Category Archives: COVID-19 Spike

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.

Throw Away Your Mask After COVID Vaccination or Not, What about the Mutations and Infection after Vaccination?

As our national mortality statistics reach over 500,000 and a third vaccine has been approved by the FDA I thought that we should examine the use of masks, etc. after vaccinations. This is an important question especially considering the increasing findings of more viral mutants.

 Recently, a spirited discussion was sparked on social media: is it acceptable to relax masking 14 days after the second COVID-19 vaccine dose? Doctor Vinay Prasad and Doctor David Aronoff, in this post will discuss the advice as to whether to continue wearing masks as well as social distancing, etc. after one completes their vaccination.

Doctor Prasad starts off by noting that having spent some time thinking about the topic, and discussing with colleagues, I have reached two conclusions. First, it is a tradeoff with residual uncertainties, and reasonable people can disagree. But also, I favor the view that generally, 14 days after vaccination, we can relax some restrictions.

The caveats

It is important to be upfront with the caveats. Everything I say applies to average people in the community — I am not speaking about enhanced precautions in high-risk settings like nursing homes or medical centers. My argument is contingent on there being no “vaccine escape,” that is, no mutation in the coronavirus that markedly reduces vaccine efficacy. If that happens, may God help us. I am not sure we will make it.

Finally, my argument is appropriate for most places and most times, but if health systems are overwhelmed, e.g., as we saw in places like southern California or New York City, it might be reasonable to temporarily increase precautions. Additionally, my guiding principle does not apply to businesses, such as grocery stores or pharmacies, which can and will enforce their own policies.

Now, having said that: for most people, once you get 14 days out of your second dose of vaccine, I believe you can ease up on masking or another restriction, such as visiting a loved one for lunch or having more than one person visit a nursing home at the same time, or a small gathering of vaccinated people for dinner without masks.

The data

There are three lines of evidence that I wish to offer for my claim. First, consider the efficacy of the vaccine. The efficacy of the two mRNA vaccines is superb, offering 95% reduction in the rate of acquisition of symptomatic COVID-19 in randomized trials. That is a remarkable result. But the key statistic here is one step beyond the vaccine efficacy. If you get two doses of the vaccine, and if you remain asymptomatic 14 days after the second dose, what is the probability you will develop COVID-19? For Moderna, the answer is there is a 99.92% chance that you won’t. Only 12 cases occurred after this time in 14,550 actively vaccinated people in the trial, while the control arm experienced nearly 3.5% cumulative incidence. For Pfizer, only eight cases occurred amongst people who had completed a second dose and went 7 days without symptoms, again a 99.95% chance of not getting COVID if one remained asymptomatic a week after the second dose. In other words, if you get 14 days past the second dose, and feel fine, the likelihood you will get COVID-19 in these studies is very low. Some argue that in the real world — where folks are not as motivated as trial participants — the rate of SARS-CoV-2 acquisition might be higher, and thus relaxing rules riskier. But this logic cuts both ways: if people in the real world are less compliant, then the rules might be relaxed no matter what we say.

Next, consider the risk of spreading SARS-CoV-2 to others. That risk is in part driven by symptomatic infections which are exceedingly rare after second doses. Risk of spreading is diminished by the brisk immune response that occurs after symptomatic infection once someone is vaccinated. In the Moderna study, there were 30 cases of severe COVID overall and zero in the vaccination arm. Less symptomatic and less severe COVID will result in a lower propensity to propagate SARS-CoV-2. Moreover, studies of both recombinant antibody products speed viral clearance from airways. If the body is primed to manufacture anti-spike antibodies through vaccination, there is likely a similar rapid clearance and subsequent reduction in infectiousness occurs.

What about asymptomatic infection and so-called silent spread? In the Moderna trial, swabs taken from asymptomatic participants as they were receiving dose 2 showed a roughly 60% reduction in PCR positivity. It is likely that a second dose and longer asymptomatic period will result in greater reduction in PCR positivity. Preliminary data from AstraZeneca’s ChAdOx1 vaccine also showed reduced in asymptomatic PCR detection. In short, it is highly likely that receipt of vaccination and a 14-day asymptomatic period afterward results in both personal protection and reduced likelihood of ongoing viral propagation.

Third, what is the effect size of masks? More correctly — what is the effect size of masks 14 days after a vaccine with 95% efficacy? What is the effect of masks if PCR positivity is only 1 in 1,000 amongst asymptomatic people? I think we must confront a forgotten truth. Masks make sense not because we have perfect randomized controlled trial data showing they protect the wearer, or others, but based on bio-plausibility, and the precautionary principle, they were a reasonable public health measure to incorporate.

Authors of a 2020 update to the Cochrane review wrote, “Compared to no masks there was no reduction of influenza-like illness (ILI) cases (risk ratio 0.93, 95% CI 0.83-1.05) or influenza (risk ratio 0.84, 95% CI 0.61-1.17) for masks in the general population, nor in healthcare workers (risk ratio 0.37, 95% CI 0.05-2.50).” But the truth is none of these trials perfectly fits the moment. And we never did a cluster RCT of cloth masks — as they are used in the politically torn U.S. — to clarify the effect size with SARS-CoV-2.

The truth is I wear a cloth mask and I quite like it. But I have seen no data that can tell me the added benefit of masks 14 days after vaccination with 95% efficacy. It’s the biological equivalent of asking what happened before the Big Bang. If you ask, what is the evidence that it’s safe to stop wearing a mask, I say, what is the evidence that it’s still beneficial?

This same line of thinking applies to other restrictions that could be eased instead. What evidence supports restricting nursing home visitors, if all parties are vaccinated and masked? What evidence supports banning a small dinner, if everyone has had the vaccine? There is no evidence that supports these continued prohibitions.

Knowing these three facts allows us to put it all together. Is it reasonable to tell someone that, if they are asymptomatic 14 days after the second vaccine, they are highly unlikely to get COVID-19, and also less likely to spread the virus — both by having less severe disease, less asymptomatic carriage, clearing virus faster, stronger antibody responses, and fewer symptomatic cases? Absolutely, is my view.

It is then reasonable to say that the theoretical benefit of the mask may be so small that easing up on its use is fine. Alternatively, you might keep the mask, but ease up on something else, and, to be honest, most people might actually prefer a different concession. You might choose to see family instead, or have a gathering with your vaccinated friends. Getting vaccinated is like getting a stack of tickets at Chuck E. Cheese — you get to decide what to trade them in for!

The politics/sociology

Some contend my stance will undermine efforts to normalize masks, send mixed messages to the public. That’s possible, but it is also possible that my message empowers and excites people to get vaccinated, which is the only viable path out of the nightmare we find ourselves in. I think the less scientists manipulate their statements while trying to guess the response the better. I have tried to be fully transparent in my thinking on this topic. None of us knows the second or third order effects. If we distort the facts and bang on harder about prolonged mask use or other restrictions, will the world actually be better? Or will we provoke a deep backlash that has been brewing for some time? Do we risk losing some folks who might otherwise get vaccinated? I am not an incarnation of God, so I don’t know. I worry that the likes and retweets on social media encourage the fearful message rather than the correct one.

Public health experts have reminded me to talk about despair. We are all facing it, and when you clamp down on a society with restrictions, a free society can only bear it for so long. There must be a path out of it, and easing restrictions — particularly when the burden may outweigh the unproven, theoretical, and at best highly marginal benefit — is a great way to renew optimism. Folks who spend time doing boots on the ground public health share their view with me that this is a great place to start.

The last objection I want to discuss is that my policy is not the safest policy. It is not absolute safety. Indeed, I acknowledge this is true. But I disagree that wearing a mask is absolute safety. I disagree that only one nursing home visitor is the safest policy, and only having a picnic outside is safest. Only truly becoming a hermit is absolute safety. Lock yourself in home, and get all foodstuffs delivered. When you go out, always wear an N95, and do this even a year or two after vaccination. After all, who knows if the vaccine will wear off? None of us really wants absolute safety. We seek reasonable safety, and I will defend the proposition that is achieved merely by a prolonged asymptomatic period after second vaccination and after that something can be relaxed — and there are several options.

The end of COVID

COVID-19 will someday no longer be the topic of daily and breathless news coverage. The virus may always circulate, and some people may always get sick, but the real end will be when we stop thinking about it every moment of every day. That’s how this pandemic will end. Not with a bang, but a whimper.

People need to know that there is light at the end of the tunnel because there is.

Vaccination in the absence of viral escape is the way out of this. Once a person is a sufficient time and distance away from the second shot, and if they are feeling well, we can start to view them differently. They are less a vector for the transmission of a plague, and more a real person — with hopes and wants and desires and seeking connection. In such a moment, if they remove their mask to share a smile with me, I can promise you, I will lower my mask, and smile back.

And Opposing View-Now Is Not the Time to Relax COVID Restrictions

Doctor David Aronoff counters the argument with the facts that the COVID-19 pandemic has now raged on for more than a year. In the U.S., we have documented more than 24.5 million cases and 400,000 COVID-19-related deaths, with between 3,000 and 4,000 people dying each day. The CDC projects we will reach nearly 500,000 total deaths within the next month. COVID-19-related hospitalizations remain at an all-time high. America continues to suffer through a third wave of disease activity that has dwarfed the peaks of the Spring and Summer of 2020.

And, while COVID-19 is beating down on us, it could be worse, believe it or not. We have learned much about how the SARS-CoV-2 virus spreads, easily, through our breath from one person to another. Most nefarious has been the extent to which transmission occurs silently, moving from infected individuals who feel well, look well, and have no idea that they are infected. However, we know that maintaining our distance from others protects against transmission, as does the use of cloth face-coverings. It has been through social distancing and mask use that we have, in the absence of vaccination and herd immunity, been able to limit the damage done by this horrible infectious disease.

Clearly, vaccines against SARS-CoV-2 are the light at the end of the tunnel, assuming that viral mutations do not escape our vaccines sooner than we can put out the fire. With estimates that more than 60% of the population will need to have immune protection against SARS-CoV-2 to benefit from herd immunity, we have a long way to go. While less than 10% of the U.S. population has been formally diagnosed with COVID-19, a recent estimate suggested that by November of 2020 we were at about 15% of the U.S. population immune to the virus. And while that figure may now exceed 20%, this leaves more than 250 million Americans without immune protection, and falls short of the roughly 200 million people who might need to be immune for herd immunity to take hold.

Vinay Prasad, MD, MPH, has authored a thoughtful, evidence-based commentary, making a strong case for why we can relax some restrictions following successful immunization against SARS-CoV-2. He succinctly lays out an argument about why and how immunization, in the absence of vaccine-escaping virus mutants, will confer strong enough protection to render tight adherence to wearing masks and other restrictions unnecessary. And, while I think he has the right idea (I would love to see more people’s faces right now and share a meal with my friends), it is premature to suggest that now is that time. It is OK for us to hold differing opinions (that’s what we do). Two well-intentioned scientists can both look at the same data and reach different policy conclusions. So, let me focus on the case for keeping our masks on, even as we roll our sleeves up. The same logic holds for other restrictions.

First, given how active COVID-19 is right now we need to be doing everything in our power to slow its spread. Lives hang in the balance. I really like the Swiss Cheese model of pandemic defense, popularized by Australian virologist Ian Mackay, PhD, which demonstrates the concept that each measure we implement to interrupt the SARS-CoV-2 pandemic is imperfect yet when layered together they cooperatively reduce transmission risk.

Even immunization is not a perfect defense. Thus far, SARS-CoV-2 vaccination has not been shown to eliminate the risk that someone will get infected or pass the virus on to others. Studies published to date on the Moderna and Pfizer-BioNTech mRNA vaccines show clear protection against developing symptomatic COVID-19. But they also show that some vaccinated people still develop symptomatic disease. And, given what we know about the disease in non-immune people, symptomatic infections represent a fraction of total infections. This predicts that despite immunization some people will develop asymptomatic infection. Do I think that SARS-CoV-2 immunization will significantly protect people against both asymptomatic and symptomatic COVID-19? Yes. Do I think the risk to an individual will be zero following successful immunization? No. Stated differently, removing masks from vaccinated people (or relaxing social distancing) is likely to increase the risk for propagating COVID-19 compared to maintaining these restrictions. And, even if that incremental risk is small, why take it, given where we are with the disease now?

There will be a time when immune people can let their guards down, allowing even non-immune people to do the same (a benefit of herd immunity). But that time is not now.

