Category Archives: Center for Disease Control

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!

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

White House / Via whitehouse.gov

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Social Media: A Parasite on Our Pandemic Mental Health

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

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

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

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

What Is Going On?

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

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

Where Are We Now?

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

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

How Can We Make It Better?

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

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

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

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

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

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

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

Toward More Productive Dialogue

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

Scientists Reveal How the AstraZeneca Vaccine Causes Unusual Clots

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Two-Step Process Leads to Clots

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

ACIP Green-Lights J&J Vax for All Adults

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Please get vaccinated!!

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!!

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Broad brush

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

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

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

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

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

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

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

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

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

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

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

No luck.

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

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

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

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

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

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

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

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

Stanton found that to be particularly frustrating, because his hospital had made a big effort to communicate with the community to “absolutely come to the hospital for true emergencies.”

He describes one patient who had suffered at home for weeks with what ended up being appendicitis. When the patient finally came to the emergency room, Stanton says, a procedure that normally would have been done on an outpatient basis “ended up being a very much more involved surgery with increased risk of complications because of that delay.”

The poll finds a majority of households in leading U.S. cities who delayed medical care for serious problems say they had negative health consequences as a result (ranging from 55% in Chicago to 75% in Houston and 63% in Los Angeles).

Dr. Anish Mahajan, chief medical officer of the large public hospital Harbor-UCLA Medical Center in Los Angeles, says the number of emergencies showing up in his hospital have been down during the pandemic, too, because patients have been fearful of catching the coronavirus there. One case that sticks in his mind was a middle aged woman with diabetes who fainted at home.

“Her blood sugar was really high, and she didn’t feel well — she was sweating,” the doctor recalls. “The family called the ambulance, and the ambulance came, and she said, ‘No, no, I don’t want to go to the hospital. I’ll be fine.’ “

By the next day the woman was even sicker. Her family took her to the hospital, where she was rushed to the catheterization lab. There doctors discovered and dissolved a clot in her heart. This was ultimately a successful ending for the patient, Mahajan says, “but you can see how this is very dangerous — to avoid going to the hospital if you have significant symptoms.”

He says worrisome reports from the Los Angeles County coroner’s office show the number of people who have died at home in the last few months is much higher than the average number of people who died in their homes before the pandemic.

“That’s yet another signal that something is going on where patients are not coming in for care,” Mahajan says. “And those folks who died at home may have died from COVID, but they may also have died from other conditions that they did not come in to get cared for.”

Like most hospitals nationwide, Harbor-UCLA canceled elective surgeries to make room for coronavirus patients — at least during the earliest months of the pandemic, and when cases surged.

In NPR’s survey of cities, about one-third of households in Chicago and Los Angeles and more than half in Houston and New York with a household member who couldn’t get surgeries or elective procedures said it resulted in negative health consequences for that person.

“Back in March and April the estimates were 80[%] to 90% of normal [in terms of screenings for cancer]” at Memorial Sloan Kettering Cancer Center in New York, says Dr. Jeffrey Drebin, who heads surgical oncology there.

“Things like mammograms, colonoscopies, PSA tests were not being done,” he says. At the height of the pandemic’s spring surge in New York City, Drebin says, he was seeing many more patients than usual who had advanced disease.

“Patients weren’t being found at routine colonoscopy,” he says. “They were coming in because they had a bleeding tumor or an obstructing tumor and needed to have something done right away.”

In June, during patients’ information sessions with the hospital, Drebin says patients typically asked if they could wait a few months before getting a cancer screening test.

“In some cases, you can, but there are certainly types of cancer that cannot have surgery delayed for a number of months,” he explains. With pancreatic or bladder cancer, for example, delaying even a month can dramatically reduce the opportunity for the best treatment or even a cure.

Reductions in cancer screening, Drebin says, are likely to translate to more illness and death down the road. “The estimate,” he says, “is that simply the reduction this year in mammography and colonoscopy [procedures] will create 10,000 additional deaths over the next few years.”

And even delays in treatment that aren’t a matter of life and death can make a big difference in the quality of a life.

For 12-year-old Nicolas Noblitt, who lives in Northridge, Calif., with his parents and two siblings, delays in treatment this year have dramatically reduced his mobility.

Nicolas has cerebral palsy and has relied on a wheelchair most of his life. The muscles in his thighs, hips, calves and even his feet and toes get extremely tight, and that “makes it hard for him to walk even a short distance with a walker,” says his mother, Natalie Noblitt. “So, keeping the spasticity under control has been a major project his whole life to keep him comfortable and try to help him gain the most mobility he can have.”

Before the pandemic, Nicolas was helped by regular Botox injections, which relaxed his tight muscles and enabled him to wear shoes.

As Nicolas says, “I do have these really cool shoes that have a zipper … and they really help me — because, one, they’re really easy to get on, and two, they’re cool shoes.” Best of all, he says they stabilize him enough so he can walk with a walker.

“I love those shoes and I think they sort of love me, too, when you think about it,” he tells NPR.

Nicolas was due to get a round of Botox injections in early March. But the doctors deemed it an elective procedure and canceled the appointment. That left him to go months without a treatment.

His muscles got so tight that his feet would uncontrollably curl.

“And when it happens and I’m trying to walk … it just makes everything worse,” Nicolas says, “from trying to get on the shoes to trying to walk in the walker.”

Today he is finally back on his Botox regimen and feeling more comfortable — happy to walk with a walker. Even so, says his mom, the lapse in treatment caused setbacks. Nicolas has to work harder now, both in day-to-day activities and in physical therapy.

‘Warp Speed’ Officials Debut Plan for Distributing Free Vaccines

Despite the president’s statements about military involvement in the vaccine rollout, officials said that for most people, “there will be no federal official who touches any of this vaccine.”

Katie Thomas reported that Federal officials outlined details Wednesday of their preparations to administer a future coronavirus vaccine to Americans, saying they would begin distribution within 24 hours of any approval or emergency authorization, and that their goal was that no American “has to pay a single dime” out of their own pocket.

The officials, who are part of the federal government’s Operation Warp Speed — the multiagency effort to quickly make a coronavirus vaccine available to Americans — also said the timing of a vaccine was still unclear, despite repeated statements by President Trump that one could be ready before the election on Nov. 3.

“We’re dealing in a world of great uncertainty. We don’t know the timing of when we’ll have a vaccine, we don’t know the quantities, we don’t know the efficacy of those vaccines,” said Paul Mango, the deputy chief of staff for policy at the Department of Health and Human Services. “This is a really quite extraordinary, logistically complex undertaking, and a lot of uncertainties right now. I think the message we want you to leave with is, we are prepared for all of those uncertainties.”

The officials said they were planning for initial distribution of a vaccine — perhaps on an emergency basis, and to a limited group of high-priority people such as health care workers — in the final three months of this year and into next year. The Department of Defense is providing logistical support to plan how the vaccines will be shipped and stored, as well as how to keep track of who has gotten the vaccine and whether they have gotten one or two doses.

However, Mr. Mango said that there had been “a lot of confusion” about what the role of the Department of Defense would be, and that “for the overwhelming majority of Americans, there will be no federal official who touches any of this vaccine before it’s injected into Americans.”

Army Lt. Gen. Paul Ostrowski said Operation Warp Speed was working to link up existing databases so that, for example, a patient who received a vaccine at a public health center in January could go to a CVS pharmacy 28 days later in another state and be assured of getting the second dose of the right vaccine.

Three drug makers are testing vaccine candidates in late-stage trials in the United States. One of those companies, Pfizer, has said that it could apply for emergency authorization as early as October, while the other two, Moderna and AstraZeneca, have said they hope to have something before the end of the year.

Coronavirus vaccine study by Pfizer shows mild-to-moderate side effects

Pfizer Inc said on Tuesday participants were showing mostly mild-to-moderate side effects when given either the company’s experimental coronavirus vaccine or a placebo in an ongoing late-stage study.

The company said in a presentation to investors that side effects included fatigue, headache, chills and muscle pain. Some participants in the trial also developed fevers – including a few high fevers. The data is blinded, meaning Pfizer does not know which patients received the vaccine or a placebo. Kathrin Jansen, Pfizer’s head of vaccine research and development, stressed that the independent data monitoring committee “has access to unblinded data so they would notify us if they have any safety concerns and have not done so to date.”

The company has enrolled more than 29,000 people in its 44,000-volunteer trial to test the experimental COVID-19 vaccine it is developing with German partner BioNTech. Over 12,000 study participants had received a second dose of the vaccine, Pfizer executives said on an investor conference call.

The comments follow rival AstraZeneca’s COVID-19 vaccine trials being put on hold worldwide on Sept. 6 after a serious side effect was reported in a volunteer in Britain.

AstraZeneca’s trials resumed in Britain and Brazil on Monday following the green light from British regulators, but remain on hold in the United States.

Pfizer expects it will likely have results on whether the vaccine works in October. “We do believe – given the very robust immune profile and also the preclinical profile … that vaccine efficacy is likely to be 60% or more,” Pfizer’s Chief Scientific Officer Mikael Dolsten said.

Rushing the COVID-19 Vaccine Could Have Serious and Fatal Side Effects

Jason Silverstein noted that States have been told by the Centers for Disease Control and Prevention they should prepare for a coronavirus vaccine by “late October or early November,” according to reports last Wednesday. But an untested coronavirus vaccine may have serious and fatal side effects, could even make the disease worse, and may very well have an effect on the election.

