic per capita, according to the Johns Hopkins University coronavirus tracking site. The nations of Eastern Europe, with older populations and high vaccine skepticism, are not far behind.
Countries have different and sometimes unreliable ways of documenting the pandemic, but some general trends are clear. Among the wealthiest nations, the United States — where the pandemic is thoroughly polarized, misinformation is rampant, and a significant fraction of the public has resisted vaccination — has had an unusually deadly pandemic. According to the Hopkins tracker, the United States ranks 21st in reported deaths per capita. Britain is not much better at 28th, while Canada is 82nd.
A group of doctors who advised President Biden during the presidential transition have urged a reset of the strategy to recognize the “new normal” of the virus, which has little chance of being eradicated and will probably continue to cause typically mild illness and require vaccination boosters at a frequency yet to be determined.
Biden took office nearly a year ago vowing to crush the pandemic, having won the presidency in part by emphasizing a more aggressive posture against the contagion than President Donald Trump. Biden’s administration pushed vaccination hard and saw millions of people a day roll up their sleeves during the spring. On July 4, after caseloads had dropped, he assembled a crowd on the South Lawn for a celebration of independence from the virus.
But the surge of infections and deaths from the delta variant proved that celebration to be premature, and the Centers for Disease Control and Prevention revised its guidelines, saying even those people fully vaccinated should resume wearing masks indoors. The delta wave began to subside in the fall, but then omicron, crammed with mutations that make it wildly more transmissible and evasive of immunity, erupted in late November.
Biden’s omicron strategy is not significantly different from what he employed against previous variants. On Dec. 2, he detailed his plans by first announcing what he would not do: “lockdowns.” He vowed to distribute 500 million rapid tests and doubled the number in recent days. His covid task force continues to emphasize the importance of vaccines, therapeutics and testing rather than restrictions on mobility and gatherings.
Fatalism and fatigue
The strategic shift toward the live-with-it strategy in many nations, including the United States, has often gone without formal acknowledgment from national leaders. Spain is one of the exceptions: Prime Minister Pedro Sánchez has said he wants the European Union to stop tracking covid as a separate disease and recognize that it is becoming an endemic pathogen.
Across the Pyrenees, French nightclubs closed as omicron swept through. Indoor masking is required, regardless of vaccination status. In bars, patrons are not allowed to consume alcohol while standing up. France, like Italy and many other European countries, has leaned heavily on vaccine passports.
French President Emmanuel Macron is blunt about his desire to make life uncomfortable for the unvaccinated by limiting their ability to go into public places. In a newspaper interview, he used graphic language that has been translated into English as “I really want to piss them off.”
Many global leaders, including those in the United States and Europe, have focused on vaccination as the key to mitigating the pandemic. The vaccines do lower the risk of severe illness. What they do not do as well is stop transmission and mild infection. The speed of omicron’s spread is the key factor in the equation that determines how much pressure it will put on hospitals — which are currently seeing record numbers of covid patients in the United States.
“If we just completely let everything go and allow the omicron epidemic to run its natural course, we’ll completely overrun our health system and be left in a situation potentially worse than what we experienced in early 2020,” said James Lawler, co-director of the University of Nebraska Medical Center’s Global Center for Health Security.
He is not seeing the precautions he saw early in the pandemic, when he was among the first disease experts to sound an alarm about the extreme transmissibility of the coronavirus. Earlier this week, he went to a grocery store and was virtually alone in wearing a mask. That’s the norm, he said, in Omaha.
“There’s not a mandate,” he said. “Across the entire experience of humanity, we should have learned by now the only way to get high levels of compliance like this is to make it mandatory. That’s what happened with seat belts.”
After Lawler made those comments, a county health commissioner imposed a mask mandate covering Omaha, but the Nebraska Attorney General filed a lawsuit to block it.
There is fatalism mixing with pandemic fatigue and, in some countries, science denial or ideological rejection of the restrictions and mandates that many public health experts consider to be common sense measures in a pandemic. And anecdotally, people may rationally feel the battle is lost, the virus has won.
Public health officials warn that this is a dangerous attitude. It’s true that for an individual, risk might be low. But when a virus spreads as quickly as omicron does, the equation suddenly spits out alarming results — millions of people sick at once, many of them with underlying conditions that have already put them on the edge of a cliff and vulnerable to a shove.
Rasmussen, the University of Saskatchewan virologist, is among the experts who think people have misunderstood the concept of endemicity — which is the point at which a virus continues to circulate at low levels but is not generating epidemic-level outbreaks. She fears some people hear the “endemic virus” talk as a sign that resistance is futile.
“People think that means we just give up,” she said. “They think ‘endemic’ means that we’re all going to get covid eventually. I’m hearing people say, ‘Why not just get it over with now, and I’ll be bulletproof?’ None of this is what endemicity means.”
Endemic COVID doesn’t mean it’s harmless or we give up, just that it’s part of life
Catherine Bennett discusses the eventual change in her article. We have experienced many bumps in the road since 2020 and one would have to be extremely brave to predict what the pandemic may throw at us next.
But in terms of the endgame, many experts believe COVID will eventually become an endemic disease. However, what this actually means is a source of considerable confusion. One of the main reasons for this is a misunderstanding of endemicity itself, and what COVID being an endemic disease would actually look like in the real world.
Let’s break it down. What does ‘epidemic’ actually mean? A disease is either epidemic or endemic. The most straightforward explanation of an epidemic disease is that it’s one in which the number of cases in the community is unusually large or unexpected. When this occurs, it signals a need for public health action to bring disease transmission under control.
In the case of a pandemic—a worldwide epidemic—this occurs on a much larger scale. Depending on the infectiousness and severity of the disease, it can represent a global public health emergency, as we’ve seen with COVID.
When you have the emergence of a completely new virus like SARS-CoV-2 that has the potential to cause severe illness while also being highly transmissible, the lack of any immunity among the population results in the drivers for disease spread being incredibly strong.
A disease being epidemic indicates there’s an imbalance between these drivers of disease spread and the factors limiting spread in the community. In short, it means the drivers for disease spread overpower the factors limiting spread. As such, the disease spreads like a raging bushfire. It’s explosive and hard to bring under control once it has seeded.
From epidemic to endemic
However, over time, the underlying forces driving an epidemic alter. As immunity begins to increase across the population—ideally in a controlled way by vaccination, but also by natural infection—the pathogen starts to run out of fuel and its ability to transmit falls. Pathogens can include a variety of microorganisms, such as viruses, bacteria and parasites. In this case, let’s assume we’re talking about a virus.
On top of immunity, we can also reduce a virus’ ability to spread by behavior changes, such as 1 / 3 limiting contact with others, mask wearing and improved hand hygiene. In addition to lowering the virus’ ability to transmit, immunity also reduces its ability to cause disease, meaning fewer people become really sick or die.
And finally, if we are lucky, over longer periods of time, the virus may also evolve to become intrinsically less severe. When will the COVID-19 pandemic end?
The net result of this is we move from an imbalance in terms of the forces driving disease to a steadier state of equilibrium. Instead of explosive and unpredictable disease spread, we reach a point where the presence of circulating disease represents a lower threat to the community than it did at the beginning of an epidemic.
Transmission becomes more predictable, but not necessarily constant—we may still see some waves, especially seasonally. But these are expected and manageable. In short, we start to live alongside the virus.
This is what we mean by an endemic disease. Examples of endemic diseases include the common cold, influenza and HIV/AIDS. Endemic doesn’t mean we drop our guard. The discussion around COVID becoming endemic becomes even more complicated by very different views about what this actually translates to in practice.
It’s important to emphasize it doesn’t mean we drop our guard, surrender to the virus or downgrade the threat the virus poses to individuals and the community. We remain vigilant and respond to surges in cases when they occur, doing what’s needed to keep transmission as low as possible.
Importantly, a disease being considered endemic doesn’t mean we consider it mild. It just means it remains a part of our lives, and therefore we still protect the vulnerable from severe illness, as we do with other diseases. It’s crucial we understand living with the virus isn’t the same thing as ignoring the virus. Instead, it represents an adjustment in the way in which we respond to the disease.
It’ll be a bumpy ride. It’s also important to highlight this transition may not necessarily be smooth and there will no doubt be challenges along the way. One of the main obstacles we’re going to face is the possible emergence of new variants and how these will impact the infectiousness and severity of the disease.
In order to reduce the likelihood of new variants emerging, it’s vital we really step up our rollout of vaccines globally to reduce virus transmission. To aid us in our transition to this next stage of the pandemic, we will, thankfully, be able to draw on many new weapons which are in the pipeline. This includes next-generation vaccines which will be more effective against the latest variants, or universal vaccines that cover all variants. We expect new vaccines will also be better at controlling transmission.
We’ll also have ever-improving treatments, and better infection prevention and control engineered for specific environments. The big question, of course is when will this transition to endemicity happen? Many experts, 2 / 3 believe huge strides will be made along this path in 2022.
It has been reported by the WHO that Omicron sub-variant has been found in 57 countries. A sub-variant of the highly contagious Omicron coronavirus strain, which some studies indicate could be even more infectious than the original version, has been detected in 57 countries, the WHO said Tuesday.
The fast-spreading and heavily mutated Omicron variant has rapidly become the dominant variant worldwide since it was first detected in southern Africa 10 weeks ago. In its weekly epidemiological update, the World Health Organization said that the variant, which accounts for over 93 percent of all coronavirus specimens collected in the past month, counts several sub-lineages: BA.1, BA.1.1, BA.2 and BA.3.
The BA.1 and BA.1.1—the first versions identified—still account for over 96 percent of all the Omicron sequences uploaded to the GISAID global science initiative, it said. But there has been a clear rise in cases involving BA.2, which counts several different mutations from the original including on the spike protein that dots the virus’s surface and is key to entering human cells.
“BA.2- designated sequences have been submitted to GISAID from 57 countries to date,” The WHO said, adding that in some countries, the sub-variant now accounted for over half of all Omicron sequences gathered. The UN health agency said little was known yet about the differences between the sub-variants, and called for studies into its characteristics, including its transmissibility, how good it is at dodging immune protections and its virulence. Several recent studies have hinted that BA.2 is more infectious than the original Omicron.
Maria Van Kerkhove, one of the WHO’s top experts on COVID, told reporters Tuesday that information about the sub-variant was very limited, but that some inital data indicated BA.2 had “a slight increase in growth rate over BA.1”
Omicron in general is known to cause less severe disease than previous coronavirus variants that have wreaked havoc, like Delta, and Van Kerkhove said there so far was “no indication that there is a change in severity” in the BA.2 sub-variant. She stressed though that regardless of the strain, COVID remained a dangerous disease and people should strive to avoid catching it. “We need people to be aware that this virus is continuing to circulate and its continuing to evolve,” she said. “It’s really important that we take measures to reduce our exposure to this virus, whichever variant is circulating.”
Merck to Deliver 3.1 million Treatment Courses of COVID Antiviral
Ralph Ellis reported that a little more than a month after receiving FDA authorization, Merck has delivered 1.4 million courses of its COVID-19 antiviral pill in the United States and expects to deliver its total commitment of 3.1 million treatment courses soon, company CEO Rob Davis said on CNBC.
Merck has also shipped 4 million courses of the pill, molnupiravir, to 25 nations across the world, he said. “We’ve shown that molnupiravir works against Omicron, which is important against that variant,” Davis said Thursday morning. “And obviously we’ll have to see how this plays out and what is the initial uptake, but right now we feel we’re off to a good start.”
In June the U.S. government agreed to buy 1.7 million courses of molnupiravir for $1.2 billion and in November agreed to buy an additional 1.4 billion courses for $1 billion.
The FDA granted emergency use authorization in late December to two antivirals for people who contract COVID: Merck’s molnupiravir and Paxlovid, which is produced by Pfizer. The drugs are designed for people with mild or moderate COVID who are more likely to become seriously ill — mainly people 65 and older or people who have chronic illnesses such as heart disease, lung disease, diabetes, obesity, or compromised immune systems.
Both antivirals require a five-day course of treatment. Merck’s is for adults ages 18 and older, and Pfizer’s for anyone age 12 and up. In clinical trials, molnupiravir reduced the risk of hospitalization or death in Covid patients by 30% but slashed the risk of dying by 90%, Davis said.
“The fact that molnupiravir does reduce the risk of death by 90%, we could have a meaningful impact in helping patients,” he said. Davis told CNBC that Merck sold $952 million in molnupiravir pills in the fourth quarter and is on track to rack up an extra $5 billion to $6 billion in sales in 2022.
Last week, Merck said laboratory studies showed molnupiravir was active against the Omicron variant. In December, Pfizer said preliminary lab studies also suggest the pill will hold up against the Omicron variant.
WHO official sees ‘plausible endgame’ to pandemic; Medicare to provide up to 8 free tests per month: COVID updates
John Bacon,Jorge L. Ortiz and Celina Tebor wrote in USA Today that the director of the World Health Organization’s Europe office said Thursday that coronavirus deaths are starting to plateau, and the continent faces a “plausible endgame” to the pandemic.
Dr. Hans Kluge said there is a “singular opportunity” for countries across Europe to take control of COVID-19 transmission as a result of three factors: high levels of immunization because of vaccination and natural infection, the virus’s tendency to spread less in warmer weather and the lower severity of the omicron variant. Data in the U.S. is similar to the data from Europe, providing similar hope.
“This period of higher protection should be seen as a cease-fire that could bring us enduring peace,” Kluge said.
At WHO’s Geneva headquarters, director-general Tedros Adhanom Ghebreyesus warned that the world as a whole is far from exiting the pandemic.
“We are concerned that a narrative has taken hold in some countries that because of vaccines, and because of omicron’s high transmissibility and lower severity, preventing transmission is no longer possible and no longer necessary,” Tedros said. “Nothing could be further from the truth.”
So, with the announcement that Pfizer has submitted their studies on 6 months to 5-year vaccine approval, the antivirals and the vaccine statistics, that the change to COVID-19 to be transitioned to the classification as an Endemic is right around the corner.
And lastly-
US Exiting ‘Full-Blown Pandemic Phase’ of COVID, Fauci Says
Carolyn Crist wrote the latest prediction from Dr. Fauci. The U.S. is heading in a positive direction in the pandemic as COVID-19 cases and hospitalizations decline, said Anthony Fauci, MD, director of the National Institute of Allergy and Infectious Diseases.
Vaccination rates, treatments, and prior infections will make the coronavirus more manageable in 2022, Fauci told the Financial Times. Broad mandates and mitigation protocols will begin to be lifted.
“As we get out of the full-blown pandemic phase of COVID-19, which we are certainly heading out of, these decisions will increasingly be made on a local level rather than centrally decided or mandated,” he told the newspaper. “There will also be more people making their own decisions on how they want to deal with the virus.”
The U.S. is reporting an average of 240,000 new COVID-19 cases per day, according to the data tracker from The New York Times. That’s a 63% decline from the previous 2 weeks.
About 100,000 people are hospitalized due to COVID-19, according to the latest data from the U.S. Department of Health and Human Services. That’s also down 28% in the past 2 weeks.
At the same time, about 2,600 deaths are being reported each day, the newspaper reported, which is the highest level seen in the U.S. in a year.
Fauci said COVID-19 restrictions around the U.S. will end soon. He didn’t give a specific timeline but said it was likely to happen in 2022.
Some states have already begun to lift pandemic rules as COVID-19 cases subside. California, Connecticut, Delaware, Oregon, and New Jersey announced on Monday that they would lift mask mandates for schools and other public spaces throughout February and March. On Wednesday, New York Gov. Kathy Hochul dropped New York’s mask mandate as well.
At the same time, Fauci stressed that the coronavirus won’t be wiped out and people will have to learn to live with it. Health officials may soon reach an “equilibrium” where they don’t need to monitor infection levels as closely, he said.
“I hope we are looking at a time when we have enough people vaccinated and enough people with protection from previous infection that the COVID restrictions will soon be a thing of the past,” he said.
And I believe that we are just about there!

COVID Hospitalizations in the US Soar to More Than 100,000, Vaccines and The Idiocy regarding Ivermectin!

Ralph Ellis reminded us that more than 100,000 people in the United States were hospitalized with COVID-19 this past few weeks — a figure not reported since late January, when vaccines were not widely available.

Statistics from the U.S. Department of Health and Human Services showed 100,317 COVID hospital patients on Wednesday, a figure that grew to 101,050 on Thursday. 

That’s about six times the number of COVID hospitalizations from about nine weeks ago, CNN says.

The HHS data shows COVID hospitalizations are highest across the Southeast, with more than 16,800 patients in Florida, 14,000 in Texas, 6,200 in Georgia, 3,000 in Alabama, and 2,300 in Missouri.

In comparison, California, the most populous state, has about 8,700 people hospitalized with COVID, the HHS said.

Alarmingly, many of these COVID patients are severely ill. About 30% of the nation’s intensive care unit beds are now occupied by COVID patients, HHS data shows.

Infections, deaths, and hospitalizations have increased since early summer as the Delta variant spread across the nation, especially in places with low vaccination rates. 

Health experts have said the majority of the hospitalized people are unvaccinated. Research shows that vaccinated people who become infected with the Delta variant generally don’t become as sick as unvaccinated people.

Paul Offit, MD, an FDA vaccine advisory committee member, said the current availability of the vaccine makes the high number of hospitalizations especially tragic.

“The numbers now…are actually in many ways worse than last August,” Offit said on CNN. “Last August, we had a fully susceptible population, (and) we didn’t have a vaccine. Now, we have half the country vaccinated…but nonetheless the numbers are worse. The Delta variant is one big game changer.”

Sources:

U.S. Department of Health and Human Services: “Hospital Utilization.”

CNN: “With more than 100,000 people in the hospital with Covid-19 in the US, this August is worse than last, expert says.”

From Cancer to COVID: Is There a Fix for Willful Medical Ignorance?

Dr. H. Jack West pointed out something very interesting as he relayed an observation. He patient saw a patient for a second opinion after developing metastatic disease, but he’d initially been diagnosed with locally advanced non–small cell lung cancer (NSCLC). His oncologist had appropriately proposed treatment with concurrent chemoradiation followed by durvalumab. He listened to the rationale and the evidence, but he refused to pursue it, favoring alternative medicine instead.

A repeat scan several months later showed obvious progression. Even though it was potentially treatable — including with curative intent — he demurred again.

Several months down the line, he developed back pain heralding a new spinal metastasis. Only then did he accept that perhaps conventional, evidence-based anticancer therapy was worth pursuing. Of course, by that time the window of opportunity to treat with the hope of cure had closed.

But in other ways, it isn’t too late for him. He can at least benefit from subsequent treatments for advanced NSCLC. Too many other patients I’ve seen have eschewed conventional medicine so long that their poor performance status precludes standard therapies that would have been effective had they pursued them as something other than a final act of desperation.

Corollaries to Coronavirus                                                                                                                 Though this dynamic has existed for decades in oncology, the current rejection of the coronavirus vaccine, on a massive scale involving a significant minority of the US population, is a reflection of this same willful ignorance.

In 2008, I started a nonprofit organization — the Global Resource for Advancing Cancer Education — dedicated to providing free, timely, and credible information to cancer patients and caregivers around the world.

It was based on the premise that if the lay public had access to the best information — in other words, the same content that informs experts and defines optimal patient management — patients would then be able to pursue these treatments to the extent that they were broadly available. And although this service and a growing number of similar efforts have since generated a virtual army of sophisticated patients (who have since become an important force in and of themselves), it has been humbling to recognize that this approach can’t help the many people who denigrate the very pursuit of evidence-based medicine.

The widespread rejection of COVID vaccines brings this into high relief for a couple of reasons. First, the selfishness of those who reject the vaccine affects not only the individual who makes that choice but the broader public. Their decision not only puts them at risk but also the unwitting person exposed to them later. At least with cancer, poor choices only affect those making them.

Another reason that COVID vaccination is such a flashpoint: everyone, including every public figure, now makes a public declaration of their support or suspicion of science and evidence-based medicine. And we are seeing an alarming fraction of people with access to very good information rejecting the evidence and our best opportunity to control the pandemic.

I am particularly disheartened that those who reject the science aren’t prone to change their views with better educational efforts. I recognize that there is a spectrum of resistance and that some of our colleagues have convinced family members and patients to reverse their prior anti-vaccine stance; but I wish it wasn’t so hard to overcome people’s biases against the establishment — biases that lead not only to self-harm but danger to the broader public.

We need to do more to understand what leads people to reject science, because it’s clearly not just ignorance and lack of better information. We have to recognize that this phenomenon is now a leading bottleneck in the progress of modern medicine, both in oncology and other settings.

I would love to learn what others think, including successes and more optimistic views — or to simply vent your frustrations with these issues.

Helping Patients Understand Breakthrough COVID Benefits Us All –Here’s how to approach the conversation.

I have been asked these questions multiple times about breakthrough infections from Covid by my patients and I thought that this would be a good time to review, especially recently with infection numbers and the discussion regarding booster shots. Dr. Gary C. Steben pointed out that the recent change in masking guidance from the CDC and reinstated public health measures from local and state governments have been met with frustration and defiance, with people understandably questioning why they got vaccinated if they have to go back to masking and distancing anyway. The answer is in the degree of exposure to SARS-CoV-2, and the explanation lies in the way vaccines work. We can help our patients understand this with three talking points:

1. The antibody levels in the bloodstream are completely helpless at preventing infection (saying it that way seems to get everybody’s attention!)

Neutralizing virus particles from the environment is the sole responsibility of the vaccine-induced antibodies in our respiratory, GI, and ocular secretions — our “frontline” defensive antibodies in our saliva, tears, nasal secretions, and pulmonary mucus. When exposed to airborne virus particles, these antibodies attach to the spike protein of SARS-CoV-2, physically preventing it from latching on to the ACE2 receptor on the surface of our respiratory epithelium and gaining entry to those cells to cause an infection. But that’s all we’ve got — if we are exposed to so many virus particles that all the antibodies in these secretions have attached themselves to virus particles, yet we continue to expose ourselves to new particles faster than we transport more antibodies into these secretions, our antibody defense gets overwhelmed, we inhale or come in contact with more virus particles than we are able to neutralize, and we get infected.

2. Circulating antibodies help to contain the infection

Once infected, the virus takes over the machinery of our cells to make more virus particles and release them, and that’s where our circulating vaccine-induced antibodies come in. They latch on to these newly minted particles to prevent them from infecting adjacent cells and from being exhaled. Therein, unfortunately, lies one of the Delta variant’s strong suits — it can reproduce itself so rapidly that our antibodies don’t slow it down much, and we see that when infected, vaccinated people are shedding virus similarly to unvaccinated folks.

3. Our vaccine-induced T-cell immunity limits disease severity

The third element of the response to the vaccine that you don’t hear as much about is the T-cell immunity that is induced. This arm of the immune system kills off our own infected cells — they’re a lost cause anyway, and will need to be replaced — and thereby limits the extent of disease. That’s why the vaccines remain effective at limiting the severity of disease, and the reason why we don’t see many vaccinated people among the hospitalized even as the number of vaccinated people infected with the Delta variant increases. That’s also why it’s so critical to get vaccinated — the vaccines are extremely effective at preventing severe illness and death from COVID-19. But it is not in the T-cell job description to go after viruses themselves. Vaccine-induced T-cells do not provide protection against getting infected; they only mitigate severity once infected.

So, the CDC revised its masking guidance because, as we’re seeing in places like Provincetown and Milwaukee’s Deer District, vaccinated people can both get and spread SARS-CoV-2. More and more vaccinated people are getting infected because they’re interpreting vaccination as carte blanche to return to pre-pandemic life without restriction and are exposing themselves to massive viral loads that overwhelm their immunity. Every single vaccinated person I spoke with during a telemedicine visit in July who got themselves infected at a Bucks championship game told me they would have taken more precautions had the meaning of vaccination been explained to them as I have above.

These principles add to the arguments surrounding whether to administer a third dose, as recently discussed. Many studies have shown that neutralizing antibody titers decline only slowly over months, while we continue to see blunted disease severity in those vaccinated individuals who get infected. Moreover, breakthrough infections are not only occurring in older people who are far out from their second dose. This suggests breakthrough infections may occur not so much because of waning immunity, but because of people’s behavior that exposes them to overwhelming viral loads, especially in the face of the new variants. If that’s the case, a third dose without behavior modification may not be enough to promote sufficient disease containment. We need data from our contact tracers on the circumstances under which breakthrough infections occurred to better inform the decision on a third dose.

I believe history will judge our response to the pandemic harshly for its reliance on mandates more than education. We physicians were not consulted appropriately early on in the pandemic for our expertise and community respect to help shape local and regional procedures tailored to maximize disease containment while mitigating economic impact. There remains no coordinated effort to promote local physician involvement in mitigation strategies, and we are seeing the fallout from that in the current surge. So we must take it upon ourselves to do everything we can to educate our patients by promoting evidence-based containment measures and offering common-sense explanations for COVID-19 and the vaccines.

This is the most important public health crisis of our careers and lifetimes, and the urgency of this situation will reach a whole new level if post-acute COVID syndrome (PACS) turns out to be a virus-triggered autoimmune response that intensifies with subsequent infections. I sure hope that will not be the case and there is no evidence for that yet, but we physicians don’t have the luxury of waiting to find out. We need to leverage the respect we’ve earned among our communities to do what we can to transcend the rhetoric and misinformation, and minimize the worsening catastrophe that we know COVID-19 can become. Now.

Anti-parasite drug for animals ivermectin flying off store shelves as COVID spikes- Ivermectin dispensing by retail pharmacies has increased’ the CDC says. After many hours of “discussions” with friends who have decided not to get vaccinated and instead an anti-parasitic drug used on horses, cows, sheep and dogs, I thought that it would be worth a discussion. Daniella Genovese reported that despite strict warnings from federal health officials, consumers around the country are still trying to get their hands on a drug commonly used to treat or prevent parasites in animals in order to protect themselves against the coronavirus.

The drug, ivermectin, has been reportedly flying off stores shelves in multiple states, including Texas and Oklahoma, even though it has not been approved for treating or preventing COVID-19 in humans. “Ivermectin dispensing by retail pharmacies has increased, as has use of veterinary formulations available over the counter but not intended for human use,” the Centers for Disease Control and Prevention said Thursday. “FDA has cautioned about the potential risks of use for prevention or treatment of COVID-19.

Earlier this month, the FDA said it has seen a “growing interest” in the drug and already received multiple reports of “patients who have required medical support and been hospitalized after self-medicating with ivermectin intended for horses.” 

However, over a dozen stores in the Dallas and Fort Worth, Texas area have sold out of the medicine, The Dallas Morning News reported.  Noah Krzykowski, who manages the Irving Feed Store in Irving, Texas, told the outlet that he is seeing droves of new customers in search of the product.  “You can tell the difference between someone who has cattle and someone who doesn’t,” Krzykowski told the Morning News. “And we’re seeing a lot of people right now who don’t have cattle.” Meanwhile, Alex Gieger, who manages the Red Earth Feed and Tack in Oklahoma City, Kansas, told KOCO that the store has been flooded with requests for the drug. 

Scott Schaeffer, managing director of the Oklahoma Center Poison and Drug Information, told FOX Business they have already received seven calls this month regarding ivermectin. This is up from three calls in July.  “We’re more concerned that people are taking medication without the input of their physician/prescriber, and that there is no reliable evidence that ivermectin is effective for the treatment or prevention of COVID,” Schaeffer said. 

Ivermectin tablets are only approved by the FDA “to treat people with intestinal strongyloidiasis and onchocerciasis, two conditions caused by parasitic worms,” the agency said. According to the FDA, some forms of ivermectin are also approved to treat parasites like head lice and for skin conditions like rosacea while other forms are “used in animals to prevent heartworm disease and certain internal and external parasites.” 

The FDA said consumers should never use medications intended for animals. “It’s important to note that these products are different from the ones for people, and safe when used as prescribed for animals, only,” the FDA said. 

US Plans COVID-19 Booster Shots at 6 Months Instead of 8: WSJ

The Reuters Staff reported that U.S. health regulators could approve a third COVID-19 shot for adults beginning at least six months after full vaccination, instead of the previously announced eight-month gap, the Wall Street Journal reported on Wednesday.

Approval of boosters for three COVID-19 shots being administered in the United States — those manufactured by Pfizer Inc and partner BioNTech SE, Moderna Inc and Johnson & Johnson — is expected in mid-September, the report said, citing a person familiar with the plans.

Pfizer and BioNTech have already started the application process for the approval of its booster shot in people 16 and older, saying it spurs a more than three-fold increase in antibodies against the coronavirus.

Earlier this week, U.S. regulators granted full approval to Pfizer’s two-dose vaccine. Moderna said on Wednesday it has completed the real-time review needed for a full approval for its jab in people 18 and above.

White House spokeswoman Jen Psaki said in her daily briefing that any such development would be under the purview of the Centers for Disease and Control and Prevention (CDC).

The CDC said the government’s plan to administer booster shot depends on pending action from the Food and Drug Administration and recommendation to it from the Advisory Committee on Immunization Practices.

The FDA, however, reiterated its joint statement from last week that said the government was gearing up to roll out the third shot from mid-September to Americans who had their initial course of two-dose vaccines made by Moderna and Pfizer more than eight months ago.

The rollout would start if the FDA and the CDC decide that boosters are needed, U.S. officials had said.

But the next question is:

Are We Jumping the Gun on COVID Boosters?- Efficacy, safety, and ethical questions linger

Dr. Vinay Prasad points out that over the last weeks, the topic of COVID-19 booster shots — a third dose of mRNA vaccine for healthy Americans — has been thrust into the spotlight. The surgeon general, CDC director, Anthony Fauci, MD, and President Biden have announced that they wish for boosters to be available by late September for healthy adults who are 8 months out from their original two-dose series. While this will be contingent on an FDA evaluation to determine the “safety and effectiveness of the third dose,” a clear path forward has already been set. And just like everything else throughout the course of the pandemic, the choice has been made with a dearth of data and an abundance of political pressure.

Diminishing vaccine effectiveness supposedly makes the case for boosters. But there are two big questions here: First, what is current vaccine effectiveness? And second, what justifies boosters? Let’s consider these in turn.

What Is Vaccine Effectiveness Now?

We have to be honest, many vaccine effectiveness studies are poorly done. All studies compare the rate of getting a breakthrough infection among vaccinated people against the rate of infection in unvaccinated people. But there are some issues with this approach. First, as time goes on, more unvaccinated people have had and recovered from COVID-19 (and these individuals may be less likely to go on to get a shot). This means that their risk of getting COVID-19 a second time is far less than the typical unvaccinated person who has never been sick. Even if vaccines “work” as well as before, this factor alone will result in the appearance of diminishing vaccine effectiveness.

Second, the order of vaccination in all nations is non-random. The folks who got vaccinated first are often the oldest and most vulnerable people with frailty and senescent immune systems. Vaccine effectiveness after 6 months, 8 months, and 12 months increasingly compares older, frailer people who got vaccinated first against unvaccinated people. These older people may always have a slightly higher risk of breakthrough infections. This bias will also give the false appearance of diminishing vaccine effectiveness.

A third consideration: We’re looking at vaccine effectiveness, but for what? People don’t want to get severely ill from SARS-CoV-2 and don’t want to die, but it might be too much to ask that vaccines prevent the nucleotide sequence of SARS-CoV-2 from ever being in your nose. In other words, vaccine effectiveness against severe disease may be much higher than vaccine effectiveness against asymptomatic or mild infection. This matters a great deal — if the vaccines continue to be highly effective against risk of severe illness and death, is it really worth boosting people in the U.S. right now?

And putting this all together, the best estimates of vaccine effectiveness do, in fact, still show high protection against severe disease and death.

What Justifies Boosters?

No matter what vaccine effectiveness is against preventing COVID-19 illness generally, the important question for boosters is whether they further lower the risk of severe disease or death. The only way to show this is through randomized controlled trials of the size and duration to measure that outcome. It is entirely possible that vaccine effectiveness is not perfect over time, or slightly lower than initial trials, but it’s also possible that boosters do not further reduce the risk of SARS-CoV-2. Only trials can answer this.

While emerging data from Israel suggest boosters may diminish the risk for COVID-19 infection and severe illness in people 60 and older, the data are not based on the types of studies we need. Pfizer has only submitted early trial results to the FDA to support their boosters, with phase III trial data forthcoming. But again, the data may be insufficient if severe outcomes are not captured.

Moreover, we have to consider the risk of new, compounding, and worse toxicity. Randomized trials and close observation will be needed to exclude worse safety signals, particularly increases in myocarditis and pericarditis. These rare adverse events are more common after the second mRNA dose — will they be even more common after dose three?

In short, diminished vaccine effectiveness does not make the case for boosters. A reduction in severe outcomes makes the case for boosters, but we have no such data to date.

Global Equity

There’s also the ethical question of how a wealthy nation can give its inhabitants a third dose when there are literally billions of vulnerable older people around the world who have not gotten any doses. The World Health Organization has begged nations not to do this, and history will judge us poorly if we pursue this. It is a human rights violation to direct limited mRNA supply and capabilities to third doses in the U.S. when the world remains vulnerable. Moreover, it is self-defeating. We are not safe from global variants.

Take a Step Back

Decisions about boosters have to be based in science and made by vaccine regulators. They should not be subject to the pressure of manufacturers, politicians, or political appointees. They should not be rushed. On Sunday television, Surgeon General Vivek Murthy, MD, was specifically asked if the third shot was safe. His response: “the plan is contingent on that…”

Excuse me? We don’t know that to be true, and yet, our top medical and public health experts are pushing for boosters? Drug safety expert Walid Gellad, MD, MPH, tweeted: “It was irresponsible to push for boosters in healthy people before safety review.”

Two days after the White House’s announcement, two people with knowledge of the FDA’s deliberation told The Washington Post that the agency was investigating myocarditis signal with the Moderna vaccination. Canadian data suggest the risk may be 2.5 times that of Pfizer’s vaccine. The timing of this internal information leaking to reporters naturally leads me to wonder if reviewers in the agency are attempting to counteract political pressure, and create space to conduct a thorough review of booster data.

Boosters are an important medical question. Their approval must have a favorable safety and efficacy profile. Only randomized trials measuring severe disease can show that. Still, recently the FDA that boosters for Pfizer is only recommended for people over 65 and those compromised.

Let’s wait for the next set of data from the Moderna post vaccination studies, which is expected by the end of November.