The issue of wearing masks has been a contentious one, not helped by mixed messaging from leaders in the federal and state government. This has translated into story after story of difficulty convincing people of the public health benefit of wearing face-coverings. What we do not need are more people out and about in public spaces without masks, which sends the wrong message at the wrong time. We cannot know if an unmasked person is unvaccinated or simply an anti-masker. Why provide fuel for people to skirt mask policies based on stating they have been vaccinated, when they might not have been? And the same holds for hosting dinner parties or participating in other gatherings.

To safely advise people that once they are immunized, they can leave their masks at home and relax other infection control measures we need to record sustained decreases in disease activity, hospitalizations, and deaths, to the point where leading infectious disease and public health experts are comfortable recommending that we can de-escalate these interventions. We also need to ensure widespread vaccine uptake, particularly among Black, indigenous, and people of color, who have been disproportionately harmed by COVID-19. Recent data show that Black Americans, for example, are getting vaccinated at lower rates than white Americans.

We remain in the thick fog of a true healthcare emergency and need to be doing all we can, especially the simple things, to shut it down. Now is not the time to let up on masking, even for the relatively few who have been immunized. Abandoning mask-wearing and social distancing, even in immunized persons, is not the right thing to recommend, yet. We need masks on and sleeves up.

COVID-19 Variants: ‘The Virus Still Has Tricks Up Its Sleeve’

Now more on the counterpoint reported by Molly Walker who interviewed Dr. Warner Greene as followed: We are honored to be joined once again by Dr. Warner Greene. He’s senior investigator at Gladstone Institutes and a professor at University of California San Francisco. As we’ve discussed, COVID-19 variants are very much in the news. Can we go over what is the latest news about the variants, even today? What do we know about them and what’s the latest that’s been happening?

Variants are very much in the news. What we’re seeing is the slow but steady evolution of the coronavirus. There are now four major variants that are of concern. And, in fact, they call them variants of concern. The first recognized was the U.K. variant, recognized in the south of the United Kingdom. It has an increased transmission efficiency. And there are some reports that it may be somewhat more virulent, particularly in men over the age of 60.

Of even greater concern is the South African variant, which contains mutations that confer resistance to certain monoclonal antibodies, like one of the two monoclonal antibodies developed by Regeneron. The Eli Lily monoclonal antibody doesn’t seem to work against the South African variant and vaccine efficiency is also reduced with the South African variant.

Similarly, the Brazilian variant has basically the same set of mutations that are conferring antibody resistance, causing real concern. What it means for the vaccines, etc.: I think that both the South African and the Brazilian variants are a major concern. And it is possible that those variants as they spread, and they are in the United States now, we may need to revise the vaccines to account for these types of variants. That’s not clear yet, but better to be prepared, in case we do need to revise the vaccine.

And then there’s a fourth type of variant, which is just kind of emerging, less well-studied at this point, but out of California. So clearly there, the virus is searching for a lock and key mechanism trying to search for ways to allow itself to replicate better. We’re applying immune pressure. So, it’s mutating away from some of that immune pressure, and that’s why this antibody resistance is emerging.

So, what types of mutations does the SARS-CoV-2 virus have to go through to make it a variant?

Well, for example, the South African variant has 27 mutations, nine of which occur in the spike protein. The spike is the protein on the surface that binds to the ACE2 receptor and allows entry and fusion into the host cell. And, of course, that’s where most of the vaccines are focused, is on the spike. That’s where the monoclonal antibody therapeutics are focused, on the spike. And so the virus is looking for ways to avoid these types of immune pressures and it’s making mutations in its receptor binding domain and the internal domain that confer resistance to certain types of neutralizing antibodies.

Given that recent studies from Novavax and Johnson & Johnson last week found somewhat reduced clinical efficacy of vaccines against these variants, what type of booster modification is required for vaccines in order to better combat them with the mRNA and the viral vector vaccines? Is it different, is it the same?

I think the booster that, for example, Moderna and Pfizer are now working on is to take the genetic sequence of the variant and use that as the immunogen. So, there is a mutation at position 484 that is absolutely key for this loss of antibody protection. You would introduce an RNA that now has that same mutation at position 484 into the vaccine to create a vaccine that is really tailored to take that particular type of virus out. And that mutation is shared between the South African and the Brazilian variants.

And so it wouldn’t require a different type, depending on the type of vaccine, it would just be the same type of reformulation. It wouldn’t be mRNA, different than a viral vector, it would just be a different formula. It’s not anything to do with the type of vaccine. It still would be an mRNA-based vaccine. It would just contain a different RNA or more likely it will be a multi-valent vaccine that would be original virus, as well as a new virus.

It’s not clear exactly how that would be administered. It may be that we want to boost immunity against the old virus, as well as the new virus, so we would use a multi-valent approach in that case. But the mRNA vaccine platform is quite amenable to this type of updating. That’s a real advantage, much more so than the adenoviral vectors, the virus-delivered vaccines. It’s a more complicated process there.

If we could just look at the vaccines as we have them now against this wild-type strain, if for some reason we didn’t have any boosters, what type of progress could we make against the pandemic? Can we vaccinate our way out of the pandemic, even if we don’t have these boosters? Have these variants prevented that?

To be clear, these variants, the Brazilian and the South African variants, are only compromising the neutralizing antibody response against the coronavirus. The T-cell immune response presumably is fully intact and remains unevaluated. So it’s quite possible that these vaccines will stand up better than we expect or predict. Clearly the U.K. variant does not appear to be a threat, although the recent acquisition of the neutralizing mutation at 484 causes concern that the virus is evolving. Even the U.K. variant is evolving.

I would say that the one thing that is disturbing to me, or that causes me pause is the story in Manaus, Brazil. Manaus is in the Amazon basin, they had a huge outbreak in the spring. It was thought, as reported, that there would probably be herd immunity within the community up to about 75%. Then this variant comes in to the community and it’s just sweeping through, causing re-infection or what appears to be re-infection.

Now did the original immunity wane and these people were all sensitive? Is it just that the variant is able to avoid both the T-cell and the antibody response that was present in the herd in Manaus? That kind of real-time experiment is concerning in terms of the spread of this virus. And I think data like that and what’s going on in South Africa is what’s really prompting the vaccine companies to get prepared now. We don’t know the full dimensions of the problem, but better to overprepare at this point in time.

So, given what happened in Brazil, do you think that’s evidence of viral escape?

Certainly, the South African and Brazilian variants, the mutations they are acquiring in their spike protein are examples of escape from the antibody neutralization. These are mutating principal antibody-binding sites that are responsible for neutralization, so that these variants are emerging under the influence of immune pressure. It’s harder to get around the T-cell immunity though, because T-cell immunity differs from person to person based on the composition of our HLA genes and our immune response. And T-cells are really the major defense mechanism against viruses, so let’s hope that our T-cells fill in for any gaps that the antibodies might come up a little short on.

I’m not sure exactly what has happened in Manaus, whether there was really ever herd immunity, whether it’s waned, but I do know that the variant there is hitting hard. So, that’s a big question mark. I think Brazil holds the answers to a lot of the future of this pandemic. We need to understand precisely what is going on there.

What do we need to be studying in Brazil specifically? And what type of data would we need to be looking at and tracking, what types of real-world studies and epidemiological studies would you like to see out of what’s happening in Brazil to help us going forward?

I would like to know whether or not there was real herd immunity. Before this new variant began to spread, was there clear evidence of a good antibody response and retention of durable antibody responses against the original strain of “wild-type” virus. So, if, in fact, there was an intact immune response, and this virus was able to overwhelm that response, well that’s not good news, but if the response had waned or had never really developed fully, then that’s a less daunting problem.

Now on the positive side, you look at the Johnson & Johnson vaccine, it’s not the world’s best at preventing you from becoming infected with or developing minor respiratory symptoms. But even with the South African variant, this vaccine protects you from severe disease, having to go to hospital and dying. And frankly, that’s what we want from a vaccine. That is fantastic. You may have a runny nose or a mild upper respiratory tract infection, but you’re not going to develop life-threatening pneumonia and require hospitalization, intubation, etc. And I’d sign up for that type of vaccine any day.

All we have from the mRNA vaccines from Pfizer and Moderna are these kinds of in vitro and in lab studies that if you expose them to these variants, this is what they’ll do, but do we need some type of clinical efficacy? Would you say at this point that we don’t have evidence of clinical efficacy against the variants with these two vaccines that are currently being distributed?

Exactly. The mRNA vaccines are not being tested extensively in areas where the variants are prospering, but one of the trial sites for Johnson & Johnson was in South Africa. So, they were able to see how their vaccines stood up against that variant and it fared very well in terms of prevention of serious disease.

When do you think that we are going to get these types of studies? Is that something that we’re going to see as the vaccine trials kind of evolve, and are we going to be able to get that from the mRNA vaccines? Are we just going to not know what their clinical efficacy is until we get a booster, we’re just going to only have the lab evidence?

It’s likely that the virus is probably replicating at higher levels or more virus is replicating in terms of country here in the United States than almost anywhere else in the world, in terms of the breadth of cases that we’ve had, etc. We just simply do not have the genomic surveillance types of apparatus to necessarily detect these variants. For example, we’re just now detecting the California variants. There may be many variants in the United States. We do know that the Brazilian, as well as the South African, variants are in the United States, and it’s possible that there is community spread of these variants. So, we just have to really ramp up our sequencing efforts to really track what’s happening within our pandemic within the country and what types of viruses that we’re dealing with.

And it’s in that kind of setting as variants begin to hold sway. For example, it’s suggested that the U.K. variant will become dominant in the United States by March. So, our prediction is that the current vaccines will do very well against that variant. Now, if that variant is replaced by, for example, a South African variant, which is more immunologically daunting, well then, we’re going to have to see how the mRNA vaccines hold up against that. And it’s that kind of real-world information that’s going to inform whether or not we need to boost the immune system with a third shot.

Are the variants occurring in regions due to the similarities in the genome of the regional population, causing the viral RNA to mutate in a specific direction, and do antigen tests pick up variants?

No, the antigen tests will not pick up the variants. You really have to do the sequencing to find these mutations. So, it’s clear that the virus has a set of mutations and it’s trying different combinations. All the virus wants to do is to replicate better. The U.K. variant has one mutation in the receptor binding domain, which confers tighter binding to the ACE2 receptor and a higher level of transmission by 40% to 70%. And that’s the variant that may become dominant here in the United States by March. In contrast, the South African and the Brazilian variants, they not only have the same mutation that the U.K. variant does, they’ve added to it. They’ve added at least two additional mutations that really take out these neutralizing antibodies.

Now, did these two variants arise independently? Some would say yes. I don’t think that we know precisely because one person coming from South Africa carrying the virus could seed the virus in Brazil. So, we don’t know, but there are subtle differences. The virus is working toward a solution here for avoiding the antibodies.

Now, another question is, is the virus throwing everything at us right now that it’s got? Is this it and can we expect a pretty much static situation from here on out? And, you know, I don’t think so. I think the virus still has tricks up its sleeve, and will continue to evolve as we put additional immune pressures on it. So, that would be my guess, but we’re right at the cusp of the evolving science. And to think that where we were a year ago with no defense, no innate or no intrinsic immunity to this virus, and nothing really therapeutic or preventive. And now we’re in a situation where we have multiple, highly effective vaccines. It’s a true triumph of science.

Can you go into how else the virus could mutate? Is there any way that it could mutate that T-cell immunity that we have that would be compromised? Is that possible or is it just not that complex a virus?

Yeah, there may be the emergence of escape mutations that escape a cytotoxic T-cell, CD8 T-cell responses, or CD4 helper T-cell responses. We could certainly see that and it’s much harder to monitor for those types of immune reactions. So, certainly, like you get immune escape against antibodies, you can have immune escape against T-cell immunity as well.

California man tests positive for COVID-19 weeks after second jab: report

Edmund DeMarche reported that a California man said he was diagnosed with COVID-19 three weeks after he received his second dose of the vaccine, reports said.

CBS Los Angeles reported that Gary Micheal, who lives in Orange County’s Lake Forest, found out he had the virus after being tested for an unrelated health concern. His symptoms are relatively minor, the report said.

He received the Pfizer vaccine, the report said. Patch.com reported that he got his first dose on Dec. 28 and his second jab on Jan. 18.

Dr. Anthony Fauci, the country’s leading infectious-disease scientist, said the latest evidence indicates that the two vaccines being used in the U.S. — Pfizer’s and Moderna’s — are effective even against the new variants.

A doctor interviewed in the CBS report said that he was not surprised to hear about Michael’s diagnosis.