What’s the worst that could happen if we give an untested vaccine to millions of people?

We received a reminder today, when one of the leading large coronavirus vaccine trials by AstraZeneca and Oxford University was paused due to a “suspected serious adverse reaction.” There are eight other potential coronavirus vaccines that have reached Phase 3, which is the phase that enrolls tens of thousands of people and compares how they do with the vaccine against people who only get a placebo. Those eight include China’s CanSino Biologics product that was approved for military use without proper testing back in July, and Russia’s coronavirus vaccine that has been tested in only 76 people.

If the CDC distributes an untested coronavirus vaccine this Fall, it would be the largest drug trial in history—with all of the risks and none of the safeguards.

“Approving a vaccine without testing would be like climbing into a plane that has never been tested,” said Tony Moody, MD, director of the Duke Collaborative Influenza Vaccine Innovation Centers. “It might work, but failure could be catastrophic.”

One concern about this vaccine is that it’s tracking to be an “October surprise.” From Henry Kissinger’s “peace is at hand” speech regarding a ceasefire in Vietnam less than two weeks before the 1972 election to former FBI Director James Comey’s letter that he would reopen the investigation into Hillary Clinton’s emails, October surprises have always had the potential to shift elections. But never before have they had the potential to catastrophically shift the health of an already fragile nation.

If there is an October surprise in the form of an untested coronavirus vaccine, it won’t be the first time that a vaccine was rushed out as a political stunt to increase an incumbent president’s election chances.

What happened with the last vaccine rush?

On March 24, 1976, in response to a swine flu outbreak, President Gerald Ford asked Congress for $135 million for “each and every American to receive an inoculation.”

How badly did the Swine Flu campaign of 1976 go? Well, one of the drug companies made two million doses of the wrong Swine Flu vaccine, vaccines weren’t exactly effective for people under 24, and insurance companies said, no way, they didn’t want to be liable for the science experiment of putting this vaccine into 120 million bodies.

By December, the Swine Flu vaccination program was suspended when people started to develop Guillain-Barré Syndrome, a rare neurological condition whose risk was seven times higher in people who got the vaccine and which paralyzed more than 500 people and killed at least 25.

What else can go wrong when vaccines are rushed

“Vaccines are some of the safest medical products in the world, but there can be serious side effects in some instances that are often only revealed by very large trials,” said Kate Langwig, Ph.D., an infectious disease ecologist at Virginia Tech.

One of the other possible side effects is known as vaccine enhancement, the very rare case when the body makes antibodies in response to a vaccine but the antibodies help a second infection get into cells, something that has been seen in dengue fever. “The vaccine, far from preventing Covid-19, might turn out to make a patient’s disease worse,” said Nir Eyal, D.Phil., a bioethics professor at Rutgers University.

We do not know whether a coronavirus vaccine might cause vaccine enhancement, but we need to. In 1966, a vaccine trial against respiratory syncytial virus, a disease that many infants get, caused more than 80 percent of infants and children who received the vaccine to be hospitalized and killed two.

All of these risks can be prevented, but safety takes patience, something that an American public which has had to bury more than 186,000 is understandably short on and Trump seems to be allergic to.

“To put this into perspective, the typical length of making a vaccine is fifteen to twenty years,” said Paul Offit, MD, the director of the Vaccine Education Center at Children’s Hospital of Philadelphia. Offit’s laboratory developed a vaccine for rotavirus, a disease that kills infants. That process began in the 1980s and wasn’t completed until 2006. The first scientific papers behind the HPV vaccine, for example, were published in the early 1990’s, but the vaccine wasn’t licensed until 2006.

An untested vaccine may also prove a deadly distraction. “An ineffective vaccine could create a false sense of security and perhaps reduce the emphasis on social distancing, mask wearing, hand hygiene,” said Atul Malhotra, MD, a pulmonologist at the UC San Diego School of Medicine.

Other issues with inadequately tested vaccines

Even worse, an untested vaccine may have consequences far beyond the present pandemic. Even today, one poll shows that only 57% of people would take a coronavirus vaccine. (Some experts argue that we need 55 to 82% to develop herd immunity.)

If we don’t get the vaccine right the first time, there may not be enough public trust for a next time. “Vaccines are a lot like social distancing. They are most effective if we work cooperatively and get a lot of people to take them,” said Langwig. “If we erode the public’s trust through the use of unsafe or ineffective vaccines, we may be less likely to convince people to be vaccinated in the future.”

“You don’t want to scare people off, because vaccines are our way out of this,” said Dr. Offit.

So, how will you be able to see through the fog of the vaccine war and know when a vaccine is safe to take? “Data,” said Dr. Moody, “to see if the vaccine did not cause serious side effects in those who got it, and that those who got the vaccine had a lower rate of disease, hospitalization, death, or any other metric that means it worked. And we really, really want to see that people who got the vaccine did not do worse than those who did not.

And finally, don’t forget to get your Flu vaccine, now!

Mood darkens in Sweden as high death rate raises tough questions over lack of lockdown, and Now A Second Wave and a Possible Kids’ Epidemic!

Richard Orange noted that Sweden, in deference to the rest of the countries believing in the strategy to lockdown their populace, decided not to use stay-at-home or lockdowns except for the elderly.  Sweden’s opposition has attacked the government for its handling of the coronavirus pandemic, with the stubbornly high death rate fueling questions over the decision not to impose a lockdown. 

Jimmie Akesson, the leader of the populist Sweden Democrats, first called for Anders Tegnell, the architect of Sweden’s less restrictive coronavirus strategy, to resign. The attacks continued in heated televised leaders’ debate on Sunday night.  

“The strategy in Sweden was not to try to hold back the infection, but instead to try to limit it at the same time as protecting risk groups,” Mr Akesson wrote in a debate article in the Dagens Nyheter newspaper.

“By that measure, it has failed miserably. Anders Tegnell should therefore resign. Only then will he show the Swedish people that he takes responsibility for the mistakes FHM [Public Health Agency of Sweden] has made.”

During a party leaders’ debate on Sunday evening, Ebba Busch-Thor, leader of the Christian Democrat party, blamed Sweden’s strategy – and by extension the government that allowed it – for some of the 4,659 deaths due to the virus. 

“What we can say about Sweden is that many of those who are mourning over those they have lost this spring are doing so because Sweden knowingly and deliberately allowed a large spread of the infection,” she said.  

Ulf Kristersson, the leader of the Moderate Party, the biggest party on the Centre-Right, held back from joining Mrs. Busch-Thor’s attack on the strategy, instead attacking the implementation of it.

“I had no problem with the strategy. It was a bit slow but, when it was in place, I had nothing against it,” he said. “But the government didn’t put any power behind the words.”

The Prime Minister, Stefan Lofven, continued to back Sweden’s strategic decision not to impose a lockdown, instead laying the blame for the death rate on failures within elderly care. 

“I think the strategy is the right one,” he said. “But it has transpired that that very many people, in certain areas, have died in elderly care. There’s no doubt that elderly care needs to be improved.” 

Mr Akesson faced an immediate counter-attack from Johan Carlsson, the director of FHM, who dismissed his call as “almost pathetic”. 

Dagens Nyheter’s political commentator Ewa Stenberg wrote on Sunday that the debate marked an end to the “borgsfred”, or “castle truce”, in Sweden.

“The tone was harsh and quite contrary to how it was when the virus hit the country. Then all the parties backed the government’s decision to let the Public Health Authority take the lead,” she wrote.

However, the return of political opposition does not yet seem to reflect a loss of support for the government among the public.

Kids During Lockdown: Is Another Epidemic About to be Revealed?

Ingrid Walker-Descartes noted that even in non-pandemic years, the summertime “back-to-school” rush of appointments in many pediatric practices can be a logistical challenge. This year could be even more hectic after many families delayed routine appointments during quarantine. Hoping to return to their routines, children and teens will need vaccines, physical exams for sports clearances and school forms, and all the regular developmental and emotional surveillance that is so important to keep them healthy.

As pediatricians, we should be adding another layer to our checklists in these visits this year. For many children, this visit may be the first time in weeks or months that someone outside their immediate family has had eyes on them.

We must be careful to listen, very carefully, to what the children and parents tell us, both in their words and in other signs. How has the family coped with the stress of being stuck at home? Are there financial struggles? Food insecurity? Other stresses? As a child abuse pediatrician, I know all of these things can put tremendous stress on a family, and ultimately can lead to a child being maltreated or abused. We have a real opportunity right now to intervene and provide critical support to families, and to protect children.

Sadly, we know from previous disasters that during these times of intense emotional and economic stress, rates of child abuse and neglect increase. Injuries and deaths among infants due to abusive head trauma increase during times of economic stress, and scattered reports among physicians at children’s hospitals in various states are reporting that is happening now, too. For example, a hospital in Fort Worth, Texas, and a hospital in Philadelphia, are reporting an increase in the number of severe physical abuse cases. Many times, this abuse occurs when a parent or caregiver is frustrated or at the “end of their rope,” and in a moment of anger, makes a devastating choice that injures a child.

For the past few months, during sheltering in place, children have lacked many of the people who often step forward as protectors — the aunt they may confide in, a teacher who sees a bruise, or a physician who notices an injury where there reasonably should be none. Reports to child abuse hotlines and child protective services have declined during the pandemic, but this is not necessarily because fewer children are being injured. We know that teachers and school counselors are the most frequent reporters of suspected abuse, and for months children have not had access to these trusted protectors. Many of them have not seen their pediatrician, either. These combined realities have left some of our most vulnerable children without several much-needed layers of protection.