203 Doctors Told Us What They Actually Think Of COVID Vaccines, And Everyone Should Hear Their Answers

A growing refrain among vaccine skeptics is that they won’t get vaccinated against COVID-19 because a handful of health scientists have told them they don’t have to.

Robert Malone, the self-proclaimed inventor of mRNA technology back in the 1980s, has been among those celebrated by the far right for voicing unproven concerns about COVID-19 vaccines to his 280,000-plus Twitter followers. While it’s easy to explain away an embittered, bruised-ego scientist, it’s much harder to dismiss the significant majority of healthcare professionals who support the vaccines and the preponderance of evidence backing them up.

Enter the anti-vaxxer’s latest unfounded claim: that most public health officials secretly don’t support vaccines. In fact, a friend of mine recently made a stunning declaration that she wholeheartedly believes: “Most experts are too afraid to speak up, but I suspect 9 out of 10 doctors would advise against COVID vaccines if you asked them privately.”

Though I could have readily dismissed such a callous and unsubstantiated statement, the journalist in me began to wonder whether I should.

After all, if a meaningful percentage of individuals with legitimate infectious disease and vaccination expertise were concerned, that would be worth reporting. Besides, I’d asked her to question her convictions, so shouldn’t I be willing to do the same?

With that in mind, I began researching epidemiologists, virologists, health department directors, pediatricians, infectious disease experts, and public health officials. I deemed it important to find such people in all 50 states and in counties that leaned both left and right in case politics had tainted anyone’s objectivity.

No one directed me where I should look nor which experts I could turn to; and I steered clear of anyone I’d seen making regular cable news appearances to ensure I was getting fresh perspectives from experts who may not have already spoken up.

In my research, I identified more than 200 such individuals, and, in the interest of taking up as little of their limited time as possible, decided to ask them all the same two yes or no questions with an invitation to elaborate if they chose to.

I also wanted them to know they could answer freely, so I offered anonymity — a condition that some appreciated and others waived.

My two questions were simply whether they believed the benefits of COVID-19 vaccinations outweigh any potential harms, and whether they’d recommended the shots to their own children if they had any in the 12–18-year-old age groups. Responses began pouring in almost immediately.

Over the next few days, I heard back from 203 of the doctors I’d reached out to. If my friend’s unfounded suspicions were correct, 183 of them should have recommended against vaccination.

Turns out the actual number against COVID vaccines was zero. And the number of vaccine experts who recommended the shots to me in our private, one-on-one interactions was a whopping 203.

None of the 203 responders raised a single concern about COVID vaccines for adults or for children. “The benefits outweigh the extremely rare harms by many miles,” one biostatistics researcher told me.

What’s more, many of the responders had a lot to say about the type of public health official who would use their academic credibility to steer people away from COVID-19 vaccines.

Abner told me she doesn’t actually know of any public health officials who have advocated against the vaccines; rather, the handful of fringe persons who have gained notoriety doing so are actually “lab scientists without any public health or epidemiological expertise. Being an expert in one area of science or medicine does not confer expertise in others.”

One health department director in Idaho put it even more bluntly: “Any public health official who discourages vaccination isn’t concerned about public health at all.”

CORRECTED-COVID SCIENCE-mRNA vaccines trigger backup immune response; some cancer drugs may help

Nancy Lapid summarized of some recent studies on COVID-19. They include research that warrants further study to corroborate the findings and that have yet to be certified by peer review.

Antibodies wane but other immune defenses remain alert.

A new study may help explain why mRNA vaccines by Pfizer/BioNTech and Moderna are more effective at preventing hospitalizations and deaths than they are at preventing infection. Test-tube experiments on blood samples from 61 fully vaccinated adults showed that by six months, vaccine-induced antibodies that can immediately neutralize the virus had declined. But so-called memory B cells, which produce new antibodies if they encounter the virus later on, had increased and become better at recognizing viral variants, according to a report posted on Monday on bioRxiv https://bit.ly/3zoCSAY ahead of peer review. “Your immune system has a backup,” said study leader John Wherry of the University of Pennsylvania Perelman School of Medicine. B-cell production of antibodies might take a few days to get underway, but then these memory B cells “kick into action and prevent severe disease,” Wherry added.

Early data favors certain cancer treatments during pandemic

Certain cancer drugs may help protect patients with malignancies from being infected with the new coronavirus, preliminary data suggests. The drugs, known as mTOR/PI3K inhibitors and antimetabolites, target the parts of cells that the virus uses to enter and make copies of itself, including a “gateway” protein on cell surfaces called angiotensin-converting enzyme 2 (ACE2). The study of 1,701 cancer patients found that after taking underlying risk factors into account, patients treated with mTOR/PI3K inhibitors or ACE2-lowering antimetabolites were 47% less likely to test positive for the virus than patients who received other drug therapies. Gemzar (gemcitabine) from Eli Lilly appeared to be particularly promising, according to the report in JAMA Oncology https://bit.ly/38icqN6 on Thursday. The study does not prove that the drugs lowered infection rates, however, and much more research is needed to confirm their potential for protecting cancer patients from the coronavirus.

One in four infected LA residents had been vaccinated

From May through July 2021, as the Delta variant spread, 43,127 residents of Los Angeles County in California were diagnosed with SARS-CoV-2 infections. One in four had been fully vaccinated, though these patients had lower rates of hospitalization (3.2% versus 7.6%), intensive care (0.5% versus 1.5%) and need for machines to help with breathing (0.2% versus 0.5%) than unvaccinated patients, public health officials reported on Tuesday in the U.S. Centers for Disease Control and Prevention’s Morbidity and Mortality Weekly Report https://bit.ly/2XWWZIx. During the study period, the prevalence of the Delta variant rose from less than 9% to at least 87%, the authors note. As of July 25, hospitalization rates were 29 times higher for unvaccinated patients, they estimated, “indicating that COVID-19 vaccination protects against severe COVID-19 in areas with increasing prevalence of the SARS-CoV-2 Delta variant.”

Infectious disease expert: Americans must ‘recalibrate’ vaccine expectations

Tim O’Donnell reiterated what I have been trying to educate my patients and friends that COVID-19 vaccines won’t eliminate the coronavirus, “no matter how many booster shots the United States gives,” Céline R. Gounder writes for The Atlantic. But that’s no reason to panic or lose confidence in them.

Grounder, an infectious disease specialist and epidemiologist at New York University’s Grossman School of Medicine and Bellevue Hospital in New York City, thinks public health messaging got out of hand early on during the vaccine drive, especially when the Centers for Disease Control and Prevention published real-world evidence that showed that two doses of the Pfizer and Moderna vaccines were 90 percent effective at preventing infections, as opposed to just disease. After that, folks got excited, believing that full vaccination status meant you could only very rarely get infected or transmit the disease. But now that the efficacy appears to be lower, there’s a lot of anxiety.

Grounder tried to ease that, explaining that vaccines are typically more effective at protecting against infection outright when battling viruses that have longer incubation periods, like measles and smallpox. In those cases, the body is trained to kick the virus out before it can really establish itself. But the coronavirus and influenza, for example, don’t take as long to start replicating and can do so before a vaccinated defense system revs up. Once it does, though, the virus doesn’t have much room to operate and is usually blocked from progressing in the lungs and causing serious damage.

With that in mind, Grounder says Americans simply need to “recalibrate our expectations about what makes a vaccine successful.” While “the public discussion of the pandemic has become distorted by a presumption that vaccination can and should eliminate COVID-19 entirely,” that’s not an attainable standard, she argues. And it’s one that makes “each breakthrough infection” look “like evidence that the vaccines are not working,” even though they’re performing “extremely well” and reducing what may have been serious infections to either mild or asymptomatic ones. Read Grounder’s full piece at The Atlantic.

Let us take a few moments of silence for the service men and women and the other civilians who lost their lives last week to the horror of the ISIS bomber.

Delta Variant Now Accounts for 83% of US Cases and Back to Mask Wearing, Even for Those Vaccinated!

Carolyn Crist reported that the nation’s top health officials said Tuesday that the Delta variant of the coronavirus is racing through the country and now is responsible for 83% of all U.S. cases.

That’s a massive increase from a week ago, when Delta was seen as responsible for just more than half of new cases, CDC Director Rochelle Walensky, MD, told a Senate committee.

And listen to her carefully…is she actually suggesting a Federal Mandate to vaccinate everyone???

“The best way to prevent the spread of COVID-19 variants is to prevent the spread of disease, and vaccination is the most powerful tool we have,” she said.

Meanwhile, several states in the South are reporting a large increase in COVID-19 cases, particularly in areas with low vaccination rates, according to The Atlanta Journal-Constitution.

Arkansas, Florida, and Missouri are reporting full-fledged outbreaks, and neighboring states such as Alabama, Georgia, Louisiana, Mississippi, Tennessee, and Texas are following behind.

“4th wave is here,” Thomas Dobbs, MD, the state health officer for Mississippi, wrote on Twitter on Monday.

Dobbs posted a graph of hospitalizations in Mississippi, which showed numbers climbing dramatically in July after hitting a low in May and June.

“Very sad indeed,” he wrote. “Didn’t have to be this way.”

Mississippi reported more than 2,300 new COVID-19 cases over the weekend, which is the state’s largest 3-day increase in cases since February, according to The Associated Press. Mississippi has one of the lowest COVID-19 vaccination rates in the country.

Florida has become one of the country’s biggest COVID-19 hot spots, now accounting for a fifth of new infections in the U.S., according to NBC News.

In Jacksonville, UF Health broke its record for hospitalized COVID-19 patients, jumping from 86 patients on Sunday to 126 on Monday.

“We’re gaining cases at such a rapid rate, we don’t really know where it’s going to stop,” Chad Neilsen, the director of infection prevention at UF Health, told NBC News.

“We aren’t even thinking a couple of months,” he said. “We’re thinking what’s going to immediately happen in the next week.”

Hospitals in Arkansas and Missouri are also preparing for a surge of patients that could strain staff and resources again, according to NBC News. If hospitalizations triple in the next 2 weeks, as projected by the University of Arkansas for Medical Sciences (UAMS), it could feel like the chaotic period at the end of 2020.

“Right now, we’re managing OK, but we’re in surge mode,” Steppe Mette, MD, the CEO of the UAMS Medical Center, told NBC News.

“We’re putting patients in physical locations where we weren’t putting them normally because of that demand,” he said.

At Houston Methodist Hospital in Texas, COIVD-19 hospitalizations have increased by 70% during the last week, according to the Houston Chronicle . On Monday, the hospital had 184 COVID-19 patients, which is double the number it had on July 1.

The Delta variant accounts for about 85% of the cases, and the hospital recorded its first hospitalization with the Lambda variant, the Chronicle reported. The Lambda variant, which was first identified in Peru, has been spreading throughout South America and is now reaching the U.S.

The Delta variant has been “running rampant” among unvaccinated people in Texas, Marc Boom, MD, the CEO of Houston Methodist, wrote in an email to hospital staff. The variant will account for nearly all COVID-19 cases in the area within the coming weeks, he said.

“It is the variant of concern in Houston,” he said. “What we’re seeing now is that Delta is far more infectious.”

Public health officials are grappling with the best way to move forward as cases and hospitalizations continue to rise. Increasing vaccinations is key, but mandating or guilting people into getting a shot would likely backfire, NBC News reported.

“People have heard our messages ad nauseam, but to see patients struggling to breathe and wishing they got vaccinated, that may make a difference,” Mette told the news outlet.

“Those are real people who are getting real sick,” he said.

What Evidence Do We Need to Move Forward With COVID Boosters?

Dr. Vinay Prasad noted that a few weeks ago, on Monday, employees of Pfizer met with high level executives in the Biden administration to discuss the role of boosters — a.k.a. a third vaccination with an mRNA vaccine for SARS-CoV-2. Some have speculated that, as with the first two doses, the emergency use authorization pathway will again be used to market boosters. With the rise of the Delta variant and others, enthusiasm in the media and the Twitter commentariat for boosters is growing. However, there are certain criteria that must be met before we jump on the booster bandwagon. Some of these criteria apply at home, and others apply abroad. What does stand out is that more data, real data, and an evaluation of several factors at home and abroad will be key in moving forward.

Abroad

As a general rule, if your goal is to avoid variants — or mutated versions of a virus — you want the virus to replicate less. When it comes to variants, it doesn’t matter where the virus does the replicating. In a globally connected world, it is only a matter of time before an advantageous mutation finds its way to all parts of the world. As such, we in the U.S., are only as safe as the least safe place in the world.

What this means is that before we shift our manufacturing capacity to develop boosters for the current variants, we must make a real effort to ensure that the vaccines we do have get distributed to the greatest number of global citizens who will take them. I argued in April that, practically, this means that children in high income nations should be vaccinated after older citizens globally – this same logic extends to boosters.

Before we shift our manufacturing to booster production, we should make sure that we have manufactured adequate supplies of the original vaccine for all global citizens. Moreover, we need to put effort toward solving the last mile problem: how to deliver very cold mRNA vaccines to places in the world where it is difficult to deliver and keep things very cold. This is a technological problem well within our scope.

Efforts to manufacture and deliver vaccine boosters to already vaccinated individuals in high-income nations cannot take priority and must not interfere with efforts to vaccinate at-risk individuals around the world. In fact, it is in our best interest to vaccinate those at-risk first. If we pursue boosters in the U.S. without helping the rest of the world, then we might as well get ready for the fourth, fifth, and sixth boosters. We will watch rising death tolls around the world, while worrying that yet new variants may end up on our shores.

At Home

Here in the U.S., there are also metrics that need to be met before we contemplate widespread dosing of hundreds of millions of people with booster shots. Specifically: show me the data! I have no doubt that a third mRNA shot will lead to higher neutralizing antibody titers. For that matter, I would guess six shots would outperform three on that metric. But the burden of evidence to accept boosters is not simply a change in antibody titer — or even demonstration of improved titers for rare variants.

We must show that boosters improve clinical endpoints before we ask Americans to roll up their sleeves again. A large randomized trial of vaccinated individuals powered for reduction in symptomatic SARS-CoV-2 or (better yet) severe COVID-19 is needed to justify the harms and inconvenience of boosters. If such a trial simply cannot be powered, or takes a very long time, due to the sparsity of serious infection in the U.S., then the argument for emergency use authorization is inherently flawed. When there’s too little disease to run the definitive trial, you are, by definition, no longer in an emergency. One way to solve this problem might be to deliver boosters only in elderly individuals or those who are immunocompromised. Here, a trial measuring COVID-19 outcomes may be possible.

Alternatively, a case for boosters can be made if evidence shows that boosters alter the epidemic course for a nation or the globe. Here, too, antibody titers are insufficient. Moreover, ironically, clinical trials would have to be larger and more complex to demonstrate this. For these reasons, I think the burden is on vaccine manufacturers to show that severe COVID-19 outcomes are averted.

Finally, we need to consider the second order effects of boosters. Would we gain more if we took the effort that would go into boosters and instead used it to try to increase vaccination uptake by those who are reluctant to get their first and second dose? Is the mere fact that news outlets and companies report the possible need for boosters a disincentive to be vaccinated? A skeptical person may now no longer see SARS-CoV-2 vaccines as the path out of the pandemic, but a recurring, and possibly someday yearly obligation that they may prefer to avoid altogether. We can’t ignore the potential impact of discussing boosters on vaccine acceptance.

Boosters Without Data

If we accept boosters in the U.S. while the rest of the world remains unvaccinated, and if we authorize them based on inevitable improved laboratory titers without clinical outcomes, we run the risk of creating a medical industrial perpetual motion machine.

We will continue to breed new variants outside of our nation, which will lead to calls for yet more boosters, and we will continue to get new boosters without any evidence they are necessary (i.e., lower severe COVID-19 outcomes). Our arms will ache, our hearts will hurt, our wallets will be empty, and so too will our brains, as we will have abandoned all principles of evidence-based medicine.

Lambda variant of COVID-19 identified at Texas hospital. Is it worse than delta?

Ryan W. Miller reported that a Houston hospital has its first case of the lambda variant of the coronavirus, but public health experts say it remains too soon to tell whether the variant will rise to the same level of concern as the delta variant currently raging across unvaccinated communities in the U.S.

About 83% of COVID-19 cases in the U.S. are from the delta variant and the vast majority of hospitalizations are among unvaccinated people, according to the Centers for Disease Control and Prevention.

The lambda variant, on the other hand, has been identified in less than 700 cases in the U.S. However, the World Health Organization in June called lambda a “variant of interest,” meaning it has genetic changes that affect the virus’ characteristics and has caused significant community spread or clusters of COVID-19 in multiple countries.

Dr. S. Wesley Long, medical director of diagnostic biology at Houston Methodist, where the case was identified, said while lambda has some mutations that are similar to other variants that have raised concern, it does not appear to be nearly as transmissible as delta.

“I know there’s great interest in lambda, but I think people really need to be focused on delta,” Long said. “Most importantly, regardless of the variant, our best defense against all these variants is vaccination.

What is the lambda variant and how is it different from the delta variant?

The lambda variant is a specific strain of COVID-19 with specific mutations. It’s one of a handful of variants identified by the WHO as variants of concern or interest. Many other variants have arisen since the outbreak was first detected in late 2019 in central China.

“The natural trajectory of viruses is that they have a tendency to have mutations, and whenever we have a significant mutation that changes the virus … we get a new variant,” said Dr. Abhijit Duggal, a staff ICU physician and director for critical care research for the medical ICU at the Cleveland Clinic.

Some of the lambda mutations occur in its spike protein, which is the part of the virus that helps it penetrate cells in the human body and is also what the vaccines are targeting.

Mutations occurring there and in other parts of lambda are similar to those in variants of concern, like alpha and gamma, Long said. But even gamma, which never took hold in the U.S. to the same level as alpha or delta, has more concerning mutations than lambda, Long said.

Duggal said there hasn’t been anything specific with the lambda variant to spark concern about it becoming the dominant variant in the U.S., but “watchful waiting and being cautious is going to be the most important thing at this point.”

Where was the lambda variant first identified?

The lambda variant was first identified in Peru in December 2020. Since April, more than 80% of sequenced cases in the country have been identified as the lambda variant.

As of June, the WHO said it had identified the lambda variant in 29 countries. Argentina and Chile have also seen rising lambda cases, the WHO said.

However, the variant hasn’t spread nearly to the same level on a global scale as the delta variant. Lambda may have become so widespread in parts of South America largely because of a “founder effect,” Long said, wherein a few cases of the variant first took hold in a densely populated and geographically restricted area and slowly became the primary driver for the spread locally over time.

Long compared lambda to the gamma variant, which first was detected in Brazil and spread in similar ways.

Are COVID-19 vaccines effective against the lambda variant?

Studies have suggested the vaccines currently authorized for use in the U.S. are highly effective at preventing severe COVID-19 and death across multiple variants.

Duggal said while there is no reason to believe the vaccines will be ineffective against the lambda variant, more data is need to know exactly how effective it will be. The efficacy may lower some, but hospitalization may still be largely preventable in variant cases with vaccination, he said.

Remember ‘Nothing in this world is 100%’: Those fully vaccinated against COVID-19 can be infected, but serious illness is rare.

However, a new study posted online Tuesday found the Johnson & Johnson vaccine was not as effective at preventing symptomatic disease when faced with the delta and lambda variants. The study was not yet peer reviewed or published in a journal, but it aligned with studies of the AstraZeneca vaccine that conclude one dose of the vaccine is 33% effective against symptomatic disease of the delta variant.

Vaccines made by Pfizer-BioNTech and Moderna have shown to keep similar levels of effectiveness against several of the variants of concern. But, just announced, a new preprint study conducted by Pfizer-BioNTech found its vaccine efficacy could drop down to 84% within 6 months.

Getting vaccinated still remains the most important factor in stopping the virus’ deadly effects and slowing down new variants, Long said.

Mutations occur in the coronavirus as it spreads from person to person. Vaccination can help prevent symptomatic disease and decrease the spread in communities with high vaccinations rates, which can then prevent mutations from occurring and new variants from arising, Duggal added.

Delta’s threat: CDC reveals data on why masks are important for the vaccinated and unvaccinated

More on the Delta mutated variant, which is becoming a real problem for the un vaccinated portion of our population and why wearing masks are important for all. Adrianna Rodriquez reported that The Centers for Disease Control and Prevention has had a busy week. 

Only a few days after announcing updated mask guidelines, the agency on Friday released new scientific data on the delta variant that gives a snapshot of how the highly contagious strain triggered a wave of coronavirus cases. 

The much-anticipated report comes a day after a presentation compiled by a doctor with the agency was leaked to the media and detailed the dangers of the delta variant and how mask-wearing is essential to bring it under control.

In a briefing Tuesday, CDC director Dr. Rochelle Walensky said the new data spurred the agency to take immediate action by recommending fully vaccinated people to wear mask indoors in public settings where coronavirus transmission is high. 

“The delta variant is showing every day its willingness to outsmart us and be an opportunist in areas where we have not shown a fortified response against it,” she said earlier this week. “This new science is worrisome and unfortunately warrants an update to our recommendations.”

Here’s everything to know about the delta variant and how it impacts fully vaccinated people. 

‘Pivotal discovery’: What the new data says about delta variant, transmission 

Fully vaccinated people made up nearly three-quarters of COVID-19 infections that occurred in a Massachusetts town during and after Fourth of July festivities, according to a CDC study published Friday in the agency’s Mortality and Morbidity Weekly Report.

Out of 469 cases that were identified in Barnstable County, Massachusetts, from July 3 to 17, the agency found 74% occurred in fully vaccinated people. The CDC sequenced samples taken from 133 patients and discovered 90% were caused by the delta variant. 

“High viral loads suggest an increased risk of transmission and raised concern that, unlike with other variants, vaccinated people infected with delta can transmit the virus,” Walensky said in a statement sent to USA TODAY on Friday. “This finding is concerning and was a pivotal discovery leading to the CDC’s mask recommendation.”

Health officials continue to reiterate the majority of COVID-19 transmission occurs among the unvaccinated, not fully vaccinated people.

“Vaccinated individuals continue to represent a very small amount of transmission occurring around the country,” Walensky said. “We continue to estimate that the risk of breakthrough infection with symptoms upon exposure to the delta variant is reduced by sevenfold. The reduction is twentyfold for hospitalizations and death.” 

Four fully vaccinated people between the ages of 20 and 70 were hospitalized, two of whom had underlying medical conditions. No deaths were reported.  

The study found 79% of patients with breakthrough infection reported symptoms including cough, headache, sore throat, muscle pain, and fever. 

Remember also that: Breakthrough COVID-19 infections after vaccination can lead to long-haul symptoms, Israeli study shows.

Of the 346 breakthrough infections, 56% of people were vaccinated with the Pfizer-BioNTech vaccine, 38% with Moderna and 7% with Johnson & Johnson. As of Friday, over 190 million doses of the Pfizer vaccine has been administered in the U.S., nearly 140 million of Moderna and 13.3 million of Johnson & Johnson, according to the CDC.

Health experts say the reason why more breakthrough infections occurred in the mRNA vaccines compared to the Johnson & Johnson vaccine is because more people in the U.S. received the Pfizer-BioNTech and Moderna vaccines. 

“When you look at the data, it may concern some people that there appears to be a higher rate of breakthrough COVID infections in people fully vaccinated with the Pfizer vaccine, however, as a percentage of people who are fully vaccinated, more people have been vaccinated with the Pfizer vaccine,” said Dr. Teresa Murray Amato, chair of emergency medicine at Long Island Jewish Forest Hills in Queens, New York.

“It still appears that all three of the current vaccines with emergency use administration authorization in the United States are safe and effective against the delta variant of the COVID-19 virus,” she added. 

While study authors say evidence suggests fully vaccinated people exposed to the delta variant can contract and spread the virus, it is not sufficient to determine the vaccines’ effectiveness against the highly contagious strain. 

Delta substantially more contagious than other variants

Although the study didn’t specify if fully vaccinated people can transmit the virus to other fully vaccinated people, health experts say they should wear a mask and socially distance largely to protect those who haven’t been vaccinated or who have a weakened immune system and can’t get full protection from the vaccine. 

“The data makes a pretty compelling justification for why we need to go back to mask wearing and other public health measures,” said Dr. Charles Chiu, an infectious disease specialist at the University of California, San Francisco. “I do think it’s because of the delta variant.”

The delta variant is known to be substantially more contagious than other variants – as contagious though deadlier than chicken pox, according to the CDC presentation. Among common infectious diseases, only measles is more contagious.

People may also be infectious for longer with the delta variant, 18 days instead of 13, the presentation says.

Vaccines remain effective at preventing hospitalization and death from COVID-19, though they worked better against the original strain and the alpha variant than they do against delta, data finds.

What do the CDC mask guidelines say?

The CDC is urging fully vaccinated Americans to wear masks indoors in areas of high or substantial coronavirus transmission. 

They’re also recommending universal indoor masking for all teachers, staff, students and visitors inside schools from kindergarten to 12th grade, regardless of vaccination status. That aligns closely with guidelines from the American Academy of Pediatrics, which recommended this month that anyone older than 2 be required to wear a mask in school. 

The CDC and the AAP are still urging that children return to full-time in-person learning in the fall.

The goal behind the guidance may be to protect both the fully vaccinated and the unvaccinated, health experts say, especially vaccinated people who may be immunocompromised and children under 12 who aren’t yet eligible to get their shot.

But the reality is there’s hardly any transmission among fully vaccinated people to truly affect community spread, they say.

“It makes sense why they did it, but I don’t think it’s going to make a major difference in the large surge that we’re having,” said Dr. Ashish Jha, dean of the Brown University School of Public Health in Providence, Rhode Island. “The real issue still is unvaccinated people who are not going around masked up. I have no reason to think that this guidance will get unvaccinated, unmasked people putting on masks. And that’s what we really need.”

Is there a test for the delta variant?

A traditional PCR test alone cannot differentiate the delta variant from the original virus.

The delta variant has distinctive mutations that serve as biological markers that can only be detected through genome sequencing.

Many U.S. laboratories sequence a small – but nationally representative – number of positive samples for epidemiological purposes. According to the CDC, more than 175,000 sequences have been collected through the agency’s surveillance program since Dec. 20.

People who test positive for COVID-19 aren’t made aware if they were infected by the delta variant, even if their sample was sequenced.

“Our patients will not learn if they have a variant or not,” said Dr. Christina Wojewoda, chair of College of American Pathologists Microbiology Committee. “It is for epidemiology purposes only and currently, there is no medical use for that result.”

However, the CDC said more than 80% of sequenced samples have the delta variant, which means people sick with COVID-19 were most likely infected with the highly contagious strain. 

“It is safe to assume in most places, if you are infected now, it is likely delta,” Wojewoda said. 

‘A Few Mutations Away’: The Threat of a
Vaccine-Proof Variant

Damian McNamara noted something that concerns me if we don’t get control of the virus using the best weapon that we have, vaccinations. The Centers for Disease Control and Prevention (CDC) Director Rochelle Walensky, MD, MPH, made a dire prediction during a media briefing this week that, if we weren’t already living within the reality of the COVID-19 pandemic, would sound more like a pitch for a movie about a dystopian future.

“For the amount of virus circulating in this country right now largely among unvaccinated people, the largest concern that we in public health and science are worried about is that the virus…[becomes] a very transmissible virus that has the potential to evade our vaccines in terms of how it protects us from severe disease and death,” Walensky told reporters on Tuesday. 

A new, more elusive variant could be “just a few mutations away,” she said.

We are already reporting the lambda variant and I predict that next will be the gamma and then the kapa variant.

“That’s a very prescient comment,” Lewis Nelson, MD, professor and clinical chair of emergency medicine and chief of the Division of Medical Toxicology at Rutgers New Jersey Medical School in Newark, told Medscape Medical News.

“We’ve gone through a few mutations already that have been named, and each one of them gets a little more transmissible,” he said. “That’s normal, natural selection and what you would expect to happen as viruses mutate from one strain to another.”

“What we’ve mostly seen this virus do is evolve to become more infectious,” said Stuart Ray, MD, when also asked to comment. “That is the remarkable feature of Delta — that it is so infectious.”

He said that the SARS-CoV-2 has evolved largely as expected, at least so far. “The potential for this virus to mutate has been something that has been a concern from early on.”

“The viral evolution is a bit like a ticking clock. The more we allow infections to occur, the more likely changes will occur. When we have lots of people infected, we give more chances to the virus to diversify and then adapt to selective pressures,” said Ray, vice-chair of medicine for data integrity and analytics and professor in the Division of Infectious Diseases at Johns Hopkins School of Medicine in Baltimore, Maryland.

“The problem is if the virus changes in such a way that the spike protein — which the antibodies from the vaccine are directed against — are no longer effective at binding and destroying the virus, and the virus escapes immune surveillance,” Nelson said.

If this occurs, he added, “we will have an ineffective vaccine, essentially. And we’ll be back to where we were last March with a brand-new disease.”

Technology to the Rescue?

The flexibility of mRNA vaccines is one potential solution. These vaccines could be more easily and quickly adapted to respond to a new, more vaccine-elusive variant.

“That’s absolutely reassuring,” Nelson said. For example, if a mutation changes the spike protein and vaccines no longer recognize it, a manufacturer could identify the new protein and incorporate that in a new mRNA vaccine.

“The problem is that some people are not taking the current vaccine,” he added. “I’m not sure what is going to make them take the next vaccine.”

When asked how likely a new strain of SARS-CoV-2 could emerge that gets around vaccine protection, Nelson said, “I think [what] we’ve learned so far there is no way to predict anything” about this pandemic.

“The best way to prevent the virus from mutating is to prevent hosts, people, from getting sick with it,” he said. “That’s why it’s so important people should get immunized and wear masks.”

Both Nelson and Ray pointed out that it is in the best interest of the virus to evolve to be more transmissible and spread to more people. In contrast, a virus that causes people to get so sick that they isolate or die, thus halting transmission, works against viruses surviving evolutionarily.

Some viruses also mutate to become milder over time, but that has not been the case with SARS-CoV-2, Ray said.

Mutations are not the only concern!

Viruses have another mechanism that produces new strains, and it works even more quickly than mutations. Recombination, as it’s known, can occur when a person is infected with two different strains of the same virus. If the two versions enter the same cell, the viruses can swap genetic material and produce a third, altogether different strain.

Recombination has already been seen with influenza strains, where H and N genetic segments are swapped to yield H1N1, H1N2, and H3N2 versions of the flu, for example.

“In the early days of SARS-CoV-2 there was so little diversity that recombination did not matter,” Ray said. However, there are now distinct lineages of the virus circulating globally. If two of these lineages swap segments “this would make a very new viral sequence in one step without having to mutate to gain those differences.”

“The more diverse the strains that are circulating, the bigger a possibility this is,” Ray said.

Protected, for Now

Walensky’s sober warning came at the same time the CDC released new guidance calling for the wearing of masks indoors in schools and in any location in the country where COVID-19 cases surpass 50 people per 100,000, also known as substantial or high transmission areas.

On a positive note, Walensky said: “Right now, fortunately, we are not there. The vaccines operate really well in protecting us from severe disease and death.”

Records have been set nearly every day lately in Tokyo, but not all of them have been by athletes competing in the Olympics.

Japan’s capital has exceeded 4,000 coronavirus infections for the first time — 4,058 cases, to be exact. That’s a record high and nearly four times as many cases were reported just a week ago.

Tokyo set new case records every day from Monday to Wednesday, experiencing just a slight dip on Thursday, when they totaled 3,300 — still one of the city’s highest daily counts on record.

So, those of you, your friends, associates who haven’t been vaccinated, your best protection is still getting vaccinated.

Just do it, get vaccinated!

Continue with COVID-19 Precautions or Declare Pandemic Under Control, Anti-vaxers and the Delta Variant?

Damian McNamara reviewed some of the controversies regarding COVID-19 pandemic and our present status. Have we arrived at a much-anticipated tipping point in the COVID-19 pandemic in the United States? Or do we still have some time before we can return to some semblance of life as we knew it in 2019?

The CDC relaxation of masking and social distancing guidance for fully vaccinated Americans is one reason for optimism, some say, as is the recent milestone where we surpassed more than 50% of Americans vaccinated.

But it’s not all good news. “Right now, we are struggling with vaccine hesitancy,” Ali H. Mokdad, PhD, told Medscape Medical News.

“My concern now is people who don’t want the vaccine are looking around them and saying, ‘Oh we are in a very good position. Infections are down, more than 50% of Americans are vaccinated. Why do I need to get a vaccine?’ ” he said.

Another potential issue is waning immunity, added Mokdad, professor of health metrics sciences at the Institute for Health Metrics and Evaluation, University of Washington, Seattle. Companies are developing booster shots and Anthony Fauci, MD, the White House chief science advisor, said they may be required in the future.

Mokdad said this could add to vaccine hesitancy now. “Someone might think ‘Why should I take this vaccine when there is a new one coming up?’ If I wait for 2 months, I’ll get a new one.'”

“We can definitely be optimistic. Things are going in the right direction,” John Segreti, MD, told Medscape Medical News when asked to comment. “The vaccines seem to be working as well as advertised and are holding up in a real-world situation.”

However, “It’s too early to say it’s over,” he stressed.

“There is still moderate to substantial transmission in the community just about everywhere in the US. It might take a while until we see transmission rates declining to the point where the pandemic will be declared over,” added Segreti, hospital epidemiologist and medical director of infection control and prevention at Rush University Medical Center in Chicago, Illinois.

The global picture is another reason for pessimism, he said. “There is not enough vaccine for around the world. As long as there is uncontrolled transmission of coronavirus somewhere in the world, there is a greater chance for selecting out variants and variants that can escape the vaccine.”

“But overall I am much more optimistic than I was 6 months ago,” Segreti added.

Vaccines vs Variant

In a study evaluating two COVID-19 vaccines against the B.1.167.2 variant first reported in India, researchers evaluated data from Public Health England and reported reassuring news that the vaccines protected against this variant of concern. They studied the efficacy of the Pfizer/BioNTech and AstraZeneca/Oxford vaccines.

“After two doses of either vaccine there were only modest differences in vaccine effectiveness with the B.1.617.2 variant,” the researchers note. “Absolute differences in vaccine effectiveness were more marked with dose one. This would support maximizing vaccine uptake with two doses among vulnerable groups.”

The study was published online May 22 as a preprint on MedRxiv. It has not yet been peer reviewed.

The positive findings generated a lot of discussion on Twitter, with some still urging caution about celebrating the end of the pandemic. For example, a tweet from Aris Katzourakis, a paleo-virologist and researcher at the University of Oxford, United Kingdom, questioned how the results could be interpreted as good news “unless your priors were unreasonably catastrophic.”