“I think I’ve heard of six or seven independent cases over the last three weeks of individuals that have been vaccinated with different timelines that have tested positive, and I think we’re going to continue to see that more and more,” Dr. Tirso del Junco Jr., chief medical officer of KPC Health, told the station.

Fauci has estimated that somewhere between 70% and 85% of the U.S. population needs to get inoculated to stop the pandemic that has killed close to 470,000 Americans.

And Now Four people in Oregon who received both doses of vaccine test positive for coronavirus

Minyvonne Burke reported that four people in Oregon have tested positive for the coronavirus after receiving both doses of the Covid-19 vaccine, health officials said.

There are two cases each in Yamhill and Lane counties, the state’s Health Authority said in a series of tweets on Friday. The cases are either mild or asymptomatic.

“We are working with our local and federal public health partners to investigate and determine case origin,” the agency said. “Genome sequencing is underway, and we expect results next week.”

The agency referred to the individuals who tested positive as “breakthrough cases,” meaning that they got sick with the virus at least 14 days after receiving both doses.

The Health Authority said more breakthrough cases could pop up.

“Clinical trials of both vaccines presently in use included breakthrough cases. In those cases, even though the participants got Covid, the vaccines reduced the severity of illness,” the agency said in a tweet.

“Based on what we know about vaccines for other diseases and early data from clinical trials, experts believe that getting a Covid-19 vaccine may also help keep you from getting seriously ill even if you do get the virus. … Getting as many Oregonians as possible vaccinated remains a critical objective to ending the pandemic.”

The agency’s announcement came the same day its health officer said there has been a decline of daily Covid-19 cases over the past several weeks. As of Friday, there were 149,576 cases in the state, according to the department’s count.

“These decreases are a testament to the actions all Oregonians are taking to slow the spread of Covid-19 and the sacrifices made – thank you,” health officer Dean Sidelinger said at a news conference Friday.

Another breakthrough case was reported in North Carolina, according to NBC affiliate WCNC-TV in Charlotte. The state’s Department of Health and Human Services told the outlet that the person had mild symptoms and did not need to be hospitalized.

The Centers for Disease Control and Prevention has said that quarantining is not necessary for fully vaccinated people within three months of having received their last doses as long as they do not develop any symptoms.

They do, however, still need to practice certain safety measures such as wearing face masks, social distancing, and avoiding crowds or poorly ventilated spaces.

“Fully vaccinated” means at least two weeks have passed since a person has completed their vaccination series and now we have the addition of the Johnson and Johnson vaccine, which is a single dose with less effectivity but about the same activity of our yearly flu vaccine.

So, as I have said before, continue to wear your masks, whether one, two, three or whatever the number of masks that we are going to be advised with future “scientific” evidence.

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!

Amid a public health crisis, Americans’ views on health care policy haven’t changed, survey says; And What will Biden do to Healthcare?

Rebecca Morin reported that over the past several weeks, the majority of Americans have had to alter their lives due to the coronavirus pandemic.

Face masks have become part of most people’s daily wardrobe. Social distancing restrictions are still being ordered in many of the states. And millions have lost their jobs, as well as their health insurance. 

Now that Joe Biden has been declared the next president, we need to consider what I have been saying, that if we have learned nothing else, a form of universal affordable health care is a necessity.

Despite the changes, the majority of Americans’ long-held beliefs surrounding health care haven’t changed, according to a new survey.

About half of Americans – 51% – said they agree that government-run health insurance should be provided to all Americans, according to a survey from the Democracy Fund + UCLA Nationscape Project. That’s just a 1 percentage point less than in February.

“The events themselves have not driven people to some radical new conclusions about whether the government should be providing certain types of services,” said Robert Griffin, research director for the Democracy Fund Voter Study Group. “These are not attitudes that have suddenly changed overnight in response to political events that have occurred.”

The new survey comes amid a public health crisis, where most of the United States was closed down for more than a month to help limit the spread of the coronavirus. Over the past couple of months, more than 36 million people have sought jobless benefits. The Labor Department said Thursday that about 3 million Americans filed initial unemployment benefit claims last week.

Are lockdowns being relaxed in my state? Here’s how America is reopening amid the coronavirus pandemic.

Half the states across the nation have also begun loosening social distancing restrictions over the past several weeks. Experts show that the curve showing the rate of new cases may be flattening, but they are estimating at least 60,000 more people will die from coronavirus by August. 

The Democracy Fund + UCLA Nationscape Project is a large-scale study of the American electorate. Throughout the 2020 election cycle, the researchers aim to conduct 500,000 interviews about policies and the presidential candidates. This survey was conducted between April 29 and May 6, with 6,366 Americans surveyed. There is a margin of error of plus or minus 2.1 percentage points.

Another policy view that hasn’t seen a lot of change? Subsidizing health insurance for lower-income people who are not receiving Medicare or Medicaid.

Sixty-three percent of Americans said that they agree with that – a 2 percentage-point drop from February. 

However, a majority of Americans believe there should be more short-term aid for those in need during the coronavirus pandemic, according to an analysis on Nationscape Insights, a project of Democracy Fund, UCLA, and USA TODAY. 

Pandemic protocols: Safety measures vary from the White House to the Supreme Court

Griffin noted that during the pandemic, Americans are “much more flexible in terms of thinking about what types of policies they might consider,” even if their attitudes about basic policies haven’t shifted much.

Seventy-nine percent of Americans strongly or somewhat support increasing spending on health insurance and food aid for the poor during the coronavirus pandemic. When broken down between Democrats and Republicans, the majority of both also support to increase spending.

The coronavirus pandemic also hasn’t affected long-standing political norms for Republicans and Democrats, according to the survey.

Sixty-nine percent of Democrats said they agree with providing government-run health insurance to all Americans. In February, that number was at 68%. In terms of agreeing on subsidizing health insurance for lower income people who are not receiving Medicare or Medicaid, Democrats are at 78%, a 2-percentage point drop from February.

For Republicans, the numbers don’t change drastically either. Thirty percent of Republicans agree to providing government-run health insurance to all Americans, compared with 33% in February. There was also a three-point drop from February to May among Republicans when asked if they agree on subsidizing health insurance for lower income people who are not receiving Medicare or Medicaid, from 53% to 50%. 

Biden Wants to Lower Medicare Eligibility Age To 60, But Hospitals Push Back

Phil Galewitz reported that President-elect Joe Biden’s plan to lower the eligibility age for Medicare is popular among voters but is expected to face strong opposition on Capitol Hill.

Of his many plans to expand insurance coverage, President-elect Joe Biden’s simplest strategy is lowering the eligibility age for Medicare from 65 to 60. Is this the first step to Medicare-for-All?

But the plan is sure to face long odds, even if the Democrats can snag control of the Senate in January by winning two runoff elections in Georgia.

Republicans, who fought the creation of Medicare in the 1960s and typically oppose expanding government entitlement programs, are not the biggest obstacle. Instead, the nation’s hospitals — a powerful political force — are poised to derail any effort. Hospitals fear adding millions of people to Medicare will cost them billions of dollars in revenue.

“Hospitals certainly are not going to be happy with it,” said Jonathan Oberlander, professor of health policy and management at the University of North Carolina at Chapel Hill.

Medicare reimbursement rates for patients admitted to hospitals are on average half what commercial or employer-sponsored insurance plans pay.

“It will be a huge lift [in Congress] as the realities of lower Medicare reimbursement rates will activate some powerful interests against this,” said Josh Archambault, a senior fellow with the conservative Foundation for Government Accountability.

Biden, who turns 78 this month, said his plan will help Americans who retire early and those who are unemployed or can’t find jobs with health benefits.

“It reflects the reality that, even after the current crisis ends, older Americans are likely to find it difficult to secure jobs,” Biden wrote in April.

Lowering the Medicare eligibility age is popular. About 85% of Democrats and 69% of Republicans favor allowing those as young as 50 to buy into Medicare, according to a Kaiser Family Foundation tracking poll from January 2019. (Kaiser Health News is an editorially independent program of the Kaiser Family Foundation.)

Although opposition from the hospital industry is expected to be fierce, it is not the only obstacle to Biden’s plan.

Critics, especially Republicans on Capitol Hill, will point to the nation’s $3 trillion budget deficit as well as the dim outlook for the Medicare Hospital Insurance Trust Fund. That fund is on track to reach insolvency in 2024. That means there won’t be enough money to pay hospitals and nursing homes fully for inpatient care for Medicare beneficiaries.

It’s also unclear whether expanding Medicare will fit on the Democrats’ crowded health agenda, which includes dealing with the COVID-19 pandemic, possibly rescuing the Affordable Care Act (if the Supreme Court strikes down part or all of the law in a current case), expanding Obamacare subsidies and lowering drug costs.

Biden’s proposal is a nod to the liberal wing of the Democratic Party, which has advocated for Sen. Bernie Sanders’ government-run “Medicare for All” health system that would provide universal coverage. Biden opposed that effort, saying the nation could not afford it. He wanted to retain the private health insurance system, which covers 180 million people.

To expand coverage, Biden has proposed two major initiatives. In addition to the Medicare eligibility change, he wants Congress to approve a government-run health plan that people could buy into instead of purchasing coverage from insurance companies on their own or through the Obamacare marketplaces. Insurers helped beat back this “public option” initiative in 2009 during the congressional debate over the ACA.

The appeal of lowering Medicare eligibility to help those without insurance lies with leveraging a popular government program that has low administrative costs.

“It is hard to find a reform idea that is more popular than opening up Medicare” to people as young as 60, Oberlander said. He said early retirees would like the concept, as would employers, who could save on their health costs as workers gravitate to Medicare.

The eligibility age has been set at 65 since Medicare was created in 1965 as part of President Lyndon Johnson’s Great Society reform package. It was designed to coincide with the age when people at that time qualified for Social Security. Today, people generally qualify for early, reduced Social Security benefits at age 62, but full benefits depend on the year you were born, ranging from age 66 to 67.

While people can qualify on the basis of other criteria, such as having a disability or end-stage renal disease, 85% of the 57 million Medicare enrollees are in the program simply because they’re old enough.

Lowering the age to 60 could add as many as 23 million people to Medicare, according to an analysis by the consulting firm Avalere Health. It’s unclear, however, if everyone who would be eligible would sign up or if Biden would limit the expansion to the 1.7 million people in that age range who are uninsured and the 3.2 million who buy coverage on their own.

Avalere says 3.2 million people in that age group buy coverage on the individual market.

While the 60-to-65 group has the lowest uninsured rate (8%) among adults, it has the highest health costs and pays the highest rates for individual coverage, said Cristina Boccuti, director of health policy at West Health, a nonpartisan research group.

About 13 million of those between 60 and 65 have coverage through their employer, according to Avalere. While they would not have to drop coverage to join Medicare, they could possibly opt to pay to join the federal program and use it as a wraparound for their existing coverage. Medicare might then pick up costs for some services that the consumers would have to shoulder out of pocket.

Some 4 million people between 60 and 65 are enrolled in Medicaid, the state-federal health insurance program for low-income people. Shifting them to Medicare would make that their primary health insurer, a move that would save states money since they split Medicaid costs with the federal government.

Chris Pope, a senior fellow with the conservative Manhattan Institute, said getting health industry support, particularly from hospitals, will be vital for any health coverage expansion. “Hospitals are very aware about generous commercial rates being replaced by lower Medicare rates,” he said.

“Members of Congress, a lot of them are close to their hospitals and do not want to see them with a revenue hole,” he said.

President Barack Obama made a deal with the industry on the way to passing the ACA. In exchange for gaining millions of paying customers and lowering their uncompensated care by billions of dollars, the hospital industry agreed to give up future Medicare funds designed to help them cope with the uninsured. Showing the industry’s prowess on Capitol Hill, Congress has delayed those funding cuts for more than six years.

Jacob Hacker, a Yale University political scientist, noted that expanding Medicare would reduce the number of Americans who rely on employer-sponsored coverage. The pitfalls of the employer system were highlighted in 2020 as millions lost their jobs and their workplace health coverage.

Even if they can win the two Georgia seats and take control of the Senate with the vice president breaking any ties, Democrats would be unlikely to pass major legislation without GOP support — unless they are willing to jettison the long-standing filibuster rule so they can pass most legislation with a simple 51-vote majority instead of 60 votes.

Hacker said that slim margin would make it difficult for Democrats to deal with many health issues all at once.

“Congress is not good at parallel processing,” Hacker said, referring to handling multiple priorities at the same time. “And the window is relatively short.”