As a pediatrician who specializes in diagnosing abuse and protecting children from further abuse, I am well versed in talking with children to understand what happened to cause their injuries. Some may convey lessons learned from their choices made due to curiosity or naivete. Others struggle to elaborate on marks or scars made in anger by a caregiver. Post COVID-19, it will be important for all pediatricians to have a careful approach as they are talking with families, listening and observing to understand what children experienced during the pandemic, and how we can help them and their families be safe and healthy.

Some families may benefit from a referral to a nutrition program, caregiver support program, parental counseling, or other resources. In other cases, a pediatrician may notice a sign of potential abuse that should be reported to the relevant child protection agencies. This is always difficult, but it can be the first step to making sure a child is safe and protected while a family gets the support they need.

The American Academy of Pediatrics (AAP) recently provided a webinar guide on how to identify child abuse during the pandemic, and additional resources are provided on the AAP website, including a list of child abuse programs across the country to help support you in this difficult role.

The stress on families and children will not end when the stay-at-home orders lift. Let’s be prepared to help all our children emerge healthy and strong, and ready to learn.

CDC wants states to count ‘probable’ coronavirus cases and deaths, but most aren’t doing it

Reinhard, Emma Brown Reis Thebault and Lena H. Sun reported that fewer than half the states are following federal recommendations to report probable novel coronavirus cases and deaths, marking what experts say is an unusual break with public health practices that leads to inconsistent data collection and undercounts of the disease’s impact.

A Washington Post review found that the states not disclosing probable cases and deaths include some of the largest: California, Florida, North Carolina and New York. That is one reason government officials and public health experts say the virus’s true toll is above the U.S. tally as of Sunday of about 1.9 million coronavirus cases and 109,000 deaths — benchmarks that shape policymaking and public opinion on the pandemic.

The U.S. Centers for Disease Control and Prevention works closely with a group of health officials called the Council of State and Territorial Epidemiologists to issue guidelines for tracking certain illnesses. The guidelines are voluntary, though states generally comply. The goal: solid comparisons between states and accurate national statistics that inform public health decision-making.

In April, as coronavirus infections multiplied and laboratory testing was limited, the CSTE and the CDC advised states to count both probable cases and deaths — where symptoms and exposure pointed to infection — along with those confirmed by tests.

Yet weeks after the guidance was handed down to standardize coronavirus reporting, a Post review found states as of early June counting cases and deaths in all sorts of ways.

At least 24 states are not heeding the national guidelines on reporting probable cases and deaths, despite previously identifying probable cases in other national outbreaks, including H1N1 flu during the country’s last pandemic in 2009.

The failure of many states to document probable coronavirus cases and deaths is “historic in many ways because there are lots of probable case classifications and probables are regularly and normally reported on,” said Janet Hamilton, the CSTE executive director. “We are definitely concerned about the undercounting of covid-19 deaths and cases.”

New Jersey says it began reporting probable cases and deaths to the CDC on May 15 but does not disclose them publicly on its website. Georgia says it tracks the information internally but is not reporting those numbers on its website or to the CDC.

“We do have intentions of sharing them but not yet,” said Nancy Nydam, a spokeswoman for the Georgia Department of Public Health, who said as of late May the department had tracked 1,658 probable cases and potentially dozens of probable deaths.

Officials in Montana, Rhode Island and the District of Columbia say they haven’t reported any probable cases or deaths because they have not had any, citing low numbers or the wide availability of testing.

Seven states did not respond to The Post’s requests for a breakdown of cases and death counts. Five of those are not reporting probable cases or deaths, according to data the CDC began publishing June 2. South Dakota reports probable deaths but not cases.

Officials in the remaining 17 states say they are reporting probable and confirmed coronavirus cases and deaths on their websites and to the CDC. Some states distinguish between probable and confirmed while others group them.

In some states not reporting probable cases, officials cite the demands of an unprecedented crisis in which Americans press for daily updates from public health data systems that are chronically underfunded and outdated.

In Washington state, where many of the nation’s first deaths occurred, health department spokeswoman Lisa Stromme Warren said documenting probable cases and deaths “is one of many urgent priorities.” The state has identified about 100 people whose death certificates list covid-19 but were never tested, so they are not included in the public death count or reported to the CDC.

“We suspect that we are actually more likely to be undercounting deaths than overcounting them,” Katie Hutchinson, the health department’s health statistics manager, said during a recent briefing.

CDC spokeswoman Kristen Nordlund said that the agency is working with health departments to improve the flow of data. “In pandemic circumstances, such as with covid-19, collecting complete information on each case is challenging,” Nordlund said. “The current case and deaths counts reported to CDC are likely an undercount.”

During the H1N1 flu pandemic, states initially counted probable and confirmed cases individually. But about three months into the outbreak, the CDC said those individual counts represented “only a fraction of the true burden” of the disease. The agency stopped collecting individual case reports and instead began publishing estimates based on hospitalizations, symptoms and other data.

The CDC is planning to come up with similar estimates for the coronavirus but has no immediate plans to stop counting individual cases. “CDC is actively working on a model to address and assess the true burden of covid-19 in the U.S.,” Nordlund said.

All eyes on numbers

For government officials assessing how quickly to reopen the economy and individuals deciding what risks to take, their daily judgment calls are based, in part, on the case and death counts publicized on television and computer screens.

That has propelled the pandemic counts into the contentious political arena, where some allies of President Trump and conservative voices on social media have claimed that the covid-19 death toll is inflated. The debate over whether counts of probables are crucial or misleading extends beyond the nation’s capital.

In Illinois, two Republican lawmakers and three businesses have sued the Democratic governor over coronavirus disaster orders. A spokeswoman for the health department, Melaney Arnold, said the state is not divulging probable deaths on its website “because there is concern from the public that the number of deaths is being inflated. . . . We need the public to have confidence in the data and therefore are reporting only those deaths that are laboratory confirmed.”

The state website lists about 5,700 deaths as of June 5, excluding the approximately 185 probable deaths tracked internally as of that day and reported to the CDC.

But a resident looking at a state chart and then turning to the CDC might not find the same numbers. The newly posted CDC table does not reflect the probables that officials in some states said they have reported. Officials say that’s because the reports sent to the CDC include those with confirmed cases in one figure and because the national update can run slightly behind state websites.

Since the 1950s, CSTE has recommended which diseases states should track and what those reports to the federal government should look like. The CDC works closely with the epidemiologists’ council and adopts its guidelines to “enable public health officials to classify and count cases consistently across reporting jurisdictions,” according to the CDC website.

States usually follow these recommendations and report the incidence of dozens of different diseases to the CDC, with some exceptions. A state may not report cases of a disease that does not occur within its borders, yet may track another illness found only in its part of the country.

Hawaii, for example, does not report Lyme disease, as every other state does, but it does report hallucinogenic fish poisoning.

“It’s more of a handshake agreement between the states and CDC that we will send you the data in this way so that you can then aggregate it,” said Kathy Turner, Idaho’s deputy epidemiologist. “In general, there’s no argument. We all do it because we realize the importance of being able to look at a disease on a national level.”

Some reportable diseases rarely result in deaths, so CSTE directives have typically focused on how to count cases, not fatalities. Then came the coronavirus and a mushrooming death toll. The CDC acknowledged in early April that the death count was an “underestimation” because it included only fatalities in which the virus was laboratory confirmed. Testing shortages, people dying at home or in nursing homes, and spotty postmortem testing meant victims were overlooked.

“When the outbreak first started and we were all just counting lab-confirmed cases by default, it became clear that we were not going to be able to describe the burden of the pandemic because so many people were not being tested,” said Turner, lead author of the CSTE statement on covid-19.

“We usually don’t approach a death separately from a case, but in this situation, we decided it was needed,” she said.

The CSTE recommended reporting probable and confirmed cases and deaths on April 5. The CDC’s written response to the recommendations, which was shared with The Post, said the agency “concurs” and that adoption by states is “very important” for covid-19 record-keeping. On April 14, the CDC noted on its website that the national tally includes probables, although the agency did not at that time provide a state-by state breakdown. The CDC also modified the form states use for coronavirus reports, adding boxes that can be checked to indicate a “lab-confirmed” case or “probable” case.

Probable cases were defined as showing symptoms and having contact with an infected person, or meeting one of those criteria and testing positive for coronavirus antibodies, rather than for the virus itself. Probable deaths meant those who were never tested for the virus but whose death certificates listed covid-19 as the cause of death or a significant condition contributing to death.

The CSTE statement also says that confirmed and probable counts should be included in the tallies “released outside the public health agency,” which could mean a state website or written report, according to the organization.

“When states are using different approaches, it always begs the question: ‘Why does one state choose one over another? Why a more conservative approach over a more sensitive one?’’’ asked Lorna Thorpe, director of the division of epidemiology at NYU Grossman School of Medicine. “That’s the reason we have standards and guidance that are technically sound.”

Information varies

The erratic reporting of coronavirus cases and deaths means that what residents can learn about the extent of the pandemic in their community varies widely.

Ohio was one the first states to begin disclosing probable cases and deaths in early April. “It usually is a given when CSTE makes a recommendation like that,” said Brian Fowler, chief data officer for the Ohio Department of Health. “When they made that recommendation, we looked at it and said, okay, well this is what we need to use.”