“It depends on what happens to hospitalizations and deaths, as Andrew Pollard said this morning,” Charlotte Houldcroft, PhD, a post-doctoral research associate at Cambridge University in the UK, replied.

Houldcroft was referring to a comment this week from Andrew Pollard, MBBS, PhD, director of the Oxford Vaccine Group, who said if most people with COVID-19 are kept out of the hospital with the current vaccines “then the pandemic is over.”

Pollard also told The Guardian: “We can live with the virus; in fact, we are going to have to live with the virus in one way or another. We just need a little bit more time to have certainty around this.”

Seasonal Variation?

Others acknowledge that even though cases are dropping in the US, it could mean COVID-19 will transition to a seasonal illness like the flu. If that’s the case, they caution, a warm weather lull in COVID-19 cases could portend another surge come the winter.

But, Segreti said, it’s too early to tell.

“It’s reasonable to expect that at some point we will need a booster,” he added, but the timeline and frequency remain unknown.

Economic Indicators

The US economy is operating at 90% of where it was before the pandemic, according to the ‘Back to Normal Index’ calculated by CNN Business and Moody’s Analytics based on 37 national and seven state measures.

The index improved in 44 states in the week prior to May 26, which could also reflect an overall improvement in the COVID-19 pandemic.

State and federal unemployment numbers, job postings and hiring rates, and personal savings appear to be trending in a positive direction. In contrast, box office sales, hotel occupancy, and domestic air travel continue to struggle.

Explained: How to Talk to Anti-Vaxxers

Collectively, by turning around those who believe otherwise, we can save lives.

I am getting very tired of trying to convince people of the safety and need for vaccinations and then I reviewed this article. Erica Weintraub Austin and Porismita Borah helps us communicate with this population group. An estimated 24,000 to 62,000 people died from the flu in the United States during the 2019-20 flu season. And that was a relatively mild flu season, which typically starts in October and peaks between December and February.

The computer model predicted 300,000 deaths from COVID-19.

With the advent of flu season, and COVID-19 cases rising, a public health disaster even worse than what we’re now experiencing could occur this fall and winter. Two very dangerous respiratory diseases could be circulating at once.

This will put the general population at risk as well as the millions of people who have pre-existing conditions. Hospitals and health care workers would likely be overwhelmed again.

We are scholars from the Edward R. Murrow Center for Media & Health Promotion Research at Washington State University. As we see it, the only way out of the reopening and reclosing cycles is to convince people to get the flu vaccine in early fall – and then the COVID-19 vaccine when it’s available. Right now, up to 20 COVID-19 vaccine candidates are already in human trials. Chances seem good that at least one will be available for distribution in 2021.

But recent studies suggest that 35% might not want to get a COVID vaccine, and fewer than half received a flu vaccine for the 2019-2020 season.

Getting Coverage

To arrest the pandemic’s spread, perhaps 70% to 80% of the population must opt in and get the vaccine. They also need the flu shot to avoid co-infection which complicates diagnosis and treatment.

Achieving herd immunity is a steep climb. We conducted a national online survey, with 1,264 participants, between June 22 and July 18. We found that only 56% of adults said they were likely or extremely likely to get the COVID-19 vaccine. Westerners were most accepting (64%), followed by Midwesterners (58%), with Southerners (53%) and Northeasterners (50%) least likely.

Anti-vaxxers, promoting unlikely scenarios and outright falsehoods about vaccine risks, are not helping.

With all this in mind, we would like to share some myths and truths about how to increase rates of vaccinations.

Facts Don’t Convince People

People who support vaccination sometimes believe their own set of myths, which actually may stand in the way of getting people vaccinated. One such myth is that people respond to facts and that vaccine hesitancy can be overcome by facts.

That is not necessarily true. Actually, knowledge alone rarely convinces people to change behavior. Most decisions are informed – or misinformed – by emotions: confidence, threat, empathy and worry are four of them.

Another myth is that people can easily separate accurate information from the inaccurate. This is not always true, either. With so much misinformation and disinformation out there, people are often overconfident about their ability to discern good from bad. Our research during the H1N1 epidemic showed that overconfidence can lead to faulty conclusions that increase risk.

Also, it’s not always true that people are motivated to get accurate information to protect themselves and their loved ones. People are often too busy to parse information, especially on complicated subjects. They instead rely on shortcuts, often looking for consistency with their own attitudes, social media endorsements and accessibility.

And, to complicate matters, people will sometimes disregard additional fact checking that contradicts their political beliefs.

Assuming that people who get the flu vaccine will also get the COVID-19 vaccine is a mistake, too.

In our survey, 52% of respondents said they got a flu or other vaccine in the past year, but only 64% of those who got a vaccine in the past year said they were somewhat or extremely likely to get the COVID-19 vaccine. On the other hand, 47% who did not get a recent vaccine said they were somewhat or extremely likely to get the COVID-19 vaccine.

Ways that Do Help

Here are five things you can do to encourage your family, friends and neighbors to vaccinate and to seek out reliable information:

  1. Help them discern trustworthy news outlets from the rest. Is the outlet clearly identified? Does it have a good reputation? Does it present verifiable evidence to back up claims? It is hard to know whether a site is advancing a political agenda but check the “about” or “sponsors” type of links in the menu on the homepage to gain a bit more information. People should be particularly suspicious if the source makes absolutist claims or evokes stereotypes. An anger-provoking headline on social media might be nothing more than manipulative clickbait, intended to sell a product or profit in some way from a reader’s attention.
  2. Make trustworthy news sources accessible and consistent by putting them on your social media feeds. Community service centers are a good one. Partner with opinion leaders people already trust. Our survey respondents viewed local news and local health departments more useful than other outlets, although favorite sources vary with their age and political orientation.
  3. Provide clear, consistent, relevant reasons to get the vaccines. Don’t forget the power of empathy. Our survey says only 49% thought a COVID-19 vaccine would help them, but 65% believed it would help protect other people. Avoid the temptation to use scare tactics and keep in mind that negatively framed messages sometimes backfire.
  4. Remember that skepticism about vaccines did not happen overnight or entirely without cause. Research shows that mistrust of news media compromises confidence in vaccination. Many are also skeptical of Big Pharma for promoting drugs of questionable quality. The government must too overcome mistrust based on past questionable tactics, including “vaccine squads” targeting African Americans and immigrants. Honesty about past mistakes or current side effects is important. Some information about vaccines, widely disseminated in the past, were later revealed to be wrong. Although the evidence for the efficacy of vaccines is overwhelming, any missteps on this subject breed mistrust. One recent example: Two major studies about COVID-19 treatments were ultimately retracted.
  5. Let them know that science is the answer, but it requires patience to get it right. Scientific progress is made gradually, with course corrections that are common until they build to consensus.

And emphasize the things we are certain of: The pandemic is not going away by itself. Not all news outlets are the same. Both flu and COVID-19 shots are necessary. And vaccines work. Collectively, by turning around those who believe otherwise, we can save lives.

How to Talk to Someone Who’s Hesitant to Get the COVID-19 Vaccine

I really like this set evaluation and set of suggestions put together by Elaine K. Howley, for Dr. Gabriel Lockhart, a pulmonologist and critical care intensivist at National Jewish Health in Denver, the question of how best to approach loved ones who are vaccine hesitant hit very close to home.

Lockhart, who is also the director of the ICU for National Jewish Health, has been on the front lines of the pandemic since the beginning, traveling to New York a few times to help out during the peak of its COVID crisis. “I had a lot of first-hand experience with the disastrous outcomes of COVID,” he says.

That, plus his background in pulmonary critical care medicine, has led to his working with Gov. Jared Polis of Colorado as part of the Governor’s Expert Emergency Epidemic Response Committee medical advisory group in collaboration with the Colorado Department of Public Health to address the pandemic in Colorado. “My specific focus was on vaccine distribution,” he says, which is a “very personal topic” for him because he’s African-American and Hispanic.

Communities of color have been hit disproportionately hard by the pandemic, and deploying vaccines to populations that are more vulnerable has been a key component of public health messaging.

But many people in these (and other) communities are hesitant to take the vaccine. And for good reason – there’s a long history of mistrust between communities of color and American health institutions.

For some people of color, there are deep-seated and legitimate concerns that this could be a repeat of Tuskegee, Lockhart says, referencing the infamous “ethically unjustified” Tuskegee study, which intended to study untreated syphilis in Black men and involved misinformation, lack of informed consent and outright manipulation of participants.

Fearing this situation might be similar, with communities of color being misled in the name of medical studies, some people expressed to Lockhart that they felt like “lab rats.” These responses caused the advisory committee in Colorado to take a step back and evaluate how they would encourage people in these communities to take the vaccine.

Lockhart says his own mother was initially resistant to getting the shot. “She finally just recently got her second dose, but that took six to eight months of me pestering her to finally get that to happen,” he says.

For his part, Lockhart was cautious too. “I wasn’t going to take the vaccine and promote it to my family and friends and patients unless I was completely confident in its safety and efficacy.”

When the clinical trials concluded, he reviewed the data and soon felt 100% comfortable about the safety and efficacy of the vaccine. He got his shots in December, among the earliest wave of health care personnel who were able to access the protective inoculation.

Making the Case for Vaccination

Since then, Lockhart has gone on to spread the message that the vaccines are safe, effective and everyone who’s able should get inoculated. He’s also learned that there’s a distinction between people who can be swayed and those who can’t be.

“When I approach people, who are hesitant about the vaccine, I think it’s first important to distinguish between those who are vaccine hesitant and those who are anti-vaxxers. Because those are two different things, in my opinion,” he explains.

“Vaccine hesitancy means they’re open to hearing information and making an educated decision based on good quality information they receive. They may not be wanting to go blindfolded into taking the vaccine. But if they’re willing to hear that information, then they can make an educated decision from that point.”

On the other hand, he says “anti-vaxxers are going to be dead set, no matter what information you tell them. They’re always going to be coming up with a firehose of misinformation and leading you down a rabbit hole of tangential information that isn’t really useful, accurate or helpful when it comes to vaccines. I don’t typically engage that much with purely anti-vaxxers because there’s really not going to be a lot of gain from that population.”

However, educational efforts can go a long way toward convincing those who are hesitant but open to learning more to take the vaccine to protect themselves and their communities, Lockhart says.

Dr. Julita Mir, a practicing internist and infectious disease physician and chief medical officer of Community Care Cooperative (C3) in Boston, urges patience and compassion when talking with others about taking the vaccine. “For most people, it’s a matter of time. We all move at different paces and accepting others’ pace is key.”

Find Out Their Concerns


Because there can be so many different, highly personal reasons why someone might be hesitant to take the vaccine, “it’s best to approach people in a supportive and respectful manner, and make it clear that your goal is to understand what their concerns are,” says Dr. Richard Seidman, chief medical officer of L.A. Care Health Plan – the largest publicly operated health plan in the country.

“We can’t assume what others are thinking or feeling, so it’s best to ask. Once we understand others’ concerns more clearly, we’re better able to engage in a meaningful discussion to explore how to best address their concerns.”

Dr. Lisa Doggett, senior medical director for HGS AxisPoint Health, a care management services company based in Westminster, Colorado, and a newly appointed fellow with American Academy of Family Physicians’ Vaccine Science Fellowship, recommends asking “if there’s anything that might change their mind. If they say, ‘absolutely not,’ it’s probably a good idea to stop and agree to disagree. By continuing you’ll often force them to dig into their beliefs with even greater conviction.”

But, she adds, that if they show some glimmer that they might be willing to consider an alternate view point, “offer to provide one,” but first, “ask for permission. If they agree, proceed with care, stay calm and offer information that’s likely to be meaningful to that particular person.”

Dr. Charles Bailey, medical director for infection prevention at Providence St Joseph Hospital and Providence Mission Hospital in Orange County, California, agrees that coming from a “place of love” often is more fruitful when trying to convince someone to get vaccinated.

He recommends saying something along the lines of: “‘I’m concerned about your reluctance to get a COVID vaccination because I care about your health and safety.’ And before going directly to examples of who you know who’s gotten the vaccine and had no or minimal problems, try to ascertain from where the reluctance originates.”

Ask questions like: “‘What in particular makes you hesitant to get vaccinated at this time?’ Phrasing it in this way provides room for a subsequent change in their decision later as more information comes to light and/or more consideration has occurred,” he explains.

Lockhart recommends “really making sure it’s a two-way conversation” that involves specific reasons. With a full explanation of where that hesitancy comes from, he says it’s possible to provide the accurate and correct information that can help move people toward getting the vaccine.

Mir also recommends “leading by example” and getting vaccinated yourself. “People tend to trust and be influenced more so by those in their close circles.”

Doggett adds, “at all costs, avoid insults and demeaning language, which would be counterproductive. And have realistic expectations. Not everyone

Countering Common Vaccine Concerns


There are a wide variety of legitimate reasons why some people may be hesitant to take the COVID-19 vaccine. These may include:

  • Speed that the vaccine was developed.
  • Safety.
  • Misinformation or misunderstanding the science.
  • Side effects.
  • Distrust of science, the government or medical authorities.
  • Underlying conditions that they believe might make them more vulnerable.

Speed of Development
For some people, the concern is the speed with which the vaccine was developed and how “new” the mRNA technology being used in two of the three shots currently available in the U.S. seems. But Lockhart notes, this approach to developing vaccines “isn’t that new. We’ve had experience with mRNA technology for the last two decades.”

Primarily, it was studied for use in cancer treatment and has also been investigated for use in vaccines against influenza, rabies and Zika. With all this scrutiny, scientists have developed “a good sense of the side effect profile when it comes to mRNA technology.”

The speed with which these vaccines were made available stems from that past experience with mRNA technology and the all-hands-on-deck approach that global health authorities took early on to bring this burgeoning crisis under control.

Lockhart uses an analogy to explain how it all came together so quickly. “It’s like having six different construction companies that were all employed to build separate skyscrapers. They’re told a skyscraper typically takes two years to build. But then they’re all told, ‘Hey, we need all of you to focus on the same skyscraper and expedite the production. Pivot your focus all on the same skyscraper.’ So, yeah. It’s gonna happen a lot faster when you already have infrastructure in place that all comes together for a common cause.”

Despite this fast-tracking, Bailey notes that the Centers for Disease Control and Prevention and the U.S. Food and Drug Administration have been clear from the beginning that “no short cuts in safety were taken” in bringing these vaccines into use this quickly. “The rapid development was facilitated primarily by massive governmental investment in private-sector pharma companies as well as liability protections.”

All the normal safety steps were taken in developing these vaccines, and because this was such an urgent need and highly scrutinized, all the trials were conducted to the most stringent standards. All three currently available vaccines in the U.S. have been found to be safe and highly effective.

The numbers may paint a clearer picture. The Pfizer-BioNTech vaccine trial included more than 43,000 participants. Of the group that received the vaccine (rather than a placebo) only eight individuals developed COVID-19. That’s compared to 162 in the placebo group. Of those infections, 10 were severe, but only one of those occurred in the vaccinated group, and the other nine were in the placebo group.

The Moderna vaccine trial included more than 30,000 people, and only five cases of COVID-19 were reported in the group that received the vaccine versus 90 in the placebo group. Of those 90 cases, 30 were severe. There were no severe cases of COVID-19 reported in the vaccine group.

The Johnson & Johnson one-dose adenovirus vector vaccine was trialed in nearly 44,000 people in eight countries. There were 116 cases of COVID-19 in the vaccine group and 348 in the placebo group at least 14 days after vaccination. Of those, only two were severe among the vaccine group, compared to 29 in the placebo group. Seven people in the placebo group died of COVID-19, while none died in the vaccine group.

For all three vaccines, the Food and Drug Administration granted emergency use authorization because they were “at least 50% more effective than placebo in preventing COVID-19,” which is consistent with the organization’s guidelines for granting authorization. “A vaccine with at least 50% efficacy would have a significant impact on disease, both at the individual and societal level,” the FDA reports.

Some of the testing steps happened in tandem, which is part of how these companies were able to condense the timeline. There was also unprecedented collaboration across pharmaceutical companies. This helped move everything along faster.

“Just because they happened faster doesn’t mean it’s not a quality product,” Lockhart adds.

Safety
Concerns about safety are also common, Seidman says. For example, concerns about very rare blood clots caused the FDA to pause distribution of the Johnson & Johnson vaccine for 11 days in April to reevaluate the data. Putting a pause on a new vaccine or medication is not unusual, and it’s an example of the system working exactly as it should.

In this case, there were six reported cases of blood clots and one death related to the J&J vaccine. More than 6.8 million doses had been administered when the pause was initiated in mid-April. In other words, the chances of developing a blood clot from the J&J vaccine were observed to be quite literally less than one in a million. However, in an abundance of caution, the FDA paused use of the vaccine to reevaluate the data and found that “it’s a very, very small concern, and compared to the risk of blood clots with contracting COVID, it’s extremely small,” Lockhart says.

A November 2020 study conducted at UC San Diego Health and involving more than 8,000 patients diagnosed with COVID-19 noted that 20% of people hospitalized with severe COVID-19 will develop blood clots. For patients in the intensive care unit, the rate was 31%. The study also noted that blood clots led to an increased risk of death by 74%. So the risk of getting a blood clot from the vaccine is miniscule in comparison to the risk of getting a blood clot from COVID-19 itself.

Doggett notes that “nearly everything we do in medicine, and in life, carries some inherent risk. Medications have side effects; treatments and procedures can have unintended consequences. Sometimes the risks and benefits are nearly equal, and choosing the right path is difficult. However, with the COVID-19 vaccine, the risks of vaccine refusal are clear and are substantially greater, for almost everyone, than the very small risk of the vaccine.”

Physicians are constantly weighing the risk versus benefit of any intervention, and the COVID vaccines have been found to be very beneficial with exceedingly small risks.

Plus, there’s reassurance in numbers, Seidman says. “The fact is that nearly 150 million people have been vaccinated in the United States alone with very few serious side effects.” This is excellent evidence that the vaccines really are very safe.

“All approved vaccines have an excellent safety profile, which is regularly tested,” says Dr. Eyal Leshem, director of the Center for Travel Medicine and Tropical Diseases at the Sheba Medical Center and a clinical associate professor in Tel Aviv University School of Medicine in Israel. This means safety testing isn’t just a one-and-done situation. These vaccines are constantly being monitored and evaluated. Any adverse effects are being carefully recorded, and if a safety concern does arise, as did with the J&J vaccine, use will be halted until further investigation can be conducted.

“Medicine in general and vaccine safety assessment specifically are scientific disciplines,” Leshem adds, and the science is showing these vaccines to be extremely safe and effective.

Misinformation or Misunderstanding the Science
“If misinformation is fueling the reluctance, simply supplying accurate information may dispel the nonacceptance,” Bailey says. To dispel some of these myths:

  • These vaccines can’t give you COVID-19. The vaccines do not include any live virus and thus cannot give you COVID-19. The vaccine triggers the immune system to manufacture antibodies against the disease.
  • They can’t affect your fertility. The CDC reports that there’s currently “no evidence that any vaccines, including COVID-19 vaccines, cause fertility problems.”
  • They don’t contain other substances or materials that are harmful or controlling. Several bizarre conspiracy theories floating around the internet have suggested that the vaccines contain microchips or other nefarious ingredients that could be used to control people. These ideas are completely false and not based in science or reality.
  • You should get vaccinated even if you had COVID-19. That’s because while having had the disease offers some protection against future infection, there’s not enough data about that level of protection to know when it tapers off or how protective it is. If you’ve recently had COVID-19, you can receive the first dose of the vaccine four weeks after the onset of symptoms. The second dose can be administered after you’ve completed your isolation period (about 10 days). If you received certain treatments for COVID, including convalescent plasma or antibody infusions, you’ll need to wait 90 days before you can take the vaccine.
  • These vaccines can’t change your DNA. Some people have misunderstood what mRNA is and how it works and believe that this approach can alter your DNA. But that’s not true. “There’s no interference of your DNA. The vaccine doesn’t affect your DNA at all,” Lockhart says.

The Moderna and Pfizer-BioNTech vaccines both use mRNA to stimulate the body to create the antibodies it needs to fight off infection from the coronavirus. mRNA is messenger RNA, and in this context, it refers to a piece of the virus’ spike protein. This molecule contains a a piece of genetic code that instructs your cells to create antibodies against the coronavirus. To do this, the mRNA doesn’t even enter the nucleus of the cell – the cell breaks it down and removes it after it’s finished using the instructions.

Side Effects
For some people, it’s a prior negative experience that’s driving their reluctance. In this case, whether the concern is a bad reaction to another vaccine or concerns about side effects that someone else has experienced, Bailey says discussing the facts around the statistics can help dispel some of that hesitation. He notes that the risk of severe side effects from the COVID vaccines is very low and much lower than the risk of getting COVID if you don’t get vaccinated.

Many people experience no side effects from any of these vaccines. But for others, after having one or both shots, they have reported experiencing:

  • Soreness, redness or swelling at the injection site.
  • Mild, flu-like symptoms, including a headache and body aches.
  • Tiredness.
  • Low-grade fevers.

Most of these side effects are mild and resolve quickly – within a day or two for most people. They’re also normal and signs that the vaccine is working to get your immune system ramped up to better meet the challenge if you’re exposed to the coronavirus in the future.

The most common side effects are also likely to be far less intense than if you were to get infected with COVID, so it’s worth it to feel a little lousy for a few hours – or even a couple days – after your shot if it means protecting yourself – and others – from a potentially far worse outcome if you caught the disease.

In very rare cases, some people have experienced more intense side effects including:

  • Severe allergic reactions including anaphylaxis. This has been observed in approximately two to five patients per million people vaccinated. This reaction also almost always occurred within 30 minutes after vaccination, which is why recipients are instructed to wait 15 to 30 minutes after each shot for observation.
  • Thrombosis with thrombocytopenia syndrome. Also called TTS, this condition involves blood clots with low platelets. This very rare syndrome has occurred almost exclusively in adult women younger than age 50 who received the J&J/Janssen vaccine. According to the CDC’s Vaccine Adverse Event Reporting System, as of May 11, 2021, more than 9 million doses of the J&J/Janssen vaccine had been given and 28 reports of TTS had been confirmed.

It’s important to underscore that these effects have been observed in a very small proportion of patients.

In addition, the CDC reports that there’s currently no evidence that there’s a causal link between the vaccine and any deaths apart from a “plausible causal relationship between the J&J/Janssen COVID-19 Vaccine and a rare and serious event – blood clots with low platelets – which has caused deaths.” The CDC and the FDA are continuing to monitor all adverse events and deaths and are reporting such to the VAERS.

Distrust of Science, the Government or Medical Authorities
Seidman also notes that “many people just don’t like being told what to do, especially if the message is coming from the government.” This is where community-based initiatives to educate and provide vaccines to people where they are can be especially useful.

“I’ve been working on talking to several community groups and leaders so they can answer questions and disseminate this information to their communities,” Lockhart says. Talking with a trusted adviser, such as a church elder or a barber, may offer more reassurance to hesitant people than speaking with a doctor, he adds. “If I can get buy-in from those folks, I think that’s the best efficacy. We can get people to accept the true information about these vaccines” because it’s coming from a trusted community leader.

Doggett adds that “for those who are concerned about personal liberties, a message that will sometimes resonate is that vaccinating more people will help encourage the government to lift restrictions and increase freedom in the long run.”

Leshem notes that this has already happened in Israel, where as of May 10, 2021, nearly 63% of the population has been vaccinated against COVID-19. “As we’re now experiencing in Israel, when most of the population are vaccinated disease spread declines and it is possible to go back to living a normal life.”

Barriers to vaccination such as the long history of racism and, as Seidman explains, “government-sanctioned experimentation on low-income people of color that has eroded trust” may be more difficult to combat. Lockhart says that while these are very legitimate concerns, avoiding the vaccine is only going to worsen the disparity in outcomes between white communities and communities of color.

Again, community-based, grassroots outreach efforts may be better for convincing people who have this as their primary concern. There needs to be a re-establishment of trust with agencies and entities that purvey medical information and care. “My advice is to get the facts from a trusted source of truth, like your doctor or from your faith-based leaders. And be careful not to accept what you might hear or read in biased media sources,” Seidman says.

“Many people tend to trust their primary care doctors, and building on that trust to overcome vaccine hesitancy is important,” Doggett says. And across the board, she adds that “the medical community needs to communicate effectively and consistently about the safety of the vaccine to help improve vaccine acceptance.”

Underlying Conditions
For some people who are pregnant or have medical conditions, such as cancer, there’s been a lot of fear and confusion surrounding whether it’s safe to take a COVID-19 vaccine.

  • Cancer. The American Cancer Society reports that for most people with cancer or a history of cancer, the vaccine is safe and should be accepted, but individual cases may have other factors to consider, so talk with your oncologist.
  • Pregnancy. Though there has been some hesitation among pregnant people in taking the vaccine, studies have found that it’s safe and could actually protect your baby from contracting the virus after birth. The CDC’s V-safe COVID-19 Vaccine Pregnancy Registry is monitoring deployment of the vaccine in pregnant people. As of May 10, 2021, more than 110,000 pregnant people have been vaccinated. Talk with your obstetrician for advice tailored to your specific situation.
  • Immune disorders. If you have a chronic immune disorder or are taking medications that suppress the function of the immune system, you are eligible to get the vaccine. But you should talk with your health care provider about your situation.
  • Negative previous reactions to vaccines. If you’ve had a previous severe allergic reaction (anaphylaxis) you should not take the vaccine. If you have severe allergies to certain medications, latex, pets, foods or other environmental triggers, talk with your health care provider about whether it’s safe for you to take the vaccine.

“Referral to a family physician, nurse specialist or an infectious disease doctor can further help in more complicated cases, such as immune compromise, severe allergy or pregnancy,” Leshem says.

Why Vaccination Matters

The sooner everyone gets vaccinated, the better our chances of putting the pandemic completely behind us. “The COVID-19 vaccines are the best tool we have to get the pandemic under control, allowing us to get back to doing all of the things we need and want to do as individuals, families, business owners and as a community,” Seidman says. “Every additional person who gets vaccinated gets us one step closer to getting the virus under control.”

Still, as Doggett notes, “over a quarter of U.S. adults say they won’t get vaccinated. Their refusal makes it harder to stop the spread of the coronavirus, increasing infection rates and health care costs, and raising the risk of new, more dangerous variants. It also makes it more difficult for us to achieve herd immunity and effectively end the pandemic.”

This ongoing hesitancy to get vaccinated will drag out the pandemic and make it more difficult to resume life as usual, she says, because “the pandemic is far from over.”

In countries where vaccination rates are high, such as the UK, Israel and some parts of the U.S., cases are declining. “But rates of COVID-19 remain dangerously high in many parts of the world,” Doggett says. The higher these rates of infection, the more likely the virus will mutate into more dangerous strains that can undermine all the efforts over the past year to stamp out the pandemic.

“Even in the U.S., we’re still seeing tens of thousands of new cases every day and hundreds of deaths. The faster people get vaccinated, the faster we can stop the virus from spreading, and the sooner we can safely resume activities that many of us have given up during the pandemic, like travel, indoor dining and visiting family.”

The bottom line, she says, “getting vaccinated is the safest way to protect yourself and everyone around you from getting sick. It’s also an important way to stop the creation of new variants of the virus, that may be more virulent, more resistant to the vaccine and could extend the pandemic.”

Vaccine refusal, on the other hand, “will lead to higher health care costs, damage to the economy, and more people living with long-term COVID-19 complications, such as damage to the heart, lungs and brain that we’ve started to see in as many as a third of COVID-19 survivors.”

“Getting vaccinated is a personal decision,” Seidman notes. But choosing “not to get vaccinated is a decision that impacts everyone.”

Estimates of the number of people who need to be vaccinated to achieve herd immunity have typically ranged from 60% to 80% or so, but there are still many open questions about how durable immunity is and when we’ll have reached the threshold of protection.

In the meanwhile, getting vaccinated and convincing your friends and loved ones to do the same is our best means of moving out of this crisis. For his part, Seidman says “the COVID-19 vaccines are really a miracle of modern science. These vaccines are very safe and effective in preventing infection, hospitalizations and deaths from the worst pandemic in 100 years.”

And now with the Delta variant, Some areas of the U.S. could see “very dense outbreaks” of the Delta coronavirus variant throughout the summer and fall, particularly in states with low vaccination rates, according to CBS News.

The Delta variant, which was first identified in India, now makes up about 20% of new cases across the country. The variant has led to surges in parts of Missouri and Arkansas where people haven’t yet received a COVID-19 vaccine.

“It’s going to be hyper-regionalized, where there are certain pockets of the country where we can have very dense outbreaks,” Scott Gottlieb, MD, former commissioner of the FDA, said Sunday on CBS News’ “Face the Nation.”

“As you look across the United States, if you’re a community that has low vaccination rates and … low immunity from prior infection, the virus really hasn’t coursed through the local population,” he added. “I think governors need to be thinking about how they can build out health care resources in areas of the country where you still have a lot of vulnerability.”

Arkansas Gov. Asa Hutchinson, who spoke on “Face the Nation” before Gottlieb, also expressed concerns about the Delta variant. Arkansas has one of the lowest vaccination rates in the country, which Hutchinson attributed to vaccine hesitancy and conspiracy theories about the COVID-19 vaccines.

“The Delta variant is a great concern to us,” he said. “We see that impacting our increasing cases and hospitalizations.”

Hospital admissions increased 30% during the last week, and the University of Arkansas Medical Center reopened its COVID-19 ward. The state is offering incentives for people to get vaccinated, but they haven’t been successful, Hutchinson said. About 50% of adults are vaccinated, and public health officials want to move the needle higher.

“If incentives don’t work, reality will,” he said. “As you see the hospitalizations go up, the cases go up, I think you’ll see the vaccination rate increase as well.”

The Delta variant has been detected in 49 states and the District of Columbia, CBS News reported. The strain is more transmissible and can cause more severe COVID-19. The U.S. and other countries have marked the Delta variant as a “variant of concern” to monitor as the pandemic continues worldwide.

The Delta variant has become the dominant strain in the U.K. and now accounts for 95% of cases that are sequenced, according to the latest update from Public Health England. On Sunday, Gottlieb said the U.S. is about a month or two behind the U.K. with local surges in cases due to the variant.

“They’re seeing cases grow,” he said. “The vast majority are in people who are unvaccinated … the experience in the U.S. is likely to be similar.”

My friend and cartoonist just succumbed to his long battle with cancer. He will be missed by us all and I thank him for being my friend, patient and cartoonist.

Damian McNamara reviewed some of the controversies regarding COVID-19 pandemic and our present status. Have we arrived at a much-anticipated tipping point in the COVID-19 pandemic in the United States? Or do we still have some time before we can return to some semblance of life as we knew it in 2019?

The CDC relaxation of masking and social distancing guidance for fully vaccinated Americans is one reason for optimism, some say, as is the recent milestone where we surpassed more than 50% of Americans vaccinated.

But it’s not all good news. “Right now, we are struggling with vaccine hesitancy,” Ali H. Mokdad, PhD, told Medscape Medical News.

“My concern now is people who don’t want the vaccine are looking around them and saying, ‘Oh we are in a very good position. Infections are down, more than 50% of Americans are vaccinated. Why do I need to get a vaccine?’ ” he said.

Another potential issue is waning immunity, added Mokdad, professor of health metrics sciences at the Institute for Health Metrics and Evaluation, University of Washington, Seattle. Companies are developing booster shots and Anthony Fauci, MD, the White House chief science advisor, said they may be required in the future.

Mokdad said this could add to vaccine hesitancy now. “Someone might think ‘Why should I take this vaccine when there is a new one coming up?’ If I wait for 2 months, I’ll get a new one.'”

“We can definitely be optimistic. Things are going in the right direction,” John Segreti, MD, told Medscape Medical News when asked to comment. “The vaccines seem to be working as well as advertised and are holding up in a real-world situation.”

However, “It’s too early to say it’s over,” he stressed.

“There is still moderate to substantial transmission in the community just about everywhere in the US. It might take a while until we see transmission rates declining to the point where the pandemic will be declared over,” added Segreti, hospital epidemiologist and medical director of infection control and prevention at Rush University Medical Center in Chicago, Illinois.

The global picture is another reason for pessimism, he said. “There is not enough vaccine for around the world. As long as there is uncontrolled transmission of coronavirus somewhere in the world, there is a greater chance for selecting out variants and variants that can escape the vaccine.”

“But overall I am much more optimistic than I was 6 months ago,” Segreti added.

Vaccines vs Variant

In a study evaluating two COVID-19 vaccines against the B.1.167.2 variant first reported in India, researchers evaluated data from Public Health England and reported reassuring news that the vaccines protected against this variant of concern. They studied the efficacy of the Pfizer/BioNTech and AstraZeneca/Oxford vaccines.

“After two doses of either vaccine there were only modest differences in vaccine effectiveness with the B.1.617.2 variant,” the researchers note. “Absolute differences in vaccine effectiveness were more marked with dose one. This would support maximizing vaccine uptake with two doses among vulnerable groups.”

The study was published online May 22 as a preprint on MedRxiv. It has not yet been peer reviewed.

The positive findings generated a lot of discussion on Twitter, with some still urging caution about celebrating the end of the pandemic. For example, a tweet from Aris Katzourakis, a paleo-virologist and researcher at the University of Oxford, United Kingdom, questioned how the results could be interpreted as good news “unless your priors were unreasonably catastrophic.”

“It depends on what happens to hospitalizations and deaths, as Andrew Pollard said this morning,” Charlotte Houldcroft, PhD, a post-doctoral research associate at Cambridge University in the UK, replied.

Houldcroft was referring to a comment this week from Andrew Pollard, MBBS, PhD, director of the Oxford Vaccine Group, who said if most people with COVID-19 are kept out of the hospital with the current vaccines “then the pandemic is over.”

Pollard also told The Guardian: “We can live with the virus; in fact, we are going to have to live with the virus in one way or another. We just need a little bit more time to have certainty around this.”

Seasonal Variation?

Others acknowledge that even though cases are dropping in the US, it could mean COVID-19 will transition to a seasonal illness like the flu. If that’s the case, they caution, a warm weather lull in COVID-19 cases could portend another surge come the winter.

But, Segreti said, it’s too early to tell.

“It’s reasonable to expect that at some point we will need a booster,” he added, but the timeline and frequency remain unknown.