Biden has room on health care, though limited by Congress

Biden’s proposals for a public health insurance option and empowering Medicare to negotiate prescription drug prices seem out of reach

President-elect Joe Biden is unlikely to get sweeping health care changes through a closely divided Congress, but there’s a menu of narrower actions he can choose from to make a tangible difference on affordability and coverage for millions of people.

With the balance of power in the Senate hinging on a couple of Georgia races headed to a runoff, and Democrats losing seats in the House, Biden’s proposals for a public health insurance option and empowering Medicare to negotiate prescription drug prices seem out of reach. Those would be tough fights even if Democrats controlled Congress with votes to spare.

But there’s bipartisan interest in prescription drug legislation to limit what Medicare recipients with high costs are asked to pay, and to restrain price increases generally. Biden also could nudge legislation to curb surprise medical bills over the finish line.

Moreover, millions of people already eligible for subsidized coverage through “Obamacare” remain uninsured. A determined effort to sign them up might make a difference, particularly in a pandemic. And just like the Trump administration, Biden is expected to aggressively wield the rule-making powers of the executive branch to address health insurance coverage and prescription drug costs.

With COVID-19 surging across the country, Biden’s top health care priority is whipping the federal government’s response into shape. In his victory speech Saturday, he pledged to “spare no effort, or commitment, to turn this pandemic around.” He appointed a pandemic task force to develop “an action blueprint” that could be put into place on Inauguration Day.

On broader health policy issues, Biden has signaled he will stick with his robust campaign platform, which called for covering all Americans by building on the Affordable Care Act, adding a new public insurance option modeled on Medicare and lowering the eligibility age for Medicare.

“We’re going to work quickly with the Congress to dramatically ramp up health care protections, get Americans universal coverage, lower health care costs, as soon as humanly possible,” the president-elect said earlier this week.

Progressives who drive the Democratic Party’s health care agenda say Biden must try as hard as he can to deliver, no matter if Sen. Mitch McConnell, R-Ky., remains majority leader of the Senate.

“I would vote for anything that improves health care for the American public, but what we need to do is push boldly and clearly for progressive policies,” said Rep. Ro Khanna, D-Calif., first vice chair of the Congressional Progressive Caucus.

Khanna says he’d like to see a President Biden calling out McConnell in public. “Right at the State of the Union, he should say, ‘One person potentially stands in the way of this, and that is Mitch McConnell,’” said Khanna.

Not in the real world, Republicans say.

They say the only way Democrats could get a big health care bill through is to first win the two Senate seats in Georgia and then rely on a special budget procedure that would allow them to pass legislation in the Senate on a simple majority vote. Either that or change Senate rules to abolish the filibuster. None of that can be done with a snap of one’s fingers.

“I put the odds of large-scale comprehensive health care reform at almost zero,” said Brendan Buck, who served as a top adviser to former House Speaker Paul Ryan, R-Wis.

Biden’s to-do list on health care begins with new hires and a rewrite of Trump administration policies.

Democrats have a deep talent pool he can tap for top jobs. Among the leading contenders for health secretary is former Surgeon General Vivek Murthy, who is a co-chair of Biden’s coronavirus task force. North Carolina state health secretary Dr. Mandy Cohen, another Obama administration alum, is also being promoted.

The rewrite project involves rescinding regulations and policies put in place by the Trump administration that allowed states to impose work requirements on Medicaid recipients, barred family planning clinics from referring women for abortions, made it easier to market bare-bones health insurance and made other changes.

But Biden can also use the government’s rule-making powers proactively. Prescription drugs is one area. The Trump administration was unable to finalize a plan to rely on lower overseas prices to limit what Medicare pays for some drugs. It’s a concept that Democrats support and that Biden may be able to put into practice.

On Capitol Hill, there doesn’t seem to be a clear path.

A Republican advocate for action to curb prescription drug costs, Sen. Chuck Grassley of Iowa, is expected to take on a new role in the next Congress, with less direct influence over health care issues.

A factor that may work in Biden’s favor is that many Republicans want to change the subject on health care. Exhaustion has set in over the party’s decade long campaign to overturn the Affordable Care Act, which has left the main pillars of former President Barack Obama’s health law standing, while knocking off some parts.

Though not ready to embrace the ACA, “Republicans have tired of banging their heads against the wall in an effort to get rid of it,” said Buck.

Brian Blase, a former Trump White House health care adviser, says he thinks there is potential on prescription drugs.

“Biden, I think, will be pragmatic in this area,” Blase said.

He expects a Biden administration to wield its rule-making powers aggressively, looking at international prices to try to limit U.S. prescription drug costs.

Coronavirus relief legislation could provide an early vehicle for some broader health care changes.

Former Health and Human Services Secretary Kathleen Sebelius, who oversaw the rollout of the ACA under Obama, says it’s not a question of all or nothing.

“Will it be as much progress as if we had had a big Senate win?” she asked.

It may not look that way.

“But can he make progress? I think he can.”

What You Need to Know About the ‘90% Effective’ COVID-19 Vaccine

There is promise—but there are also questions.

Marty Munson noted that on  Monday, a COVID-19 vaccine made by the drug company Pfizer in conjunction with BioNTech made headlines. An early analysis released by the drug maker suggested that the vaccine could be more than 90 percent effective in preventing COVID-19.

No doubt it’s promising news—in fact, a CNN report says that Anthony Fauci, M.D., the nation’s top infectious diseases expert, texted CNN and called it “extraordinarily good news.”

The early analysis is of a trial that involved nearly 44,000 subjects; half receiving a placebo and the other half receiving a two-dose regimen of the new vaccine. The report says that 94 people got COVID-19. It’s not clear how many of those received a placebo and not the vaccine, but it would have to be most of them for the reports to claim more than 90 percent efficacy.

The excitement among scientists and the financial sector isn’t just about the robustness of the results. This vaccine uses a new technology, known as mRNA, a gene-based drug technology that has never been used in a vaccine before. So, the potential success of this drug is also a huge success for science. The Wall Street Journal quotes Professor John Bell, a UK health-policy advisor involved in the Oxford-AstraZeneca vaccine as saying, “the most important message is that you can make a vaccine against this critter.”

What it means so far

The news is encouraging, but the vaccine is not a panacea yet. The New York Times pointed out on Tuesday that “independent scientists have cautioned against hyping early results before long-term safety and efficacy data has been collected. And no one knows how long the vaccine’s protection might last.”

Data hasn’t been released on whether any people in the trial developed milder forms of COVID-19, what kind of side effects are associated with it, and how long protection might last. A few more considerations that moderate enthusiasm for the results: The results were released by the company, not in a medical journal, and the trial hasn’t concluded, so the numbers may change, The New York Times report points out.

If the company does receive emergency authorization of the vaccine after it collects the required amount of safety data, there are still questions and concerns about whether it is effective in all populations, how much vaccine the company can produce and how quickly, who would get it first, how it will be transported and delivered and whether people will accept the vaccine and get it when it’s offered.

What else to know

The news is promising and especially with the latest information regarding the Moderna vaccine, but there’s more data to come out, and many more problems need to be solved before a vaccine is a reality for most Americans. The pandemic is far from over, and this news doesn’t change that yet. So for now, at a time when there have been about 110,000 COVID-19 cases a day surging in the U.S., it’s still important to wear masks and continue to use social distancing measures and common sense. It seems that we are all forgetting common sense.

So, as my favorite candidate for the presidency. Governor Larry Hogan, says-Wear the damn masks and…get your flu shots!!!!

Also, I have included a cartoon from Rick Kollinger who has suffered a setback in his fight with his cancer. But after my visit with him, and my harassment he has attempted to draw a few more cartoons for me and his fans. Thank you Rick and please get better!


 [r1]

Time to prepare for an even more deadly pandemic and Trump’s Healthcare Plan

What a confusing time and how disappointed can one be when one candidate running for President convinces a group of physicians to complain about Trump’s response to the Pandemic. I am embarrassed to say that they are in the same profession that I have been so proud to call my own. Can you blame the President for the pandemic as all the other countries that are experiencing the increased wave of COVID? Can you blame Trump for the lack of PPE’s when former President Obama and yes, Vice President Biden refused to restock the PPE’s used for the other SAR’s viruses?  What a pathetic situation where the average American is so hateful and, yes, the word is stupid, and with no agreement in our Congress except to make us all hate them. Where is the additional financial support, the stimulus package promised, for the poor Americans without jobs and huge debts? This is a difficult situation when we have such poor choices for the most important political office and can’t see through the media bias.

I just had to get all that off my chest as I am like many very frustrated. How did we get here and who do we believe as we hear more about Biden’s connection with his son’s foreign dealings?

Thomas J. Bollyky and Stewart M. Patrick reported that the winner of the presidential election, whether that is Donald Trump or Joe Biden, will need to overcome the COVID-19 pandemic — the worst international health emergency since the 1918 influenza outbreak — and also begin preparing the United States and the world for the next pandemic.

Think it is too soon to worry about another pandemic? World leaders have called the coronavirus outbreak a “once-in-100-year” crisis, but there is no reason to expect that to be true. A new outbreak could easily evolve into the next epidemic or a pandemic that spreads worldwide. As lethal as this coronavirus has been, a novel influenza could be worse, transmitting even more easily and killing millions more people.

Better preparation must begin with an unvarnished assessment of what has gone wrong in the U.S. and in the global response to the current pandemic and what can be done to prepare for the next one when it strikes, as it inevitably will.

Preparedness needs to start with investment. Despite multiple recent threats, from SARS (2003) to H5N1 (2007) to H1N1 (2009) to Ebola (2013-2016); many blue ribbon reports and numerous national intelligence assessments; international assistance for pandemic preparedness has never amounted to more than 1% of overall international aid for health.

The United States devoted an even smaller share of its foreign aid budget in 2019 — $374 million out of $39.2 billion — to prepare for a pandemic that has now cost the country trillions of dollars. Meanwhile, funding for the Centers for Disease Control and Prevention’s support to states and territories has fallen by more than a quarter since 2002. Over the last decade, local public health departments have cut 56,360 staff positions because of lack of resources.

Preparation isn’t only about investing more money. It is also about embracing the public health fundamentals that allowed some nations to move rapidly and aggressively against the coronavirus. The United States has been hard hit by this pandemic, but all countries were dealt this hand.

But we can do better. Here are four measures, outlined in a new report from the Council on Foreign Relations, that would make Americans and the rest of the world safer.

First, the United States must remain a member of the World Health Organization, while working to reform it from within. The agency is hardly perfect, but it prompted China to notify the world of the coronavirus and it has coordinated the better-than-expected response to the pandemic in developing nations. Yet, the agency has no authority to make member states comply with their obligations and less than half of the annual budget of New York-Presbyterian Hospital. The WHO needs more dedicated funding for its Health Emergencies Program and should be required to report when governments fail to live up to their treaty commitments.

Second, we need a new global surveillance system to identify pandemic threats, one that is less reliant on self-reporting by early affected nations. An international sentinel surveillance network, founded on healthcare facilities rather than governments, could regularly share hospitalization data, using anonymized patient information. Public health agencies in nations participating in this network, including the CDC, can assess that data, identify unusual trends and more quickly respond to emerging health threats.

The U.S. should take the lead in forming a coalition to work alongside the WHO to develop this surveillance network. We should also work with like-minded G-20 partners, as well as private organizations, in this coalition to reduce unnecessary trade and border restrictions; increase the sharing of vaccines, therapeutics and diagnostics; and work with international financial institutions to provide foreign aid and debt relief packages to hard-hit nations.

Third, responding to a deadly contagion requires a coordinated national approach. Too often in this pandemic, in the absence of federal leadership, states and cities competed for test kits and scarce medical supplies and adopted divergent policies on reopening their economies. The next administration needs to clarify the responsibilities of the federal government, states and 2,634 local and tribal public health departments in pandemic preparedness and response. Elected leaders, starting with the president, must also put public health officials at the forefront of communicating science-based guidance and defend those officials from political attacks.

Finally, the U.S. must do better by its most exposed and vulnerable citizens. More than 35% of deaths in the U.S. from COVID-19 have been nursing home residents. Many others have been essential workers, who are disproportionately Black and Latinx and from low-income communities. Federal, state and local governments should direct public health investments to these groups as a matter of social justice and preparedness for future threats.

All of this will require leadership and marshaling support at home and abroad. The next president need not be doomed to replay this current catastrophe — provided he acts on the tragic lessons learned from the COVID-19 pandemic.