As of June 5, Ohio’s website showed 2,117 confirmed deaths and 222 probables. By breaking out the numbers separately, Fowler said, “you can’t be accused of hiding information and you can’t be accused of inflating numbers — it’s all out there.”

The transition to counting probables was not “a huge lift,” Fowler said. Epidemiologists at the health department were already reviewing all suspected coronavirus cases.

Some health officials were candid about how adding probable deaths would boost the overall tally. “I want to make sure that everyone understands that these are not new deaths,” Indiana Health Commissioner Kristina Box said at an April 20 news conference. “Rather, we are capturing the deaths that have occurred really since this pandemic began.” Box suggested other states would do the same: “Indiana — like every other state — will include these deaths in our reporting in order to better capture the toll that covid-19 has truly taken.”

One week earlier, Michigan officials had said they intended to begin disclosing probable cases and deaths. When the state finally began doing that on June 5, more than 5,000 cases and 200 deaths were added to coronavirus totals.

California’s state health department is reviewing the process to track probable deaths and “working to provide as much data as possible about COVID 19 while ensuring that the data are valid and useful for understanding the pandemic,” according to a May 20 email to The Post.

Hilda Solis, a supervisor in Los Angeles County who represents a heavily Hispanic and impoverished district, said she was surprised that the state is not following national recommendations on counting coronavirus deaths. She has called for more post-mortem testing by the medical examiner. “A lot of people are dying at home. Poor people are dying at home. Homeless people are dying,” said Solis, a former U.S. labor secretary under President Barack Obama. “I do believe covid-19 is being underreported and that we need to take more responsibility.”

The scale of undercounting that results from reporting only confirmed cases became clear when New York City on April 14 added more than 3,700 probable deaths to its numbers, sending the city’s tally over 10,000.

The city that sits at the epicenter of the pandemic in the United States still is not counting probable cases, however. New York Gov. Andrew M. Cuomo, a Democrat praised for his command of daily news briefings during the pandemic, has indicated skepticism about recording probable cases. “Probable is different than confirmed,” he said at a news conference in late May. “Probable is ‘probable, but I have to check, I don’t know, I have to do further testing.’ We’ve had many cases that were probable coronavirus and turned out not to be coronavirus and that’s why they call them probable.” Covid-19 websites for New York and New Jersey include probable deaths at nursing homes, but those numbers are not included in the states’ overall death totals. A spokesperson for North Carolina’s health department said the state is not reporting probables because of wariness about the reliability of antibody tests, and because of concerns that the CSTE’s definition of a probable case is overly broad. Officials in Florida did not respond to repeated requests for comment about why the state isn’t following federal guidelines.

People behind ‘probables’

Behind each probable death is a person. Barnes O’Neal, 83, checked into the Brightmoor Nursing Center in Georgia in March to recover from a 10-day hospitalization. Less than a month into his stay at the facility about 40 miles south of Atlanta, a coronavirus outbreak forced a lockdown. O’Neal developed a fever and pneumonia. His daughter, Natalie Turner, pleaded with her father’s caretakers and the state health department for a coronavirus test. She said she wanted his illness on the record.

On April 20, just hours after Turner had spoken with him by phone, O’Neal died. He was never tested, but Turner said his doctor told her there was “zero doubt” it was covid-19 and wrote it on her father’s death certificate.

Still, her father, a frequent volunteer at the local soup kitchen, would not be included in the death toll on the state website because he was never tested. “It’s just important to me because my dad’s life counted,” Turner said. “I feel like there’s a face behind every statistic, and that’s forgotten many times.”

And now the pandemic’s overall death toll in U.S. has exceeded 100,000, but what are the real numbers?

Second U.S. Virus Wave Emerges as Cases Top 2 Million

Emma Court and David Baker noted that a second wave of coronavirus cases is emerging in the U.S., raising alarms as new infections push the overall count past 2 million Americans. Texas on Wednesday reported 2,504 new coronavirus cases, the highest one-day total since the pandemic emerged. A month into its reopening, Florida this week reported 8,553 new cases — the most of any seven-day period. California’s hospitalizations are at their highest since May 13 and have risen in nine of the past 10 days.

A fresh onslaught of the novel coronavirus is bringing challenges for residents and the economy in pockets across the U.S. The localized surges have raised concerns among experts even as the nation’s overall case count early this week rose just under 1%, the smallest increase since March.

“There is a new wave coming in parts of the country,” said Eric Toner, a senior scholar at the Johns Hopkins Center for Health Security. “It’s small and it’s distant so far, but it’s coming.”

Though the outbreaks come weeks into state reopenings, it’s not clear that they’re linked to increased economic activity. And health experts say it’s still too soon to tell whether the massive protests against police brutality that have erupted in the past two weeks have led to more infections.

In Georgia, where hair salons, tattoo parlors and gyms have been operating for a month and a half, case numbers have plateaued, flummoxing experts.

Puzzling differences show up even within states. In California, which imposed a stay-at-home order in late March, San Francisco saw zero cases for three consecutive days this week, while Los Angeles County reported well over half of the state’s new cases. The White House Coronavirus Task Force has yet to see any relationship between reopening and increased cases of Covid-19, Food and Drug Administration Commissioner Stephen Hahn said on a podcast.

But in some states, rising numbers outpace increases in testing, raising concerns about whether the virus can be controlled. It will take a couple of weeks to know, Toner said, but by then “it’s going to be pretty late” to respond.

Since the pandemic initially swept the U.S. starting early this year, 2 million people have been infected and more than 112,000 have died.

After a national shutdown that arrested the spread, rising illness had been expected as restrictions loosened. The trend has been observed across 22 states in recent weeks, though many increases are steady but slow.

In New York, the state hardest hit by Covid-19, Governor Andrew Cuomo only recently started reopening by region. New York City, the epicenter, began the first of four phases Monday.

“We know as a fact that reopening other states, we’re seeing significant problems,” Cuomo said Tuesday. “Just because you reopen does not mean you will have a spike, but if you are not smart, you can have a spike.”

Experts see evidence of a second wave building in Arizona, Texas, Florida and California. Arizona “sticks out like a sore thumb in terms of a major problem,” said Jeffrey Morris, director of the division of biostatistics at University of Pennsylvania’s Perelman School of Medicine.

Arizona Spike

Arizona’s daily tally of new cases has abruptly spiked in the last two weeks, hitting an all-time high of 1,187 on June 2.

This week, its Department of Health Services urged hospitals to activate emergency plans. Director Cara Christ, told a Phoenix television station that she was concerned about the rising case count and percentage of people tested who are found to be positive.

Valleywise Health, the public hospital system in Phoenix, has seen an increase in Covid-19 cases during the past two weeks. It’s expanded its intensive-care capacity and those beds are 87% full, about half with Covid patients, according to Michael White, the chief medical officer.

White said Valleywise has adequate protective gear for staff, but hospitals aren’t getting their entire orders. A surge in Covid cases could put that supply under stress, he said.

The increase in transmission follows steps to resume business and public life as well as the riots and protests.

“Within Phoenix, we’ve been more relaxed than I’ve seen in some of the other parts of the country,” White said, with some people disregarding advice to wear masks and maintain six feet of distance from others. “People are coming together in environments where social distancing is challenging.”

Texas on Wednesday reported a 4.7% jump in hospitalizations to 2,153, the fourth consecutive daily increase. The latest figures showing an escalation came as Governor Greg Abbott tweeted a public service announcement featuring baseball legend Nolan Ryan urging Texans to wash their hands and to not be “a knucklehead.”

Abbott was criticized for an aggressive reopening last month. Mobile-phone data show activity by residents is rebounding toward pre-Covid levels, according to the Children’s Hospital of Philadelphia’s PolicyLab.

That could reflect a perception that the virus wasn’t “ever a big threat,” said Morris, who recently moved to Philadelphia after 20 years in Houston.

Florida’s health department said in a statement that it attributes the increase in cases to “greatly expanded efforts in testing,” and noted that overall positivity rates remain low, at about 5.5%.

Bucking the trend is Georgia, which was the first U.S. state to reopen. Covid cases there have plateaued. Despite local outbreaks in the state, “their sea levels did not rise,” said David Rubin, director of the PolicyLab, which has been modeling the virus’ spread. “They’ve kind of held this fragile equilibrium.”

Creeping In

California was the earliest state to shut down its economy over the coronavirus, after one of the nation’s first outbreaks in the San Francisco Bay Area. It has been slower than most to reopen.

Even so, the state has also seen the number of people hospitalized with Covid-19 rebound in the past two weeks, as commerce accelerates. Case counts are climbing too, although officials attribute that to increased testing and say it’s a sign of preparation.

In part, rising numbers represent the virus spreading into places that largely avoided the first round of infections, including rural Imperial County in California’s southeastern desert. Yet the contagion remains present in places that bore the brunt of the first wave, including Los Angeles County. Hospitalizations there are lower than at the start of May, but deaths remain stubbornly high, with 500 in the past week alone.

Barbara Ferrer, Los Angeles County public health director, said the region has likely not seen the end of the first wave. And despite concerns about infections coming out of mass demonstrations in the sprawling city, she thinks the reopening of the economy will have a bigger impact.

“We’re not at the tail end of anything,” Ferrer said. “We never had a huge peak. We’ve kind of been within this band. We’re not in decline, we’re kind of holding our own in ways that protect the health-care system.” But, she added, “go to Venice and see the crowds, and you’ll understand why I have concerns.”