Economic Indicators

The US economy is operating at 90% of where it was before the pandemic, according to the ‘Back to Normal Index’ calculated by CNN Business and Moody’s Analytics based on 37 national and seven state measures.

The index improved in 44 states in the week prior to May 26, which could also reflect an overall improvement in the COVID-19 pandemic.

State and federal unemployment numbers, job postings and hiring rates, and personal savings appear to be trending in a positive direction. In contrast, box office sales, hotel occupancy, and domestic air travel continue to struggle.

Explained: How to Talk to Anti-Vaxxers

Collectively, by turning around those who believe otherwise, we can save lives.

I am getting very tired of trying to convince people of the safety and need for vaccinations and then I reviewed this article. Erica Weintraub Austin and Porismita Borah helps us communicate with this population group. An estimated 24,000 to 62,000 people died from the flu in the United States during the 2019-20 flu season. And that was a relatively mild flu season, which typically starts in October and peaks between December and February.

The computer model predicted 300,000 deaths from COVID-19.

With the advent of flu season, and COVID-19 cases rising, a public health disaster even worse than what we’re now experiencing could occur this fall and winter. Two very dangerous respiratory diseases could be circulating at once.

This will put the general population at risk as well as the millions of people who have pre-existing conditions. Hospitals and health care workers would likely be overwhelmed again.

We are scholars from the Edward R. Murrow Center for Media & Health Promotion Research at Washington State University. As we see it, the only way out of the reopening and reclosing cycles is to convince people to get the flu vaccine in early fall – and then the COVID-19 vaccine when it’s available. Right now, up to 20 COVID-19 vaccine candidates are already in human trials. Chances seem good that at least one will be available for distribution in 2021.

But recent studies suggest that 35% might not want to get a COVID vaccine, and fewer than half received a flu vaccine for the 2019-2020 season.

Getting Coverage

To arrest the pandemic’s spread, perhaps 70% to 80% of the population must opt in and get the vaccine. They also need the flu shot to avoid co-infection which complicates diagnosis and treatment.

Achieving herd immunity is a steep climb. We conducted a national online survey, with 1,264 participants, between June 22 and July 18. We found that only 56% of adults said they were likely or extremely likely to get the COVID-19 vaccine. Westerners were most accepting (64%), followed by Midwesterners (58%), with Southerners (53%) and Northeasterners (50%) least likely.

Anti-vaxxers, promoting unlikely scenarios and outright falsehoods about vaccine risks, are not helping.

With all this in mind, we would like to share some myths and truths about how to increase rates of vaccinations.

Facts Don’t Convince People

People who support vaccination sometimes believe their own set of myths, which actually may stand in the way of getting people vaccinated. One such myth is that people respond to facts and that vaccine hesitancy can be overcome by facts.

That is not necessarily true. Actually, knowledge alone rarely convinces people to change behavior. Most decisions are informed – or misinformed – by emotions: confidence, threat, empathy and worry are four of them.

Another myth is that people can easily separate accurate information from the inaccurate. This is not always true, either. With so much misinformation and disinformation out there, people are often overconfident about their ability to discern good from bad. Our research during the H1N1 epidemic showed that overconfidence can lead to faulty conclusions that increase risk.

Also, it’s not always true that people are motivated to get accurate information to protect themselves and their loved ones. People are often too busy to parse information, especially on complicated subjects. They instead rely on shortcuts, often looking for consistency with their own attitudes, social media endorsements and accessibility.

And, to complicate matters, people will sometimes disregard additional fact checking that contradicts their political beliefs.

Assuming that people who get the flu vaccine will also get the COVID-19 vaccine is a mistake, too.

In our survey, 52% of respondents said they got a flu or other vaccine in the past year, but only 64% of those who got a vaccine in the past year said they were somewhat or extremely likely to get the COVID-19 vaccine. On the other hand, 47% who did not get a recent vaccine said they were somewhat or extremely likely to get the COVID-19 vaccine.

Ways that Do Help

Here are five things you can do to encourage your family, friends and neighbors to vaccinate and to seek out reliable information:

  1. Help them discern trustworthy news outlets from the rest. Is the outlet clearly identified? Does it have a good reputation? Does it present verifiable evidence to back up claims? It is hard to know whether a site is advancing a political agenda but check the “about” or “sponsors” type of links in the menu on the homepage to gain a bit more information. People should be particularly suspicious if the source makes absolutist claims or evokes stereotypes. An anger-provoking headline on social media might be nothing more than manipulative clickbait, intended to sell a product or profit in some way from a reader’s attention.
  2. Make trustworthy news sources accessible and consistent by putting them on your social media feeds. Community service centers are a good one. Partner with opinion leaders people already trust. Our survey respondents viewed local news and local health departments more useful than other outlets, although favorite sources vary with their age and political orientation.
  3. Provide clear, consistent, relevant reasons to get the vaccines. Don’t forget the power of empathy. Our survey says only 49% thought a COVID-19 vaccine would help them, but 65% believed it would help protect other people. Avoid the temptation to use scare tactics and keep in mind that negatively framed messages sometimes backfire.
  4. Remember that skepticism about vaccines did not happen overnight or entirely without cause. Research shows that mistrust of news media compromises confidence in vaccination. Many are also skeptical of Big Pharma for promoting drugs of questionable quality. The government must too overcome mistrust based on past questionable tactics, including “vaccine squads” targeting African Americans and immigrants. Honesty about past mistakes or current side effects is important. Some information about vaccines, widely disseminated in the past, were later revealed to be wrong. Although the evidence for the efficacy of vaccines is overwhelming, any missteps on this subject breed mistrust. One recent example: Two major studies about COVID-19 treatments were ultimately retracted.
  5. Let them know that science is the answer, but it requires patience to get it right. Scientific progress is made gradually, with course corrections that are common until they build to consensus.

And emphasize the things we are certain of: The pandemic is not going away by itself. Not all news outlets are the same. Both flu and COVID-19 shots are necessary. And vaccines work. Collectively, by turning around those who believe otherwise, we can save lives.

How to Talk to Someone Who’s Hesitant to Get the COVID-19 Vaccine

I really like this set evaluation and set of suggestions put together by Elaine K. Howley, for Dr. Gabriel Lockhart, a pulmonologist and critical care intensivist at National Jewish Health in Denver, the question of how best to approach loved ones who are vaccine hesitant hit very close to home.

Lockhart, who is also the director of the ICU for National Jewish Health, has been on the front lines of the pandemic since the beginning, traveling to New York a few times to help out during the peak of its COVID crisis. “I had a lot of first-hand experience with the disastrous outcomes of COVID,” he says.

That, plus his background in pulmonary critical care medicine, has led to his working with Gov. Jared Polis of Colorado as part of the Governor’s Expert Emergency Epidemic Response Committee medical advisory group in collaboration with the Colorado Department of Public Health to address the pandemic in Colorado. “My specific focus was on vaccine distribution,” he says, which is a “very personal topic” for him because he’s African-American and Hispanic.

Communities of color have been hit disproportionately hard by the pandemic, and deploying vaccines to populations that are more vulnerable has been a key component of public health messaging.

But many people in these (and other) communities are hesitant to take the vaccine. And for good reason – there’s a long history of mistrust between communities of color and American health institutions.

For some people of color, there are deep-seated and legitimate concerns that this could be a repeat of Tuskegee, Lockhart says, referencing the infamous “ethically unjustified” Tuskegee study, which intended to study untreated syphilis in Black men and involved misinformation, lack of informed consent and outright manipulation of participants.

Fearing this situation might be similar, with communities of color being misled in the name of medical studies, some people expressed to Lockhart that they felt like “lab rats.” These responses caused the advisory committee in Colorado to take a step back and evaluate how they would encourage people in these communities to take the vaccine.

Lockhart says his own mother was initially resistant to getting the shot. “She finally just recently got her second dose, but that took six to eight months of me pestering her to finally get that to happen,” he says.

For his part, Lockhart was cautious too. “I wasn’t going to take the vaccine and promote it to my family and friends and patients unless I was completely confident in its safety and efficacy.”

When the clinical trials concluded, he reviewed the data and soon felt 100% comfortable about the safety and efficacy of the vaccine. He got his shots in December, among the earliest wave of health care personnel who were able to access the protective inoculation.

Making the Case for Vaccination

Since then, Lockhart has gone on to spread the message that the vaccines are safe, effective and everyone who’s able should get inoculated. He’s also learned that there’s a distinction between people who can be swayed and those who can’t be.

“When I approach people, who are hesitant about the vaccine, I think it’s first important to distinguish between those who are vaccine hesitant and those who are anti-vaxxers. Because those are two different things, in my opinion,” he explains.

“Vaccine hesitancy means they’re open to hearing information and making an educated decision based on good quality information they receive. They may not be wanting to go blindfolded into taking the vaccine. But if they’re willing to hear that information, then they can make an educated decision from that point.”

On the other hand, he says “anti-vaxxers are going to be dead set, no matter what information you tell them. They’re always going to be coming up with a firehose of misinformation and leading you down a rabbit hole of tangential information that isn’t really useful, accurate or helpful when it comes to vaccines. I don’t typically engage that much with purely anti-vaxxers because there’s really not going to be a lot of gain from that population.”

However, educational efforts can go a long way toward convincing those who are hesitant but open to learning more to take the vaccine to protect themselves and their communities, Lockhart says.

Dr. Julita Mir, a practicing internist and infectious disease physician and chief medical officer of Community Care Cooperative (C3) in Boston, urges patience and compassion when talking with others about taking the vaccine. “For most people, it’s a matter of time. We all move at different paces and accepting others’ pace is key.”

Find Out Their Concerns


Because there can be so many different, highly personal reasons why someone might be hesitant to take the vaccine, “it’s best to approach people in a supportive and respectful manner, and make it clear that your goal is to understand what their concerns are,” says Dr. Richard Seidman, chief medical officer of L.A. Care Health Plan – the largest publicly operated health plan in the country.

“We can’t assume what others are thinking or feeling, so it’s best to ask. Once we understand others’ concerns more clearly, we’re better able to engage in a meaningful discussion to explore how to best address their concerns.”

Dr. Lisa Doggett, senior medical director for HGS AxisPoint Health, a care management services company based in Westminster, Colorado, and a newly appointed fellow with American Academy of Family Physicians’ Vaccine Science Fellowship, recommends asking “if there’s anything that might change their mind. If they say, ‘absolutely not,’ it’s probably a good idea to stop and agree to disagree. By continuing you’ll often force them to dig into their beliefs with even greater conviction.”

But, she adds, that if they show some glimmer that they might be willing to consider an alternate view point, “offer to provide one,” but first, “ask for permission. If they agree, proceed with care, stay calm and offer information that’s likely to be meaningful to that particular person.”

Dr. Charles Bailey, medical director for infection prevention at Providence St Joseph Hospital and Providence Mission Hospital in Orange County, California, agrees that coming from a “place of love” often is more fruitful when trying to convince someone to get vaccinated.

He recommends saying something along the lines of: “‘I’m concerned about your reluctance to get a COVID vaccination because I care about your health and safety.’ And before going directly to examples of who you know who’s gotten the vaccine and had no or minimal problems, try to ascertain from where the reluctance originates.”

Ask questions like: “‘What in particular makes you hesitant to get vaccinated at this time?’ Phrasing it in this way provides room for a subsequent change in their decision later as more information comes to light and/or more consideration has occurred,” he explains.

Lockhart recommends “really making sure it’s a two-way conversation” that involves specific reasons. With a full explanation of where that hesitancy comes from, he says it’s possible to provide the accurate and correct information that can help move people toward getting the vaccine.

Mir also recommends “leading by example” and getting vaccinated yourself. “People tend to trust and be influenced more so by those in their close circles.”

Doggett adds, “at all costs, avoid insults and demeaning language, which would be counterproductive. And have realistic expectations. Not everyone

Countering Common Vaccine Concerns


There are a wide variety of legitimate reasons why some people may be hesitant to take the COVID-19 vaccine. These may include:

  • Speed that the vaccine was developed.
  • Safety.
  • Misinformation or misunderstanding the science.
  • Side effects.
  • Distrust of science, the government or medical authorities.
  • Underlying conditions that they believe might make them more vulnerable.

Speed of Development
For some people, the concern is the speed with which the vaccine was developed and how “new” the mRNA technology being used in two of the three shots currently available in the U.S. seems. But Lockhart notes, this approach to developing vaccines “isn’t that new. We’ve had experience with mRNA technology for the last two decades.”

Primarily, it was studied for use in cancer treatment and has also been investigated for use in vaccines against influenza, rabies and Zika. With all this scrutiny, scientists have developed “a good sense of the side effect profile when it comes to mRNA technology.”

The speed with which these vaccines were made available stems from that past experience with mRNA technology and the all-hands-on-deck approach that global health authorities took early on to bring this burgeoning crisis under control.

Lockhart uses an analogy to explain how it all came together so quickly. “It’s like having six different construction companies that were all employed to build separate skyscrapers. They’re told a skyscraper typically takes two years to build. But then they’re all told, ‘Hey, we need all of you to focus on the same skyscraper and expedite the production. Pivot your focus all on the same skyscraper.’ So, yeah. It’s gonna happen a lot faster when you already have infrastructure in place that all comes together for a common cause.”

Despite this fast-tracking, Bailey notes that the Centers for Disease Control and Prevention and the U.S. Food and Drug Administration have been clear from the beginning that “no short cuts in safety were taken” in bringing these vaccines into use this quickly. “The rapid development was facilitated primarily by massive governmental investment in private-sector pharma companies as well as liability protections.”

All the normal safety steps were taken in developing these vaccines, and because this was such an urgent need and highly scrutinized, all the trials were conducted to the most stringent standards. All three currently available vaccines in the U.S. have been found to be safe and highly effective.

The numbers may paint a clearer picture. The Pfizer-BioNTech vaccine trial included more than 43,000 participants. Of the group that received the vaccine (rather than a placebo) only eight individuals developed COVID-19. That’s compared to 162 in the placebo group. Of those infections, 10 were severe, but only one of those occurred in the vaccinated group, and the other nine were in the placebo group.

The Moderna vaccine trial included more than 30,000 people, and only five cases of COVID-19 were reported in the group that received the vaccine versus 90 in the placebo group. Of those 90 cases, 30 were severe. There were no severe cases of COVID-19 reported in the vaccine group.

The Johnson & Johnson one-dose adenovirus vector vaccine was trialed in nearly 44,000 people in eight countries. There were 116 cases of COVID-19 in the vaccine group and 348 in the placebo group at least 14 days after vaccination. Of those, only two were severe among the vaccine group, compared to 29 in the placebo group. Seven people in the placebo group died of COVID-19, while none died in the vaccine group.

For all three vaccines, the Food and Drug Administration granted emergency use authorization because they were “at least 50% more effective than placebo in preventing COVID-19,” which is consistent with the organization’s guidelines for granting authorization. “A vaccine with at least 50% efficacy would have a significant impact on disease, both at the individual and societal level,” the FDA reports.

Some of the testing steps happened in tandem, which is part of how these companies were able to condense the timeline. There was also unprecedented collaboration across pharmaceutical companies. This helped move everything along faster.

“Just because they happened faster doesn’t mean it’s not a quality product,” Lockhart adds.

Safety
Concerns about safety are also common, Seidman says. For example, concerns about very rare blood clots caused the FDA to pause distribution of the Johnson & Johnson vaccine for 11 days in April to reevaluate the data. Putting a pause on a new vaccine or medication is not unusual, and it’s an example of the system working exactly as it should.

In this case, there were six reported cases of blood clots and one death related to the J&J vaccine. More than 6.8 million doses had been administered when the pause was initiated in mid-April. In other words, the chances of developing a blood clot from the J&J vaccine were observed to be quite literally less than one in a million. However, in an abundance of caution, the FDA paused use of the vaccine to reevaluate the data and found that “it’s a very, very small concern, and compared to the risk of blood clots with contracting COVID, it’s extremely small,” Lockhart says.

A November 2020 study conducted at UC San Diego Health and involving more than 8,000 patients diagnosed with COVID-19 noted that 20% of people hospitalized with severe COVID-19 will develop blood clots. For patients in the intensive care unit, the rate was 31%. The study also noted that blood clots led to an increased risk of death by 74%. So the risk of getting a blood clot from the vaccine is miniscule in comparison to the risk of getting a blood clot from COVID-19 itself.

Doggett notes that “nearly everything we do in medicine, and in life, carries some inherent risk. Medications have side effects; treatments and procedures can have unintended consequences. Sometimes the risks and benefits are nearly equal, and choosing the right path is difficult. However, with the COVID-19 vaccine, the risks of vaccine refusal are clear and are substantially greater, for almost everyone, than the very small risk of the vaccine.”

Physicians are constantly weighing the risk versus benefit of any intervention, and the COVID vaccines have been found to be very beneficial with exceedingly small risks.

Plus, there’s reassurance in numbers, Seidman says. “The fact is that nearly 150 million people have been vaccinated in the United States alone with very few serious side effects.” This is excellent evidence that the vaccines really are very safe.

“All approved vaccines have an excellent safety profile, which is regularly tested,” says Dr. Eyal Leshem, director of the Center for Travel Medicine and Tropical Diseases at the Sheba Medical Center and a clinical associate professor in Tel Aviv University School of Medicine in Israel. This means safety testing isn’t just a one-and-done situation. These vaccines are constantly being monitored and evaluated. Any adverse effects are being carefully recorded, and if a safety concern does arise, as did with the J&J vaccine, use will be halted until further investigation can be conducted.

“Medicine in general and vaccine safety assessment specifically are scientific disciplines,” Leshem adds, and the science is showing these vaccines to be extremely safe and effective.

Misinformation or Misunderstanding the Science
“If misinformation is fueling the reluctance, simply supplying accurate information may dispel the nonacceptance,” Bailey says. To dispel some of these myths:

  • These vaccines can’t give you COVID-19. The vaccines do not include any live virus and thus cannot give you COVID-19. The vaccine triggers the immune system to manufacture antibodies against the disease.
  • They can’t affect your fertility. The CDC reports that there’s currently “no evidence that any vaccines, including COVID-19 vaccines, cause fertility problems.”
  • They don’t contain other substances or materials that are harmful or controlling. Several bizarre conspiracy theories floating around the internet have suggested that the vaccines contain microchips or other nefarious ingredients that could be used to control people. These ideas are completely false and not based in science or reality.
  • You should get vaccinated even if you had COVID-19. That’s because while having had the disease offers some protection against future infection, there’s not enough data about that level of protection to know when it tapers off or how protective it is. If you’ve recently had COVID-19, you can receive the first dose of the vaccine four weeks after the onset of symptoms. The second dose can be administered after you’ve completed your isolation period (about 10 days). If you received certain treatments for COVID, including convalescent plasma or antibody infusions, you’ll need to wait 90 days before you can take the vaccine.
  • These vaccines can’t change your DNA. Some people have misunderstood what mRNA is and how it works and believe that this approach can alter your DNA. But that’s not true. “There’s no interference of your DNA. The vaccine doesn’t affect your DNA at all,” Lockhart says.

The Moderna and Pfizer-BioNTech vaccines both use mRNA to stimulate the body to create the antibodies it needs to fight off infection from the coronavirus. mRNA is messenger RNA, and in this context, it refers to a piece of the virus’ spike protein. This molecule contains a a piece of genetic code that instructs your cells to create antibodies against the coronavirus. To do this, the mRNA doesn’t even enter the nucleus of the cell – the cell breaks it down and removes it after it’s finished using the instructions.

Side Effects
For some people, it’s a prior negative experience that’s driving their reluctance. In this case, whether the concern is a bad reaction to another vaccine or concerns about side effects that someone else has experienced, Bailey says discussing the facts around the statistics can help dispel some of that hesitation. He notes that the risk of severe side effects from the COVID vaccines is very low and much lower than the risk of getting COVID if you don’t get vaccinated.

Many people experience no side effects from any of these vaccines. But for others, after having one or both shots, they have reported experiencing:

  • Soreness, redness or swelling at the injection site.
  • Mild, flu-like symptoms, including a headache and body aches.
  • Tiredness.
  • Low-grade fevers.

Most of these side effects are mild and resolve quickly – within a day or two for most people. They’re also normal and signs that the vaccine is working to get your immune system ramped up to better meet the challenge if you’re exposed to the coronavirus in the future.

The most common side effects are also likely to be far less intense than if you were to get infected with COVID, so it’s worth it to feel a little lousy for a few hours – or even a couple days – after your shot if it means protecting yourself – and others – from a potentially far worse outcome if you caught the disease.

In very rare cases, some people have experienced more intense side effects including:

  • Severe allergic reactions including anaphylaxis. This has been observed in approximately two to five patients per million people vaccinated. This reaction also almost always occurred within 30 minutes after vaccination, which is why recipients are instructed to wait 15 to 30 minutes after each shot for observation.
  • Thrombosis with thrombocytopenia syndrome. Also called TTS, this condition involves blood clots with low platelets. This very rare syndrome has occurred almost exclusively in adult women younger than age 50 who received the J&J/Janssen vaccine. According to the CDC’s Vaccine Adverse Event Reporting System, as of May 11, 2021, more than 9 million doses of the J&J/Janssen vaccine had been given and 28 reports of TTS had been confirmed.

It’s important to underscore that these effects have been observed in a very small proportion of patients.

In addition, the CDC reports that there’s currently no evidence that there’s a causal link between the vaccine and any deaths apart from a “plausible causal relationship between the J&J/Janssen COVID-19 Vaccine and a rare and serious event – blood clots with low platelets – which has caused deaths.” The CDC and the FDA are continuing to monitor all adverse events and deaths and are reporting such to the VAERS.

Distrust of Science, the Government or Medical Authorities
Seidman also notes that “many people just don’t like being told what to do, especially if the message is coming from the government.” This is where community-based initiatives to educate and provide vaccines to people where they are can be especially useful.

“I’ve been working on talking to several community groups and leaders so they can answer questions and disseminate this information to their communities,” Lockhart says. Talking with a trusted adviser, such as a church elder or a barber, may offer more reassurance to hesitant people than speaking with a doctor, he adds. “If I can get buy-in from those folks, I think that’s the best efficacy. We can get people to accept the true information about these vaccines” because it’s coming from a trusted community leader.

Doggett adds that “for those who are concerned about personal liberties, a message that will sometimes resonate is that vaccinating more people will help encourage the government to lift restrictions and increase freedom in the long run.”

Leshem notes that this has already happened in Israel, where as of May 10, 2021, nearly 63% of the population has been vaccinated against COVID-19. “As we’re now experiencing in Israel, when most of the population are vaccinated disease spread declines and it is possible to go back to living a normal life.”

Barriers to vaccination such as the long history of racism and, as Seidman explains, “government-sanctioned experimentation on low-income people of color that has eroded trust” may be more difficult to combat. Lockhart says that while these are very legitimate concerns, avoiding the vaccine is only going to worsen the disparity in outcomes between white communities and communities of color.

Again, community-based, grassroots outreach efforts may be better for convincing people who have this as their primary concern. There needs to be a re-establishment of trust with agencies and entities that purvey medical information and care. “My advice is to get the facts from a trusted source of truth, like your doctor or from your faith-based leaders. And be careful not to accept what you might hear or read in biased media sources,” Seidman says.

“Many people tend to trust their primary care doctors, and building on that trust to overcome vaccine hesitancy is important,” Doggett says. And across the board, she adds that “the medical community needs to communicate effectively and consistently about the safety of the vaccine to help improve vaccine acceptance.”

Underlying Conditions
For some people who are pregnant or have medical conditions, such as cancer, there’s been a lot of fear and confusion surrounding whether it’s safe to take a COVID-19 vaccine.

  • Cancer. The American Cancer Society reports that for most people with cancer or a history of cancer, the vaccine is safe and should be accepted, but individual cases may have other factors to consider, so talk with your oncologist.
  • Pregnancy. Though there has been some hesitation among pregnant people in taking the vaccine, studies have found that it’s safe and could actually protect your baby from contracting the virus after birth. The CDC’s V-safe COVID-19 Vaccine Pregnancy Registry is monitoring deployment of the vaccine in pregnant people. As of May 10, 2021, more than 110,000 pregnant people have been vaccinated. Talk with your obstetrician for advice tailored to your specific situation.
  • Immune disorders. If you have a chronic immune disorder or are taking medications that suppress the function of the immune system, you are eligible to get the vaccine. But you should talk with your health care provider about your situation.
  • Negative previous reactions to vaccines. If you’ve had a previous severe allergic reaction (anaphylaxis) you should not take the vaccine. If you have severe allergies to certain medications, latex, pets, foods or other environmental triggers, talk with your health care provider about whether it’s safe for you to take the vaccine.

“Referral to a family physician, nurse specialist or an infectious disease doctor can further help in more complicated cases, such as immune compromise, severe allergy or pregnancy,” Leshem says.

Why Vaccination Matters

The sooner everyone gets vaccinated, the better our chances of putting the pandemic completely behind us. “The COVID-19 vaccines are the best tool we have to get the pandemic under control, allowing us to get back to doing all of the things we need and want to do as individuals, families, business owners and as a community,” Seidman says. “Every additional person who gets vaccinated gets us one step closer to getting the virus under control.”

Still, as Doggett notes, “over a quarter of U.S. adults say they won’t get vaccinated. Their refusal makes it harder to stop the spread of the coronavirus, increasing infection rates and health care costs, and raising the risk of new, more dangerous variants. It also makes it more difficult for us to achieve herd immunity and effectively end the pandemic.”

This ongoing hesitancy to get vaccinated will drag out the pandemic and make it more difficult to resume life as usual, she says, because “the pandemic is far from over.”

In countries where vaccination rates are high, such as the UK, Israel and some parts of the U.S., cases are declining. “But rates of COVID-19 remain dangerously high in many parts of the world,” Doggett says. The higher these rates of infection, the more likely the virus will mutate into more dangerous strains that can undermine all the efforts over the past year to stamp out the pandemic.

“Even in the U.S., we’re still seeing tens of thousands of new cases every day and hundreds of deaths. The faster people get vaccinated, the faster we can stop the virus from spreading, and the sooner we can safely resume activities that many of us have given up during the pandemic, like travel, indoor dining and visiting family.”

The bottom line, she says, “getting vaccinated is the safest way to protect yourself and everyone around you from getting sick. It’s also an important way to stop the creation of new variants of the virus, that may be more virulent, more resistant to the vaccine and could extend the pandemic.”

Vaccine refusal, on the other hand, “will lead to higher health care costs, damage to the economy, and more people living with long-term COVID-19 complications, such as damage to the heart, lungs and brain that we’ve started to see in as many as a third of COVID-19 survivors.”

“Getting vaccinated is a personal decision,” Seidman notes. But choosing “not to get vaccinated is a decision that impacts everyone.”

Estimates of the number of people who need to be vaccinated to achieve herd immunity have typically ranged from 60% to 80% or so, but there are still many open questions about how durable immunity is and when we’ll have reached the threshold of protection.

In the meanwhile, getting vaccinated and convincing your friends and loved ones to do the same is our best means of moving out of this crisis. For his part, Seidman says “the COVID-19 vaccines are really a miracle of modern science. These vaccines are very safe and effective in preventing infection, hospitalizations and deaths from the worst pandemic in 100 years.”

And now with the Delta variant, Some areas of the U.S. could see “very dense outbreaks” of the Delta coronavirus variant throughout the summer and fall, particularly in states with low vaccination rates, according to CBS News.

The Delta variant, which was first identified in India, now makes up about 20% of new cases across the country. The variant has led to surges in parts of Missouri and Arkansas where people haven’t yet received a COVID-19 vaccine.

“It’s going to be hyper-regionalized, where there are certain pockets of the country where we can have very dense outbreaks,” Scott Gottlieb, MD, former commissioner of the FDA, said Sunday on CBS News’ “Face the Nation.”

“As you look across the United States, if you’re a community that has low vaccination rates and … low immunity from prior infection, the virus really hasn’t coursed through the local population,” he added. “I think governors need to be thinking about how they can build out health care resources in areas of the country where you still have a lot of vulnerability.”

Arkansas Gov. Asa Hutchinson, who spoke on “Face the Nation” before Gottlieb, also expressed concerns about the Delta variant. Arkansas has one of the lowest vaccination rates in the country, which Hutchinson attributed to vaccine hesitancy and conspiracy theories about the COVID-19 vaccines.

“The Delta variant is a great concern to us,” he said. “We see that impacting our increasing cases and hospitalizations.”

Hospital admissions increased 30% during the last week, and the University of Arkansas Medical Center reopened its COVID-19 ward. The state is offering incentives for people to get vaccinated, but they haven’t been successful, Hutchinson said. About 50% of adults are vaccinated, and public health officials want to move the needle higher.

“If incentives don’t work, reality will,” he said. “As you see the hospitalizations go up, the cases go up, I think you’ll see the vaccination rate increase as well.”

The Delta variant has been detected in 49 states and the District of Columbia, CBS News reported. The strain is more transmissible and can cause more severe COVID-19. The U.S. and other countries have marked the Delta variant as a “variant of concern” to monitor as the pandemic continues worldwide.

The Delta variant has become the dominant strain in the U.K. and now accounts for 95% of cases that are sequenced, according to the latest update from Public Health England. On Sunday, Gottlieb said the U.S. is about a month or two behind the U.K. with local surges in cases due to the variant.

“They’re seeing cases grow,” he said. “The vast majority are in people who are unvaccinated … the experience in the U.S. is likely to be similar.”

My friend, former patient and cartoonist, Rick Kollinger, succumbed to his long battle with cancer picture him at the Golden Gates with a sketchpad in hand waiting to draw all of those that he surely will meet, possible insult, and entertain. I and many others will miss you.

Happy Fourth of July to ALL! Let us reflect on the history and the future of our great country. Take a moment to consider what we all have achieved this past year and focus on what we can accomplish in our future.

The Pandemic Will Likely End In One Of These Four Ways; Social Media and More About Vaccines.

I am getting really frustrated having to try to convince friends and patients of the value of vaccinations for Covip-19. Vaccinations promise an end to the coronavirus pandemic in the US. What kind of ending, though, is up to us?

I “loved” the excuse that she knew that the GOVERNMENT was putting tracers in the vaccines to track our every move and racist thoughts.

And with the cases and deaths due to COVID increasing in such very high numbers, while Israel as a country is the only country that has reached herd immunity. Their vaccinations are over 80% of their population and their new cases are so very low.

Reporter Dan Vergano noted that if the White House’s vision goes according to plan, vaccinations will end the pandemic in the US in time for 4th of July fireworks. Or the pandemic won’t end, and these shots will be the first of many we’ll get for years. Or they’ll offer a brief summer respite — before a more severe version of the coronavirus catches fire.

A return to a life resembling normalcy looks closer than ever now that, as of Monday, vaccines are available to every adult in America. Around 80 million people are already fully vaccinated, and President Joe Biden said on Wednesday that the US has already reached his goal of 200 million shots in the first 100 days of his administration, eight days early.

But with half of the population still unvaccinated and COVID-19 cases once more rising, just how close are we to the pandemic ending, both in the US and across the world?

Whether the pandemic ends in the US by Independence Day — or much further in the future — will depend on the vaccines, the virus, and decisions people make, experts say. The big questions include how long the vaccines’ protection lasts, how well they fight off new coronavirus variants, and whether the entire globe can hold off these emerging threats. Then there’s the X factor of how many people will be willing to get shots.

The benchmark for a successful vaccination campaign has long been considered to be “herd immunity” — having enough people vaccinated to keep sick ones from sparking outbreaks. That might require 80% of US adults getting vaccinated, according to infectious disease researcher William Schaffner of the Vanderbilt University School of Medicine.

Other experts have urged Americans to not obsess over herd immunity. “I can’t say it’s going to be ‘this’ percent,” Anthony Fauci, head of the National Institute of Allergy and Infectious Diseases, said this month, although he has previously floated percentages ranging from 70% to 85%. “We’ll know it when we see it. It’ll be obvious.”

Getting to that turning point could take very different routes, experts told BuzzFeed News. Although the summer everyone hopes for is within reach, worse outcomes are also possible. At this pivotal moment in the crisis, a lot depends on how willing people are to help themselves by continuing to wear masks and isolating until they are fully vaccinated — and to help people around the world get vaccinated too.

“It depends on decisions we make,” Lauren Ancel Meyers, a University of Texas epidemiologist, said this month at a Stanford University symposium about herd immunity.

Here are four ways that the pandemic could end in the US.

1. The Better Ending: Vaccination Returns Life Close to “Normal”

By June, most US adults get vaccinated. The shots halt the spread of SARS-CoV-2, even the more transmissible variants. And people feel safe shopping, traveling, and visiting each other, almost like they did before the pandemic.

This is the best outcome — and it isn’t completely far-fetched. Half of US adults have received at least one shot. Even with Johnson & Johnson’s vaccine paused, more than 3 million shots are being administered a day; at that rate, every adult American could receive one by late June.

Israel offers a glimpse of this future. There, a fast-paced campaign had immunized more than half of the population by mid-April. The results have been striking in the country of 9 million, with new cases falling to around 200 a day, 2% of the January peak. Starting this weekend, an outdoor mask mandate will be lifted.

White House / Via whitehouse.gov

White House COVID-19 briefing slide, showing case drop with 62% vaccination

Similarly, in the US, new cases among nursing home residents dropped by 96% and deaths by 91% between December, when vaccinations started, and March. After a slow start, more than 4.8 million people in nursing facilities have received at least one shot.

Although case numbers have increased in recent weeks, Deepta Bhattacharya, an immunologist at the University of Arizona College of Medicine, predicts “a smaller bump over the next couple months that should by the summer settle down to a pretty low level of cases.”

That doesn’t mean that masking would stop. It’s worth noting that the declines in both Israel and nursing homes happened while restrictions were maintained. Under current US plans, young teens won’t start getting shots until the fall and elementary school–age children in the winter of 2022, meaning that their schools will likely keep face coverings, some virtual classes, and other restrictions for the foreseeable future.

But most partial or full closures of shops, restaurants, universities, and bars could end this summer if US cases fall like they did in Israel.

The bottom line is that the Pfizer and Moderna vaccines, which make up the great majority of US shots, have proven 90% effective in real-world studies against COVID-19. Although some people have gotten infected despite vaccination, their numbers are small: about 6,000 cases out of 84 million fully vaccinated people, or .007%, according to CDC data.

“It is not unexpected — the vaccine is not 100% protective,” Scott Lindquist, a Washington state health department official, said in a recent press briefing about “breakthrough” infections there. “But what we saw were mostly very mild symptoms, if any at all.”