In search of President Trump’s mysterious health care plan

Hunter Walker responded to questions about President Trump’s healthcare plan noting that President Trump’s health care plan has become one of the most highly anticipated, hotly debated documents in Washington. And depending on whom you ask, it might not exist at all. 

The contents — and the whereabouts — of the health plan have been a growing mystery since 2017, when efforts to pass a White House-backed replacement for Obamacare stalled in the Senate. Since then, Trump has repeatedly vowed to unveil a new health plan. In July, it was said to be two weeks away. On Aug. 3, Trump said the plan would be revealed at the end of that month. Last month, White House press secretary Kayleigh McEnany said it would be released within two weeks. At other points, Trump has suggested the plan is already complete. That shifting schedule has lent Trump’s health plan an almost mythical status.

Let me state here that if President Trump doesn’t win this election his lack of a healthcare plan as well as the blame for the pandemic will be the deciding reason that even previous GOP supporters will vote for Biden. Hard to believe, right? In fact, weeks to months ago I related the need for the President to release his healthcare plan to further prove to the voters that he is fulfilling his promises.

The mystery surrounding the president’s vision for health care has added urgency because the Supreme Court is currently scheduled to hear oral arguments in a case that could decide the future of former President Barack Obama’s signature health care law on Nov. 10, exactly one week after the election. That case was brought by Republican attorneys general and joined by the Trump administration. The argument that Obamacare is unconstitutional could lead to the current health care framework being struck down, but Trump has yet to present an alternative. 

With both the election and the court date looming, questions about Trump’s health care plan have intensified on the campaign trail. And the White House’s answers have only added to the uncertainty. 

During the first presidential debate last month, Trump was pressed by Fox News moderator Chris Wallace about the fact he has “never in these four years come up with a plan, a comprehensive plan, to replace Obamacare.”

“Yes, I have,” Trump replied. “Of course, I have.”

He was apparently referring to the Republican tax bill passed in 2017 that eliminated the tax penalty for individuals who did not purchase health insurance, or obtain it through their jobs or government assistance. That so-called individual mandate was a critical part of the Affordable Care Act, more commonly known as Obamacare, meant to ensure that even healthy people would buy health insurance and spread the costs out across the population. Other parts of the Affordable Care Act remain in place, but the Republican lawsuit argues that without the mandate the entire program should be overturned. 

That could end the most popular feature of Obamacare: the requirement that insurance companies provide affordable coverage for preexisting conditions. While Trump has repeatedly insisted, he wants to maintain that protection, any details of his plan or evidence of how he would do it have remained elusive.  

During the final debate last week, Democratic nominee Joe Biden argued that the administration “has no plan for health care.”

“He’s been promising a health care plan since he got elected. He has none,” Biden said of Trump. “Like almost everything else he talks about, he does not have a plan. He doesn’t have a plan. And the fact is, this man doesn’t know what he’s talking about.” 

The issue also came up during the vice-presidential debate on Oct. 7, when Vice President Mike Pence said, “President Trump and I have a plan to improve health care and protect preexisting conditions for every American.” 

“Obamacare was a disaster, and the American people remember it well,” Pence said.

But Trump seemed to admit during last week’s debate that his plan is more of a dream than a concrete proposal. 

“What I would like to do is a much better health care, much better,” he said, adding, “I’d like to terminate Obamacare, come up with a brand-new, beautiful health care.”

However, by the end of last weekend, the idea of a written, completed Trump health plan was back on the table — literally. 

During the president’s contentious “60 Minutes” interview that aired on Sunday, host Lesley Stahl asked Trump about his repeated promises of a health plan coming imminently.

“Why didn’t you develop a health plan?” Stahl asked.  

“It is developed,” Trump responded. “It is fully developed. It’s going to be announced very soon.”

And after Trump ended the interview and walked out on Stahl, McEnany, the White House press secretary, came in and handed the “60 Minutes” correspondent a massive binder.

“Lesley, the president wanted me to deliver his health care plan,” McEnany said. “It’s a little heavy.” 

Indeed, Stahl struggled with the huge book. The situation seemed reminiscent of other instances where Trump tried to dissuade debate by presenting massive piles of paper that didn’t stand up to scrutiny, and it sparked speculation that the contents of the massive binder were blank. However, the conservative Washington Examiner newspaper subsequently reported it contained more than 500 pages comprising “13 executive orders and 11 other pieces of healthcare legislation enacted under Trump.”

Stahl was unimpressed. After perusing the gigantic tome, she declared, “It was heavy, filled with executive orders, congressional initiatives, but no comprehensive health plan.”

McEnany took issue with that assessment and shot back with a tweet that declared, “@60Minutes is misleading you!!”

“Notice they don’t mention that I gave Leslie 2 documents: a book of all President @realDonaldTrump has done & a plan of all he is going to do on healthcare — the America First Healthcare Plan which will deliver lower costs, more choice, better care,” the press secretary wrote.

McEnany had implied one of Washington’s most wanted documents was printed, bound and ready for review. It even had a name! Were we really this close to seeing the Trump health plan?

Not exactly. 

After Yahoo News requested a copy of the “health care plan” that she presented to Stahl, McEnany provided a statement detailing the contents of the enormous binder.

“The book contains all of the executive orders and legislation President Trump has signed,” McEnany said.

She credited those actions with “lowering health care premiums and drug costs” compared with where they were under Obama and Vice President Biden. Trump has previously claimed premiums and costs have gone down during his administration, but these assertions aren’t entirely backed up by the data. And many of Trump’s executive orders on health care have been largely symbolic. 

McEnany also provided us with a copy of the second document that she described on Twitter and Stahl had supposedly ignored. It was a 10-page report (including front and back covers) with a large-print, bullet-pointed list of highlights from Trump’s previous actions on health care and slogans making promises for the future. 

“The America First Healthcare Plan lays out President Trump’s second term vision animated by the principles that have brought us lower cost, more choice and better care,” McEnany said. 

The White House’s immense binder clearly didn’t contain Trump’s “health care plan” as McEnany declared during the dramatic on-camera delivery. But it did hold a fragment of the president’s policy vision. 

Perhaps more pieces of the puzzle could be found on Capitol Hill. After all, in April 2019, Trump proclaimed on Twitter that “the Republicans … are developing a really great HealthCare Plan.” That comment followed reports that a group of Republican senators including Mitt Romney of Utah, John Barrasso of Wyoming, Rick Scott of Florida and Bill Cassidy of Louisiana were working on drafting a proposal. Trump said this plan would “be far less expensive & much more usable than ObamaCare.” The president further suggested it would be complete and ready to be voted on “right after the election.”

So, is there a finished plan floating around Capitol Hill ready to make its debut in a matter of weeks? No.

A Republican Senate source who has been privy to the talks told Yahoo News that a group of GOP senators including Romney, Barrasso, Lindsey Graham of South Carolina and Senate Health Committee Chairman Lamar Alexander of Tennessee have been “exploring” an alternative to Obamacare “over the course of the past year and a half.” However, with the coronavirus pandemic and a Supreme Court confirmation dominating the agenda, the source, who requested anonymity to discuss the deliberations, suggested the planning had stalled.

“I don’t think they’ve talked about this stuff for months now due to other pressing issues,” the source said of the health care planning.

The source predicted that activity on health care would not resume until the outcome of the election and the Supreme Court’s Obamacare case are clear. 

“Depending on how things in November shake out and … what the Supreme Court does with the ACA, maybe those discussions will be revived,” the source said. “But there really has not been much going on of late.”

Nevertheless, the source contended that, even though there is no finished plan, Trump and his Republican allies on the Hill have made some real progress toward “a potential plan that would preserve private insurance but also seek to lower costs.” They suggested Senate efforts to lower drug prices and end surprise medical billing are part of the “frameworks,” as are some of the executive orders issued by Trump.

“There have been sort of piecemeal efforts in this area. … The executive branch has done what they can do within their authority to try to lower costs,” the source said. “There just hasn’t been … a wholesale piece of legislation or framework that everyone has coalesced around. That’s just something that has not come together.”

In the end, perhaps the truest answer to the ongoing mystery of Trump’s proposed Obamacare replacement came from the president himself during the “60 Minutes” interview. In the conversation, Trump suggested that his health plan exists in a realm beyond the bounds of space and time.

“A new plan will happen,” he said. “Will and is.” 

As you can tell from the lead in to this post, that many of us who can really think and put enough words together to make a understandable sentence our choices are not good but it is really important for us all to go and turn out to vote, either in person, with masks in place and socially distancing or by mail in or drop off ballots.

Also, make sure you all get your new flu shots!!

Pandemic fears are boosting demand for trustworthy news; And What Have We Learned from Sweden’s Experience?

During these last few months of the pandemic one of my concerns is the lack consistent reliable data with which the media pundits of all sorts deliver their predictions and many times with false knowledge and predictions. Question, what is the correct social distancing length? Studies keep on changing! One of the key features of the web is its ability to turn regular people into citizen journalists. The cost of publishing text on the web is almost nil. The barriers to entry in the media industry are low, too. And many readers are not picky about where their news comes from: the stories that go viral can come from amateur scribes or veteran ones, media startups or established outfits. But this is not always the case. New research suggests that when a crisis hits, readers turn to reliable sources.

In 2018 Paul Resnick and James Park, two researchers at the University of Michigan, devised a pair of tools for measuring the popularity of English-language news stories on Facebook and Twitter. The first, dubbed the “Mainstream Quotient”, measured the proportion of highly-shared links that came from mainstream news sources, such as the New York Times, the BBC and, yes, The Economist. The second, the “Iffy Quotient”, measured the share originating from less trustworthy sources, based on ratings provided by NewsGuard, a company that tracks misinformation published online.

Both indices have shifted significantly during the pandemic. Beginning in February, when the coronavirus started to spread outside China, traffic to traditional media outlets and news sites surged, whereas dodgier sites attracted fewer readers. The Mainstream Quotient rose steadily during this period, a phenomenon Messrs Resnick and Park call a “flight to quality”. The Iffy Quotient, meanwhile, tumbled. The drop was particularly steep during March, when many countries instituted lockdown measures (see chart).

The researchers argue that consumers seek out reliable news sources during times of uncertainty, in the same way that fearful investors turn to gold. Whether these patterns will last remain unclear. The Iffy Quotient has already started to creep back up, for both Facebook and Twitter. And recent efforts by social-media platforms to crack down on fake news may prove only temporary. Once the pandemic subsides, demand for unreliable news may return to pre-covid levels. For now, at least, the flight to quality has taken off.

Pandemic Spike in Telehealth Levels Off

Crystal Phend of MedPage pointed out that Telehealth’s early bonanza during the pandemic has given way to persistently elevated use in primary care, a Department of Health and Human Services (HHS) report showed.

Analysis of Medicare fee-for-service (FFS) data showed an increase in Medicare primary care visits from 0.1% of all primary care in February to 43.5% in April, representing an increase from about 2,000 to 1.28 million telehealth visits per week.

Meanwhile, there was a “precipitous” drop in in-person visits for primary care in mid-March as COVID-19 took hold in the U.S., then a rise from mid-April through May, according to the report from the Office of the Assistant Secretary for Planning and Evaluation.

Use of telehealth in primary care “declined somewhat but appears to have leveled off at a persistent and significant level by the beginning of June,” the report noted. It still accounted for 22.7% of Medicare beneficiaries’ primary care visits as of June 3rd.

Overall, weekly primary care visit rates have not yet returned to pre-pandemic levels.

“Based on early experience with Medicare primary care telehealth at the start of the COVID-19 public health emergency, there is evidence that Medicare’s new telehealth flexibilities played a critical role in helping to maintain access to primary health care services — when many beneficiaries and providers were concerned with transmission of COVID-19,” the authors noted. “The stable and sustained use of telehealth after in-person primary care visits started to resume in mid-April suggests there may be continued demand for telehealth in Medicare, even after the pandemic ends.”

The findings overall match those from healthcare provider databases suggesting a 60% to 70% drop in health care office visits, partially offset by telehealth visits, with the start of the pandemic. Drug market research firm IQVIA has reported from physician surveys that about 9% of patient interactions were via telehealth prior to the pandemic but 51% during the shutdown, with expectation of a 21% rate after the pandemic, the HHS report noted.

There have been calls for Medicare to make the loosened rules around telemedicine permanent, and some legislative movement in that direction, but private insurers have signaled the opposite.

Fred Pelzman, MD, an internal medicine physician at Weill Cornell Medicine in New York City (and MedPage Today columnist), said an informal survey of his patients indicated they would be willing to do up to 50% of their care via video tools.