Another Onslaught

The U.S. has long been bracing for another wave, but future outbreaks are likely to take a different shape. Social distancing and mask-wearing, as well as careful behavior by individuals, are likely to have staying power even as economies reopen.

Experts are steeling for autumn, when changes in weather and back-to-school plans could have damaging repercussions.

“The second wave isn’t going to mirror the first wave exactly,” said Lance Waller, a professor at Emory University’s Rollins School of Public Health in Atlanta. “It’s not snapping back to exactly the same thing as before, because we’re not exactly the way we were before.”

Daniel Lucey, a fellow at the Infectious Diseases Society of America, compared the virus’ new paradigm with a day at the beach: The U.S. has been bracing for another “high tide” like the one that engulfed New York City. Today is a low tide, but “the waves are always coming in.”

Dr. Atlas and Others on coronavirus lockdowns: ‘The policy … is killing people’ and Not from the Corona virus!

As a physician I only stopped seeing my patients for two weeks during the pandemic. Why? I considered my patients cancer care a necessary demand. My cancer patients needed surgical procedures and the hospital didn’t consider those procedures urgent. So, I offered to do their surgical procedures in my office surgical suite under local anesthesia. If I didn’t the tumors would continue to grow and possibly metastasize or spread reducing their chances for cure. This brings up the important consideration that this pandemic is allowing our regular medical and surgical patient to result in delayed diagnoses and treatment. Victor Garcia reported that the Coronavirus lockdowns may be “killing” just as many people as the virus because as I mentioned, many people with serious conditions unrelated to the virus have been skipping treatment, Hoover Institution senior fellow Dr. Scott Atlas said Saturday on “Fox Report.”

“I think one thing that’s not somehow receiving attention is the CDC just came out with their fatality rates,” Atlas said. “And lo and behold, they verify what people have been saying for over a month now, including my Stanford epidemiology colleagues and everyone else in the world who’s done this analysis — and that is that the infection fatality rate is less than one-tenth of the original estimate.”

Even White House coronavirus task force member Dr. Anthony Fauci is acknowledging the harm caused by the lockdown, Atlas said. “The policy itself is killing people. I mean, I think everyone’s heard about 650,000 people on cancer, chemo, half of whom didn’t come in. Two thirds of cancer screenings didn’t come in. 40 percent of stroke patients urgently needing care didn’t come in,” Atlas said. “And now we have over half the people, children in the United States not getting vaccinations. This is really what [Fauci] said was irreparable harm.”

More on Dr. Fauci later in this post.

“And I and my colleagues from other institutions have calculated the cost of the lockdown in terms of lives lost,” Atlas said. “Every month is about equal to the entire cost of lives lost during the COVID infection itself. This is a tragic, misguided public policy to extend this lockdown, whether or not it was justifiable in the beginning.”

Many states are currently reopening their economies slowly, while a few have pledged to extend the lockdowns through the summer.

The doctor also argued against keeping children out of schools, saying there’s no reason they can’t go back. “There’s no science whatsoever to keep K-through-12 schools closed, nor to have masks or social distancing on children, nor to keep summer programs closed,” Atlas said. “What we know now is that the risk of death and the risk of even a serious illness is nearly zero in people under 18.”

Lockdown measures have kept nearly 80 million children from receiving preventive vaccines

Caitlin McFall of Fox News reported that the coronavirus pandemic has resulted in stay-at-home orders that are putting young children at risk of contracting measles, polio and diphtheria, according to a report released Friday by the World Health Organization (WHO).

Routine childhood immunizations in at least 68 countries have been put on hold due to the unprecedented spread of COVID-19 worldwide, making children under the age of one more vulnerable.

More than half of 129 counties, where immunization data was readily available, reported moderate, severe or total suspensions of vaccinations during March and April.

“Immunization is one of the most powerful and fundamental disease prevention tools in the history of public health,” said WHO Director-General Tedros Adhanom Ghebreyesus. “Disruption to immunization programs from the COVID-19 pandemic threatens to unwind decades of progress against vaccine-preventable diseases like measles.”

The WHO has reported the reasons for reduced immunization rates vary. Some parents are afraid to leave the house due to travel restrictions relating to the coronavirus, whereas a lack of information regarding the importance of immunization remains a problem in some places.

Health workers are also less available because of COVID-19 restrictions.

The Sabin Vaccine Institute, the United Nations Children’s Fund (UNICEF) and GAVI, The Vaccine Alliance also contributed to the report.

Experts are worried that worldwide immunization rates, which have progressed since the 1970s, are now being threatened.

“More children in more countries are now protected against more vaccine-preventable diseases than at any point in history,” said Gavi CEO Dr. Seth Berkley. “Due to COVID-19 this immense progress is now under threat.”

UNICEF has also reported a delay in vaccine deliveries because of coronavirus restrictions and is now “appealing to governments, the private sector, the airline industry, and others, to free up freight space at an affordable cost for these life-saving vaccines.”

Experts say that children need to receive their vaccines by the age of 2. And in the case of polio, 90 percent of the population need to be immunized in order to wipe out the disease. Polio is already making a comeback in some parts of the world, with more than a dozen African countries reporting polio outbreaks this year.

“We cannot let our fight against one disease come at the expense of long-term progress in our fight against other diseases,” said UNICEF’s Executive Director Henrietta Fore. “We have effective vaccines against measles, polio and cholera,” she said. “While circumstances may require us to temporarily pause some immunization efforts, these immunizations must restart as soon as possible or we risk exchanging one deadly outbreak for another.”

Six Social Health System Teams to Encourage People to Seek Healthcare

Alexandra Wilson Pecci noted that the campaign, which aims to encourage people to get healthcare when they need it, comes as providers across the country have seen a dramatic drop in visits and revenue during the COVID-19 pandemic.

Six of Los Angeles County’s largest nonprofit health systems with hospitals, clinics, and care facilities are teaming for BetterTogether.Health, a campaign that aims to encourage people to get healthcare when they need it, despite the current pandemic.

The campaign, from Cedars-SinaiDignity HealthProvidenceUCLA HealthKeck Medicine of USC, and Kaiser Permanente, comes as hospitals and healthcare provider offices across the country have seen a dramatic drop in visits and revenue.

“We know many patients who in the past dialed 911 for life-threatening emergencies are now not accessing these vital services quickly,” Julie Sprengel, President, Southwest Division of Dignity Health Hospitals, CommonSpirit Health, said in a statement. “We are instead seeing patients that delayed, postponed or cancelled care coming to emergency departments with serious conditions that should have been treated far earlier.”

Indeed, outpatient hospital visits experienced a record one-week 64% decline during the week of April 5-11, compared to pre-COVID-19 volumes, according to research from TransUnion Healthcare. In addition, hospital visit volumes further declined 33%-62% between the weeks of March 1-7 and April 12-18.

Those stats were echoed in a Medical Group Management Association (MGMA) survey last month showing that physician practices reported a 60% average decrease in patient volume and a 55% average decrease in revenue since the beginning of the public health emergency. 

In addition, nearly two-thirds of hospital executives expect full year revenues will decline by at least 15% due to the coronavirus disease 2019 (COVID-19) outbreak, according to a Guidehouse analysis of a survey conducted by the Healthcare Financial Management Association (HFMA).

The campaign’s website and PSAs communicate messages like “Life may be on pause. Your health isn’t.,” “Thanks L.A. for doing your part.,” and “Get care when you need it.”

In addition to lost revenue, healthcare providers are warning of a “silent sub-epidemic” of those who are avoiding getting medical care when they need it, which could result in serious, negative health consequences that could be avoided.

“There is concern that patients with serious conditions are putting off critical treatments,” Tom Jackiewicz, CEO of Keck Medicine of USC, said in a statement. “We know that seeking immediate care for heart attacks and strokes can be life-saving and may minimize long-term effects. Our hospitals and health care providers are ready and open to serve your needs.”

The BetterTogether.Health public service effort combines those health systems’ resources to create a joint message that will include multi-language television and radio spots, and billboards, messages in newspapers, magazines, digital, and social media; online information, and links to healthcare resources.

It’s reminding people to seek care for things ranging from heart attack symptoms to keeping up with children’s immunization schedules.

“Receiving timely treatment by skilled medical professionals is essential to helping us achieve for our patients and communities the best possible outcomes,” Tom Priselac, President and CEO of Cedars-Sinai Health System. “Please do not delay getting your health care. We encourage you to call a trusted health care provider like your doctor’s office, hospital or urgent care center.”

Doctors raise alarm about health effects of continued coronavirus shutdown: ‘Mass casualty incident’

Furthermore, Tyler Olson reported something that most of us physicians realized as this pandemic continued that and that more than 600 doctors signed onto a letter sent to President Trump Tuesday pushing him to end the “national shutdown” aimed at slowing the spread of the coronavirus, calling the widespread state orders keeping businesses closed and kids home from school a “mass casualty incident” with “exponentially growing health consequences.”

The letter what I stated in the beginning of this post, which outlines a variety of consequences that the doctors have observed resulting from the coronavirus shutdowns, including patients missing routine checkups that could detect things like heart problems or cancer, increases in substance and alcohol abuse, and increases in financial instability that could lead to “poverty and financial uncertainty,” which “is closely linked to poor health.”