And existing vaccines appear to protect against new coronavirus variants, such as the B.1.1.7 strain, according to CDC data. “If you lose a little bit of protection to a variant, but the vaccine still keeps you safe, that’s still a good result,” Bhattacharya said. Vaccines aside, he noted that a sizable chunk of the population — more than 1 in 5 Americans by one recent estimate — also has some natural immunity from past infections, though studies suggest that this protection likely isn’t as long-lasting or robust as vaccination.

“I do think we’ll be OK by the summer,” said the immunologist, who is personally planning to travel to see his family in cities across the country. “Tickets booked for early July!”

In this future, the coronavirus cools down enough to be managed like the measles: a virus tamed by a vaccine that is added to childhood shot regimens, with occasional outbreaks in unvaccinated communities.

2. A Mixed Ending: Defanging, Not Defeating, the Virus

Mass vaccination delivers yet another future: the death rate from COVID-19 drops drastically, because the shots prevent severe and fatal illness, but outbreaks continue, largely among pockets of unvaccinated people, including younger people who are less targeted for vaccines or less worried about getting sick in the first place.

“A more realistic scenario is that older, more vulnerable individuals will receive a disproportionate number of doses,” said infectious disease modeler Jack Buckner of the University of California, Davis, by email. “Under these conditions additional outbreaks are more likely but the case fatality rate would be lower.”

Last month, CDC Director Rochelle Walensky was asked whether a sharp decline in death rates, with case numbers remaining high over the summer, might lessen the public’s urgency to get vaccinated. She called it a concern, but noted that children are dying of COVID-19, albeit very rarely, and that long-term complications from infections, also known as “long COVID,” plague even people with mild cases. A recent study from Sweden, for example, found 1 in 10 healthcare workers who had mild cases have felt effects, like loss of smell and taste, fatigue, and breathing problems, for months after.

“We’re going to defang the virus rather than defeat it.”

In this mixed scenario, we dodge a summer surge of deaths, but outbreaks occur in some counties or states. Herd immunity is also never quite reached in this future, because variants circle the globe every year like variations of the seasonal flu. Post–mass vaccination, the coronavirus would then enter a “mild endemic state,” where SARS-CoV-2 is reduced to a childhood cold, said Harvard epidemiologist Marc Lipsitch at the recent Stanford symposium about herd immunity. “We’re going to defang the virus rather than defeat it,” he said. “We’ll make it a nuisance that makes people a bit ill, rather than something that kills people in large numbers and causes the hospital system to groan under the weight.”

A related possibility is that vaccination only delivers immunity for a year or two and requires regular booster shots for older and younger people alike, which the heads of Pfizer and Moderna have told investors might be the case. (On Sunday, Fauci said on NBC’s Meet the Press that the FDA and CDC — not vaccine makers — will decide by fall about boosters.)

“Even if we reach the herd immunity threshold in the US or in rich countries, this virus is going to continue to circulate,” said Lipsitch.

Right now, doses are only promised on the order of hundreds of millions, and the planet is home to 7.8 billion people. The World Health Organization has warned that global under vaccination would be a catastrophic moral failure, prolonging coronavirus transmission around the world.

3. A Worse Ending: A Fourth Surge for the Summer

The better outcomes are far from inevitable. White House officials regularly say that the US is in a race between vaccination and more contagious coronavirus variants. In this scenario, we lose the race. The result: a fourth surge.

The reasons for worry are plain in case numbers that have stopped declining and are instead trending upward again, now averaging around 67,000 newly-reported infections a day. The more transmissible and dangerous B.1.1.7 coronavirus strain is quickly becoming the predominant one nationwide, now accounting for 26% of all new cases.

“We remain in a complicated stage,” the CDC’s Walensky said Monday. “On the one hand, more people in the United States are being vaccinated every single day and at an accelerated pace. On the other hand, cases and hospitalizations are increasing in some areas of the country, and cases among younger people who have not yet been vaccinated are also increasing.”

If the US falls behind on vaccinations, then a second lockdown period might result. Rising hospital admissions could lead governors and mayors to shutter bars, restaurants, and stores once again.

“We are in real risk of throwing away all the gains we have made, and losing another summer,” Debra Furr-Holden, a Michigan State University epidemiologist, told BuzzFeed News.

Her state, as well as the rest of the Upper Midwest and the Northeast, is in the thick of massive outbreaks right now. Some counties reopened bars, gyms, and restaurants too early, Furr-Holden believes, which in her view should serve as a warning to the rest of the country.

Although 74% of US adults say they want a shot, up from half in September, that’s still not enough to achieve herd immunity, some suggest. “We have to get about 80% of adults vaccinated,” said Schaffner, the infectious disease specialist at Vanderbilt. “We’ve never done that with any vaccine in the United States.”

Some areas of the country are also much more resistant to vaccination than others. In states like Tennessee, Kentucky, Alabama, and Mississippi, as many as 37% of people tell pollsters they don’t want a shot. Politics clearly plays a role. Older, rural conservatives express the most hesitation, and their fears are reinforced by misinformation and fearmongering on right-wing cable channels.

“We are running into people who have expressed some hesitancy, so we have to listen to them and address their concerns,” said Schaffner, who is based in Nashville. Walensky acknowledged this week that “the administration of vaccines across the country is not uniform.”

But Andy Slavitt, the senior White House COVID-19 adviser, said he was unwilling to entertain the idea of the federal vaccination campaign shifting doses to parts of the country clamoring for shots and sending less to ones in areas where they go unused. “We are not going to quote-unquote ‘punish’ less-ready areas,” Slavitt told BuzzFeed News during a briefing this week. The key, he said, is to convey to people that while vaccines were hard to get during the initial rollout, there are now more than 60,000 vaccination sites nationwide, and at least one of them is within 5 miles of where 95% of the population lives.

Whether enough Americans will take that message to heart remains to be seen. If not, we may only reach herd immunity after another painful surge.

4. The Bad Ending: After the Summer, Global Variants Revive the Pandemic

Then there’s the worst-case scenario. In a mostly unvaccinated world, a new and more deadly coronavirus variant — or variants — overpowers vaccines and restarts the global pandemic all over again. The US, along with everyone else, has to begin again with new vaccines.

“Coronavirus mutates a lot — they can do it in humans, they can do it in animals — and the question is how important are these mutants going to be,” Stanford University infectious disease expert Julie Parsonnet said at the herd immunity symposium held at her university. “We don’t live just in Palo Alto, or just in California, or just in the United States. We live in a world where there are a lot of unvaccinated people, and as long as we don’t focus on the world more globally, we’re going to have problems.”

For now, the available vaccines are effective against the variants circulating in the US. But experts are surprised at the speed at which more transmissible ones have arisen, said Bhattacharya of the University of Arizona. Their arrival reflects just how widely the coronavirus has spread from host to host, each acting as a lab for new mutations to emerge.

“The places where the variants are growing, they’re not growing because they are evading the immune system, they are going nuts because there aren’t enough people that are immune,” Bhattacharya said. “Obviously this isn’t the best situation, because the longer you let this go, the better the odds that you will get some weird thing that will eventually start to grow out because it can evade the immune system.”

Last week, the White House announced a $1.7 billion effort to detect such new strains. Pfizer, Moderna, and other vaccine makers are already testing prototype booster shots that are designed explicitly against variants, such as the B.1.1.7 strain.

In the face of this threat, a recent risk analysis led by George Ioannou, an expert on veteran care at the University of Washington, offers a framework for who should get prioritized for vaccines. To prevent deaths as much as possible, people with the most severe risk factors, such as diabetes, heart failure, or kidney failure, should be given shots first, this work suggests. At the same time, if there is enough supply, vaccines should be administered as quickly and widely as possible to combat the new variants.

“You really don’t want that threat just hanging around,” Bhattacharya said.

But even in this worst case, the silver lining is that the coronavirus has nevertheless proven amenable to vaccination, he and other experts noted, unlike HIV, which for decades has thwarted vaccines. A coronavirus strain that evades the current vaccines will almost certainly be susceptible to shots that have yet to be designed.

That means vaccines will at some point deliver an end to the pandemic, no matter how many changes in work, school, and daily life it leaves behind, said Yale sociologist Nicholas Christakis, author of Apollo’s Arrow: The Profound and Enduring Impact of Coronavirus on the Way We Live.

“Eventually it will return to normal,” Christakis told BuzzFeed News. “Plagues end — they just do.”

Social Media: A Parasite on Our Pandemic Mental Health

Doctor Vinay Prasad reported that recently, a physician colleague of mine, someone whom I’ve met in person and with whom I’ve shared a laugh, began to tweet increasingly hostile barbs about me. In a certain respect, it was a typical social media interaction — an uncharitable reading of one’s point of view and a scornful reply. But it was also unusual, as we have met in person, face to face.

In my experience, online anger like this is summoned only when the other person has been depersonalized — just a face dissociated from a person. I’d rarely experienced it from someone who I knew in real life. Just as I started to wonder what might be going on, a mutual friend called to say they had seen the out-of-character barbs. Apparently, this colleague has been suffering from a serious medical illness and was going through a hard time. By the end of the call, I was left feeling sympathetic.

Later that day, I noticed that a professor whose tweets I greatly enjoyed had shut down their account. Poof! They, and their astute comments, were gone entirely. I sent them a note, mostly to let them know that I had been affected by their sharp thinking over the years, and was sorry to see them go. The person wrote back that the growing hostility had driven them away. Every time they said anything, they felt mobbed by a sea of increasingly angry voices. They didn’t need the stress.

Finally, the same day, a colleague from another university called me to ask for some advice. She had been on Twitter, and was troubled by increasingly hostile and negative feedback. The specifics were ugly, and I could tell from the tone in her voice that my colleague was pained. I gave the few tips I know and went for a long run to think.

What Is Going On?

In the best of times, social media is a double-edged sword. It is a great way to get a message to many people, but it is de-personal, and driven by the economy of attention. Anger, disgust, and outrage are the emotions that engage and addict the users. People, good people, can become disinhibited and say things they don’t truly mean, or would never say in real life. Of course, this is during the best of times.

We are not in the best of times. People have been cut off from friends, family, and co-workers, and many are living in isolation. In fact, it is the loneliest year in human history. The largest number of people in history (billions) have deprived themselves of, at least some, social interactions. Mental health is suffering, and physicians, healthcare workers, researchers are suffering alongside everyone else. When we are tired and angry we are not our best selves, and paired with the algorithms of social media, it is a recipe for disaster.

Where Are We Now?

Every day people go online and the difficulties of the last year loom large in our minds — over 500,000 dead Americans, disjointed and often incoherent policy responses, the list goes on. Some are angry that we didn’t do more, sooner. Others are angry about interventions and restrictions that were broadly implemented that might not have helped, and even hurt. Both groups might be right: we were unwilling to do some things that might have helped, and simultaneously pursued other interventions that didn’t, and unfortunately hurt less-fortunate Americans. It will take years to tease these apart, as I have written. Regardless, we are angry. So, we go online looking to vent that anger. If we felt the bigger error was not enough restrictions, we get angry when someone is critical of restrictions. And if vice versa, we find a different scapegoat. A philosopher recently told me, we get most angry when other people don’t follow restrictions that we are able to follow.

The angry train goes off the rails when we invent motivations for others. Folks who share our point of view are always good people who want to save lives, and folks who disagree with us are people indifferent to human beings, grifters, ideologues, or attention-seekers. But, if one steps back, how can that possibly be? Surely people on all sides of an issue — whether that be school reopening or best vaccination practices — have varied reasons for holding their view. A tiny fraction may have some ulterior motive, but surely the vast majority hold their view for the same reason folks who disagree hold their view — an alternative interpretation of facts and values. I suspect a year from now the idea that the world is full of strictly good and bad people will look particularly ridiculous.

How Can We Make It Better?

I don’t know how we can improve the situation on social media, and more critically, reverse the anguish so many are facing in real life — but I do have some tips about how we might help ourselves.

1. Get offline. The professor who deleted their account had the right idea. Each of us has to decide if social media serves our purposes and makes us better informed or happier, but probably all of us should use it less. Read it less, and post less.

2. Mute all notifications. I did this a few years ago, and I quickly found more joy in my life. Say what you have to say, and let it go. No need to reply to anyone, and the easiest way is to set the accounts to never disturb you again.

3. Don’t reply to others. If you read a point of view you disagree with, what value is there in replying to the other person? Just state your point of view in your terms on your feed. No need to pick a fight. Just make your point on your terms.

4. If you are having a hard time at home or work, don’t use social media. It is hard enough to manage when you wake up in a good mood, but when you are feeling tired, scared, afraid or sick, it is too much. Corollary: If you love someone, and they are hurting, suggest they do the same.

5. Meet or call someone every day. Social media thrives from our loneliness — it’s a cheap way to feel less lonely in the loneliest year of human history. But it is a neon light to the sun. Call someone. Visit someone. Interact more in real life.

6. Tell someone you don’t know you appreciate their thoughts. Perhaps the best thing we can do to combat negative emotions is to give some positive feedback to folks we appreciate. I have sent some emails to people, but perhaps I am not thinking big enough. I plan to go on social media and talk openly about people whose thinking delighted me over this last year. It is the least I can do to combat the animosity.

Toward More Productive Dialogue

When we are feeling powerless, getting angry at someone is seductive. It is a way to channel and reorient your energy. Unfortunately, it leaves all involved worse off. Instead, consider using your energy to articulate or refine your perspective, to push for positive change. That doesn’t mean that there are not real errors — but jumping on a single tweet by a minor character in a drama is unlikely to be the change-maker. My tips are just suggestions, but all meant to re-orient the compass toward productive dialogue.

Scientists Reveal How the AstraZeneca Vaccine Causes Unusual Clots

Brenda Goodman reported that scientists in Germany say they’ve worked out the two-step mechanism by which the AstraZeneca vaccine causes rare but devastating blood clots that gobble up the body’s supply of platelets.

So far, European regulators have reported more than 220 cases of unusual blood clots and low levels of platelets in patients who received the vaccine, called Vaxzevria, which was developed with funding from Operation Warp Speed as part of the race to develop a suite of vaccines to protect people from COVID-19. Vaxzevria has not yet been authorized for use in the United States.

“This is, in my opinion, rock-solid evidence,” said Andreas Greinacher, MD, head of the Institute of Immunology and Transfusion Medicine, University Hospital Greifswald, Germany, who was among the first scientists in the world to link the rare clots to antibodies against the platelet factor 4 protein.

Greinacher said he found the same mechanism using three different technologies to gather evidence: dynamic light scattering, super-resolution microscopy, and electron microscopy.

“This is what scientists usually think is confirmatory evidence,” he said in a call with reporters hours after publishing his study as a preprint ahead of peer review on the Research Square server.

Greinacher said he felt an urgent need to get the information out as soon as possible. He said his team had worked around the clock for 5 weeks to get answers, “because we are in the middle of the vaccination campaign. This was the driving force for us and the big motivation to provide these data as fast as any other possible,” he told reporters on the call.

Greinacher said that he believes the mechanism linking the vaccine with the rare clotting reactions is likely to apply to other vaccines that also use adenoviruses to ferry instructions for making the virus’s spike protein into cells.

“My assumption is, and that’s a hypothesis, that this is a class effect of vaccines using adenovirus,” he said. He added that he could not be certain because he only studied reactions to the Vaxzevria vaccine. But previous studies have shown that adenoviruses can cause the type of platelet activation he saw in the reactions he studied.

Greinacher said that he had worked out an agreement with Johnson & Johnson about an hour before the call to collaborate on studying its COVID-19 vaccine. The company had previously been unwilling to share information, he said.

At least seven cases of the same pattern of unusual clots have been documented in people who received the one-dose Johnson & Johnson vaccine, which also uses an adenovirus as its delivery vehicle. Over 7 million Johnson & Johnson vaccines have been given in the United States so far.

While the reactions are extremely rare, they can be serious. One person, a 45-year-old woman in Virginia, has died. That led the US Centers for Disease Control and Prevention and the US Food and Drug Administration to call for a pause on administering the Johnson & Johnson vaccine last week. The company also announced that it would hold clinical trials to get more answers about the reactions.

In his new study, Greinacher and colleagues describe a cascade of events that has to happen in the body before the vaccines broker these large clots. He explained that while everyone has the basic immune machinery that leads to the unusual clots, it is almost always kept in balance. The body uses a series of checks to prevent any step in the process from getting out of control.

In some cases, however, there’s a perfect storm where each stage progresses to the next and the end result is very hard to control. That autoimmune attack, which causes the body to go into a hyper-clotting state, typically burns itself out after a few weeks. So if patients can get rapid treatment, the condition nearly always goes away.

He said he only knew of one case of an autoimmune syndrome like this lasting 10 years, but that was in a patient who had taken the blood thinner heparin, which can cause a nearly identical syndrome.

Two-Step Process Leads to Clots

In the first step, the adenovirus shell in the vaccine, along with proteins from the cells where the vaccine is grown, come into contact with platelets from the blood.

Platelets are best known as colorless cell fragments that rush to the site of an infection or injury, helping the blood congeal to stop bleeding; they also play a key role in the body’s immune response.

When activated, they surround invaders like bacteria and change shape to release chemical signals they store in granules.

When platelets are activated en masse, as can happen rarely after a person takes the blood thinner heparin or gets the Vaxzevria vaccine, they release a flood of these signals, Greinacher explained. These blaring signals recruit an ancient and hard-to-control branch of the immune response.

“Imagine this is like a dragon in the cave who was sleeping for a long time [but] which now got alerted by someone’s throwing a stone on it,” he said. The chemical signals awaken B-cells that then produce massive amounts of antibodies against the platelet factor 4 protein, which helps coordinate blood clotting.

The body erroneously thinks it is reacting to massive amounts of pathogens in the body, so the immune system overshoots. The antibodies bind the platelets, the platelets recruit white blood cells, and “then the whole thing is exploding,” he said.

The second key step in these reactions is caused by EDTA, a calcium-binding agent and stabilizer that is added to the Vaxzevria vaccine.

EDTA is not listed as an ingredient in the Johnson & Johnson vaccine.

EDTA opens junctions between cells that form the walls of blood vessels, causing them to become leaky. This allows the giant complexes formed by proteins and platelets to enter the blood circulation, where they — on very rare occasions — trigger that bodywide alarm.

Asked if he thought there was anything that could be done to make the vaccine safer, Greinacher said his first thought would be to try to get rid of the EDTA, which causes the second step in the process. But he said he was not a vaccine developer and didn’t know how important it might be to its formulation.

Why might the Johnson & Johnson vaccine lead to similar types of clots, even though it doesn’t contain EDTA? Greinacher speculated that size might play a role.

When this reaction occurs in patients who have taken heparin, the size of the heparin molecule matters. With unfractionated heparin, the longest kind of molecule, the reaction is 10 times more common than when patients take smaller low-molecular weight heparins.

Other vaccines might form smaller antibody-protein complexes that generate smaller warning signals, making the reaction less likely.

As for why the reaction appeared to be more common in women, Greinacher said he was growing skeptical that there is a large gender bias. He pointed out that most of the first vaccine recipients in Europe had been healthcare workers, who are disproportionately women.

He noted that women might be slightly more susceptible because of hormones and because women are more likely to develop autoimmune diseases, but that the risk was probably more balanced between men and women than it first seemed.

“It’s not a disease of young women,” he said.

Several European countries have changed or abandoned their use of the AstraZeneca vaccine.

Last week, Denmark said it would no longer include Vaxzevria as part of its vaccination program. Italy has recommended that AstraZeneca vaccine only be used in people over age 60. UK officials said people under age 30 should be offered an alternative.

Meanwhile, the European Medicines Agency said a warning about the risk of blood clots and low platelets should be added to product information for the Johnson & Johnson vaccine.

ACIP Green-Lights J&J Vax for All Adults

Finally, Molly Walker reported that the pause is lifted, and Johnson & Johnson’s COVID-19 vaccine is once again recommended for adults, according to the CDC’s Advisory Committee on Immunization Practices (ACIP).

In a 10-4 vote, with one abstention, ACIP said in updated interim guidance that the Johnson & Johnson vaccine is recommended under FDA emergency use authorization (EUA) for all adults.

They ultimately decided that including a separate warning on the vaccine, as well as in an FDA EUA fact sheet and materials on the CDC website, was sufficient. One choice the committee chose not to vote on would have added language that women under age 50 should be aware of the increased risks of rare clotting events, and may opt for a different authorized COVID-19 vaccine. The committee agreed that any further qualifiers would be too cumbersome for local jurisdictions to implement and might contribute to vaccine hesitancy.

Johnson & Johnson researchers unveiled a proposed warning that the FDA agreed to add to the vaccine’s current EUA. It warns about the risks of thrombosis with thrombocytopenia syndrome (TTS), and recommends that clinicians consult with the published American Society of Hematology guidance for diagnosis and treatment of the condition.

ACIP member Grace Lee, MD, of Stanford University School of Medicine, said that putting a qualifier for any demographic group would be “extremely confusing,” because every ACIP recommendation “is a benefit/risk balance.”

The committee believed that the benefits of one-dose vaccination outweighed the risks, as it makes this vaccine available for vulnerable populations, including people experiencing homelessness, incarcerated populations, and home-bound populations.

The “no” votes came from members who felt that younger women would not be adequately informed about the risks of this rare adverse event by a warning label and EUA fact sheet.

“I did not object to the recommendation. I objected to the absence of any kind of guidance from us,” said ACIP member, Sarah Long, MD, of Drexel University College of Medicine in Philadelphia. “This is an age group that is most at risk and is getting the vaccine predominantly to save other people’s lives. I’m very sorry we haven’t chosen to put up front the knowledge we have that … there are options.”

ACIP chair, José Romero, MD, ultimately voted yes, but added that he thought there was a bit of a “selective interpretation” in terms of how much younger women would be informed. He urged vaccination sites to have a second vaccine available so that younger women are not forced to shop for vaccines.

“These events are rare, but they are serious,” Romero said.

The American Medical Association (AMA) reiterated their support for the Johnson & Johnson vaccine and pledged to help inform patients about the rare adverse events.

“The AMA will continue to work with the FDA and the [CDC] to ensure physicians and patients are aware of the rare, but increased risk of [TTS] in women under the age of 50, as well as the appropriate treatment, so they can act quickly,” said AMA president Susan Bailey, MD, in a statement.

On April 13, CDC and FDA agreed to a “pause” on use of Johnson & Johnson’s COVID-19 vaccine out of an abundance of caution. At that point, there were six cases of cerebral venous sinus thrombosis (CVST) with thrombocytopenia, one fatal. ACIP met on April 14, but agreed to wait to vote until more data accrued on the available cases, including potential risk factors.

As of April 21, the number of cases rose to 15, with three deaths. Seven patients remain hospitalized, including four in the ICU, while five were discharged home.

Thirteen of these cases were in women ages 18-49, with two in women older than 50. Based on these data, Tom Shimabukuro, MD, of the CDC, estimated that the rate of TTS was 7.0 per million doses in younger women, and 0.9 per million in older women. Seven cases of 15 were among women ages 30-39.

While all cases were in women, Shimabukuro noted that some data were still under review, “including potentially male cases,” although as of now, there were no cases reported in men.

Median patient age was 37, with a median time to onset of 8 days following vaccination. While 12 cases were CVST, three were other forms of thrombosis. Seven patients had obesity, while two patients apiece reported oral contraceptive use, hypothyroidism, or hypertension. No patients had established coagulation disorders.

All patients had thrombocytopenia, with 10 patients having severe thrombocytopenia, or platelet levels under 50,000. Of the 11 patients where a platelet factor 4 heparin-induced thrombocytopenia ELISA antibody test was performed, all were positive. Four patients did not have available results. Seven patients with CVST experienced intracerebral hemorrhage.

Non-heparin anticoagulants were used to treat 12 patients and intravenous immunoglobulin to treat eight patients, while platelet transfusion was used for seven patients and heparin for six patients. Shimabukuro noted that the six patients received heparin prior to the CDC Health Alert about treating this condition.

Shimabukuro said that cases under investigation may increase, as researchers plan to broaden their case definition to harmonize with the draft Brighton Collaboration case definition for TTS. This could include other thrombotic events, including venous thromboembolism, deep vein thrombosis, pulmonary embolism, ischemic stroke, and acute myocardial infarction.

As I try to conquer my depression in my interaction with some of my patients who refuse to get vaccinated, I wonder if we, our country will ever reach herd immunity as Israel has accomplished. I am trying to figure out whether it is worth keeping these patients in my practice due to my concern for my staff, my other patients and our families.

Please get vaccinated!!

U.S. Hits Highest 1-Day Toll from Coronavirus With 3,054 Deaths, Hospitalizations and Answers to the Questions About the Vaccines

I have rewritten this post about 15 times but finally decided with the approval of the Pfizer vaccine for emergency use that I needed to answer a number of questions. So, here we go.

Vanessa Romo reported on the Covid Tracking Project and found that the coronavirus pandemic has pushed the U.S. past another dire milestone Wednesday, the highest daily death toll to date, even while the mortality rate has decreased as health experts learn more about the disease.

The Covid Tracking Project, which tracks state-level coronavirus data, reported 3,054 COVID-19 related deaths — a significant jump from the previous single-day record of 2,769 on May 7.

The spread of the disease has shattered another record with 106,688 COVID-19 patients in U.S. hospitals. And overall, states reported 1.8 million tests and 210,000 cases. According to the group, the spike represents more than a 10% increase in cases over the last 7 days.

Additionally, California nearly topped its single-day case record at 30,851. It is the second highest case count since December 6, the organization reported.

The staggering spike in fatalities and infections has overwhelmed hospitals and intensive care units across the nation, an increase attributed by many experts to people relaxing their precautions at Thanksgiving.

New Data Reveal Which Hospitals Are Dangerously Full. Is Yours?

Audrey Carlsen reported that Health care workers at United Memorial Medical Center in Houston face another full-throttle workday last week.

The federal government on Monday released detailed hospital-level data showing the toll COVID-19 is taking on health care facilities, including how many inpatient and ICU beds are available on a weekly basis.

Using an analysis from the University of Minnesota’s COVID-19 Hospitalization Tracking Project, NPR has created a tool that allows you to see how your local hospital and your county overall are faring. 

It focuses on one important metric — how many beds are filled with COVID-19 patients — and shows this for each hospital and on average for each county.

The ratio of COVID-19 hospitalizations to total beds gives a picture of how much strain a hospital is under. Though there’s not a clear threshold, it’s concerning when that rate rises above 10%, hospital capacity experts told NPR.

Anything above 20% represents “extreme stress” for the hospital, according to a framework developed by the Institute for Health Metrics and Evaluation at the University of Washington.

If that figure gets to near 50% or above, the stress on staff is immense. “It means the hospital is overloaded. It means other services in that hospital are being delayed. The hospital becomes a nightmare,” IHME’s Ali Mokdad told NPR.

At Hospitals, A Race to Save ‘Hundreds of Thousands’ Of Lives with New Vaccine

Sarah McCammon noted that lately, Jon Horton has been dreaming about freezers.

“I was opening the freezer and I was taking something out of the freezer and putting it in something else,” Horton said. “And it was just like — whew!”

And not just an ordinary freezer. Horton is pharmacy operations director at Sentara — a health care network based in Norfolk, Va.

Sentara officials are working out every detail of the logistics involved in rolling out the coronavirus vaccine from Pfizer, which has to be kept at nearly minus 100 degrees Fahrenheit or risk losing effectiveness.

“At a certain point, you’re just trying to figure out what needs to be done next,” Horton said during an interview with NPR at Sentara Norfolk General Hospital. “So, you’re focusing on this process, and as you open up that door, you learn a little more.”

As federal regulators prepare to meet Thursday to consider whether they’ll approve Pfizer’s brand-new coronavirus vaccine, employees like Horton are preparing to receive the vaccine at hospitals around the United States.

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The Sentara health system has four of the ultracold freezers that the vaccine requires, including one obtained through collaboration with a local medical school.

“We usually just deal with freezing temperatures, you know, a typical freezer,” said Tim Jennings, Sentara’s chief pharmacy officer. “That’s why we had to actually go out and acquire a special freezer for this.”

For sites that don’t, there’s dry ice. Jennings opens a big blue bin full of it, which resembles white “cheese doodles,” he notes.

There’s little room for error here: The vaccines must be monitored to make sure the temperature is stable each step of the way. And they’re in short supply right now; the first shipment from Pfizer is expected to include only about 72,000 doses for all of Virginia, a state of more than 8 million people.

Michelle Hood, chief operating officer at the American Hospital Association, said health care administrators across the country are gearing up for a major logistical undertaking.

“We’ve never done anything like this as a country or in the world, as significant as this exercise is,” Hood said. “And everything is new.”

The first vaccines will go mostly to front-line health care workers at the highest risk of exposure.

That’s where Mary Morin, a vice president in charge of employee vaccination at Sentara, comes in. She has a lot to think about as well.

“I did wake up last night and I’m going, ‘Oh, my God,’ ” Morin said.

Morin, whose background is as a registered nurse, has to turn Centers for Disease Control and Prevention guidelines about who should be first in line for the coronavirus vaccine into a real-life plan for her hospital workers.

“A front door to the hospital is the emergency department. You may have a security guard there. They’re patient facing. They’re forward facing,” she said. “So, it’s the staff — it isn’t just the nurses and the physicians.”

Unlike the flu shot, Sentara officials say, the coronavirus vaccine will be optional for staff. Large studies indicate the Pfizer vaccine is about 95% effective with few side effects. But it’s brand-new, and convincing people to take it may be a challenge.

The challenge ahead for hospital staff members like Jennings is making sure the vaccine is properly stored and administered to those who are willing and able to take the first doses. If the vaccine receives federal approval, officials say it could start being given to health care workers within days.

“We realize if we do this right, we could save thousands of lives,” Jennings said, “if not hundreds of thousands.”

The Covid-19 Vaccine: When Will It Be Available for You?

I was included in the set of clinical trials for the COVID-19 vaccine. But I was just notified that I was being “kicked out” due to the fact that the Committee wanted to make sure that I was vaccinated and not having the possibility of being given the placebo as per the trials due to the fact as a physician I am seeing cancer patients daily.

Vaccines, especially as one is already approved by the FDA and the other should be approved for emergency use this coming week.

I thought that I would review a number of questions that many have regarding the new vaccines.

First U.S. rollouts of doses could start in December, with health-care workers, older Americans likely to take priority

Peter Loftus and Betsy McKay reported that Pfizer Inc.  and its partner, BioNTech SE, have asked the U.S. Food and Drug Administration to authorize use of their coronavirus vaccine, and an FDA decision could come as soon as this weekend. Moderna Inc.  has made a similar request for its shot, and other vaccines could follow. The first rollouts could begin within days.

Here is what we know and don’t know about how, and when, the vaccine will get to you.

How will the Covid-19 vaccines be approved, and who decides who will get them?

The FDA will determine whether to authorize Covid-19 vaccines for use. An FDA advisory committee of outside experts voted Thursday in favor of Pfizer’s request for authorization of its vaccine. The FDA is expected to decide imminently.

The FDA has scheduled a Dec. 17 advisory committee meeting to consider Moderna’s request for authorization. A separate advisory committee to the U.S. Centers for Disease Control and Prevention has voted to recommend that health workers and residents of nursing homes and other long-term care facilities be first in line for the limited number of doses. The same committee will hold additional votes on which groups should be next in line. But governors can make the final call within their states.

How will the vaccines be distributed?

The federal government has a contract with McKesson Corp. to be a centralized distributor of Covid-19 vaccines, with the exception of Pfizer’s. Pfizer has set up its own distribution network. Federal health officials say initial doses would be shipped within 24 hours of any FDA authorization, and immunizations could begin within about 48 hours. The federal government also has partnerships with national pharmacy chains CVS and Walgreens to vaccinate residents and staff at long-term care facilities.

Some experts say it could take more than 48 hours for dosing to begin, as hospital workers and others get used to procedures for opening specialized, temperature-controlled boxes of vaccine vials and learn the risks and benefits of the shots.

“Many providers are going to need a few days to get it up and running, if not a week,” said Claire Hannan, executive director of the Association of Immunization Managers, whose members run state, territorial and local vaccination programs.

What logistics are in place to deliver the vaccines?

McKesson, the centralized distributor for vaccines other than Pfizer’s, also will receive and package kits of medical supplies needed to administer the Covid-19 vaccine, such as needles and syringes and alcohol prep pads. It will send the kits and vials of the vaccine out to pharmacies, doctors’ offices and other facilities, at a minimum of 100 doses per order, based on order information supplied by the CDC.

Pfizer plans to use its own distribution centers and ship its vaccine in specially designed reusable containers that can keep thousands of doses at the ultracold temperatures required for it.

How many doses will be available at first?

The initial expected supply of Pfizer’s vaccine after authorization is about 6.4 million doses, according to Gen. Gustave Perna, chief operating officer of the U.S. government’s Operation Warp Speed initiative.

Of this, about 2.9 million doses will be shipped within 24 hours. A federal official said Wednesday that an additional 2.9 million doses would be held back and shipped about three weeks later for those initial vaccine recipients to get the second of the two-dose regimen. Another 500,000 doses from the initial supply would be held in reserve in case any problems arise, the official said. If Moderna’s vaccine is authorized, officials estimate the initial allocation will be about 12.5 million, which may also be sent in separate shipments to accommodate the second injection.

Including that initial supply, federal officials have estimated there would be enough doses to vaccinate 20 million Americans in December.

How many doses will be available next year?

Federal officials have estimated there could be enough to vaccinate about 30 million people in the U.S. in January and then about 50 million in February, with more in the months following. Globally, Pfizer expects to produce up to 1.3 billion doses in 2021 and Moderna expects up to 1 billion.

Who will get the first doses?

The first doses will likely go to health-care workers and residents of nursing homes and other long-term care facilities, which together number about 24 million. After that, the CDC vaccine advisory committee is considering recommending that essential workers such as teachers, police and food workers get vaccinated, followed by adults with underlying conditions that put the at high risk, and seniors age 65 and older.

The committee hasn’t completed its recommendation beyond the first phase, and decisions on which groups get vaccinated when could depend in part on the particular vaccine and what its data show about effectiveness among different age groups or health conditions.

Is there any debate about who should get vaccinated first?

Yes. Some health officials and experts believe health-care workers should be vaccinated first, while others are advocating for the most vulnerable—older Americans—to be first in line. And some state governors have singled out occupations such as teachers that should be at or near the top of the list. There is a similar debate about whether non-health-care essential workers such as teachers and police should be ahead of adults with high-risk medical conditions and people age 65 and over who aren’t in congregate settings.