“We went from a handful of video visits in our practice to several thousand over the course of the months,” he said. “It’s a great way to take care of people, kept a lot of people safe, we think. What has happened is that as we started to open our practice back up again and offer appointments, the floodgates have opened and patients are declining video visits.”

Those patients opting for in-person visits tend to be older, braving what feels like a quiet time in the pandemic for the state to take care of necessary visits, he noted. “I think ultimately that we’ll plateau. It will probably come down a little more.”

The study included Medicare FFS Part B claims from January through May 2020 for primary care services along with preliminary Medicare Part B primary care claims data up to June 3. Primary care services included evaluation and management, preventive services, and advance care planning.

Telehealth usage increased most in urban counties early in the pandemic and saw smaller declines in May compared with rural counties across the country. Among cities, Boston had the greatest proportion of primary care visits by telehealth (73.1%) and Phoenix the lowest (37%).

Notably, the rate “was not strongly associated with differences in COVID-19 severity across cities as measured by rate of hospitalizations per thousand Medicare FFS beneficiaries,” the report pointed out.

I read an article predicting that telehealth visits are the future of medicine. This is truly worrisome due to the many incorrect diagnoses as well as poor control of chronic diseases that I have seen coming through my office alone. Physical diagnosis is made by looking at the patient, listening to the patient, hearing what the patient is really saying, touching the patient and using the different diagnostic tools such stethoscopes, ophthalmoscopes, otoscopes, percussion hammers, etc. to make the correct diagnoses and to follow our patients. How is that done virtually? The only ones benefitting the most from these virtually visits are the practices and the electronic medical record companies selling the practices additional software to utilize telehealth. And patients are finding that not all telehealth “visits” are paid for by their insurance companies.

How Did Sweden Flatten Its Curve Without a Lockdown?

One expert credits a “good-enough strategy”; others worry that it won’t last. Who is correct?

Kristina Fiore, Director of Enterprise & Investigative Reporting, MedPage reported that

Despite never implementing a full-scale lockdown, Sweden has managed to flatten its curve, prompting its health leadership to claim victory — but others question the cost of the strategy, as the country has a far higher death toll than its Scandinavian neighbors.

In late July, Sweden’s 7-day moving average of new cases was about 200, down from a peak of around 1,140 in mid-June. Its daily death totals have been in the single digits for two weeks, well below its mid-April peak of 115 deaths in a single day.

However, on a per-capita basis, Sweden far outpaces its Scandinavian neighbors in COVID deaths, with 567 deaths per million people compared with Denmark’s 106 deaths per million, Finland’s 59 deaths per million, and Norway’s 47 deaths per million. The Swedish figure is closer to Italy’s 581 deaths per million.

While the positive trends have led Anders Tegnell, PhD, chief epidemiologist at the Swedish Public Health Agency and architect of Sweden’s coronavirus strategy, to state that the “Swedish strategy is working,” others have criticized the approach, including two dozen Swedish academics who published a recent USA Today editorial.

“In Sweden, the strategy has led to death, grief, and suffering,” they wrote. “On top of that, there are no indications that the Swedish economy has fared better than in many other countries. At the moment, we have set an example for the rest of the world on how not to deal with a deadly infectious disease.”

The Swedish Public Health Agency has not openly stated that herd immunity was its goal, though many suspect that this was the intention. Tegnell told reporters last week he thought the recent trends indicated that immunity was now widespread in the country. But with rates of antibody positivity around 10%, that seems impossible. (Officials at the agency did not respond to MedPage Today‘s request for comment.)

So how has Sweden managed to get its outbreak under control?

Behavior Change

While Sweden didn’t officially lock down, many in the country have described a locked-down “feeling” that has eased in the summer months.

At the start of the outbreak, only high schools and universities closed; daycare and elementary schools have been open. Businesses have also remained open, but typically at reduced hours, and restaurants have functioned at reduced capacity.

Swedes have been asked to keep their distance in public, refrain from non-essential travel, and work from home when possible. Gatherings of more than 50 people are also banned. People age 70 and over are advised to stay away from others as much as possible.

Masks were never required and aren’t commonly worn.

This response hasn’t changed over time, through the June surge and into today’s decline, so there’s no definitive explanation for the flattening, though, and experts have several theories.

“Swedes in general have changed their behavior to a great extent during the pandemic and the practice of social distancing as well as physical distancing in public places and at work has been widespread,” said Maria Furberg, MD, PhD, an infectious diseases expert at Umea University Hospital in northeastern Sweden.

“During the months of March to early June, all shops were practically empty, people stopped dining with friends, and families stopped seeing even their closest relatives,” Furberg told MedPage Today. “A lock-down could not have been more effective. Handwashing, excessive use of hand sanitizers, and staying home at the first sign of a cold became the new normal very quickly.”

Mozhu Ding, PhD, an epidemiologist at the famed Karolinska Institute, said the decline is “likely to be a combination of measures taken by individuals, businesses and a widespread information campaign launched by the government.”

“Even without a strict lockdown order, many businesses allowed employees to work from home, and universities are offering distance courses to the students,” Ding told MedPage Today. “Individuals are also taking personal hygiene more seriously, as items like hand sanitizers and single-use gloves are often sold out in pharmacies and grocery stores.”

Immunity

Experts told MedPage Today there weren’t clear data to prove Tegnell’s assertion of widespread immunity in Sweden.

Furberg said there is likely “some sort of unspecific immunity that protects parts of the population from contracting COVID-19” but it’s not necessarily secondary to SARS-CoV-2 exposure.

For instance, a study by the Karolinska Institute and Karolinska University Hospital recently found that about 30% of people with mild or asymptomatic COVID showed T-cell-mediated immunity to the virus, even though they tested negative for antibodies.

“This figure is [more than] twice as high as the previous antibody tests, meaning that the public immunity to COVID-19 is probably much higher than what antibody studies have suggested,” Ding told MedPage Today. “This is of course very good news from a public health perspective, as it shows that people with negative antibody test results could still be immune to the virus at a cellular level.”

Indeed, T-cell immunity is coming into focus as a potentially important factor in COVID infection. A paper published in Nature in mid-July found that among 37 healthy people who had no history of either the first or current SARS virus, more than half had T cells that recognized one or more of the SARS-CoV-2 proteins.

Another 36 people who had mild-to-severe COVID-19 were all found to have T-cell responses to several SARS-CoV-2 proteins, and another 23 people who had SARS-CoV-1 (the virus responsible for the SARS outbreak in 2003) all had lasting memory T cells — even 17 years later — that also recognized parts of SARS-CoV-2.

It could be that T cell immunity is the result of a previous infection with common cold coronaviruses, but this hasn’t yet been established; nor is it certain that T cell immunity is driving Sweden’s decline in COVID cases.

Path Forward

Summertime is another factor that may account for the decline, which began around late June — not directly because of the weather, but social factors related to it.

Swedes are “outdoors more, and students are not at school,” said Anne Spurkland, MD, a professor of immunology at the University of Oslo in Norway.

Also, “perhaps Sweden has finally gotten better control over the disastrous spread of the virus in nursing homes which to some extent can explain their relatively high death rates,” Spurkland told MedPage Today. About half of Sweden’s 5,730 deaths occurred among those in elder care homes.

Norway is still requiring that Swedes quarantine for 10 days when coming into Norway, and Denmark has not fully reopened its borders to its neighbor yet either.

That doesn’t bode well for the Swedish economy. If the goal of avoiding a lockdown was to spare economic woe, its success has been limited.

According to Business Insider, “international tourism and trade are decimated. … Sweden’s National Institute of Economic Research predicts Sweden’s GDP will fall 5.4% in 2020, after predicting a 1% rise [in] December 2019. It also expects unemployment to rise around three percentage points, to 9.6%, between the end of 2019 and the end of 2021.”

Spurkland said it’s still “too early yet to conclude whether the Swedish approach was the wisest over all,” as it remains to be seen whether Norway and other countries that did lock down will avoid a second wave of infections in the fall.

Yet she cautions that choosing to take on a higher case load may have health consequences far beyond the immediate infection.

“What we have learned these months is that COVID-19 is not only about death, it is also about ill health,” Spurkland said. “Quite a number of people going through the infection have long-term symptoms, that may be stopping them from resuming their daily life. We do not know yet how large a proportion of those who get the virus will fall into this category, but it is certainly a concern.”

“So, when deciding on taking a herd immunity approach to handle a totally new virus we do not know anything about,” she said, “the Swedish government has also unknowingly put the general population at risk for much long-term ill-health caused by the virus.”

Furberg doesn’t see it that way: “I am very proud of the way Swedes have adapted to the restrictions and regulations and I believe the Public Health Agency of Sweden has picked a good-enough strategy for our country.”

What Americans Need to Understand About the Swedish Coronavirus Experiment

Sweden made headlines for never shutting down. Here’s what’s really happening there.

Matthew Zeitlin pointed out that Tooutsiders, life in Stockholm, Sweden, appears perfectly normal: Walk down a cobblestone street, and you may see two friends sitting at a cafe enjoying the spring air or a group of kids kicking a soccer ball in the park. Cars and bicyclists may zip by; a family may walk past you on their afternoon stroll.

Whereas most of the Western world has been in lockdown for weeks, Sweden has opted to forgo any sort of shelter-in-place policy in response to the coronavirus and instead allow businesses and parks to stay open and groups of under 50 to gather.

That’s not to say the country hasn’t been proactive at all. The policy in effect in Sweden is similar to what had been implemented in much of the United States before shelter-in-place orders were issued — and the one that will soon be in place in states that reopen. The Swedish government has recommended that people wash their hands frequently, maintain social distance, work from home if they can, and those who are elderly or more susceptible to Covid-19 stay home. The government recommended that universities switch to online teaching; they quickly followed course. Social distance is required by law in restaurants, and bar service is banned. The government changed its sick leave rules to encourage anyone who is feeling symptoms to stay home. “Instead of saying ‘close down all of society,’ we have looked at society and closed down… aspects of society,” where the disease is most likely to spread, Anders Tegnell, the epidemiologist at Sweden’s Public Health Agency in charge of recommending policy to the government, told The Daily Show. “I think that’s had a great effect.”

Sweden may not be so much an alternative, as a glimpse of the future.

Sweden’s approach has been hailed by critics of American and European pandemic policies as a less restrictive — and less economically devastating — alternative to state or national shutdowns, but it’s also been lambasted by others as an unnecessarily risky strategy that has led Sweden to have the highest Covid-19 death toll among the Nordic nations. As more and more areas of the United States reopen, Sweden may not be so much an alternative as a glimpse of the future.

As of Sunday afternoon, the country had 25,921 confirmed cases and3,220deaths, according to the Johns Hopkins Coronavirus Resource Center. These are much higher figures than those of the country’s neighbors, but lower than those in some other wealthy Western European countries on both an overall and population-adjusted basis. Sweden also has suffered problems familiar to residents of countries that have had more severe outbreaks and stricter policies. Nursing homes have been hard hit, and Tegnell described Sweden’s failure to protect nursing home residents as its greatest shortcoming so far. Immigrant and ethnic minority communities also have suffered, due in part to their larger households. Just over half of all households in Sweden in 2016 consisted of only one person, while immigrants were substantially more likely than native-born residents to live in overcrowded conditions or multigenerational household.

Even with the less aggressive containment measures, the economic effects of the virus have been severe for the country. Sweden’s National Institute for Economic Research projected that gross domestic product would contract by 7% in 2020 and the unemployment rate would rise to just over 10%. The large fall in consumer and business confidence, the institute said in a release, point “to a rapid and severe downturn, not least in large parts of the service sector.”

“The economy will shrink both due to a drop in exports and is already contracting due to lower consumption. But the underlying causes differ: The export sector is mostly affected by the international situation, whereas the drop in consumption is directly related to the government’s recommendation of social distancing,” said Lina Maria Ellegård, an economist at Lund University.

In the first three months of the year, the Swedish economy contracted by less than 1% — less than the United States’ fall — but the production of both goods and services declined in March. The car industry — one of Sweden’s major export sectors — along with real estate, hospitality, and restaurants led the way.

That’s because even without lockdowns or orders, the behavior of Swedes still changed — to an extent. According to data collected by Google and Apple, Swedes have cut back on their travel to places like stores and restaurants and decreased their use of transit-like buses substantially, though not as dramatically as their Nordic neighbors in Denmark. Still, travel over the Easter holiday fell by 90%, Tegnell said on The Daily Show.