“We are alarmed at what appears to be the lack of consideration for the future health of our patients,” the doctors say in their letter. “The downstream health effects … are being massively under-estimated and under-reported. This is an order of magnitude error.”

The letter continues: “The millions of casualties of a continued shutdown will be hiding in plain sight, but they will be called alcoholism, homelessness, suicide, heart attack, stroke, or kidney failure. In youths it will be called financial instability, unemployment, despair, drug addiction, unplanned pregnancies, poverty, and abuse.

“Because the harm is diffuse, there are those who hold that it does not exist. We, the undersigned, know otherwise.”

The letter comes as the battle over when and how to lift coronavirus restrictions continues to rage on cable television, in the courts, in protests and among government officials. Those for lifting the restrictions have warned about the economic consequences of keeping the shutdowns in effect. Those advocating a more cautious approach say that having more people out and about will necessarily end with more people becoming infected, causing what National Institute of Allergy and Infectious Diseases Director Dr. Anthony Fauci warned in a Senate hearing last week would be preventable “suffering and death.”

But these doctors point to others that are suffering, not from the economy or the virus, but simply from not being able to leave home. The doctors’ letter lists a handful of patients by their initials and details their experiences.

“Patient E.S. is a mother with two children whose office job was reduced to part-time and whose husband was furloughed,” the letter reads. “The father is drinking more, the mother is depressed and not managing her diabetes well, and the children are barely doing any schoolwork.”

“Patient A.F. has chronic but previously stable health conditions,” it continues. “Her elective hip replacement was delayed, which caused her to become nearly sedentary, resulting in a pulmonary embolism in April.”

 Dr. Mark McDonald, a psychiatrist, noted in a conversation with Fox News that a 31-year-old patient of his with a history of depression who was attending school to get a master’s degree in psychology died about two weeks ago of a fentanyl overdose. He blames the government-imposed shutdown.

“She had to stay in her apartment, essentially in-house arrest as most people here in [Los Angeles] were for weeks and weeks, she could not see her therapist — she could speak to the therapist over the phone but she couldn’t see her in person. She could not attend any of her group meetings, which were helping to maintain her abstinence from opiates … and she relapsed into depression.

“She was just too withdrawn to ask for help,” McDonald continued before noting that due to regulations only six people could be at her funeral. “She was simply trying to escape from her pain… I do blame these actions by the government for her death.”

Fox News asked McDonald, as well as three other doctors who were involved with the letter, if they thought the indirect effects of the shutdowns outweighed the likely direct consequences of lifting them — the preventable “suffering and death” Fauci referred to in last week’s Senate hearing. All four said that they believe they do.

“The very initial argument … which sounded reasonable three months ago, is that in order to limit the overwhelmed patient flux into hospitals that would prevent adequate care, we needed to spread out the infections and thus the deaths in specific locales that could become hotspots, particularly New York City… It was a valid argument at the beginning based on the models that were given,” McDonald said. “What we’ve seen now over the last three months is that no city — none, zero — outside of New York has even been significantly stressed.”

McDonald is referring to the misconception that business closures and stay-at-home orders aimed at “flattening the curve” are meant to reduce the total number of people who will fall ill because of the coronavirus. Rather, these curve-flattening measures are meant largely to reduce the number of people who are sick at any given time, thus avoiding a surge in cases that overwhelms the health care system and causes otherwise preventable deaths because not all patients are able to access lifesaving critical care.

McDonald said that “hospitals are not only not overwhelmed, they’re actually being shut down.” He noted that at one hospital in the Los Angeles area where Dr. Simone Gold, the head organizer of the letter, works “the technicians in the ER have been cut by 50 percent.”

Gold also said the effects of the shutdown are more serious for the vast majority of people than the potential virus spread if it is quickly lifted.

“When you look at the data of the deaths and the critically ill, they are patients who were very sick to begin with,” she said, “There’s always exceptions. … But when you look at the pure numbers, it’s overwhelmingly patients who are in nursing homes and patients with serious underlying conditions. Meaning, that that’s where our resources should be spent. I think it’s terribly unethical… part of the reason why we let [the virus] fly through the nursing homes is because we’re diverting resources across society at large. We have limited resources we should put them where it’s killed people.”

People of all ages, of course, have been shown to be able to catch the coronavirus. And there have been reported health complications in children that could potentially be linked to the disease. Fauci also warned about assuming that children are largely protected from the effects of the virus.

“We don’t know everything about this virus … especially when it comes to children,” Fauci said in a Senate hearing last week. “We ought to be careful and not cavalier.”

Newport Beach, Calif., concierge doctor Dr. Jeffrey Barke, who led the letter effort with Gold, also put an emphasis on the disparity in who the virus effects.

“There are thousands of us out there that don’t agree with the perspective of Dr. Fauci and [White House coronavirus response coordinator] Dr. Deborah Birx that believe, yes, this virus is deadly, it’s dangerous, and it’s contagious, but only to a select group of Americans,” he said. “The path forward is to allow the young and healthy, the so-called herd, to be exposed and to develop a degree of antibodies that both now is protective to them and also prevents the virus from spreading to the most vulnerable.”

Dr. Scott Barbour, an orthopedic surgeon in Atlanta, reflected the comments the other doctors made about how the medical system has been able to handle the coronavirus without being overwhelmed, but also noted that the reported mortality rates from the coronavirus might be off.

“The vast majority of the people that contract this disease are asymptomatic or so minimally symptomatic that they’re not even aware that they’re sick. And so the denominator in our calculation of mortality rate is far greater than we think,” he said. “The risk of dying from COVID is relatively small when we consider these facts.”

Gold, an emergency medicine specialist based in Los Angeles, led the letter on behalf of a new organization called A Doctor a Day.

A Doctor a Day has not yet formally launched but sent the letter, with hundreds of signatures from physicians nationwide, to the White House on Tuesday. Gold and the group’s co-founder, Barke, said they began the organization to advocate for patients against the government-imposed coronavirus shutdowns by elevating the voices of doctors who felt that the negative externalities of the shutdowns outweigh the potential downside of letting people resume their normal business.

To gather signatures for the letter, Gold and Barke partnered with the Association of American Physicians and Surgeons (AAPS), a doctors’ group that advocates for less government interference in the relationship between doctors and patients, and notably has taken part in legal challenges against the Affordable Care Act and advocated to allow doctors to use hydroxychloroquine on themselves and their patients.

Gold, in a conversation with Fox News, lamented that the debate around hydroxychloroquine has become politicized, noting that it is taken as a preventative measure for other diseases and that the potentially harmful effects of the drug mainly affect people with heart issues.

The drug is approved to treat malaria, lupus and rheumatoid arthritis, but the Food and Drug Administration has said that “hydroxychloroquine and chloroquine have not been shown to be safe and effective for treating or preventing COVID-19.”

The FDA has also warned health professionals that the drug should not be used to treat COVID-19 outside of hospital or research settings.

Gold said she has direct knowledge of physicians who are taking hydroxychloroquine and said that although “we will see” about its efficacy as it is studied more, there have been some indicators that it could be effective at preventing or mitigating COVID-19 and she could therefore understand why doctors might take the drug themselves or prescribe it to their patients.

There is also other research that appears to indicate hydroxychloroquine is not an effective treatment for the coronavirus, which has largely informed the consensus that the risks of the drug outweigh the potential benefits.

Gold, who is a member of the national leadership council for the Save Our Country Coalition — an assortment of conservative groups that aim “to bring about a quick, safe and responsible reopening of US society” — also said she was concerned that her message about the harms of shutdowns is becoming politicized. She said that she agreed with the general principles of the coalition and decided to sign on when asked, but hasn’t done much work with it and is considering asking to have her name removed because people are largely associating her message on reopening the country with a conservative political point of view.

“I haven’t done anything other than that,” she said. “It’s causing a big misunderstanding about what I’m doing so I actually think I’m just going to take my name off because it’s not really supposed to be political.”

Gold also said she is not associated with the Trump reelection campaign in any way, referring to her inclusion in an Associated Press story about the Trump campaign’s efforts to recruit doctors to support the president’s message on lifting coronavirus restrictions. The AP story details a call organized CNP Action, also part of the Save Our Country Coalition, which involved a senior Trump campaign staffer and was aimed at recruiting “extremely pro-Trump” doctors to make television appearances calling for the reopening of the economy as quickly as possible.

Fauci says extended stay-home orders could cause ‘irreparable damage’

Just recently Dr. Fauci changed his view on stay-home orders. Dom Calicchio reported that stay-home orders that extend too long could cause the U.S. “irreparable damage,” Dr. Anthony Fauci finally warned Friday.

Strict crackdowns on large gatherings and other orders, such as for home quarantines, were needed when the coronavirus first hit the nation, but those rules can now begin to be lifted in many parts of the country, Fauci said during an interview on CNBC.

“I don’t want people to think that any of us feel that staying locked down for a prolonged period of time is the way to go,” the member of the White House coronavirus task force said.

“But now is the time, depending upon where you are and what your situation is, to begin to seriously look at reopening the economy, reopening the country to try to get back to some degree of normal.” He warned, however, against reckless reopenings and called for the use of “very significant precautions” as restrictions are lifted.

Fauci told CNBC that staying closed for too long could cause “irreparable damage.” He said the US had to institute severe measures because #Covid19 cases were exploding “But now is the time, depending upon where you are and what your situation is” to open.