When can the general public expect to have access?

Secretary of Health and Human Services Alex Azar said he expects there to be enough vaccine doses starting in the second quarter of 2021 so that anyone who wants a vaccine can get it. Other federal health officials have said in the spring or summer. The timeline could change if manufacturing doesn’t go as planned.

How will vaccine doses be allocated to U.S. states?

For the initial supplies, the federal government plans to allocate doses to states proportionally based on the size of their adult populations. It is unclear how long the federal government would stick with population-based proportions and how it would allocate supplies later.

How do states decide to distribute doses?

State, territorial and some local immunization programs, working with the CDC, have drawn up plans to distribute doses within their jurisdictions and to conduct vaccination campaigns. These plans include identifying facilities where vaccination campaigns can be conducted, enrolling them and ensuring the necessary equipment is in place to conduct them. States also have estimated their populations of high-priority groups like health-care workers.

Does the vaccine work the same way in all population groups?

Pfizer and Moderna haven’t yet provided full breakdowns of vaccine efficacy by age and race or ethnicity, but the companies have said efficacy was consistent across these groups.

Does everyone get the same dose regardless of age or other demographic?

Yes.

Coronavirus Daily Briefing and Health Weekly

How many people need to get vaccinated to stop the pandemic in the U.S.?

Moncef Slaoui, chief adviser to Operation Warp Speed, has said if 70% of the population were immunized, that level would achieve herd immunity, based on the approximately 95% effectiveness of both the Pfizer and Moderna vaccines.

A vaccine would need to be at least 80% effective, with about 75% of a population receiving it, to extinguish an epidemic without any other public-health measures, according to a study published in October in the American Journal of Preventive Medicine.

Reaching those levels of immunization would require educating millions of Americans about the safety and effectiveness of vaccines and confronting a strong antivaccine movement, said Peter Hotez, a vaccine scientist at the Baylor College of Medicine and an author of the paper. Those are steps the government hasn’t taken yet, he said. “To use a vaccine to eliminate this virus—it is a really high bar,” he said.

One open question is how effective the vaccines are at preventing people from transmitting the virus to others, Dr. Hotez said. Both vaccines were tested primarily for their effectiveness at preventing people from becoming ill. They are expected to be evaluated for effectiveness at preventing infection regardless of symptoms, but those data haven’t been released yet.

What is herd immunity?

Epidemiologists estimate that between 60% and 70% of a population needs to develop an immune response to the virus to reach “herd immunity,” a state in which enough people have either been infected or vaccinated to stop transmission of the virus. Some epidemiologists say herd immunity to Covid-19 might be achieved at a lower threshold of 50%.

When the vaccines are widely available, how will I get the shot?

Federal officials say they want to make getting a Covid-19 vaccine as easy as going to a pharmacy to get a flu shot. The government has formed partnerships with about 60% of U.S. pharmacies to administer Covid-19 vaccines to the broader population after high-priority groups are vaccinated. Manufacturers would ship doses to distributors to get them to hospitals, pharmacies, nursing homes and other administration sites, as determined by state and federal plans. Pfizer’s vaccine requires ultracold shipping and storage, while Moderna’s can be shipped at higher—though still freezing—temperatures. After thawing, doses can be kept in refrigerators for certain periods.

How many doses will I need?

Vaccines from Pfizer, Moderna and AstraZeneca PLC are given in two doses, three or four weeks apart. Federal and state officials are planning to issue reminders to people to come back for their second doses. A Johnson & Johnson vaccine is being tested as a single dose, but the company hasn’t yet reported how well that works.

How much does it cost? Will insurance cover it?

Both the Trump administration and President-elect Joe Biden have said the vaccine would be free of charge to all Americans, with administration fees billed to private or government insurance plans or to a special government relief fund for the uninsured.

Does it have to be a needle?

The vaccines closest to authorization are given as injections. Merck & Co. is exploring an oral formulation of a Covid-19 vaccine, but it isn’t expected to be available in the near term.

Should I get a vaccine if I’ve already been infected?

You can still benefit from the vaccine, the CDC says. Scientists don’t yet know how long someone is protected from getting sick again once they have had Covid-19. There is some evidence that natural immunity doesn’t last long.

How long does immunity last after vaccination?

The median follow-up period in the large clinical trials was only about two months after vaccination, so it isn’t yet known how long protection will last beyond that.

Will my child be able to get vaccinated? Has it been tested in children?

Children likely won’t get vaccinated until later because they are much less likely to have severe Covid-19 than adults. Pfizer has requested U.S. authorization of use of the vaccine in people 16 and older. Pfizer and Moderna have started to test the vaccine in children as young as 12, and other companies also plan to test their Covid-19 vaccines in children.

Can I stop wearing a mask after getting a COVID-19 vaccine?

Moncef Slaoui, head of the U.S. vaccine development effort, has estimated the US could reach herd immunity by May, based on the effectiveness of the Pfizer and Moderna vaccines if enough people are vaccinated

Can I stop wearing a mask after getting a COVID-19 vaccine?

No. For a couple reasons, masks and social distancing will still be recommended for some time after people are vaccinated.

To start, the first coronavirus vaccines require two shots; Pfizer’s second dose comes three weeks after the first and Moderna’s comes after four weeks. And the effect of vaccinations generally isn’t immediate.

People are expected to get some level of protection within a couple of weeks after the first shot. But full protection may not happen until a couple weeks after the second shot.

It’s also not yet known whether the Pfizer and Moderna vaccines protect people from infection entirely, or just from symptoms. That means vaccinated people might still be able to get infected and pass the virus on, although it would likely be at a much lower rate, said Deborah Fuller, a vaccine expert at the University of Washington.

And even once vaccine supplies start ramping up, getting hundreds of millions of shots into people’s arms is expected to take months.

Fuller also noted vaccine testing is just starting in children, who won’t be able to get shots until study data indicates they’re safe and effective for them as well.

Moncef Slaoui, head of the U.S. vaccine development effort, has estimated the country could reach herd immunity as early as May, based on the effectiveness of the Pfizer and Moderna vaccines. That’s assuming there are no problems meeting manufacturers’ supply estimates, and enough people step forward to be vaccinated.

FDA panel endorses Pfizer coronavirus vaccine for emergency use.

Thomas Barrabi reported that the U.S. Food and Drug Administration advisory panel voted Thursday to endorse the Pfizer-BioNTech coronavirus vaccine, clearing the way for FDA leaders to authorize emergency mass distribution amid an ongoing surge of COVID-19 cases across the country. And Friday it was official that the Pfizer vaccine is approved for emergency use.

Vaccine shipments would begin within hours of the FDA’s decision, which could come by as early as Friday, with the first vaccinations to follow soon afterward. Pfizer’s vaccine will be available in limited quantities, with initial doses earmarked for frontline health care workers and high-risk patients.

In November, Pfizer announced that its coronavirus vaccine was 95 percent effective and has not displayed any major side effects.

The advisory panel, comprised of outside experts, based its decision on data from clinical trials. Members were asked to vote on “whether the benefits of the Pfizer-BioNTech COVID-19 Vaccine outweigh its risks for use in individuals 16 years of age and older” based on the totality of available evidence.

Some committee members raised concerns about the wording of the question and whether trials have provided enough information regarding the vaccine’s effects on people aged 16 and 17 years old. The committee opted to vote on the question as it was originally worded.

Of the committee’s 23 members, 17 voted to recommend the vaccine and four voted against the recommendation. One member abstained in its endorse

Pfizer is one of several companies in the final stages of development. The FDA is expected to decide whether to approve a vaccine developed by Moderna for mass use later this month. Johnson & Johnson and AstraZeneca also have vaccines in the works.

More than 290,000 Americans have died from COVID-19 since the pandemic began. More than 15.4 million cases have been reported.

Convincing people to get COVID vaccine is vital — here’s how to do it

Dr. Austin Baldwin and Jasmin from Fox News makes us aware that the decision by the Food and Drug Administration Friday night to issue an emergency use authorization for Pfizer’s COVID-19 vaccine is a critical breakthrough in the battle against the disease that has infected more than 15.7 million Americans and killed nearly 300,000.

The FDA ruling that the Pfizer vaccine is safe and effective is just a first step in a massive rollout of the vaccine. Now the enormous task of distributing the vaccine around the nation begins.

But a crucial obstacle to widespread vaccinations will be public hesitancy to take the vaccine, driven by doubts, fears, and misinformation spreading throughout the nation and the world.

The same challenge will face other vaccines now awaiting approval in the U.S. and vaccines distributed globally. Gaining public acceptance for the Pfizer vaccine and other vaccines is vital, because we won’t end the worst global health crisis in a century until the majority of the world’s 7.7 billion people are vaccinated against COVID-19. The disease has infected more than 70 million people around the world and killed nearly 1.6 million.

Behavioral science will be as important to vaccine acceptance as basic science was to vaccine development. If government and health care leaders take the right approach to educating the public about the vaccines, we can create a pathway for the public to assess options and choose to get vaccinated. Given the accelerated development of the Pfizer vaccine and other vaccines not yet approved, convincing people that the vaccines are safe and effective is critical.

The World Health Organization identified vaccine hesitancy as a top global health threat in 2019 — just months before the COVID-19 outbreak. An Axios-Ipsos survey found that only half of Americans say they are likely to get a COVID-19 vaccine as soon as it is available. These numbers are even lower among African Americans, at just more than a quarter. Why?

Historically, minority communities have been suspicious of new health technologies and biomedical research due to past unethical experimentation on African Americans and Native Americans.

Given that African Americans are hardest hit by COVID-19, public health officials must respond to these concerns. Beliefs in vaccine conspiracies and rumors that the government is cutting corners in testing and development must also be addressed if we are to achieve herd immunity, the threshold of 70 percent of the population needed in order for person-to-person transmission to be largely eliminated.

As plans are developed to roll out the Pfizer vaccine and later other COVID-19 vaccines throughout the nation, public health officials and other health care leaders should consider three steps.

Transparency to build trust

Leaders at all levels of government and the health care community must be upfront that science is always evolving and that knowledge about the vaccines will continue to accumulate.

Communications should stress that the Pfizer vaccine and the Moderna vaccine (not yet approved) are 90 to 95% percent effective. It’s also important to emphasize that while the development, testing, and approval processes for vaccines have been accelerated, no steps were skipped.

When people are asked if they’re willing to get a vaccine that is “more than 90% effective” or one that has been “proven safe and effective,” willingness to be vaccinated increases to 65 to 70%.

Transparency also means being upfront about potential side effects of vaccines. These include possible arm soreness (as with most vaccines) and possible fatigue a day or two after vaccination. If people expect knowledge to evolve and believe public health leaders will be upfront, reports of new side effects are less likely to undermine confidence and trust.

 Active engagement with vaccine information

Communications about the vaccines should pose questions such as: “How will my family and I benefit from the vaccine?” or “If I don’t get a vaccine and then later get COVID-19, to what extent would I regret that decision?”

Such questions lead people to more actively engage with the information rather than simply being told that the vaccine is safe.

We took this approach when we developed an app and website to address parental hesitancy about the HPV vaccine among diverse populations. We are now working to adapt this approach to provide information on COVID-19 vaccines.

Interactive technology makes it more likely that people will become engaged in the decision to be vaccinated and be motivated to follow through to get the required second dose. 

Meeting different informational needs and styles of decision-making among people 

Some people will want detailed information to weigh the scientific evidence before being vaccinated against COVID-19. Others will want information mediated through a trusted source, like health care providers, faith-based leaders and public figures.

To accommodate different needs and maintain transparency, educational materials should provide information in a stepped manner. Basic information from trusted sources is presented first. This is followed by more detailed information using different media such as print, video and formats such as personal stories and graphics to explain numbers and risk.

Websites and apps that enable people to navigate to their level of desired information provide another level of empowerment. We found our app’s stepped approach led previously hesitant parents to be 2.5 times more likely to decide in favor of the HPV vaccine.

Our major investments in vaccine development and testing will fall short of achieving their potential impact unless the public takes the COVID-19 vaccines. We must work proactively to communicate better than ever before.

So, as I have said before about the flu vaccine, if it is offered to you, get the COVID-19 vaccine and be part of the solution to ending this Pandemic.

And wear the Damn MASKS, as Governor Hogan keeps telling us!

Trump health officials “not aware” of how he would replace Obamacare; and what about the Vaccines?

Trump health officials “not aware” of how he would replace Obamacare; and what about the Vaccines?

It is truly amazing how out of touch the GOP and, I believe President Trump is, on health care, especially “after” or during this COVID pandemic. Consider the amount of monies spent on caring for the millions of patients diagnosed with COVID-19. One must remember that due to the EMTALA Act, which ensures public access to emergency services regardless of ability to pay. Think of all the COVID testing and ICU care that has been provided for all that needed it. This experience, etc. should convince, even the clueless that we need a type of universal health care policy.

They, the GOP and the President, promised us all that they would create, provide a wonderful healthcare for all, better than Obamacare. But have they? No!

And now is the time to produce a well-designed alternative, or consider Obamacare as a well thought out program, except for the lack of financial sustainability. And guess what happened after I had a phone call with a member of the Trump administration. He asked me what I thought Trump’s chances of winning re-election. I responded that I thought he had about a 20% chance of getting re-elected. He pressed me as what I thought that would increase his chances. My response was to finally reveal their, the GOP/Trump’s

, plan and I suggested that they should adopt the Affordable Care Act but outline a plan to sustainably finance the healthcare plan.

My suggestion- embrace the Affordable Care Act as a good starting point and use a federal sales tax to finance it instead of putting the onus on the young healthy workers.

 At a hearing on the coronavirus response, Senator Dick Durbin asked the Trump administration’s top health officials about the president’s comments touting a plan to replace the Affordable Care Act, also known as Obamacare. They said they did not know about such a plan.

And a Republican victory in Supreme Court battle could mean millions lose health insurance in the middle of a pandemic.

John T. Bennett noted that Ruth Bader Ginsburg, Barack Obama, Donald Trump and Mitch McConnell could soon be forever linked if the late Supreme Court justice’s death leads to the termination of the 44th president’s signature domestic policy achievement: the Affordable Care Act

All sides in the coming battle royal over how to proceed with filling the high court seat she left behind are posturing and pressuring, floating strategic possibilities and offering creative versions of history and precedent. Most Republicans in the Senate want to hold a simple-majority floor vote on a nominee Mr. Trump says he will announce as soon as this week before the end of the calendar year. Democrats say they are hypocrites because the blocked a Barack Obama high court pick during his final year.

It appears Democrats have only extreme options as viable tactics from preventing confirmation hearings and a floor vote before this unprecedented year is up. Speaker Nancy Pelosi on Sunday refused to rule bringing articles of impeachment against the president or even William Barr, his attorney general whom the Democrats say has improperly used his office to help Mr. Trump’s friends and use federal law enforcement unjustly against US citizens.

Unless Ms Pelosi pulls that politically dangerous lever, the maneuvering of the next few weeks most likely will end after Congress returns after the 3 November election with a high court with a 6-3 conservative bend. Analysts already are warning that conservatives appear months away from being able to partially criminalize abortion and also take down the 2011 Affordable Care Act, also known as Obama care.

Democrats have sounded off since Ms. Ginsburg’s death to warn that millions of Americans could soon lose their health insurance, especially those with pre-existing conditions. Last year, 8.5m people signed up for coverage using the Affordable Care Act, according to the Congressional Budget Office.

“Healthcare in this country hangs in the balance,” Joe Biden, who is the Democratic nominee for president and was vice president when Mr. Obama signed the health plan now linked to his name into law, said on Sunday.

Mr. Biden accused Republicans of playing a “game” by rushing the process to replace Ms. Ginsburg on the court because they are “trying to strip healthcare away from tens of millions of families.”

Doing so, he warned, would “strip away their peace of mind” because insurance providers would no longer be required to give some Americans policies. Should a 6-3 court decide to uphold a lower court’s ruling that the 2011 health law be taken down, those companies would “drop coverage completely for folks with pre-existing conditions,” Mr. Biden warned in remarks from Philadelphia.

“If Donald Trump has his way, the complications from Covid-19 … would become the next deniable pre-existing condition for millions of Americans.” That means they would lose their health insurance and be forced to either pay for care out of their pocket or use credit lines. Both could force millions into medical bankruptcy or otherwise create dire financial hardships.

Mr. Trump about a month ago promised to release a new healthcare plan that, if ever passed by both chambers of Congress and signed into law, would replace Obamacare.

So far, however, he has yet to unveil that alleged plan.

Trump Press Secretary Kayleigh McEnany told reporters last week that the White House’s Domestic Policy Council is leading the work on the plan. But when pressed for more details, she chose to pick a fight with a CNN reporter.

“I’m not going to give you a readout of what our healthcare plan looks like and who’s working on it,” Ms. McEnany said. “If you want to know, if you want to know, come work here at the White House.”

When pressed, Ms. McEnany said “stakeholders here in the White House” are working on a plan the president has promised for several years. “And, as I told you, our Domestic Policy Council and others in the White House are working on a healthcare plan,” she insisted, describing it as “the president’s vision for the next five years.”

The president frequently mentions healthcare during his rowdy campaign rallies, but only in general terms. He promises a sweeping plan that will bring costs down across the board and also protect those with pre-existing conditions. But he mostly brings it up to hammer Mr. Obama and Mr. Biden for pushing a flawed law that he has been forced to tinker with to make it function better for consumers.

Broad brush

His top spokeswoman echoed those broad strokes during a briefing on Wednesday. “In aggregate, it’s going to be a very comprehensive strategy, one where we’re saving healthcare while Democrats are trying to take healthcare away,” she told reporters. “We’re making healthcare better and cheaper, guaranteeing protections for people with preexisting conditions, stopping surprise medical billing, increasing transparency, defending the right to keep your doctor and your plan, fighting lobbyists and special interests, and making healthier and making, finding cures to diseases.”

If there is a substantive plan that would protect millions with pre-existing conditions and others affected by Covid-19, it would have made a fine backbone of Mr. Trump’s August Republican National Committee address in which he accepted his party’s presidential nomination for a second time. But healthcare was not the major focus, even though it ranks in the top two issues – along with the economy – in just about every poll that asks voters to rank their priorities in deciding between Mr. Trump and Mr. Biden.

If there is a coming White House healthcare plan that would protect those with pre-existing conditions and prevent millions from losing coverage as the coronavirus pandemic is ongoing, the president is not using his campaign rallies at regional airport hangars to describe or promote it.

“We will strongly protect Medicare and Social Security and we will always protect patients with pre-existing conditions,” said at a campaign stop Saturday evening in Fayetteville, North Carolina, before pivoting to a completely unrelated topic: “America will land the first woman on the moon, and the United States will be the first nation to land an astronaut on Mars.”

The push to install a conservative to replace the liberal Ms. Ginsburg and the lack of any expectation Mr. Trump has a tangible plan has given Democrats a new election-year talking point less than two months before all votes must be cast.

“Whoever President Trump nominates will strike down the Affordable Care Act,” Hawaii Democratic Senator Mazie Hirono told MSNBC on Sunday. “It will throw millions of people off of healthcare, won’t protect people with pre-existing conditions. It will be disastrous. That’s why they want to rush this.”

 About 1 In 5 Households in U.S. Cities Miss Needed Medical Care During Pandemic

Patti Neighmond noted that when 28-year-old Katie Kinsey moved from Washington, D.C., to Los Angeles in early March, she didn’t expect the pandemic would affect her directly, at least not right away. But that’s exactly what happened.

She was still settling in and didn’t have a primary care doctor when she got sick with symptoms of what she feared was COVID-19.

“I had a sore throat and a debilitating cough,” she says, “and when I say debilitating, I mean I couldn’t talk without coughing.” She couldn’t lie down at night without coughing. She just wasn’t getting enough air into her lungs, she says.

Kinsey, who works as a federal consultant in nuclear defense technology, found herself coughing through phone meetings. And then things got worse. Her energy took a dive, and she felt achy all over, “so I was taking naps during the day.” She never got a fever but worried about the coronavirus and accelerated her effort to find a doctor.

No luck.

She called nearly a dozen doctors listed on her insurance card, but all were booked. “Some said they were flooded with patients and couldn’t take new patients. Others gave no explanation, and just said they were sorry and could put me on a waiting list.” All the waiting lists were two to three months’ long.

Eventually Kinsey went to an urgent care clinic, got an X-ray and a diagnosis of severe bronchitis — not COVID-19. Antibiotics helped her get better. But she says she might have avoided “months of illness and lost days of work” had she been able to see a doctor sooner. She was sick for three months.

Kinsey’s experience is just one way the pandemic has delayed medical care for Americans in the last several months. A poll of households in the four largest U.S. cities by NPR, the Robert Wood Johnson Foundation and Harvard’s T.H. Chan School of Public Health finds roughly one in every five have had at least one member who was unable to get medical care or who has had to delay care for a serious medical problem during the pandemic (ranging from 19% of households in New York City to 27% in Houston).

We had people come in with heart attacks after having chest pain for three or four days, or stroke patients who had significant loss of function for several days, if not a week.

There were multiple reasons given. Many people reported, like Kinsey, that they could not find a doctor to see them as hospitals around the U.S. delayed or canceled certain medical procedures to focus resources on treating COVID-19.

Other patients avoided critically important medical care because of fears they would catch the coronavirus while in a hospital or medical office.

“One thing we didn’t expect from COVID was that we were going to drop 60% of our volume,” says Ryan Stanton, an emergency physician in Lexington, Ky., and member of the board of directors of the American College of Emergency Physicians.

“We had people come in with heart attacks after having chest pain for three or four days,” Stanton says, “or stroke patients who had significant loss of function for several days, if not a week. And I’d ask them why they hadn’t come in, and they would say almost universally they were afraid of COVID.”

Stanton found that to be particularly frustrating, because his hospital had made a big effort to communicate with the community to “absolutely come to the hospital for true emergencies.”

He describes one patient who had suffered at home for weeks with what ended up being appendicitis. When the patient finally came to the emergency room, Stanton says, a procedure that normally would have been done on an outpatient basis “ended up being a very much more involved surgery with increased risk of complications because of that delay.”

The poll finds a majority of households in leading U.S. cities who delayed medical care for serious problems say they had negative health consequences as a result (ranging from 55% in Chicago to 75% in Houston and 63% in Los Angeles).

Dr. Anish Mahajan, chief medical officer of the large public hospital Harbor-UCLA Medical Center in Los Angeles, says the number of emergencies showing up in his hospital have been down during the pandemic, too, because patients have been fearful of catching the coronavirus there. One case that sticks in his mind was a middle aged woman with diabetes who fainted at home.

“Her blood sugar was really high, and she didn’t feel well — she was sweating,” the doctor recalls. “The family called the ambulance, and the ambulance came, and she said, ‘No, no, I don’t want to go to the hospital. I’ll be fine.’ “

By the next day the woman was even sicker. Her family took her to the hospital, where she was rushed to the catheterization lab. There doctors discovered and dissolved a clot in her heart. This was ultimately a successful ending for the patient, Mahajan says, “but you can see how this is very dangerous — to avoid going to the hospital if you have significant symptoms.”

He says worrisome reports from the Los Angeles County coroner’s office show the number of people who have died at home in the last few months is much higher than the average number of people who died in their homes before the pandemic.

“That’s yet another signal that something is going on where patients are not coming in for care,” Mahajan says. “And those folks who died at home may have died from COVID, but they may also have died from other conditions that they did not come in to get cared for.”

Like most hospitals nationwide, Harbor-UCLA canceled elective surgeries to make room for coronavirus patients — at least during the earliest months of the pandemic, and when cases surged.

In NPR’s survey of cities, about one-third of households in Chicago and Los Angeles and more than half in Houston and New York with a household member who couldn’t get surgeries or elective procedures said it resulted in negative health consequences for that person.

“Back in March and April the estimates were 80[%] to 90% of normal [in terms of screenings for cancer]” at Memorial Sloan Kettering Cancer Center in New York, says Dr. Jeffrey Drebin, who heads surgical oncology there.

“Things like mammograms, colonoscopies, PSA tests were not being done,” he says. At the height of the pandemic’s spring surge in New York City, Drebin says, he was seeing many more patients than usual who had advanced disease.

“Patients weren’t being found at routine colonoscopy,” he says. “They were coming in because they had a bleeding tumor or an obstructing tumor and needed to have something done right away.”

In June, during patients’ information sessions with the hospital, Drebin says patients typically asked if they could wait a few months before getting a cancer screening test.

“In some cases, you can, but there are certainly types of cancer that cannot have surgery delayed for a number of months,” he explains. With pancreatic or bladder cancer, for example, delaying even a month can dramatically reduce the opportunity for the best treatment or even a cure.

Reductions in cancer screening, Drebin says, are likely to translate to more illness and death down the road. “The estimate,” he says, “is that simply the reduction this year in mammography and colonoscopy [procedures] will create 10,000 additional deaths over the next few years.”

And even delays in treatment that aren’t a matter of life and death can make a big difference in the quality of a life.

For 12-year-old Nicolas Noblitt, who lives in Northridge, Calif., with his parents and two siblings, delays in treatment this year have dramatically reduced his mobility.

Nicolas has cerebral palsy and has relied on a wheelchair most of his life. The muscles in his thighs, hips, calves and even his feet and toes get extremely tight, and that “makes it hard for him to walk even a short distance with a walker,” says his mother, Natalie Noblitt. “So, keeping the spasticity under control has been a major project his whole life to keep him comfortable and try to help him gain the most mobility he can have.”

Before the pandemic, Nicolas was helped by regular Botox injections, which relaxed his tight muscles and enabled him to wear shoes.

As Nicolas says, “I do have these really cool shoes that have a zipper … and they really help me — because, one, they’re really easy to get on, and two, they’re cool shoes.” Best of all, he says they stabilize him enough so he can walk with a walker.

“I love those shoes and I think they sort of love me, too, when you think about it,” he tells NPR.

Nicolas was due to get a round of Botox injections in early March. But the doctors deemed it an elective procedure and canceled the appointment. That left him to go months without a treatment.

His muscles got so tight that his feet would uncontrollably curl.

“And when it happens and I’m trying to walk … it just makes everything worse,” Nicolas says, “from trying to get on the shoes to trying to walk in the walker.”

Today he is finally back on his Botox regimen and feeling more comfortable — happy to walk with a walker. Even so, says his mom, the lapse in treatment caused setbacks. Nicolas has to work harder now, both in day-to-day activities and in physical therapy.

‘Warp Speed’ Officials Debut Plan for Distributing Free Vaccines

Despite the president’s statements about military involvement in the vaccine rollout, officials said that for most people, “there will be no federal official who touches any of this vaccine.”

Katie Thomas reported that Federal officials outlined details Wednesday of their preparations to administer a future coronavirus vaccine to Americans, saying they would begin distribution within 24 hours of any approval or emergency authorization, and that their goal was that no American “has to pay a single dime” out of their own pocket.

The officials, who are part of the federal government’s Operation Warp Speed — the multiagency effort to quickly make a coronavirus vaccine available to Americans — also said the timing of a vaccine was still unclear, despite repeated statements by President Trump that one could be ready before the election on Nov. 3.

“We’re dealing in a world of great uncertainty. We don’t know the timing of when we’ll have a vaccine, we don’t know the quantities, we don’t know the efficacy of those vaccines,” said Paul Mango, the deputy chief of staff for policy at the Department of Health and Human Services. “This is a really quite extraordinary, logistically complex undertaking, and a lot of uncertainties right now. I think the message we want you to leave with is, we are prepared for all of those uncertainties.”

The officials said they were planning for initial distribution of a vaccine — perhaps on an emergency basis, and to a limited group of high-priority people such as health care workers — in the final three months of this year and into next year. The Department of Defense is providing logistical support to plan how the vaccines will be shipped and stored, as well as how to keep track of who has gotten the vaccine and whether they have gotten one or two doses.

However, Mr. Mango said that there had been “a lot of confusion” about what the role of the Department of Defense would be, and that “for the overwhelming majority of Americans, there will be no federal official who touches any of this vaccine before it’s injected into Americans.”

Army Lt. Gen. Paul Ostrowski said Operation Warp Speed was working to link up existing databases so that, for example, a patient who received a vaccine at a public health center in January could go to a CVS pharmacy 28 days later in another state and be assured of getting the second dose of the right vaccine.

Three drug makers are testing vaccine candidates in late-stage trials in the United States. One of those companies, Pfizer, has said that it could apply for emergency authorization as early as October, while the other two, Moderna and AstraZeneca, have said they hope to have something before the end of the year.

Coronavirus vaccine study by Pfizer shows mild-to-moderate side effects

Pfizer Inc said on Tuesday participants were showing mostly mild-to-moderate side effects when given either the company’s experimental coronavirus vaccine or a placebo in an ongoing late-stage study.

The company said in a presentation to investors that side effects included fatigue, headache, chills and muscle pain. Some participants in the trial also developed fevers – including a few high fevers. The data is blinded, meaning Pfizer does not know which patients received the vaccine or a placebo. Kathrin Jansen, Pfizer’s head of vaccine research and development, stressed that the independent data monitoring committee “has access to unblinded data so they would notify us if they have any safety concerns and have not done so to date.”

The company has enrolled more than 29,000 people in its 44,000-volunteer trial to test the experimental COVID-19 vaccine it is developing with German partner BioNTech. Over 12,000 study participants had received a second dose of the vaccine, Pfizer executives said on an investor conference call.

The comments follow rival AstraZeneca’s COVID-19 vaccine trials being put on hold worldwide on Sept. 6 after a serious side effect was reported in a volunteer in Britain.

AstraZeneca’s trials resumed in Britain and Brazil on Monday following the green light from British regulators, but remain on hold in the United States.

Pfizer expects it will likely have results on whether the vaccine works in October. “We do believe – given the very robust immune profile and also the preclinical profile … that vaccine efficacy is likely to be 60% or more,” Pfizer’s Chief Scientific Officer Mikael Dolsten said.

Rushing the COVID-19 Vaccine Could Have Serious and Fatal Side Effects

Jason Silverstein noted that States have been told by the Centers for Disease Control and Prevention they should prepare for a coronavirus vaccine by “late October or early November,” according to reports last Wednesday. But an untested coronavirus vaccine may have serious and fatal side effects, could even make the disease worse, and may very well have an effect on the election.

What’s the worst that could happen if we give an untested vaccine to millions of people?

We received a reminder today, when one of the leading large coronavirus vaccine trials by AstraZeneca and Oxford University was paused due to a “suspected serious adverse reaction.” There are eight other potential coronavirus vaccines that have reached Phase 3, which is the phase that enrolls tens of thousands of people and compares how they do with the vaccine against people who only get a placebo. Those eight include China’s CanSino Biologics product that was approved for military use without proper testing back in July, and Russia’s coronavirus vaccine that has been tested in only 76 people.

If the CDC distributes an untested coronavirus vaccine this Fall, it would be the largest drug trial in history—with all of the risks and none of the safeguards.

“Approving a vaccine without testing would be like climbing into a plane that has never been tested,” said Tony Moody, MD, director of the Duke Collaborative Influenza Vaccine Innovation Centers. “It might work, but failure could be catastrophic.”

One concern about this vaccine is that it’s tracking to be an “October surprise.” From Henry Kissinger’s “peace is at hand” speech regarding a ceasefire in Vietnam less than two weeks before the 1972 election to former FBI Director James Comey’s letter that he would reopen the investigation into Hillary Clinton’s emails, October surprises have always had the potential to shift elections. But never before have they had the potential to catastrophically shift the health of an already fragile nation.

If there is an October surprise in the form of an untested coronavirus vaccine, it won’t be the first time that a vaccine was rushed out as a political stunt to increase an incumbent president’s election chances.

What happened with the last vaccine rush?

On March 24, 1976, in response to a swine flu outbreak, President Gerald Ford asked Congress for $135 million for “each and every American to receive an inoculation.”

How badly did the Swine Flu campaign of 1976 go? Well, one of the drug companies made two million doses of the wrong Swine Flu vaccine, vaccines weren’t exactly effective for people under 24, and insurance companies said, no way, they didn’t want to be liable for the science experiment of putting this vaccine into 120 million bodies.

By December, the Swine Flu vaccination program was suspended when people started to develop Guillain-Barré Syndrome, a rare neurological condition whose risk was seven times higher in people who got the vaccine and which paralyzed more than 500 people and killed at least 25.

What else can go wrong when vaccines are rushed

“Vaccines are some of the safest medical products in the world, but there can be serious side effects in some instances that are often only revealed by very large trials,” said Kate Langwig, Ph.D., an infectious disease ecologist at Virginia Tech.

One of the other possible side effects is known as vaccine enhancement, the very rare case when the body makes antibodies in response to a vaccine but the antibodies help a second infection get into cells, something that has been seen in dengue fever. “The vaccine, far from preventing Covid-19, might turn out to make a patient’s disease worse,” said Nir Eyal, D.Phil., a bioethics professor at Rutgers University.

We do not know whether a coronavirus vaccine might cause vaccine enhancement, but we need to. In 1966, a vaccine trial against respiratory syncytial virus, a disease that many infants get, caused more than 80 percent of infants and children who received the vaccine to be hospitalized and killed two.

All of these risks can be prevented, but safety takes patience, something that an American public which has had to bury more than 186,000 is understandably short on and Trump seems to be allergic to.

“To put this into perspective, the typical length of making a vaccine is fifteen to twenty years,” said Paul Offit, MD, the director of the Vaccine Education Center at Children’s Hospital of Philadelphia. Offit’s laboratory developed a vaccine for rotavirus, a disease that kills infants. That process began in the 1980s and wasn’t completed until 2006. The first scientific papers behind the HPV vaccine, for example, were published in the early 1990’s, but the vaccine wasn’t licensed until 2006.

An untested vaccine may also prove a deadly distraction. “An ineffective vaccine could create a false sense of security and perhaps reduce the emphasis on social distancing, mask wearing, hand hygiene,” said Atul Malhotra, MD, a pulmonologist at the UC San Diego School of Medicine.

Other issues with inadequately tested vaccines

Even worse, an untested vaccine may have consequences far beyond the present pandemic. Even today, one poll shows that only 57% of people would take a coronavirus vaccine. (Some experts argue that we need 55 to 82% to develop herd immunity.)