Multiple experts in Sweden I spoke to agreed that because a recommendation made by Swedish leadership is culturally viewed as more of a demand, the freedoms allowed have not resulted in free-for-alls. “There’s a basic misconception that there’s one big huge after-ski party,” said Lars Trägårdh, a Swedish historian. “That’s not true.”

Sweden’s voluntary restrictions policy is made possible by the high levels of trust throughout Swedish society. “We have a lot of social trust and a lot of trust in the institutions, and the institutions have confidence in the citizens,” said Trägårdh. “That’s why we decided to have this voluntary approach as opposed to one that’s more hardcore.”

The photos circulating online don’t fully represent the broader reality on the ground either. “I’ve seen pictures in the newspapers and news media of what looks to be crowded restaurants in Stockholm. What I’ve seen is mostly pretty sparse restaurants. Every other table is empty, and there’s very little business,” said Bo Becker, an economist at the Stockholm School of Economics. “Life doesn’t go on as usual, but maybe the lockdown is less severe than in other countries.”

But even if Sweden’s policy of allowing businesses to open and people to move out and about is not that different from some policies American states have or will soon implement, there’s been one major difference: the schools. Schools for children up to age 15 have remained open, all the way down to daycares and preschool. “That makes a world of difference,” Trägårdh told me. “It’s a gender issue.”

Sweden has one of the highest rates of female participation in the labor force for rich countries. Forcing young children to stay home would put many mothers in a bind or even knock them out of the workforce entirely.

“Closing down schools works well if you are in a well-to-do, middle-class family that has a house and a garden and can afford to have one person staying at home,” Trägårdh said. “That may not look like a doable proposition if you are a single parent or do not make a lot of money.”

Shutting down daycare and schools could increase risk as well, Erik Angner, a philosopher and economist at Stockholm University, explained, by leading working parents to turn to their own parents for help. “If you close daycares, then either one parent has to stop working or grandma or grandpa shows up,” he said. But since the elderly are most at risk, it was even more important to keep schools and daycares open

As other countries work through their peak infections, they will have to figure out how to reach a new status quo where the disease’s spread is still slow but restrictions can be lightened. “Now that everybody else is starting to shift toward opening up, people are talking about Sweden,” said Trägårdh. “Other Nordics are realizing you can’t keep schools closed forever. We’re in the long run here. It’s not a 60-meter race, it’s more like a marathon.”

While Sweden has a higher death rate than its Nordic neighbors and other wealthy European nations like Germany, it has been lower than rates in the Netherlands, France, and the United Kingdom. According to the Financial Times’ figures, Sweden has seen an 18% jump in excess deaths since the start of the outbreak, while Denmark has seen a 5% rise. Excess deaths in England and Wales are up 37%.

“The data out of Finland, Norway, and Denmark looks much better,” said Angner. “But everything will hinge on what will happen next.”

There’s some evidence that Sweden has managed to take the heaviest blow from the virus already — about a fourth or fifth of the population of Stockholm may have been infected, which would put the infection rate at a level similar to that found in New York City, which has had many more deaths and been under a near-total lockdown for almost two months. On Tuesday, health officials in Stockholm said the number of new deaths linked to Covid-19 was slowly decreasing from one week to the next.

The Swedish example carries both optimistic and pessimistic tidings for the United States as it embraces a partial, scattered reopening cheered on by the White House. It suggests that, even without punitive mandates, people can and will take measures to keep themselves safe from the disease. But even though people are protecting themselves without formal orders, the economy will be only slightly better off than it was under lockdown. Meanwhile, the American push to reopen is being driven by distrust of the government combined with the absence of robust safety-net programs to stem the economic bleeding. In the American context, Sweden’s example may be no example at all.

As a paper that was just accepted for publication, written by this author and two coauthors, we need reliable data to evaluate our progress as well as our failures to predict, based on appropriate statistical models and in order to lead us all in the correct path for future strategies for this pandemic and future crises.

Coronavirus update: Florida spike raises doubts over reopening strategy; mask debate gets more political. Then there is the Brazil and Sweden Experience! When will we Learn?

Senior reporter Anjalee Khemlani reported that recently Florida became the focus of rising fears it could become the next U.S. coronavirus hotspot, with surging cases in the West and South leading to increased safety measures, and fanning doubts about nationwide plans to reopen.

Globally cases have surged past 8.5 million, and more than 454,000 have died. In the U.S. nearly 2.2. million cases have been reported, and more than 118,000 are dead. On Friday, the Sunshine State reported a rise in COVID-19 cases of 4.4%, sharply higher than the previous 7-day average of 3.2%.

The relentless climb in domestic cases prompted California’s governor to require mask-wearing in public, while Texas and Arizona recently began to ok enforcing masks in public, amid a spike in new diagnoses in those states. The question is who is going to enforce these regulations? More to come.

Meanwhile, the economy has sent mixed signals about the trajectory of a recovery, according to Morgan Stanley data, underscoring volatility in markets hopeful for a “V-shaped” rebound.

“We note a continuous upward inflection in eating out in restaurants to 26% (from 17% two weeks ago), mainly driven by the South region and rural areas. Visits to the mall, albeit still low, are up to 13% from 8% a month ago,” the bank wrote on Friday.

Political debate over masks

As the debate over wearing face coverings in public gets increasingly political, critics point out that several areas have been lax with mask and distancing measures. The mask controversy — which took center stage in a debate over President Donald Trump’s weekend rally in Tulsa — is rooted in a perceived infringement on individual freedom, and disputed claims about face masks reducing the intake of oxygen.

Yet public health experts point to the success in New York and New Jersey, two former epicenters that are now relaxing stay-at-home orders, in implementing such measures to control the outbreak. Actually, if you want to see success, look at the Maryland strategy regarding the management, restrictions, etc. of the coronavirus complexities.

Public health experts expressed concerns with AMC’s (AMC) plan to reopen theaters without enforcing masks Thursday. The company’s CEO explained he wanted to avoid the politically controversial topic of mask-wearing — a decision that sparked more debate.

The company reversed the decision Friday, announcing in a statement that moviegoers will be required to wear masks.

Dr. Ashish Jha, director of Harvard’s Global Public Health Institute, said on Twitter the politicizing of masks will create more confusion and a “dilemma” for businesses eager to return to normal.

“It may feel easier to let customer choose. But long run success requires companies courageously undertake evidence-based actions that keep customers safe,” Jha said.

Separately, Japan has lifted all coronavirus restrictions for businesses, marking another country’s full reopening this month. The country has had fewer than 100 cases daily in the past month.

Vaccine coverage

China appeared to gain a leg up in the worldwide race for a COVID-19 vaccine, announcing on Friday that one of its pharmaceutical companies could begin the next phase of human tests as early as the fall.

Senior U.S. government officials said this week that any successful COVID-19 vaccine was likely to be free to “vulnerable” individuals who can’t afford them.

In addition, health plans are likely to cover at no cost to members— similar to the coverage of testing and inpatient services, which has seen bills as high as $1.1 million settled between insurers and funding from Congress.

Vulnerable individuals, those without insurance or on Medicaid, belong to a largely underserved population. Some providers refuse to accept Medicaid because of its traditionally low reimbursement for care.

The CARES Act has provisions, along with the preventative coverage mandates of the Affordable Care Act, that could address some pockets of accessibility. The bill includes language “to cover (without cost-sharing) any qualifying coronavirus preventive service” for commercial insurers.

For Medicare, in addition to the flu vaccine, the law now includes “COVID–19 vaccine and its administration,” and for Medicaid, states are required to cover “any testing services and treatments for COVID– 19, including vaccines, specialized equipment, and therapies” without cost-sharing.

But it still leaves out self-insured and uninsured — which make up more than half of the U.S. population. At least 56% of the population is on self-insured plans, which have had the option to cover. members’ COVID-19 testing and hospital visits during the pandemic.

As states see coronavirus surges, health officials say combination of factors responsible

So, what is the cause of these surges? Bryn McCarthy reported that this past week, states throughout the nation have seen surges in coronavirus cases, with the average number of new cases per day increasing by about 20 percent to nearly 24,000 cases per day. Health officials say a combination of factors is likely responsible for these increases.

“It’s multifactorial,” said Dr. Janette Nesheiwat, family and emergency medicine physician and medical director of CityMD, said. “The initial wave of COVID-19 is still with us, hitting each state at different points in time. We see more cases because we are doing more testing. Also, the country is reopening, which means an increase in mobility of people, which by nature means we will have more cases.”

States reopening, increased testing and “quarantine fatigue” are largely responsible for these surges, according to experts. Dr. Marty Makary, professor of surgery, health policy and management at Johns Hopkins and Fox News medical contributor, said the disregard for distancing and use of masks in some parts of the country has greatly influenced the hospitalization highs of late. “We are seeing increases in hospitalizations in Texas, North Carolina, South Carolina, Arizona, Florida, Arkansas and other states resulting not from institutional spread, such as nursing homes and meatpacking outbreaks,” Makary said, “but instead from daily activity.”

Health officials stress the importance of hospitalization rates and number of deaths over the number of positive cases. Over the past week, there were, on average, about 660 deaths due to COVID-19 in the U.S. Over the past three days there were on average about deaths 770. “This is very concerning because we are seeing these increases amidst an expected seasonal decline associated with entering the summer,” Makary said. “I’m concerned we’ll have a lot of cases seeding the next wave in the fall. If you think about it, the current wave was seeded by a few dozen cases in January and early February. We may be seeding the next wave with 100,000-200,000 cases going into the next cold season.”

A model produced by the University of Washington predicts that the United States will have over 201,000 COVID-19 deaths by Oct. 1. Nesheiwat feels this prediction is accurate. “We have roughly 600 to 700 cases per day,” Nesheiwat said. “Mobility increases transmission of COVID, for example, the protests where we had massive large crowd gatherings with people shouting and screaming spewing viral particles into the air close in contact with each other, or Mother’s Day church gatherings, or states that opened without following recommended guidelines.”

So how can we bring these numbers back down? “Aggressive case management is the way to bring down case numbers and hospitalizations,” said Dr. Amesh Adalja, infectious disease doctor and senior scholar at the Johns Hopkins Center for Health Security. “The virus is with us. People need to take actions realizing that there is nothing that is without risk. It will be important to think about social distancing as we go through this pandemic without a vaccine.” He says the best way for people to decrease their risk of becoming infected is by decreasing their physical interaction with others, observing social distancing norms, handwashing frequently, avoiding highly congregated places and possibly wearing face shields.

Makary said it’s all about slowing the spread. “More important than creating new regulations is convincing people to practice good behavior around best practices,” Makary said. “I would say that complacency is our greatest threat going into the fall.”

Health experts are urging people to reconsider nonessential activities in areas where cases and hospitalizations are on the rise. “For example, schools can hold classes but should consider postponing nonessential field trips and contact sports this year in areas with active infections,” Makary said. “National organizations should postpone their in-person conferences since travel is a well-known vector of transmission. Retail should attempt to move their activities outdoors if feasible to do so.”

While health officials recognize that humans are, by nature, social creatures who crave interaction with others, the novel virus and its deathly effects are not exaggerated, as some have started to believe. “COVID is not an exaggeration,” Nesheiwat said. “I have seen firsthand patients dying in my arms. It is heart-wrenching to see someone’s life taken too soon. The virus can affect anyone at any age. It is still here and it’s deadly.”

Makary agreed, reiterating how the virus affects all of society, especially the most vulnerable members, such as children, those with disabilities and the elderly. But nonetheless he remains optimistic and urges others to do the same. “This is not a fate we have to accept, but one we can impact,” Makary said.

Brazil’s coronavirus cases top 1 million as the virus spreads

Caitlin McFall noted that Brazil’s government announced Friday that its coronavirus outbreak has surpassed a million cases, making it second-leading nation in the world to the United States in coronavirus infection rates. “Almost half of the cases reported were from the Americas,” World Health Organization General-Director Tedros Adhanom Ghebreyesus told a virtual briefing. “The world is in a new and dangerous phase … the virus is still spreading fast, it is still deadly, and most people are still susceptible.”

The Brazilian President Jair Bolsonaro maintains that the repercussions from social distancing measures still outweigh the severity of the virus in the country. Bolsonaro has repeatedly downplayed the virus, referring to the coronavirus as a “little flu,” and told reporters earlier this month that he “regret[s] all the dead but it is everyone’s destiny.”