“In general, I think most of the country is doing it in a prudent way,” he said. “There are obviously some situations where people might be jumping over that. I just say, ‘Please, proceed with caution if you’re going to do that.’”

Fauci’s comments came one day after two top Republicans – Sen. Rand Paul of Kentucky and Rep. Andy Biggs of Arizona – wrote in an op-ed that Fauci’s initial safety recommendations had “emasculated” the nation’s health care system and “ruined” its economy.

“Fauci and company have relied on models that were later found to be deficient. He even has suggested that he can’t rely, on any of the models, especially if the underlying assumptions are wrong,” the pair wrote in USA Today. “Yet, Fauci persists in advocating policies that have emasculated the medical care system and ruined the economy.”

They also pointed to Fauci’s testimony last week before a Senate committee that opening too soon would “result in needless suffering and death.”

“What about the countless stories of needless suffering and death produced by Fauci’s one-size-fits-all approach to public health?” Paul and Biggs asked.

They called for policies based on trusting the risk assessment of the American people rather than a federal government mandate.

Earlier Friday, Fauci said it was “conceivable” that the U.S. could begin to distribute a coronavirus vaccine by December. “Back in January of this year when we started the phase 1 trial, I said it would likely be between a year and 18 months before we would have a vaccine,” Fauci said during an interview on NPR. “I think that schedule is still intact.

“I think it is conceivable,” he continued, “if we don’t run into things that are, as they say, unanticipated setbacks, that we could have a vaccine that we could be beginning to deploy at the end of this calendar year, December 2020, or into January, 2021.”

My question is what does the future of medicine look like going forward from this pandemic and how do we plan for a better healthcare system and assist in the recovery of our economy?

More on that in future posts.

Telehealth use, Coverage by Insurers Soaring in Response to COVID-19; COVID Testing, Contact Tracing and How to Reopen the US and Pandemic Resilience?

Dr. Sarah-Anne Schumann, UnitedHealthcare’s chief medical officer for employer and individual health care plans in North Texas and Oklahoma, says telehealth visits are soaring.

The growth of telemedicine is apparent at UnitedHealthcare’s sister company, Optum, which went from 1,000 telemedicine-trained care providers to 5,000 in a matter of weeks. That number is expected to grow to 10,000 providers by the end of April.

In the interview that follows, Schumann, who is a family doctor in addition to her role with UnitedHealthcare, gives us a look at the growth of telemedicine during the coronavirus from the viewpoint of both the insurer and the physician.

How has the acceptance and reliance on telehealth grown given the COVID-19 pandemic?

Telehealth has been around for a long time, and basically what telehealth does is it allows people to see a doctor anywhere and anytime on a mobile device or computer. It’s available 24 hours a day, seven days a week. People can get their medical conditions diagnosed and treated that way. With the coronavirus, now that there’s a lot of risk with going into a doctor’s office — a risk of you exposing other people or you being exposed to coronavirus — more and more doctors’ practices have very quickly scaled up their technology to allow their doctors to provide telehealth.

Can you quantify the growth?

I have some statistics. Seventy-six percent of hospitals can connect patients and care providers using digital and other technology. On the employer side, nearly nine out of 10 employers offer telemedicine to their employees.

When did UnitedHealthcare start allowing for telehealth visits?

We did allow for telehealth before COVID, but our policies have changed. We have much broader coverage since COVID. Our policy now is we are covering telehealth with no cost-sharing at all. That started on March 31. As of now through June 18, we are waiving all cost-sharing for in-network health visits for our Medicaid, Medicare Advantage and our fully insured individual and group health plans. For self-funded employers, they can opt in to telehealth with no cost-sharing.

That’s not just for COVID-related visits, but for absolutely any telehealth visits. It’s not just primary care and urgent care, but also for outpatient behavioral health and physical therapy, occupational therapy and speech therapy.

Did UnitedHealthcare broaden the coverage because of the COVID-19 pandemic?

Yes. Some primary care offices are closed right now both for safety and because there’s decreased volume for a lot of the businesses. This is a very safe way to get people assessed when they’re feeling sick but not sick enough to go to an emergency room.

It’s my understanding that insurance won’t pay the same for a telehealth visit vs. an in-person doctor visit. Is that true with UnitedHealthcare?

They are covered at a different rate, but there are many ongoing conversations. Right now, with COVID, for the doctors’ practices that have moved over to provide telehealth, they are being reimbursed at the same rate as an in-person visit. Another change, because the doctor’s offices had to pivot so quickly to start offering this, right now, there can even be phone-only visits that are covered.

Typically, do you Facetime or how do the providers get the visuals from the patient?

If you have a smartphone, which most people have, or a tablet or computer, that’s usually how it works. But right now, you can do phone-only visits.

How does a patient find out if their existing doctor is signed up and licensed to practice telemedicine?

Call the practice or go on their website. It’s best to try your own doctor first, but if that doesn’t work, try your (insurance company’s) website and it will connect you with a national provider.

What should employers know about telehealth?

Telehealth, of course, is not for everything. But for simple, urgent medical issues like allergy symptoms or pink-eye or rashes or fever, telehealth is a great way for their employees to access care. It reduces the burden on the health care system and it reduces cost and improves accessibility to care. Another thing for employers to think about is, right now while people are at home, there’s a lot of increased stress and anxiety, and virtual visits can be a way to connect with a therapist or psychologist or psychiatrist.

Do you think the COVID-19 pandemic will cause permanent changes in how people access health care?

A lot of the changes that we are experiencing in society because of the pandemic are going to be permanent changes. Things like people working from home. Some people are more productive when they’re working from home. It’s the same thing with telemedicine. Now that people are introduced to this, I think in the cases where telemedicine is a good substitute, waiting to see the doctor for urgent-care type visits where you don’t need to have a blood test done or get IV medication or things like that, people are going to see that telemedicine is a great substitute.

How to reopen the US, according to Johns Hopkins and Harvard: Test 20 million people a day, hire an army of contact tracers, and expand healthcare coverage

Hilary Bruek reported that experts from Harvard and Johns Hopkins, as well as the former FDA commissioner, have each released their plans for how to reopen the country safely.

The plans suggest the US will need to massively ramp-up its disease testing and tracing capabilities to allow people to return to work and school. 

Collectively, the reports suggest the US will need: around 5 million tests a day by July, 100,000 public health workers to contact trace, and a “national infectious disease forecasting center.” 

Most Americans are still stuck at home, but a trio of reports, out from Harvard, Johns Hopkins, and former US Food and Drug Administration Commissioner Scott Gottlieb, are starting to lay a foundation for what reopening the country might look like, if done safely.

Though staying inside is certainly keeping more infections at bay right now, it’s not without its costs.

Aside from the strain stay-at-home orders are putting on families, friends and communities, the newfound national quiet means the US is “hemorrhaging $100 billion to $350 billion a month,” according to the new Harvard analysis, which was released on Monday.

A hasty, careless reopening would be a deadly disaster, though.

If everyone rushed back into the streets, hugging, kissing, shaking hands, and entirely abandoning social distancing measures, more than 300,000 people nationwide could die, according to federal documents from the Department of Health and Human Services, first released in a report from the Center for Public Integrity on Tuesday.

That’s why any thoughtful plan to reopen the country must involve massive additional investments in public health, especially the testing and tracing of US coronavirus cases.

Here are the key topline suggestions from the experts for not only emerging from the coronavirus crisis successfully and safely, but also, as the Harvard report put it, becoming a “pandemic resilient” nation.

Harvard’s Roadmap to Pandemic Resilience says more testing is fundamental to recovery 

Broadly, the Harvard report suggests the task ahead of us is “bigger than most people realize.”

“We need to massively scale-up testing, contact tracing, isolation, and quarantine—together with providing the resources to make these possible for all individuals,” the authors write. 

Here’s how:

In the coming months, the US should rapidly ramp up its capacity to test for the coronavirus, eventually testing upwards of 2 to 6% of the population on any given day. (Currently, the US tests around 150,000 people per day, or about 0.04% of the population.) The plan starts with: 5 million tests per day by early June, and continues trending upward towards 20 million tests a day nationwide, by late July. That kind of widespread testing would be on a scale larger than Germany (testing 0.06% of the country per day, with more than 50,000 coronavirus tests), and would even surpass South Korea, which so far has tested more than 1.1% of the country, overall, for COVID-19.

But “even this number may not be high enough to protect public health,” the report authors warn.

“Given that 40% of the economy is already open,” the report says, “our first priority for a massively scaled up pandemic testing program should be to stabilize the essential workforce.” Policy makers should listen to worker voices, the report also said, “because workers have expert knowledge about how to make their jobs safe and when safety-related rules are not being followed.” 

Tests will eventually also be needed for others, including:

  1. Everyone with coronavirus symptoms, and their close contacts.
  2. People with presumed exposure (healthcare workers, essential workers, etc.)
  3. Nursing home residents and staff.
  4. Incarcerated people.
  5. Companies and schools.
  6. Those who have tested negative within a very recent window and those who show immunity in reliable antibody tests (assuming these prove feasible) should be free to return to work,” the report said.
  7. The authors were cautious about the idea of immunity cards or passports, though. “Certificates of immunity should be used only in contexts where people have equal access to testing and where a recent negative test result provides the same access to mobility as immunity,” the report says. “Any other use of immunity certificates would be likely to violate constitutional equal protection requirements.” 
  8. In order to be able to follow 14-day quarantine orders successfully, people will need to be supported with more job protection and healthcare, the report added.
  9. The cost of testing and tracing at this scale is an estimated $50 – 300 billion over two years, which, the authors write is still far cheaper than “the economic cost of continued collective quarantine,” at $100 to 350 billion a month. 
  10. Pandemic Testing Board should also be established by the federal government, the report suggests, with a National Director of Testing Supply appointed to help ramp up testing efforts. “In virtually every successful historical example of such rapid coordination, a central authority has set goals and ensured that each part of the chain meets the interlocking goals required for the chain to succeed,” the report authors add.  