If we don’t get the vaccine right the first time, there may not be enough public trust for a next time. “Vaccines are a lot like social distancing. They are most effective if we work cooperatively and get a lot of people to take them,” said Langwig. “If we erode the public’s trust through the use of unsafe or ineffective vaccines, we may be less likely to convince people to be vaccinated in the future.”

“You don’t want to scare people off, because vaccines are our way out of this,” said Dr. Offit.

So, how will you be able to see through the fog of the vaccine war and know when a vaccine is safe to take? “Data,” said Dr. Moody, “to see if the vaccine did not cause serious side effects in those who got it, and that those who got the vaccine had a lower rate of disease, hospitalization, death, or any other metric that means it worked. And we really, really want to see that people who got the vaccine did not do worse than those who did not.

And finally, don’t forget to get your Flu vaccine, now!

Coronavirus: Top scientist who battled COVID-19 says we will never live normally without vaccine! Nursing Homes, Packed Coffee Houses, and When will it Be Over?

As anyone else noticed the advertisements on television? They are mainly auto dealerships who will delivery your new car to your home and more attorney companies who will sue whomever you want and will not get charged unless they will your case. One of my former professors during my MBA program is a federal judge who warned me that judges are expecting to see many cases of malpractice cases coming to the courts secondary to the COVID-19 cases. Unbelievable!

 Ross McGuinness reported that a top scientist who fell ill with COVID-19 has said the world will never return to normal unless there is a coronavirus vaccine.

Peter Piot, director of the London School of Hygiene & Tropical Medicine, spent a week in hospital after contracting the virus in March. The Belgian virologist, who led the Joint United Nations Program on HIV/AIDS between 1995 and 2008, said climbing a flight of stairs still leaves him breathless.

Last week, a World Health Organization (WHO) official warned there may never be a coronavirus vaccine.

Prof Piot, one of the discoverers of the Ebola virus, is currently a coronavirus adviser to European Commission president Ursula von der Leyen. In an interview with Belgian magazine Knack, later translated by Science Magazine, he warned that a vaccine is needed for people to live normally again.

“The Commission is strongly committed to supporting the development of a vaccine,” he said. “Let’s be clear: Without a coronavirus vaccine, we will never be able to live normally again. “The only real exit strategy from this crisis is a vaccine that can be rolled out worldwide.

“That means producing billions of doses of it, which, in itself, is a huge challenge in terms of manufacturing logistics. And despite the efforts, it is still not even certain that developing a COVID-19 vaccine is possible.”

Prof Piot criticized anti-vaxxers, saying: “Today there’s also the paradox that some people who owe their lives to vaccines no longer want their children to be vaccinated. “That could become a problem if we want to roll out a vaccine against the coronavirus, because if too many people refuse to join, we will never get the pandemic under control.”

He said he hoped the coronavirus pandemic can help ease political tensions, citing how polio vaccination campaigns have led to truces between countries. He said he hoped the WHO could be “reformed to make it less bureaucratic”, saying it too often resembles a “political battleground”.

According to Johns Hopkins University, the US is the worst-hit country by coronavirus, with more than 79,500 deaths, followed by the UK with more than 31,900 and Italy with more than 30,500.

On Sunday, British prime minister Boris Johnson announced a range of new measures to ease the UK out of its COVID-19 lockdown. However, his announcement of the government’s measures was criticized by scientists, opposition politicians and workers’ unions, who called it confusing.

The government was left scrambling on Monday to bring some kind of clarity to the new measures. A 50-page document outlining the easing of restrictions was published on Monday. From Wednesday, people will be able to meet one person from another household in a park as long as they stay two meters apart.

Covid-19: nursing homes account for ‘staggering’ share of US deaths, data show

Reporter Jessica Glenza noted that residents of nursing homes have accounted for a staggering proportion of Covid-19 deaths in the US, according to incomplete data gathered by healthcare researchers.

Privately compiled data shows such deaths now account for more than half of all fatalities in 14 states, according to the Kaiser Family Foundation. Only 33 states report nursing home-related deaths.

“I was on a phone call last week, where four or five patients came into our hospital just in one day from nursing homes,” said infectious disease specialist Dr Sunil Parikh, of Yale School of Public Health in Connecticut. “It’s just a staggering number day to day.”

Despite early warnings that nursing homes were vulnerable to Covid-19, because of group living settings and the age of residents, the federal government is only beginning to gather national data.

In Connecticut, 194 of 216 nursing homes have had at least one Covid-19 case. Nearly half the Covid-19 deaths in the state – more than 1,200 people – have been of nursing home residents. The proportion is higher elsewhere. In New Hampshire, 72% of deaths have been nursing home residents.

Parikh said limited testing and a lack of personal protective equipment such as masks hampered efforts to curb the spread of Covid-19 in care homes. Due to limited testing capacity, most state nursing homes are still only able to test residents with symptoms, even though the disease is known to spread asymptomatically.

“What I would like to see is the ability to test the entire nursing homes,” Parikh said. “This symptomatic approach is just not cutting it. Many states, including Connecticut, are starting to move in that direction … but I hope it becomes a national effort.”

Nursing homes have been closed to the public for weeks but a bleak picture has nonetheless emerged. In New Jersey, Governor Phil Murphy called in 120 members of the state national guard to help long-term care facilities, after 17 bodies piled up in one nursing home.

In Maine, a 72-year-old woman who went into a home to recover from surgery died just a few months later, in the state’s largest outbreak.

“I feel like I failed my mom because I put her in the wrong nursing home,” the woman’s daughter, Andrea Donovan, told the Bangor Daily News. “This facility is responsible for so much sadness for this family for not protecting their residents.”

Fifteen states have moved to shield nursing homes from lawsuits, according to Modern Healthcare.

Nursing home residents were among the first known cases of Covid-19 in the US. In mid-February in suburban Kirkland, Washington, 80 of 130 residents in one facility were sickened by an unknown respiratory illness, later identified as Covid-19.

Statistics from Kirkland now appear to tell the national story. Of 129 staff members, visitors and residents who got sick, all but one of the 22 who died were older residents, according to the US Centers for Disease Control and Prevention (CDC).

By early March, most Covid-19 deaths in the US could still be traced to Kirkland.

“One thing stands out as the virus spreads throughout the United States: nursing homes and other long-term care facilities are ground zero,” wrote Dr Tom Frieden, the former head of the CDC, for CNN on 8 March.

That day, Frieden called on federal authorities to ban visitors from nursing homes. US authorities announced new measures to protect residents several days later.

The CDC investigation into Kirkland was released on 18 March. It contained another warning: “Substantial morbidity and mortality might be averted if all long-term care facilities take steps now to prevent exposure of their residents to Covid-19.”

It was not until 19 April that the head of the Centers for Medicare and Medicaid Services promised to track all deaths in nursing homes. That requirement went into effect this Friday, but there is still a two-week grace period for compliance. During the period from 19 April to 8 May, 13,000 people died, according to an NBC News analysis.

“This is really decimating state after state,” said Parikh. “We have to have a very rapid shift [of focus] to the nursing homes, the veteran homes … Covid will be with us for many months.”

Texas begins to reopen after Covid-19 quarantine – but political controversy and health risks await

Three reporters contributed to this article, Erum Salam, Nina Lakhani and Oliver Laughland, where they noted that Tim Handren, the chief executive of Santikos Entertainment, a small cinema chain in San Antonio, admits his business is not essential. But while the giants of the industry keep their screens closed, he has taken a different approach.

Since last weekend, three of nine Santikos cinemas have reopened to the public, among the first in America to do so during the coronavirus pandemic.

“Take your mask off and relax,” Handren said in a recorded message to customers. “Breathe in some great buttery popcorn smells, watch a great movie, and just enjoy some time with your family.”

The reopening is among the starker examples in Texas, where one of the quickest and most expansive efforts to reignite the economy has drawn significant controversy.

On the one hand, some civil liberty advocates have argued that their right to drink at bars, have their hair cut and dine at restaurants has been curtailed. On the other, many public health experts warn thousands will become infected as the state reopens.

Handren, who is also the mayor of the small town of Boerne, said that although his cinemas would keep patrons 6ft apart and offer a reduced menu there remained debate in the community about whether the shutdown had been necessary at all.

“Unfortunately, I still interact with people that believe Covid-19 is a hoax concocted by the media after all this time. That’s the extreme on that side of the equation … ‘We should have never shut down’. Even the lieutenant governor said that. And then there are others who want to hunker down and hibernate for the next six months. I’ve had to, as a mayor, balance health and economics.”

Abbott, a Republican, last week ended a stay-at-home order and allowed businesses including barber shops and retail outlets to open. The move followed decisions in other southern states including Florida and Georgia, and earned praise from Donald Trump.

The president told reporters: “Texas is opening up and a lot of places are opening up. And we want to do it, and I’m not sure that we even have a choice. I think we have to do it. You know, this country can’t stay closed and locked down for years.”

In private, Abbott has acknowledged that his decision to reopen is likely to cause an increase in coronavirus cases. Leaked audio obtained by the Daily Beast captured comments during a private call with state lawmakers.

Abbott, who has sought to downplay the increased risk to the public, said: “The more that you have people out there, the greater the possibility is for transmission. The goal never has been to get transmission down to zero.”

Infectious disease experts predict the average daily Covid-19 positive test rate in Texas could rise from 1,053 at the beginning of May to up to 1,800 by June.

As of this weekend, Texas had an estimated 16,670 active cases and 1,049 deaths. With the occasional dip, the number of cases continues to rise even while testing lags behind other states.

Harris county, which includes Houston, has 157 coronavirus cases per 100,000 people – 31% higher than the state average. Last month, officials said African Americans accounted for two-thirds of Covid-19 deaths in the city despite making up only 22.5% of the population.

Harris county judge Lina Hidalgo, a Democrat, has attempted to enforce a mandatory mask order. Abbott has publicly criticized her.

Dr Andrew Miller, a pediatric ophthalmologist in Harris county, reopened his clinic last week with social distancing in place. He told the Guardian that even after his decision to reopen, because of the pressing needs of patients, he was experiencing significant anger from those who refuse to wear masks.

He said: “We’ve had some pushback from families because we won’t let them in without a mask. They’ve been ugly to the staff. While I respect their civil liberties, I am entitled to not see them.”

Last week, Abbott took power away from officials who arrest Texans for certain Covid-19 violations. The move was prompted by a conservative backlash against the arrest of a salon owner in Dallas – another hotspot – who opened up against local rules. In an act that exacerbated the divisions on the case, Texas senator Ted Cruz appeared at the salon to receive a haircut from the recently released owner.

Houston lies in a sprawling industrial region with more than 500 petrochemical facilities, a busy shipping channel, large highways and commercial railroads, and one of the highest densities of polluting industries in the country, if not the world.

Air quality, specifically particulate matter, which increases the risk of multiple lung and heart conditions also associated with Covid-19 complications, has been worse in some parts of the city despite the lockdown, leading environmentalists to criticize the decision to reopen so quickly.

“It’s a blind, uninformed decision based on optimism that everything will be better, even though the evidence points to the contrary,” said Elena Craft, senior director at the Environmental Defense Fund (EDF), which coordinates a local project tracking air quality.

The meatpacking industry is also linked to several emerging hotspots in the Texas panhandle, a semi-rural region of 26 northern counties where Trump won 79.9% of the vote in 2016 and the Republican party dominates every level of government.

Moore county has the highest infection rate in Texas. Its death rate is 28 per 100,000 people, almost 10 times higher than Harris county and the state average.

Moore, where around 55% of residents identify as Latino or Hispanic, is home to the massive Brazilian-owned JSB meatpacking plant, which employs mostly Hispanic and migrant workers, many bussed in on company shuttles from towns including Amarillo. Nationwide, industrial meat plants have emerged as incubators for coronavirus spread.

Amarillo, the region’s largest city, situated across Potter and Randall counties, had 1,304 cases as of last Wednesday, including at least 18 deaths. The infection rate is rapidly rising. Potter county has the second worst rate in Texas, with infections doubling every seven or eight days.

Just to the south, in the city of Odessa, a group of armed militia men were arrested last week as they protested alongside bar owner Gabrielle Ellison, who attempted to reopen in violation of an executive order which mandates bars should remain closed.

The six men were members of a militia named Open Texas, which according to reports has operated across the state, offering armed support to business owners.

Ellison, who was also arrested, told local news from jail: “I think some rights were taken away from us, which one of them was like a right to survive. We have to survive and I think those rights were stripped from us.”

But looked what happened in Colorado!

Customers in Packed Colorado Coffee Shop Ignore Mask and Distancing Advice

 We have many stupid people as this next story proves. Customers in a Colorado coffee outlet on Sunday, May 10, resisted official calls for people to wear face masks and gloves – and to distance from one another – when in public.

This video shows the crowded scene inside a C&C Coffee and Kitchen store in Castle Rock on Mother’s Day morning. Few customers appear to be wearing face masks or distancing from one another to the extent suggested by federal and state officials.

Colorado Gov Jared Polis’s ‘Safer at Home’ order, which encourages six feet of distance between people, remains in effect until May 27.

As of May 10, Colorado had reported 19,703 confirmed cases of the coronavirus and 971 deaths.

Opinion: The coronavirus is accelerating America’s decline

Arvind Subramanian reported that the federal government’s response to the pandemic exposes incompetence and decay. The consequences will play out over years to come.

The COVID-19 crisis augurs three watersheds: the end of Europe’s integration project, the end of a united, functional America, and the end of the implicit social compact between the Chinese state and its citizens.                                                                                                                    As a result, all three powers will emerge from the pandemic internally weakened, undermining their ability to provide global leadership.                                                           Europe                                                                                                                                                Start with Europe. As with the 2010-12 eurozone crisis, the bloc’s fault line today runs through Italy. Drained over decades of dynamism and fiscally fragile, it is too big for Europe to save and too big to let fail. During the pandemic, Italians have felt abandoned by their European partners at a moment of existential crisis, creating fertile ground for populist politicians to exploit. The images of Bergamo’s COVID-19 victims being carried in body bags by military convoy to their anonymous, unaccompanied burials, will long remain etched in the Italian collective psyche.                                                                                    Meanwhile, when addressing how to help pandemic-stricken member states, the European Union’s technocratic, ostrich-like elites lapse into the institutional alphabet soup — ECB, ESM, OMT, MFF and PEPP — that has become their default language. The continent’s leaders have faltered and dithered, from European Central Bank President Christine Lagarde’s apparent gaffe in March — when she said that the ECB was “not here to close spreads” between member states’ borrowing costs — to the bickering over debt mutualization and COVID-19 rescue funds and the reluctant, grudging incrementalism of the latest agreement.                                                                                                                          Suppose, as seems likely, that the successful economies of the EU core recover from the crisis while those on the bloc’s periphery falter. No political integration project can survive a narrative featuring a permanent underclass of countries that do not share their neighbors’ prosperity in good times and are left to their own devices when calamity strikes.                             U.S.                                                                                                                                                      The United States’ decline, meanwhile, is over-predicted and under-believed. Even before the COVID-19 crisis, key U.S. institutions signaled decay: the incontinent presidency of Donald Trump, a gerrymandered Congress, a politicized Supreme Court, fractured federalism and captured regulatory institutions (with the U.S. Federal Reserve being an outstanding exception).                                                                                                                          Deep down, however, many of those Americans who see the decay reject the thesis of decline. They remain convinced that the country’s thick web of non-state institutions and underlying strengths — including its universities, media, entrepreneurial spirit, and technological prowess, as well as the global supremacy of the dollar — provide the resilience America needs to maintain its pre-eminence.

But so far, the world’s richest country has been by far the worst at coping with the pandemic. Although the US has less than 5% of the world’s population, it currently accounts for about 24% of total confirmed COVID-19 deaths and 32% of all cases.

In rapid succession, therefore, America’s credibility and global leadership have been buffeted by imperial overreach (the Iraq war), a rigged economic system (the global financial crisis), political dysfunction (the Trump presidency), and now staggering incompetence in tackling COVID-19. The cumulative blow is devastating, even if it is not yet fatal.                                                                                                                                                              Many of these pathologies in turn stem from the deep and poisonous polarization in US society. Indeed, Trump is now goading his supporters into insurrection. Come November, even the basic democratic criterion of holding free and fair elections could end up being flouted.                                                                                                                                         This is a critical moment. Prepare for the trading day with MarketWatch’s Need to Know newsletter. Our flagship email guides investors to the most important, insightful items required to chart the trading a day ahead.                                                      Of course, it would be alarmist and premature to see America’s far-reaching failures in the face of the COVID-19 crisis as threatening U.S. democracy or nationhood. But clinging adamantly to American exceptionalism at such a time seems like dangerous denialism.    China                                                                                                                                         Finally, there is China. Since the time of Deng Xiaoping, the country has thrived on a simple, implicit agreement: citizens remain politically quiescent, accepting curbs on freedom and liberties, and the state — firmly under the control of the Communist Party of China — guarantees order and rising prosperity. But the COVID-19 crisis threatens that grand bargain in two ways.                                                                                         First, the Chinese authorities’ terrible initial handling of the pandemic, and in particular their catastrophic suppression of the truth about the COVID-19 outbreak in Wuhan, has called the regime’s legitimacy and competence into question. After all, the social contract looks less attractive if the state cannot guarantee citizens’ basic well-being, including life itself. China’s true COVID-19 death toll, which is almost certainly higher than the authorities are admitting, will eventually come to light. So, too, will the stark contrast with the exemplary response to the pandemic by the freer societies of Taiwan and Hong Kong.  Second, the pandemic could lead to an external squeeze on trade, investment, and finance. If the world deglobalizes as a result of COVID-19, other countries will almost certainly look to reduce their reliance on China, thus shrinking the country’s trading opportunities. Similarly, more Chinese companies will be blocked from investing abroad, and not just on security grounds — as India has recently signaled, for example. And China’s Belt and Road Initiative — its laudable effort to boost its soft power by building trade and communications infrastructure from Asia to Europe — is at risk of unraveling as its pandemic-ravaged poorer participants start defaulting on onerous loans.                              The COVID-19 crisis will therefore probably hurt China’s long-term economic prospects. Widespread internal rumblings have begun, even if they are less evident externally. Domestic disorder is unlikely, because President Xi Jinping could ratchet up repression even more ruthlessly and effectively than he already has. But the current social contract will seem increasingly Faustian to the average Chinese citizen.

Command of resources is a prerequisite for power. But, as international-relations theory reminds us, projecting power beyond one’s borders requires a modicum of cohesion and solidarity within them. Weak, fractured societies, no matter how rich, cannot wield strategic influence or provide international leadership — nor can societies that cease to remain models worthy of emulation.                                                                                                     We have been living for some time in a G-minus-2 world of poor leadership by the U.S. and China. Both have been providing global public “bads” such as trade wars and erosion of international institutions, instead of public goods such as stability, open markets, and finance. By further weakening the internal cohesion of the world’s leading powers, the COVID-19 crisis threatens to leave the world even more rudderless, unstable, and conflict-prone. The sense of three endings in Europe, America, and China is pregnant with such grim geopolitical possibilities.                                                                                                            And Now Wuhan reported its first new coronavirus case in more than a month                                                                                                                      Aly Song from Reuters reported that Wuhan reported their first new COVID case.

  • The central Chinese city of Wuhan has reported its first new coronavirus case in more than a month.
  • The Wuhan Municipal Health Commission said Sunday that an 89-year-old man was confirmed to have the virus on Saturday. His wife, along with several members of the community, were recorded as asymptomatic cases, which are not included in official case tallies.
  • On Sunday, the National Health Commission revealed that 14 new symptomatic cases were reported on Saturday, marking the largest increase since April 28.

The central Chinese city of Wuhan, where the coronavirus first appeared last year, reported its first new case in more than a month on Sunday. The Wuhan Municipal Health Commission announced Sunday an 89-year-old male with a history of various health problems, tested positive for the virus on Saturday after showing symptoms.

His wife, who tested positive without symptoms, has been recorded as an asymptomatic case. Several other members of the community were also recorded as asymptomatic cases. The health commission said the elderly man, who resides in the Dongxihu district, lived in an area where 20 other people previously tested positive for the virus. The risk level for his district was raised to medium on Sunday. The new case is, according to multiple outlets, the first case reported in Wuhan since April 3.

Wuhan, the Chinese city hardest hit by the virus, has reported a total of 50,334 coronavirus cases and at least 3,869 deaths. In mid-April, the city revised its death toll, increasing it by 50%. The numbers coming out of China have repeatedly been called into question, especially by US officials, including the president.

China has argued that numbers are low because it took decisive action. The strict quarantine of Wuhan, a sprawling city of 11 million people, began on Jan. 23 and ended on April 8. Similar action was taken in cities across China.

On Sunday, China’s National Health Commission announced that there were 14 new coronavirus cases reported nationwide on Saturday, marking the largest single-day increase since April 28, according to Reuters. The majority of the new cases were reported in Shulan, a city in China’s northeastern Jilin province. Local officials raised the risk level to high in response.

China also reported 20 new asymptomatic cases, which are not included in the total tally. The country has reported 82,901 cases and 4,633 deaths.

How a COVID-19 Testing Model No One Is Talking About Could Save Thousands of Lives

Andrea Galeotti noted that with solid data in short supply relating to the characteristics and spread of COVID-19, many governments and health officials are struggling to formulate suitable health and economic policies. As a consequence, some although not all, countries are effectively waging a war against the coronavirus based on the dynamics of a game of chance. This in turn is producing considerable anxiety about when lockdowns might end and the first steps towards economic activity might begin to occur.

This absence of data and resultant lack of concrete purpose is perhaps best illustrated in the U.S. where the federal government has left individual states to decide when to reopen in phases, without clarity on how widespread COVID-19 actually is. What state governments should be doing is formulating a reopening procedure that is based on selecting and testing a representative sample of the population.

There is now abundant evidence that asymptomatic individuals are the key diffusers of COVID-19 and as such firmly locating those individuals is the only way to stop further waves of contagion. Testing has always been of paramount importance, but this should not be seen as a mandate to test on a massive scale. That option is clearly not practicable and should urgently be substituted for well-designed testing strategies that determine the rate of infection in the local communities of individuals being tested, as well offering a firmer bearing on the general prevalence and diffusion of the virus within the greater population. Based on this information, contact tracing and smart containment strategies can be designed in order to ensure that contagion curve is kept flat and the health system can operate within its capacity.

COVID-19 has shown it can infect people regardless of age, race, gender, and geography, and therefore has proved unpredictable and difficult to contain. This unpredictability has been mirrored by the divergent testing strategies of different governments around the world. Countries such as Italy, U.K., and the U.S. have principally been testing patients with severe symptoms and have largely withheld testing asymptomatic individuals. By contrast, in countries such as Germany, Iceland and South Korea, the testing regimen has quickly expanded to mildly symptomatic cases, and to asymptomatic individuals who work in jobs where, should the become infected, have a high chance of spreading the virus to many others. That includes, for example, medical staff and workers in transportation hubs.

These different approaches may have been dictated by different logistical constraints, yet it is clear those countries that have employed intelligent testing and contact tracing strategies have in turn been more successful in containing COVID-19. For example, Iceland, South Korea, Australia, and Singapore all have strong testing and contact tracing initiatives and their infection and mortality numbers are a fraction of the U.S.’s.

A key piece of the exit strategy for countries like the U.S., Italy, and the U.K., then, seems simple: develop a serological testing program on a representative sample of the population, while also gathering information on demographic characteristics such as age, gender, number of children, type of working sector, skills, social and working associations.

Serological tests detect the presence of antibodies for COVID-19 and make sense for this purpose for a few reasons. PCR tests, which detect RNA evidence of a virus, can only reveal a current or recent infection. Antibody tests, on the other hand, can, in theory, identify someone who was exposed to the virus months ago. By testing with this method, governments will be able to capture a clear picture to what extent the virus has already spread and identify trends across geographical regions as well as across individual characteristics such as age, gender, working sectors and skills.

Gathering this representative sample would be relatively easy and cost-effective to implement. It is also easy because countries can use representative samples of the population that are regularly used for socio-economic surveys. For example, the U.S. Bureau of Labor Statistics’ “Labor Force Statistics from the Current Population Survey” could be adapted to run such tests. Secondly, the data collected can be analyzed though standard statistical methods, which will help to infer a body of valuable analysis related to the spread across the wider population.

There are aspects of the design of such test programs that will need to be very carefully managed. For example, they could be vulnerable to outcomes that wrongly indicate the presence of COVID-19 in a given region, or, conversely, identify regions that notionally suggest low infection rates. In both examples, test validation is critical.

Through the collection and statistical analysis of such data, governments will be in a position to make an informed choice and evaluate the advantages and the disadvantages that are inherent in any policy that will relax social distancing before a vaccine is available. Formulating an exit strategy without this information amounts to flipping a coin—the proverbial game of chance and is the new cases of COVID-19 a signal of what we could see in this country as we ease self-quarantine and the “severe” lock-down in states and cities?

We need a comprehensive collection of data using contact as well as post infection patient tracing to get a handle on this pandemic and the possible recurrent waves!

Decline in measles vaccination is causing a preventable global resurgence of the disease

UntitledNotreDame

What a horrible week with the burning or Notre Dame, the Democrats all piling on to tear apart the Mueller report and threaten to impeach the President and the tragedy in Sri Lanka. But the thing that really annoyed me is the increasing number of patients with measles, now over 500 in this country due to non vaccinated children, etc.. These anti-vaxers are spoiled and selfish. But I bet that when their children get really sick they will demand the best care from any and all hospitals, physicians and nurses out there or threaten to sue them. So, the Single-payer healthcare discussion will have to wait a week!

The NIH/National Institute of Allergy and Infectious Diseases pointed out that in 2000, measles was declared to be eliminated in the United States when no sustained transmission of the virus was seen in this country for more than 12 months. Yes, you read that right; it was declared to have been eliminated. What happened then?

Today, however, the United States and many other countries that had also eliminated the disease are experiencing concerning outbreaks of measles because of declines in measles vaccine coverage. Without renewed focus on measles vaccination efforts, the disease may rebound in full force, according to a new commentary in the New England Journal of Medicine by infectious diseases experts at the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, and the Penn State University College of Medicine’s Milton S. Hershey Medical Center.

Measles is an extremely contagious illness transmitted through respiratory droplets and aerosolized particles that can remain in the air for up to two hours. Most often seen in young children, the disease is characterized by fever, malaise, nasal congestion, conjunctivitis, cough, and a red, splotchy rash. Most people with measles recover without complications within a week. However, for infants, people with immune deficiencies, and other vulnerable populations, the consequences of measles infection can be severe. Rare complications can occur, including pneumonia, encephalitis, other secondary infections, blindness, and even death. Before the measles vaccine was developed, the disease killed between two and three million people annually worldwide. Today, measles still causes more than 100,000 deaths globally each year.

Measles can be prevented with a vaccine that is both highly effective and safe. Each complication and death related to measles is a “preventable tragedy that could have been avoided through vaccination,” the authors write. Some people are reluctant to vaccinate their children based on widespread misinformation about the vaccine. For example, they may fear that the vaccine raises their child’s risk of autism, a falsehood based on a debunked and fraudulent claim. A very small number of people have valid medical contraindications to the measles vaccine, such as certain immunodeficiencies, but almost everyone can be safely vaccinated.

When levels of vaccine coverage fall, the weakened umbrella of protection provided by herd immunity—indirect protection that results when a sufficiently high percentage of the community is immune to the disease—places unvaccinated young children and immunocompromised people at greater risk. This can have disastrous consequences with measles. The authors describe a case in which a single child with measles infected 23 other children in a pediatric oncology clinic, with a fatality rate of 21 percent.

Now, look at the situation in New York City.

If vaccination rates continue to decline, measles outbreaks may become even more frequent, a prospect the authors describe as “alarming.” This is particularly confounding, they note since measles is one of the most easily prevented contagious illnesses. In fact, it is possible to eliminate and even eradicate the disease. However, they say, achieving this goal will require collective action on the part of parents and healthcare practitioners alike.

New York Declares Measles Emergency, Requiring Vaccinations in Parts of Brooklyn

New York City on Tuesday declared a health emergency following a measles outbreak in the Orthodox Jewish community in Brooklyn. Demetrius Freeman for The New York Times reported.

Tyler Pager and Jeffery Mays reported that for months, New York City officials have been fighting a measles outbreak in ultra-Orthodox Jewish communities in Brooklyn, knowing that the solution — the measles vaccine — was not reaching its target audience.

They tried education and outreach, working with rabbis and distributing thousands of fliers to encourage parents to vaccinate their children. They also tried harsher measures, like a ban on unvaccinated students from going to school.

But with measles cases still on the rise and an anti-vaccination movement spreading, city health officials on Tuesday took a more drastic step to stem one of the largest measles outbreaks in decades.

Mayor Bill de Blasio declared a public health emergency that would require unvaccinated individuals living in Williamsburg, Brooklyn, to receive the measles vaccine. The mayor said the city would issue violations and possible fines of $1,000 for those who did not comply.

“This is the epicenter of a measles outbreak that is very, very troubling and must be dealt with immediately,” Mr. de Blasio said at a news conference in Williamsburg, adding: “The measles vaccine works. It is safe, it is effective, it is time-tested.”

The measure follows a spike in measles infections in New York City, where there have been 285 confirmed cases since the outbreak began in the fall; 21 of those cases led to hospitalizations, including five admissions to the intensive care unit.

City officials conceded that the earlier order in December, which banned unvaccinated students from attending schools in certain sections of Brooklyn, was not effective. Mr. de Blasio said on Tuesday that the city would fine or even temporarily shut down yeshivas that did not abide by the measure.

“There has been some real progress in addressing the issue, but it’s just not working fast enough and it was time to take a more muscular approach,” Mr. de Blasio said.

To enforce the order, health officials said they did not intend to perform random spot checks on students; instead, as new measles cases arose, officials would check the vaccination records of any individuals who were in contact with those infected.

“The point here is not to fine people but to make it easier for them to get vaccinated,” Dr. Oxiris Barbot, the city’s health commissioner, said at the news conference.

If someone is fined but still refuses to be vaccinated, Dr. Barbot said that would be handled on a “case-by-case basis, and we’ll have to confer with our legal counsel.”

Across the country, there have been 465 measles cases since the start of 2019, with 78 new cases in the last week alone, the Centers for Disease Control and Prevention said on Monday.

In 2018, New York and New Jersey accounted for more than half of the measles cases in the country, and the continuing outbreak has led to unusual measures.

In Rockland County, N.Y., a northern suburb of New York City, county health officials last month barred unvaccinated children from public places for 30 days. Last week, however, a judge ruled against the order, temporarily halting it.

“This is the epicenter of a measles outbreak that is very, very troubling and must be dealt with immediately,” Mayor Bill de Blasio said on Tuesday.

“This is the epicenter of a measles outbreak that is very, very troubling and must be dealt with immediately,” Mayor Bill de Blasio said on Tuesday.CreditJohn Taggart for The New York Times

Despite the legal challenge to Rockland County’s efforts, Mr. de Blasio said the city had consulted its lawyers and felt confident it was within its power to mandate vaccinations.

“We are absolutely certain we have the power to do this,” Mr. de Blasio said. “This is a public health emergency.”

[In Rockland County, an outbreak spread fear in an ultra-Orthodox community.]

Dr. Paul Offit, a professor of pediatric infectious diseases at Children’s Hospital of Philadelphia, said there was the precedent for Mr. de Blasio’s actions, pointing to a massive measles outbreak in Philadelphia in 1991. During that outbreak, officials in that city went even further, getting a court order to force parents to vaccinate their children.

“I think he’s doing the right thing,” Dr. Offit said about Mr. de Blasio. “He’s trying to protect the children and the people of the city.”

He added: “I don’t think it’s your unalienable right as a United States citizen to allow your child to catch and transmit a potentially fatal infection.”

Nonetheless, the resistance to the measles vaccine remains among some ultra-Orthodox in Brooklyn.

Gary Schlesinger, the chief executive of Parcare, a health and medical center with locations in Williamsburg and Borough Park, called the public health emergency a necessary “step in the right direction.”

“Any mother that comes in and says that they don’t want to vaccinate, our providers will tell them please go find another health center,” Mr. Schlesinger said.

He said he often reminded Orthodox parents that there was no religious objection to getting vaccinated. “Any prominent rabbi will say that you should vaccinate,” he said.

Just outside the public library where Mr. de Blasio held his news conference, some Hasidic mothers raised concerns about the emergency declaration.

“I don’t think it’s up to the city to mandate anything. We all have constitutional rights,” said a woman who only identified herself by Gitty. She refused to give her last name for fear of being harassed for her rejection of vaccinations.

She said she had five children and that none had been or would be vaccinated, an action she called “a medical procedure by force.”

“We are marginalized,” she said. “Every minority that has a different opinion is marginalized.”

In nearby South Williamsburg, reaction to the emergency order was mixed. Some agreed with the need for vaccinations, but did not believe the law should require them; others agreed with the mayor.

“He’s right,” said Leo Yesfriedman, a 33-year-old father of four who said he had his family vaccinated.

He said he had followed news of the measles outbreak. Of people in his community opposed to vaccinations, he said, “It’s a very, very little percentage of crazy people.”

Measles Outbreak: Yeshiva’s Preschool Program Is Closed by New York City Health Officials

The program is the first one to be closed as part of the city’s escalating effort to stem the country’s largest measles outbreak in decades.

Children leaving a yeshiva’s preschool program in Williamsburg on Monday. It is the first to be closed by New York City officials for violating a Health Department order.

The New York Times John Taggart reported that New York City closed a preschool program at a yeshiva in Brooklyn on Monday for violating a Health Department order that required it to provide medical and attendance records amid a measles outbreak.

The preschool at United Talmudical Academy, which serves 250 students between the ages of 3 and 5 in the Williamsburg area, is the first program to be closed by the city, as it escalates efforts to stem the country’s largest measles outbreak in decades.

New York City has confirmed 329 measles cases since the outbreak began in the fall, and the cases have largely been confined within the ultra-Orthodox Jewish community. The outbreak began after unvaccinated individuals returned from celebrating Sukkot, a Jewish harvest festival, in Israel.

The closing of the preschool comes as tensions have risen in the ultra-Orthodox community over increased scrutiny and fears of an anti-Semitic backlash. On the one hand, most in the ultra-Orthodox community are vaccinated, and the vast majority of prominent rabbis have urged people to vaccinate their children. However, the city’s response to the outbreak has caused vaccine skeptics to double down on their opposition to immunization. The anti-vaccination movement’s well-coordinated and sophisticated messaging campaign, highlighted by magazines, hotlines, and conference calls, has convinced some parents that vaccines are dangerous and that diseases, like measles, are not.