The United States, which has a population 56 percent bigger than Brazil, has reported over 2.2 million cases. But health experts believe that the infection rate could be as much as seven times higher in Brazil. Johns Hopkins University has reported that Brazil is conducting 14 tests a day for every 100,000 people, but medical officials say the number of tests is up to 20 percent less than what they should be to accurately track the virus. Although data shows that the virus is reaching a plateau in the cities near the Atlantic in the north, the rural countryside towns, which are less equipped to deal with the crisis, are seeing a spike in cases.

“There is a lot of regional inequality in our public health system and a shortage of professionals in the interior,” Miguel Lago, executive director of Brazil’s Institute for Health Policy Studies. said. “That creates many health care deserts, with people going long distances to get attention. When they leave the hospital, the virus can go with them,” Lago added.

Brazil, which has seen 50,000 deaths according to their Ministry of Health, has struggled to maintain a health minister during the crisis. Former Health Minister Dr. Nelson Teich resigned in May, after serving in office for only month. Reports later surfaced of his disagreements with Bolsonaro on social distancing measures and whether or not the anti-malaria drug, chloroquine, should be distributed. Teich referred to the drug as “an uncertainty” and differed with the president over how to balance the economy with the crisis.

His predecessor, Luiz Henrique, was fired from his position of health minister after also disagreeing with the president on how to handle the pandemic. Bolsonaro has not yet filled the health minster role, even as the country has evolved into the new epicenter of the coronavirus.

California county sheriff says he won’t enforce Newsom’s coronavirus mask order

Remember my question at the beginning of this post, who will enforce the mask and then stay-at home orders? Nick Givas reported that the sheriff’s office for Sacramento County announced on Friday that it will not enforce Gov. Gavin Newsom’s coronavirus order, which requires residents to wear masks or facial coverings while they are out in public. Can you blame them?

The announcement came just one day after Newsom, a Democrat, issued the statewide order mandating the use of facemasks.

In a statement posted to Facebook, the sheriff’s office said residents should be “exercising safe practices” in the face of COVID-19, including the use of masks, but it also deemed the idea of enforcement to be “inappropriate,” because it would criminalize average Americans for a relatively small infraction.

“Due to the minor nature of the offense, the potential for negative outcomes during enforcement encounters, and anticipating the various ways in which the order may be violated, it would be inappropriate for deputies to criminally enforce the Governor’s mandate,” Sheriff Scott Jones’ statement read. Deputies will instead work “in an educational capacity,” alongside health officials, to avoid any further escalation between bystanders and law enforcement.

Jones added, however, that employees will comply with the governor’s order as much as is pragmatically possible. “As for the Sheriff’s Office and its employees, we will comply with the Governor’s mask recommendations to the extent feasible,” the message concluded.

Newsom said in his initial statement that, “Science shows that face coverings and masks work,” and “they are critical to keeping those who are around you safe, keeping businesses open and restarting our economy.” This news comes as California gets ready to broadly reopen the state economy. People can now shop, dine in at restaurants, get their hair done and go to church in most counties. Overall, there have been 157,000 reported cases of coronavirus in the state and more than 5,200 deaths, as of Thursday.

New Study Casts More Doubt on Swedish Coronavirus Immunity Hopes

Johan Ahlander reported that Sweden’s hopes of getting help from herd immunity in combating the coronavirus received a fresh blow on Thursday, when a new study showed fewer than anticipated had developed antibodies.

Sweden’s has opted for a more liberal strategy during the pandemic, keeping most schools, restaurants, bars and businesses open as much of Europe hunkered down behind closed doors.

While Health Agency officials have stressed so-called herd immunity is not a goal in itself, it has also said the strategy is only to slow the virus enough for health services to cope, not suppress it altogether.

However, the study, the most comprehensive in Sweden yet, showed only around 6.1% of Swedes had developed antibodies, well below levels deemed enough to achieve even partial herd immunity.

“The spread is lower than we have thought but not a lot lower,” Chief Epidemiologist Anders Tegnell told a news conference, adding that the virus spread in clusters and was not behaving like prior diseases.

“We have different levels of immunity on different parts of the population at this stage, from 4 to 5% to 20 to 25%,” he said.

Herd immunity, where enough people in a population have developed immunity to an infection to be able to effectively stop that disease from spreading, is untested for the novel coronavirus and the extent and duration of immunity among recovered patients is equally uncertain as well.

Sweden surpassed 5,000 deaths from the coronavirus on Wednesday, many times higher per capita than its Nordic neighbors but also lower than some countries that opted for strict lockdowns, such as Britain, Spain and Italy.

Now No-lockdown Sweden is compelling parents to send their children to school. Some fear their kids could ultimately be taken away if they refuse.

Sweden has kept schools open for children under 15, part of its policy of avoiding a widespread lockdown during the coronavirus pandemic. Its policy is that students must physically attend school in almost all circumstances, including students with conditions that some evidence suggests may make them more at risk of catching COVID-19.

Business Insider spoke to parents across Sweden who are disobeying the rules to keep their kids home. Many say local officials have threatened to involve social services if the parents do not relent and send their children to school. Some parents say their ultimate fear is having their children taken away.

Swedish officials told Business Insider they would not usually resort to such an extreme measure, though did not deny that it is a possibility. Sweden is compelling parents to keep sending their children to school — including students with conditions that some evidence suggests may make them more at risk of catching COVID-19 — as part of its policy to avoid a full scale lockdown in response to the coronavirus.

While school systems in other countries have ceased or greatly restricted in-person learning, Sweden says that anyone under 15 should keep going to school. There are almost no exceptions. Some parents have refused to comply, sparking a stand-off with state officials. They worry this could eventually end with their children being taken away — the ultimate reprisal from the government — though officials stress that this would only happen in extreme scenarios.

Business Insider spoke to seven parents and teachers across Sweden, many of whom have decided to keep their children home despite instructions from the government to the contrary. For some, it is their children who they believe are at elevated risk for COVID-19, while others consider themselves vulnerable and fear their children could bring the disease home. In each case, Business Insider contacted officials responsible for the child’s education, but none offered a response by the time of publication. Mikaela Rydberg and Eva Panarese are both mothers in Stockholm who are keeping their children home.

Ryberg’s son Isac, who is eight years old, has cerebral palsy and suffers badly from respiratory illnesses. Rydberg said he had been hospitalized before with colds and flu. However, her efforts to persuade his school that he should be kept home to shield from COVID-19 have not been successful.

Swedish health officials do not consider children as a group to be at risk from the coronavirus — even children like Isac. As this is the official advice, doctors have declined to give Isac a medical exemption from school. Instead, Rydberg has kept him home since March against the school’s instructions, which she said prompted local government officials to tell her that they may have to involve social services. 

The school did not respond to Business Insider’s request for comment, while the local government, Upplands Väsby, said, “We follow the recommendations from our authorities and we do not give comments on individual cases.” She said that because it is a question of her child’s welfare, she is not worried about what could follow. “I am so certain myself that I am right, I am not worried about what they threaten me with,” she said.

“Unless you can 100% reassure me that he won’t be really, really sick or worse by this virus, then I will not let him go to school.”

‘School is compulsory’- This is lunacy!!

Eva Panarese is a mother of two. She is keeping her son home to minimize exposure to her husband, who has recently suffered from pneumonia. Panarese said she reluctantly sent her daughter back to school because exam seasons is approaching and she felt there was no other option.

Emails from the child’s school reviewed by Business Insider insist that children come to school during the pandemic, citing government policy. One message, sent in April, said: “We need to emphasize again that school is compulsory.”

Panarese said her situation shows that it isn’t possible to protect some members of a household if others are still obliged to go to school and risk infection. “I don’t know who will be right or wrong but I don’t want the risk,” she said. “I don’t want to be part of a grand experiment.” The school did not respond to Business Insider’s request for comment.

No exceptions

Sweden’s Public Health Agency says there is “no scientific evidence” that closing schools would help mitigate the spread of the virus. The agency said doing so “would have a negative impact on society” by leaving essential workers struggling to find childcare. It said such a policy might put other groups of people — like grandparents — at increased risk if they care for children.

Sweden has strong beliefs in the rights of the child, which includes the right to education, and typically does not allow that learning to take place outside of school. Only staff or children with symptoms should stay home, the Public Health Agency says.

Sweden does not include children as an at-risk group, even children who have conditions that they acknowledge increase the vulnerability of adults, like diabetes, blood cancers, immunosuppressive conditions, or ongoing cancer treatments.

Studies suggest children are generally less at-risk than other groups, but most countries have nonetheless closed schools, or radically changed the way they operate. New effects of the virus on children are also being discovered as the pandemic progresses.

The government is continuing its usual policy, which says that when children are repeatedly absent, schools are supposed to investigate and, in some cases, report the situation to local authorities, which can involve social services. Fears over the coronavirus is not considered a valid reason for keeping children home.

Afraid of losing their kids

Ia Almström lives in Kungälv, around half an hour’s drive from Sweden’s second-largest city, Gothenburg. Authorities there have threatened to take her to court if her kids remain out of school. Almström has three children, whom she has kept home since April because she faces an increased risk from the virus because of her asthma. She received a letter from the local government on May 5, seen by Business Insider, which said that she could be referred to social services, where she could face a court order or a fine.

The authority in question, Kungälvs Kommun, declined to comment on Almström’s case. Almström said: “It is heartless how Sweden treats us. They do not take our fears seriously. We get no help, only threats.” Almström said she and many parents “are afraid to lose our children or something.” “That is what they do when they think that parents [cannot] take care of the children. Then they move the children away. So that’s something we are afraid of.”

Last resort. Read on This is more than lunacy!!

A spokeswoman for Sweden’s National Board of Health and Welfare said that taking a child away is the government’s last resort. She said: “Normally, the social services will talk to the child, parents, and the school – trying to find out the underlying problem.” “It is a big step to take a child away from the parents – not only school absence will normally be a reason to place a child in residential care or in foster home,” she said, implying that other issues with how the children are being treated or raised would need to be found for the action to take place.

However, escalation is not the only way out — some parents reach a compromise with their schools. Jennifer Luetz, who is originally from Germany, lives some 100 miles from Stockholm in the town of Norrköping. She said she contacted her children’s school on March 12 to say they would be staying home, as she has a weakened immune system.

She said the school was “understanding” and helped her children to work at home. The officials, she said, decided not to escalate her case as she what she described as a “valid reason” to keep her them at home.

Other parents have struggled to reach similar agreements. And Luetz said she is still worried by Sweden’s public health approach, and has faced social consequences for her decision. “My Swedish support network basically dried up overnight,” she said. “My Swedish friends stopped talking to me.” 

Teachers worry, too

One teacher in Stockholm, who asked to remain anonymous as they were not authorized to speak, said that they agree with many of the parents keeping their children away.

The teacher told Business Insider: “I do not believe that a good epidemiologist would make us send our children to school when many homes have at-risk people living in the same household.” The teacher is originally from the US but has lived in Stockholm for six years, and said their spouse is in a risk group. The teacher said they worry for the health of older teachers and parents who are elderly or otherwise vulnerable. 

Andreia Rodrigues, a preschool teacher who also works in Stockholm, called the government’s plan “unacceptable.” She said it leaves parents having “to decide if they want to take on a fight with the school and then take the consequences.” “Even if kids have parents who are confirmed to have COVID-19 at home, they are still allowed to be there,” she said. “We cannot refuse taking kids, even if the parents come to us and admit ‘I have COVID-19.'” ‘We have been lucky not to be reported yet’

Lisa Meyler, who lives in Stockholm, said she has been keeping her 11-year-old daughter home since March. Meyler has an autoimmune disease while her husband is asthmatic. “We refuse to knowingly put our daughter’s health and life at risk,” Meyler said, saying she will “not let her be a part of this herd immunity experiment.” “We have been lucky not to be reported yet, but it has been made clear that it is not an option to let her stay home after the summer holidays.”

The school that her daughter attends did not respond to Business Insider’s request to clarify its policy. She said having “children taken away is the ultimate fear” for parents.

Fauci: Next Few Weeks ‘Critical’ in COVID Fight

I think that Dr. Fauci is correct in his comments before the House panel. Dr. Anthony Fauci testified before a House panel Tuesday, and his assessment of the coronavirus fight is notably darker than President Trump’s. Fauci summed it up as a “mixed bag,” citing progress in states such as New York but a “disturbing surge in infections” elsewhere, in part because of “community spread.” That’s in contrast to statements from Trump and Mike Pence chalking up the rise to increased testing, reports the Washington Post. Fauci’s warning: “The next couple of weeks are going to be critical in our ability to address those surges we are seeing in Florida, Texas, Arizona, and other states,” he said, per the New York Times.