In December, the city issued exclusion orders, barring unvaccinated students from attending school in certain neighborhoods. The city issued violations to 23 yeshivas and day care centers for breaking that order. But, last month, the city said it would no longer issue violations; rather, it would immediately close yeshivas.

“The challenge has been with this particular school that they have been unable and/or unwilling to provide documentation as required when we visit,” Dr. Oxiris Barbot, the city’s health commissioner, said at a news conference on Monday. “So we have visited on a number of occasions and offered support, but in spite of all of that it’s been to no avail.”

The Health Department said the preschool would not be allowed to reopen until its staff had “submitted a corrective action plan approved by the department.”

At the news conference, health officials said two students associated with the school had contracted measles, though they did not know for sure whether the students had been infected with the virus at the school or elsewhere.

Last week, Mayor Bill de Blasio declared a public health emergency, requiring all individuals living in certain ZIP codes of Brooklyn to be vaccinated against measles or face a $1,000 fine. On Monday, a group of parents filed a lawsuit against the order, arguing it was unjustified because of “insufficient evidence of a measles outbreak or dangerous epidemic.”

“Our attempts at education and persuasion have failed to stop the spread of measles,” Nick Paolucci, a spokesman for the city’s Law Department, said in a statement. “We had to take this additional action to fulfill our obligation to ensure that individuals do not continue to put the health of others at risk. We are confident that the city’s order is within the health commissioner’s authority to address the very serious danger presented by this measles outbreak.”

A judge declined to issue an emergency injunction against the city on Monday, and the parties will appear in court on Thursday.

There have been no deaths associated with this outbreak, but 25 individuals have been hospitalized. Two patients remain in the intensive care unit.

90 New Cases of Measles Reported in the U.S. as Outbreak Continues Record PaceApril 15, 2019

“This outbreak will continue to worsen, and the case count will grow if child care programs and schools do not follow our direction,” Dr. Barbot said in a statement. “It’s crucial in this outbreak that child care programs and schools maintain up-to-date and accurate immunization and attendance records. It’s the only way we can make sure schools are properly keeping unvaccinated students and staff out of child care centers to hasten the end of this outbreak.”

A teacher at United Talmudical Academy, who declined to give his name, said that all students who were not vaccinated were sent home weeks ago.

“It was a few kids who didn’t take the shots,” he said, as he exited the building. “They’re not coming back.”

A 68-year-old community member, who declined to give his name, said he did not think the school should be closed down.

“The parents should be held accountable,” he said.

He added that the community will be “very angry” that the school was shut down.

Measles outbreaks have also been reported in Rockland and Westchester Counties, suburbs of New York. Since January, 555 cases of measles have been reported in the United States, the Centers for Disease Control and Prevention said on Monday, noting the outbreak is on pace to be the largest since the country declared measles eradicated in 2000.

Exemptions Surge As Parents And Doctors Do ‘Hail Mary’ Around Vaccine Laws

Barbara Feder Ostrov noted that at two public charter schools in the Sonoma wine country town of Sebastopol, more than half the kindergartners received medical exemptions from state-required vaccines last school year. The cities of Berkeley, Santa Cruz, Nevada City, Arcata, and Sausalito all had schools in which more than 30% of the kindergartners had been granted such medical exemptions.

Nearly three years ago, with infectious disease rates ticking up, California enacted a fiercely contested law barring parents from citing personal or religious beliefs to avoid vaccinating their children. Children could be exempted only on medical grounds if the shots were harmful to health.

Yet today, many of the schools that had the highest rates of unvaccinated students before the new measure continue to hold that alarming distinction. That’s because parents have found end-runs around the new law requiring vaccinations. And they have done so, often, with the cooperation of doctors — some not even pediatricians. One prolific exemption provider is a psychiatrist who runs an anti-aging clinic.

Doctors in California have broad authority to grant medical exemptions to vaccination and to decide the grounds for doing so. Some are wielding that power liberally and sometimes for cash: signing dozens — even hundreds — of exemptions for children in far-off communities.

“It’s sort of the Hail Mary of the vaccine refusers who is trying to circumvent SB 277,” the California Senate bill signed into law by Gov. Jerry Brown in 2015, said Dr. Brian Prystowsky, a Santa Rosa pediatrician. “It’s really scary stuff. We have pockets in our community that is just waiting for measles to rip through their schools.”

The number of California children granted medical exemptions from vaccinations has tripled in the past two years.

Medical Exemptions On The Rise

The number of California children with medical vaccine exemptions has tripled in the two years since California enacted a 2016 law banning exemptions based on personal beliefs.

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Across the nation, 2019 is shaping up to be one of the worst years for U.S. measles cases in a quarter-century, with major outbreaks in New York, Texas, and Washington state, and new cases reported in 12 more states, including California. California’s experience underlines how hard it is to get parents to comply with vaccination laws meant to protect public safety when a small but adamant population of families and physicians seems determined to resist.

When Senate Bill 277 took effect in 2016, California became the third state, after Mississippi and West Virginia, to ban vaccine exemptions based on personal or religious beliefs for public and private school students. (The ban does not apply to students who are home-schooled.)

In the two subsequent years, SB 277 improved overall child vaccination rates: The percentage of fully vaccinated kindergartners rose from 92.9% in the 2015-16 school year to 95.1% in 2017-18.

But those gains stalled last year due to the dramatic rise in medical exemptions: More than 4,000 kindergartners received these exemptions in the 2017-18 school year. Though the number is still relatively small, many are concentrated in a handful of schools, leaving those classrooms extremely vulnerable to serious outbreaks.

Based on widely accepted federal guidelines, vaccine exemptions for medical reasons should be exceedingly rare. They’re typically reserved for children who are allergic to vaccine components, who have had a previous reaction to a vaccine, or whose immune systems are compromised, including kids being treated for cancer. Run-of-the-mill allergies and asthma aren’t reasons to delay or avoid vaccines, according to the U.S. Centers for Disease Control and Prevention. Neither is autism.

Before California’s immunization law took effect, just a fraction of 1% of the state’s schoolchildren had medical exemptions. By last school year, 105 schools, scattered across the state, reported that 10% or more of their kindergartners had been granted medical exemptions. In 31 of those schools, 20% or more of the kindergartners had medical exemptions.

Seesawing Exemptions

As of July 2016, California no longer allows parents to exempt their children from state-required vaccinations based on personal beliefs. Many of the same schools that once had the highest percentage of students with personal belief exemptions now lead the state in student medical exemptions.

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Annotation 2019-04-22 220303

 

Credit: Harriet Blair Rowan/California Healthline

Source: California Department of Public Health Get the data created with Datawrapper

The spike in medical exemptions is taking place amid a politically tinged, often rancorous national conversation over vaccines and personal liberty as measles resurges in the U.S. and worldwide. At least 387 cases of measles had been reported nationwide through March 28, according to the CDC. In California, 16 cases had been reported, two of them requiring hospitalization.

The problem in California, state officials say, is how the immunization law was structured. It removed the ability of parents to cite “personal belief” as a reason for exempting their children from vaccine requirements in daycare and schools. A licensed physician who provides a written statement citing a medical condition that indicates immunization “is not considered safe” now must authorize exemptions.

But the law does not specify the conditions that qualify a student for a medical exemption, nor does it require physicians to follow federal guidelines.

The wording has led to a kind of gray market in which parents share names of “vaccine-friendly” doctors by word of mouth or in closed Facebook groups. And some of those doctors are granting children blanket exemptions — for all time and all vaccines — citing a range of conditions not supported by federal guidelines, such as a family history of eczema or arthritis.

Amid growing concerns about suspect exemptions, the California Department of Public Health recently launched a review of schools with “biologically unlikely” numbers of medical exemptions, said the agency’s director, Dr. Karen Smith. Doctors who have written questionable exemptions will be referred to the Medical Board of California for a possible investigation.

The medical board, which licenses doctors, has the authority to levy sanctions if physicians have not followed the standard medical practice in examining patients or documenting specific reasons for an exemption.

In recent years, however, the board has sanctioned only one doctor for inappropriately writing a medical vaccine exemption in a case that made headlines. Since 2013, the board has received 106 complaints about potentially improper vaccine exemptions, including nine so far this year, said spokesman Carlos Villatoro.

One pending case involves Dr. Ron Kennedy, who was trained as a psychiatrist and now runs an anti-aging clinic in Santa Rosa.

Medical board investigators took the unusual step of subpoenaing 12 school districts for student medical records after receiving complaints that Kennedy was writing inappropriate exemptions. They found that Kennedy had written at least 50 exemptions, using nearly identical form letters, for students in multiple communities, including Santa Rosa, Fremont, and Fort Bragg, saying that immunizations were “contraindicated” for a catchall list of conditions including lupus, learning disability, food allergies and “detoxification impairment.”

Dr. Dean Blumberg, chief of pediatric infectious diseases at UC Davis Children’s Hospital and the medical board’s expert witness, said that the exemptions issued by Kennedy appear to have been provided “without appropriate evaluation,” according to court documents.

Kennedy has refused to respond to the board’s subpoenas seeking the medical records of three of his patients, according to court documents. The board has yet to file a formal accusation against Kennedy, and he continues to practice.

Like Kennedy, many of the doctors granting unorthodox exemptions cite their belief in parental rights or reference concerns not supported by conventional medical science. Kennedy is suing the medical board and its parent agency, the California Department of Consumer Affairs, saying the state did not have the legal right to subpoena school districts for his patients’ medical records without first informing him so he could challenge the action in court. The case is ongoing.

Kennedy declined to comment to Kaiser Health News. “I don’t want to be out in the open,” he said in a brief phone exchange. “I’ve got to go. I’ve got a business to run.”

In Monterey, Dr. Douglas Hulstedt is known as the doctor to see for families seeking medical exemptions. In a brief phone interview, he said he was worried about being targeted by the state medical board. “I have stuck my neck way out there just talking with you,” he said. Hulstedt does not give exemptions to every child he examines, he said, but does believe vaccines can cause autism — a fringe viewpoint that has been debunked by multiple studies.

In March, the online publication Voice of San Diego highlighted doctors who write medical exemptions, including one physician who had written more than a third of the 486 student medical exemptions in the San Diego Unified School District. District officials had compiled a list of such exemptions and the doctors who provided them.

State Sen. Richard Pan (D-Sacramento), a pediatrician who sponsored California’s vaccine law, has been a vocal critic of doctors he says are skirting the intent of the legislation by handing out “fake” exemptions. Last month, he introduced follow-up legislation that would require the state health department to sign off on medical exemptions. The department also would have the authority to revoke exemptions found to be inconsistent with CDC guidelines.

“We cannot allow a small number of unethical physicians to put our children back at risk,” Pan said. “It’s time to stop fake medical exemptions and the doctors who are selling them.”

8 Common Arguments Against Vaccines And why they don’t make any sense at all

Gid M-K noted that because whilst vaccines have been accepted by public health organizations the world over as the most important medical innovation of the 20th century, and one of the most lifesaving interventions that we’ve ever come up with, there is a small minority of people who are convinced that vaccines are bad for their child’s health.

A small, very vocal, minority but this minority is causing real problems for others as well as their own kids.

One would like not to criticize parents. Because it’s very important to note that most parents want the best for their kids. They are trying to look out for their children, and occasionally in this pursuit, they get misled. And make no mistake, the people who sell vaccine fear are professionals in the art of deception. They know exactly how to convince a worried parent that the most dangerous thing in the world for their child is the vaccine, rather than, say, the measles.

It’s not the parents who are spreading vaccine denial. They are victims of professionals. If you are a parent who is worried about vaccination: don’t stress. You are a good parent. You have just been lied to. Have a read of this article, and maybe go have a chat with your doctor about why immunization is important and why it’s a good thing for your kids.

Whenever you talk vaccines, the anti-vax professionals come up with the same arguments time and again. Let’s look at my top 8, and why they make no sense whatsoever:

8

Vaccines Cause Autism. I’m not really going to go into this, because it has been refuted time and again. Virtually every study involving a) humans, b) more than 10 participants, and c) researchers who haven’t been convicted of fraud, has shown that there is no link between vaccines and autism. It was a valid concern in the early 90s, but we have 30 years of evidence showing that autism is in no way linked to vaccines.

VACCINES DO NOT CAUSE AUTISM ALL REPUTABLE STUDIES HAVE SHOWN THIS FOR DECADES

7

There Hasn’t Been Much Research. This is always a bit of a weird one because people are usually claiming that on the one hand there hasn’t been enough research done on vaccines to prove them safe, but on the other, they know the truth because they’ve done their research and it shows vaccines to be basically poison.

It’s a strange argument to make, but it comes up all the time.

This is simply a lie told by vaccine-deniers to make parents scared. Vaccines are one of the most well-researched interventions of all time. We have data from literally millions of children across the world demonstrating their safety. There has been more research on vaccines than almost any other medical intervention.

The research has been done. Time and again. Vaccines are safe and effective.

6

Vaccines Are Enormously Profitable. This is also a weird one, because…so what? So are any number of things. The international flour market is gigantic, but that doesn’t make every bread advert a missive from the devil. Flour millers have actually been influential in protecting babies worldwide by fortifying their products with macronutrients and preventing neural tube defects.

It’s also untrue. Pharma companies make far more money from so-called ‘blockbuster’ drugs than vaccines — for example, AstraZeneca’s Nexium, despite being no more effective than cheaper options for gastrointestinal problems, has made them more than $50 billion. The yearly earnings have been somewhere between 2 and 5 times as much as the flu vaccine. In fact, if you look at the top 20 earners for pharma companies, not one of them is a vaccine.

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5

Vaccines Cost Loads. Perhaps more importantly than this, however: vaccines don’t cost much at all. Take the whooping cough vaccine. A full 3 doses costs around 100 USD. That seems like quite a bit until you remember that a single case of whooping cough can easily top $10,000if it requires significant treatment.

Vaccines are actually cost-saving. What this means is that for every dollar you spend on vaccines, you get about seven dollars back because you stop people from getting sick and dying from their illnesses. Generally speaking, it would be much more profitable for the medical industry to not vaccinate, because the disease tends to be really expensive.

4

The CDC Is Lying. This is one of my favorite red herrings because it is just so easy to disprove. Whenever someone brings up the CDC, my response is…so what? Let’s say the CDC is evil, awful, in the pocket of Big Pharma. It’s not — the people who work at the CDC are dedicated, honest, and usually incredibly good at public health — but for the sake of argument, let’s say the CDC is corrupt.

Who cares?

People who focus on the CDC ignore one glaring truth: the US isn’t the only country in the world. If the CDC is corrupt, what about every other public health organization in the world that recommends vaccines. Australia. France. The UK. Japan. China. The list goes on. Forget about the CDC. Have a look at the Australian Department of Health on vaccines. Or the Japanese immunization schedule. Or one of the hundreds of other countries that all choose to vaccinate. Either there’s a global conspiracy including countries that are literally at war with one another — a bit unlikely — or immunization is a good thing no matter what you think of the CDC.

3

The US Is Special. This is another one that I love because it’s so easily disprovable. No, the US doesn’t give a uniquely high number of immunizations. Much of the OECD has a virtually identical vaccine schedule to the US, bar a few minor differences. The US also has significantly less punitive laws in terms of vaccination than other countries — for example, in France, you can go to jail for failing to vaccinate your kids.

So no. The US isn’t special. It’s just another country, trying to stop nasty diseases like polio, diphtheria, and measles from killing children.

2

Vaccine Manufacturers Can’t Be Sued For Making Kids Sick. This is actually a very simple lie. You can sue whoever you want, even in the US. What the 1986 National Childhood Vaccine Injury Act actually does is make it much easier to get compensation for children who have suffered vaccine injuries. If you can demonstrate that you had a vaccine and suffered a recognized issue — let’s say anaphylaxis — there is a reasonably simple method of gaining access to compensation in the US.

Elsewhere in the world, for example, Australia, often all you can do is sue in civil courts. And even if you’ve suffered genuine harm from vaccination, proving this in a court of law is next to impossible, meaning that people who do suffer injuries are almost never compensated.

It’s also worth noting that saying “vaccine manufacturers can’t be sued” is again a uniquely American piece of nonsense. There are hundreds of other countries. Most of them allow anyone to try and sue anyone. And yet, the UK court system isn’t flooded with cases of vaccine manufacturers being successfully sued.

I wonder why?

1

Vaccine Injury Is Common/People Are Getting Sicker. Last but not least, the most common one of the bunch. Forget the CDC, forget the pharmaceutical companies, this is the real evil.

Every year, people are getting sicker. And it’s all down to vaccines.

There are two parts to this story. Firstly, we aren’t getting sicker. Not even a little bit. Life expectancy is marching steadily upward, with some people predicting that we will be living past 100 in this century. Not only that, but infant and child mortality is at record lows, and is only heading swiftly down. This isn’t just true for wealthy countries mind you — the entire world is getting stubbornly healthier.

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Secondly, vaccine injury is an amazingly well-researched field. We know the rate of injuries associated with vaccines all too well. It’s a roughly 1 serious problem for every million vaccinations given. This is a number that has been replicated worldwide, from Japan to Thailand to Australia to Finland and yes, to the US.

Vaccines Rock

There’s not really much more to say. These are common arguments, mostly just based on simple lies. Vaccines are safe and effective, not because pharmaceutical companies say it’s so or because the CDC has proclaimed it, but because thousands of dedicated researchers the world over have spent decades checking to make sure that they are.

So go and get your kids vaccinated. It’s good for society, it will save us all money, but most of all it might save their life.

Vaccines rock.

It’s as simple as that. So, stop all your chest beating complaining about your constitutional rights being trampled on! Vaccinations are for the benefit of the children yours and those who will come in contact with non-vaccinated people and get severely sick. Cut it out and get vaccinated or suffer the consequences!!

Best wishes for the Easter and Passover holidays!

States Move To Restrict Parents’ Refusal To Vaccinate Their Kids. Our Goal and the Rest of the World!

50201675_1876827435780240_8947739925063663616_nI don’t know whether you all remember my last few sentences of last week’s post but I was so encouraged this week because it seems that maybe some of the politicians are reading my blog (yeah right!?!?) or they recognize the severity of the measles problem today. So, I want to continue the discussion starting with a number of States who get the message.

Patti Neighmond wrote that all U.S. states require most parents to vaccinate their children against some preventable diseases, including measles, mumps, rubella, and whooping cough, to be able to attend school. Such laws often apply to children in private schools and day care facilities as well as public schools.

At the same time, beyond medical exemptions, most states also allow parents to opt out of this vaccination requirement for religious reasons. And 17 states permit other exemptions — allowing families to opt out of school vaccination requirements for personal or philosophical reasons.

Michelle Mello, a professor of law and health research and policy at Stanford University, says the bar for claiming an exemption from vaccine requirements has been very low in many states. “You can believe that vaccines don’t work or that they are unsafe or they simply fly in the face of your parenting philosophy,” she says.

But this winter’s outbreaks of measles across the nation are resulting in challenges to many exemptions: At least eight states, including some that have experienced measles outbreaks this year, want to remove personal exemptions for the measles vaccine. And some states would remove the exemption for all vaccines.

Most of this year’s measles cases have been among children who were not vaccinated against the virus.

Once considered eradicated in the U.S., measles has sickened at least 159 people since the start of 2019, according to the Centers for Disease Control and Prevention, in outbreaks ranging from Washington and Oregon to Texas and New York. Last year, there were 372 reported cases of measles nationwide.

The move among state legislatures to tighten vaccine requirements is good news to Diane Peterson, the associate director for immunization projects with the pro-vaccine advocacy group Immunization Action Coalition.

“Measles is not like a common cold,” Peterson says. “Children get very, very sick and can be hospitalized,” she says, adding that measles can even lead to death.

The virus is highly contagious, airborne and easily spreads. It can survive in the air for a couple of hours.

“A patient with measles can go to the doctor, cough in the exam room and two hours later another patient coming into the same exam room can be infected,” Peterson says.

The virus is spreading fast this winter, she says, because of the “pockets of children who have not been vaccinated, mostly due to parents who have decided not to vaccinate them.”

This leaves not only those unvaccinated school children vulnerable to the virus but also many adults who have suppressed immune systems and infants who are not old enough to be vaccinated.

According to the Association of State and Territorial Health Officials, bills to restrict exemptions are now pending in a growing number of states.

None of this sits well with activists who want their states to maintain personal and philosophical exemptions.

“Nobody should sit in judgment of another person’s religious and spiritual beliefs,” says Barbara Loe Fisher, a spokesperson for the National Vaccine Information Center, a group that lobbies against mandatory vaccination and thinks parents should have a choice. “No person should be allowed to force someone to violate their conscience when they’re making a decision about the use of a pharmacological product that carries a risk of harm.”

The scientific consensus about any risk from vaccines is that serious side effects are extremely rare. A suggestion that immunization might be tied to severe consequences like autism was debunked years ago after findings supporting that link were proved fraudulent.

Mello, the Stanford law professor who has been following the exemption debate, notes that the courts have repeatedly held that when a public health intervention is necessary to safeguard the public, individuals generally can be required to give up some personal liberty, particularly if that liberty is tied to a government benefit like school.

So far, only three states — Mississippi, West Virginia and California — prohibit nearly all vaccine exemptions, including the one exempting families who say their religious belief conflicts with vaccination. (All states allow medical exemptions when, for example, a child has a compromised immune system.)

The California state Legislature made that decision in 2015, less than a year after the state experienced a significant measles outbreak that got its first foothold among unvaccinated children visiting Disneyland.

A measles outbreak in the US has triggered debate on the ease with which parents can opt out of mandatory vaccine rules.

I noted last week that a total of 159 people have come down with the disease in 10 states since January, but one small area, in particular, Clark County in Washington State, has illustrated the dangers of these exemptions, which are sought for religious, personal or philosophical reasons.

Just north of Portland, Oregon, Clark County accounts for 65 measles cases, 47 of them among children under age 10. In almost all 65 cases, patients had not been vaccinated.

Fifteen years ago, 96 percent of school children aged five in Clark County got measles shots. But in 2017-2018, the proportion was down to 84 percent.

In some schools, mainly private ones, the rate of use of the so-called MMR vaccination against measles, mumps, and rubella was only 20 to 30 percent. In some of the schools, more than half the students had received exemptions.

Local lawmakers in Washington State have responded to the outbreak by advancing legislation that would do away with exemptions on personal or philosophical grounds. Opt-outs for religious reasons would still be allowed.

Such exemptions are widely available in the United States. Only three of the 50 states—California, Mississippi, and Virginia do not allow them.

California did away with exemptions for personal reasons in 2015. In the most populous US state, exemptions are permitted only for medical reasons.

In recent years other states have toughened their laws. Connecticut, for instance, requires parents claiming an exemption for religious reasons to provide a yearly, notarized statement to this effect. Since 2015, Delaware has allowed schools to temporarily exclude non-vaccinated kids.

Vermont wants to get rid of religious exemptions, after eliminating those sought for philosophical reasons four years ago, according to The Washington Post. Arizona, Iowa, Minnesota are also debating stricter laws.

Congressional hearing

The US Congress will hold a hearing Wednesday on the issue of vaccinating children.

Overall, the vaccination rate of kids in the US has remained stable, according to the Centers for Disease Control and Prevention, which monitors such trends closely.

It reports that in the 2017-2018 school year, around 95% of American kindergarteners were vaccinated against MMR, chicken pox and diphtheria, tetanus and whooping cough.

But the national rate masks wide disparities from state to state and even from one school to the next, as the case of Clark County illustrates.

And health authorities are alarmed because the previous school year was the third in a row in which requests for exemptions from vaccination increased, even though the rises were small.

And the proportion of kids reaching age two without having received any kind of vaccination is also growing, albeit slowly: 0.9 percent of children born in 2011 to 1.3 percent among those born in 2015. Vaccination-free kids were practically unheard of at the turn of the century.

Exemptions alone do not explain why children are not vaccinated. Many vaccines are recommended for American children in their first two years of life—the CDC advises they be used for 14 diseases—and this is hard for parents to keep up with, especially for vaccines that require three or four shots.

Another problem is access to health insurance. Children in families without such insurance make up a disproportionate amount of those who go without shots, according to the CDC.

In Congress, the measles outbreak has prompted lawmakers to act.

The disease routinely infected American kids before a vaccine was introduced in 1963. Before that, it killed 400 to 500 people a year in the US. In 2000 it was declared eliminated. But since then, over the years anywhere from 50 to 600 cases have been reported annually.

Two US senators recently called on the CDC to explain what it is doing in response to what they called “pockets of unvaccinated people.”

‘We Need to Get to Zero’ on Measles: NIAID Chief to House Panel

I think we all agree and members from both parties express support for measles, mumps, and rubella vaccine

Our friend Joyce Frieden, the News Editor of MedPage Today, reported that the views that some House committee members expressed Wednesday in favor of vaccination brought to mind a line from a character on a British television show: “I am unanimous in this.”

“It wasn’t until the development of the MMR [measles, mumps, and rubella] vaccine that we as a country were able to stop this horrific illness,” said Rep. Diana DeGette (D-Colo.), chairman of the House Energy & Commerce Subcommittee on Oversight and Investigations, at a hearing on recent measles outbreaks in the U.S. “But despite that success, here we are again 20 years later.”

Rep. Greg Walden (R-Ore.), a ranking member of the full Energy & Commerce Committee, noted that one in four people diagnosed with measles will end up being hospitalized. “If we don’t reverse the downward trend in vaccination, we risk bringing back measles in full force,” he said.

DeGette called the recent measles outbreaks “a real cause for national concern” and pointed out that the national measles vaccination rate for children stands at 91%.

“That may seem high to some, but it’s well below the 95% vaccination rate required to protect communities and give them herd immunity,” she said. “And while the overall national rate of MMR vaccines is currently at 91%, the rate in some communities is much lower — some as low as 77%. Outbreaks like the one we’re seeing with measles remind us of just how interconnected our communities are … As a nation, to stop the spread of deadly diseases, we have to address the root cause of the problem and we have to define concrete steps … We need to support additional research into vaccine safety to further increase consumer confidence in these vaccines.”

Nearly 160 Cases This Year

Once again the numbers are important and so from Jan. 1, 2019 to Feb. 21, 2019, there have been 159 confirmed measles cases in 10 states, Nancy Messonnier, MD, director of the CDC’s National Center for Immunization and Respiratory Diseases, told the committee. The states reporting outbreaks include California, Colorado, Connecticut, Georgia, Illinois, Kentucky, New York, Oregon, Texas, and Washington. In 2018, 372 people in 25 states and the District of Columbia were reported to have measles; most of those cases involved unvaccinated people, she added.

Although measles was officially eliminated in the U.S. in 2000, and the rate of measles vaccination coverage is fairly high nation-wide, “there are pockets of people who are vaccine hesitant who delay or even refuse to vaccinate themselves and their children,” which can cause outbreaks, Messonnier said. Many of those live in close-knit communities where they share the same religious beliefs or ethnic backgrounds as their neighbors. Others simply have a strong personal belief against vaccination.

“In the past 5 years, there have been 26 measles outbreaks of more than five cases, 12 of which were in close-knit communities, including a Somali community in Minnesota in 2017 and Orthodox Jewish communities in New York City and New York state in 2018; these 12 outbreaks account for over 75% of cases in the past 5 years,” she said, adding that “Vaccine hesitancy is the result of a misunderstanding of the risk and seriousness of disease combined with misinformation regarding the safety and effectiveness of vaccines. However, the specific issues fueling hesitancy vary by community” and must be attacked locally with the help of the CDC.

The federal government’s Vaccines for Children (VFC) program is a “critical component” of the fight against vaccine-preventable diseases, Messonnier said. “Because of VFC, we have seen significant decreases in disparities in vaccination coverage … For each dollar invested [in the program], there are $10 of societal savings and $3 in direct medical savings.”

‘I Am a Measles Survivor’

Anthony Fauci, MD, director of the National Institute of Allergy and Infectious Diseases (NIAID) in Bethesda, Maryland, said that measles was “one of the most contagious pathogens we know of” and explained that since the virus has been well sequenced, “we can tell, when the virus is reintroduced into our country, from where it comes.” For example, researchers were able to determine that a measles virus that led to an outbreak among a community of Hasidic Jews in Brooklyn in New York City came from Israel.

“I consider it really an irony that you have one of the most contagious viruses known to man, juxtaposed against one of the most effective vaccines that we have, and yet we don’t do and have not done what could be done — namely, completely eliminate and eradicate this virus.” Fauci showed a slide delineating the recent outbreaks. “This slide is really unacceptable; this is a totally vaccine-preventable disease … What we all should strive for, that measles in the United States, we need to get to zero.”

A few hearing participants shared their own experience with the disease. “I am a measles survivor,” said Rep. Michael Burgess, MD (R-Texas). “I was at an age where the measles vaccine was not available. Even though I was very young when that happened, I still remember … the heart-shaking chills, the muscle pain, and the rash that’s [emblematic] of measles.” Fauci said he also had the disease and that it was “very uncomfortable and very scary.” Rep. Brett Guthrie (R-Ky.), the subcommittee’s ranking member said that one of his close childhood friends “was essentially born without a hand” after the friend’s mother contracted rubella during her pregnancy. “I’ve always thought of measles and how devastating it can be.”

Guthrie also asked Fauci whether people could “self-medicate” with vitamin A to prevent measles. Fauci responded that children with vitamin A deficiency who get measles “have a much more difficult course, so vitamin A [supplements] can actually protect you from some of the toxic and adverse effects,” but that doesn’t apply in developed countries where such deficiencies are rare. “It doesn’t prevent measles, but it’s important in preventing complications in societies in which vitamin A deficiency might exist,” he said.

The Thimerosal Question

Burgess asked about whether thimerosal — a mercury-containing preservative often mistakenly claimed to cause problems with vaccines — was in the measles vaccine. “No, it’s preservative-free,” said Fauci. Burgess asked whether there was ever any evidence that mercury or thimerosal was unsafe. Messonnier said thimerosal had been removed from vaccines “out of an abundance of caution at a time when there wasn’t enough evidence, but evidence since then has been very conclusive” that thimerosal is safe.

The hearing was also marked by a few disruptions, including some shouts from the audience when Fauci, responding to a question, said that the measles vaccine couldn’t cause encephalitis. DeGette told the audience that such disruptions were in violation of House rules; Messonnier then said that the vaccine doesn’t cause brain swelling or encephalitis in healthy children.

Guthrie remarked that whether or not parents choose to vaccinate their children, they do so with the best of intentions. “Whatever decisions they’re making, they’re making it in the love and best interest of their child,” he said. “So I think it’s important we do have the science … and people with credentials and reputations to present this evidence, and hopefully people have the opportunity to see it and read it.”

Measles cases soar worldwide, UN warns of ‘complacency’

Outside of the U.S., I think it is necessary to see how this disease is affecting other countries. I brought up the statistics regarding the incidence and the deaths in the Philippines but on a broader scale Cynthia Goldsmith reviewed the statistics with regard  of the measles problem in the world and noted that just 10 countries were responsible for three-quarters of a global surge in measles cases last year, the UN children’s agency said Friday, including one of the world’s richest nations, France.

Ninety-eight countries reported more cases of measles in 2018 compared with 2017, and the world body warned that conflict, complacency and the growing anti-vaccine movement threatened to undo decades of work to tame the disease.

“This is a wakeup call. We have a safe, effective and inexpensive vaccine against a highly contagious disease—a vaccine that saved almost a million lives every year over the last two decades,” said Henrietta Fore, executive director of UNICEF.

“These cases haven’t happened overnight. Just as the serious outbreaks we are seeing today took hold in 2018, lack of action today will have disastrous consequences for children tomorrow.”

Measles is more contagious than tuberculosis or Ebola, yet it is eminently preventable with a vaccine that costs pennies.

But the World Health Organization last year said cases worldwide had soared nearly 50 percent in 2018, killing around 136,000 people.

Ukraine, the Philippines, and Brazil saw the largest year-on-year increases. In Ukraine alone, there were 35,120 cases—nearly 30,000 more than in 2017.

Brazil saw 10,262 cases in 2018 after having none at all the year before, while the Philippines reported 15,599 cases last year compared to 2,407 in 2017.

Taken together, the ten nations accounting for 75 percent of the increase from 2017 to 2018 account for only a tenth of the global population.

The countries with the highest rate of measles last year were Ukraine (822 cases per million people), Serbia (618), Albania (481), Liberia (412), Georgia (398), Yemen 328), Montenegro (323) and Greece (227).

While most of the countries that experienced large spikes in cases are beset by unrest or conflict, France saw its caseload jump by 2,269.

In the United States, there was a 559 percent year-on-year increase in cases from 120 to 791.

Misinformation and mistrust

The resurgence of the disease in some countries has been linked to medically baseless claims linking the measles vaccine to autism, which have been spread in part on social media by members of the so-called “anti-vax” movement.

The WHO last month listed “vaccine hesitancy” among the top 10 most pressing global health threats for 2019.

“Almost all of these cases are preventable and yet children are getting infected even in places where there is simply no excuse,” Fore said.

“Measles may be the disease, but all too often the real infection is misinformation, mistrust and complacency.”

In war-torn Yemen, where health services in many regions have collapsed, UNICEF and the World Health Organization joined with local authorities last month in a campaign to vaccinate some 13 children aged six months to 15 for measles and rubella.

UN officials estimated that 92 percent of the targeted children were jabbed during the one-week push, which ended on February 14.

Yemen also figured on UNICEF’s “top 10” list of countries showing the largest increases last year in measles cases with a 316 percent hike, from 2,101 cases in 2017 to 8,742 cases in 2018.

Other countries with huge jumps last year compared to 2017 are Venezuela (4,916 more cases, up 676 percent), Serbia (4,355 more cases, up 620 percent), Madagascar (4,307 more cases, up 5,127 percent), Sudan (3,496 more cases, up 526 percent) and Thailand (2,758 more cases, up 136 percent).

A few countries saw declines in the number of confirmed cases of measles.

In Romania, reported cases dropped 89 percent from 8,673 to 943, and in Indonesia, the number declined by 65 percent from 11,389 to 3,995.

Nigeria, Pakistan, Italy, and China also saw drops of 35 to 55 percent.

So, the number of worldwide resurgence of cases of measles is huge and we as a community need to step up and push our healthcare community and the government to step up and demand that we protect our youth both here in the U.S.A. and yes, in the world. Also, we need to ignore the politics and the misinformation and mistrust and get the job done for our kids, and future generations!