There’s just one problem, though: the Harvard approach relies on all coronavirus tests being accurate, but some are not

Claudio Furlan/LaPresse noted that the swab-the-nose-and-throat coronavirus testing delivers about 30% false negatives, which means that roughly 3 in 10 people who have the virus could wrongly assume they don’t after they’re tested, and then could go on to infect others at work or at school.

Coronavirus blood tests, which are meant to determine whether a person has been infected in the past with the coronavirus and developed disease-fighting antibodies, have so far performed much worse than the swab tests, with some operating at just 30% accuracy, the New York Times recently reported.

Johns Hopkins’ ‘National Plan to Enable Comprehensive COVID-19 Case Finding and Contact Tracing in the US’ adds an army of contact tracers to the Harvard testing plan

The goal of deploying thousands of contact tracers across the US, the report authors write, is to “find every COVID-19 case in the midst of a national epidemic … and then work quickly to contain spread through intensive case and contact tracing interventions,” by warning others who might’ve been exposed to those sick people to stay home.

“This entire operation has never been done before,” New York Governor Andrew Cuomo said Wednesday, as he announced during a news conference that his state would be partnering with Johns Hopkins to roll out a new army of contact tracers in the tri-state area, to the tune of $10 million.

“You’ve never heard the words testing, tracing, isolate before,” Cuomo said. “No one has. We’ve just never done this.”

Here’s how the plan could work, nationwide:

  • Hire “an extra 100,000 contact tracers across the United States,” the report says. “While this figure may be stunning, it is still the equivalent of less than half the number [of contact tracers] employed in Wuhan,” the authors point out. 
  • Contact tracers will need to be trained by existing state and territorial public health departments on: disease transmission, principles of case isolation and quarantine, ethics of public health data collection and use, risk communication, cultural sensitivity, and more. 
  • The plan could provide jobs for: former government employees, retired public health and public safety workers & medical personnel, medical and public health students, Medical Reserve Corps or Peace Corps members, community health workers, and others “seeking employment—especially those who have lost their jobs due to COVID-19.” People with good communication and interviewing skills would be especially well-qualified for the task.
  • The new workforce will cost the US an estimated $3.6 billion, and the report authors urge Congress to fund this idea in its fourth stimulus package.
  • The cost of not tracing is also high: “It is estimated that each infected person can, on average, infect two to three others,” the authors write. “This means that if one person spreads the virus to three others, that first positive case can turn into more than 59,000 cases in 10 rounds of infections.” 

Apple and Google have also released their own plans to make contact tracing and surveillance happen more automatically on our phones

Apple and Google are both working on new apps and other press-of-a-button opt-in functionalities for phones that would harness Bluetooth technology to track where we’ve been, and then warn others who’ve been near us, in the event we get sick with the coronavirus, in a new brand of push notification-friendly contact tracing.

The companies promise that “user privacy and security” will be paramount in any forthcoming app design.

Other countries have already tried out similar Bluetooth-reliant tracing techniques, but they’re not always very successful, as you need a large percentage of the population to use them in order to have any major impact on transmission. 

Scott Gottlieb’s ‘Road Map to Reopening’ from the American Enterprise Institute adds in the element of a weather forecasting service for pandemics 

James Gathany reviewed that Scott Gottlieb reviewed the “Road Map to Reopening” from the American Institute and reported that Gottlieb calls it a “National Infectious Disease Forecasting Center,” and says “this permanent federal institution would function similarly to the National Weather Service, providing a centralized capability for both producing models and undertaking investigations to improve methods used to advance basic science, data science, and visualization capabilities.” 

Gottlieb also cautioned that we should not rush to return the US to business-as-usual, even as some restrictions are lifted. As schools and businesses reopen, “teleworking should continue where convenient” he said, and “social gatherings should continue to be limited to fewer than 50 people wherever possible.”

‘It’s going to be brutal,’ billionaire Mark Cuban says of economy’s recovery from coronavirus, and ‘there’s no way to sugarcoat it’

‘It’s going to be brutal. There’s no way to sugarcoat it at all.’

That is outspoken billionaire and Dallas Mavericks owner Mark Cuban, who has been increasingly visible as the National Basketball Association has been temporarily suspended due to the deadly COVID-19 pandemic.

Reporter DeCambre reviewed an interview with Mark Cuban with Maria Bartiromo. Cuban, speaking with Fox Business anchor Maria Bartiromo, explained why he thought the recovery from the economic fallout wrought by the illness caused by a novel coronavirus strain could be a long and ugly one for the average American and small businesses in particular.

“It’s going to be brutal. There’s no way to sugarcoat it at all. And when we get to the other side, companies are going to be operating differently,” Cuban said on the business network.

The entrepreneur, who boasts a net worth of $4.3 billion, according to Forbes, says that challenges for businesses are manifold and include additional costs that will be incurred to sanitize and retrofit spaces as nearly shutdown economies attempt to reboot after a virus-imposed hibernation.

“Companies are going to have to be agile … Companies are going to have to build from the bottom up,” Cuban said.

The “Shark Tank” star said he remains confident that some normalcy will return in two to three years but predicts that investors and business owners will need to endure some pain to get to the other side.

His comments came as Robert Redfield, director of the Centers for Disease Control and Prevention, was quoted in the Washington Post as saying in an interview published on Tuesday that “there’s a possibility that the assault of the virus on our nation next winter will actually be even more difficult than the one we just went through.”

The deadly contagion that was first identified late last year in Wuhan, China, has, infected more than 2.6 million people globally and killed about 179,000, according to data aggregated by Johns Hopkins University, as of Wednesday morning.

On Thursday, investors and others will be watching for a House vote on a nearly $500 billion aid package for small businesses amid the coronavirus pandemic, after the Senate passed the measure on Tuesday.

The passage of the bill and the possibility of restarting stalled economies may be conferring some optimism on markets, with the Dow Jones Industrial Average DJIA, +1.10%, the S&P 500 SPX, +1.39% and the Nasdaq Composite Index COMP, +1.64% all closing sharply higher Wednesday.

That said, Cuban believes that small businesses may require at least a third installment of funds to operate through the crisis, and he is looking to invest in companies that sit outside the criteria for obtaining government-backed loans.

“We haven’t talked about those companies that are 501 and up. They are suffering the most,” he said, referring to language that stipulates that businesses need to have 500 or fewer employees to qualify for the small-business recovery funding. 

So, when do we really reopen the economy and back to the “new” normal and do we use scientific data? I think as we can see we need data based on more testing, but the testing has to be accurate and more sensitive and then we need comprehensive contact tracing and case follow-up tracing. Also, what technology will we use for contact tracing and could it be the use of APPS on our phones or other home health and fitness wearables or other real time monitors?

This technology needs to integrate multiple longitudinal electronic medical records across all sources including healthcare providers and healthcare facilities, labs, clinics, pharmacies, long-term care facilities, etc. with nationwide coverage and interoperability and more important it needs to be HIPPA compliant to respect personal information.

Big wishes and needs, which will lead the way to solutions and attaining our goals of defeating COVID-19 and also prepare the US for whatever the next possible pandemic may raise its ugly head!

Can You Afford To Get Coronavirus? How to Prepare for the Virus andHow The U.S. Healthcare System Is Failing Us

This is a lengthy post but with all the fear regarding COVID-19 I thought that it would be worth the time. I became more aware as we traveled to the West Coast for a half marathon at Napa Valley. There were many people on our planes wearing masks and my wife was so worried about our planned trip to Europe in April.  The cruise companies now our offering  to either give one hundred percent refund or hold the paid fees for 2 years to allow rescheduling of the cruises.  Can you imagine what the Corona Virus scare is doing to economies around the world>

Sarah Midkiff reported that as the deadly coronavirus outbreak approaches pandemic status, the U.S. government remains in the midst of approving legislation for a $7.5 billion emergency spending bill. Meanwhile, coronavirus continues its spread in the U.S. — with 100 confirmed cases and six deaths across 15 states — so the need for these funds is more imperative than ever. The emergency bill will allocate money to the Department of Health and Human Services for vaccine development, protective and medical equipment, and aid for state and local governments affected by an outbreak, according to the Washington Post.

But, what legislators have yet to mention is whether subsidizing treatment or funding low-cost and free clinics will be part of the plan. The bill may address availability of vaccine development, but it does not directly address affordability of testing or treatment, which is of the utmost importance during a pandemic.

A report published by America’s Health Insurance Plans (AHIP) on Thursday stated that the Centers for Disease Control and Prevention (CDC) is currently the only facility equipped to test for COVID-19. The CDC is not billing for testing, but the test itself isn’t the only line item on a possible medical bill. There is the cost of the doctor’s visit; other tests they might run in conjunction with COVID-19, such as standard flu tests; treatment and medication, as well as getting the vaccine when it becomes available. And, medical bills can grow astronomically high if someone requires in-patient care, like an overnight stay in the hospital.

Stories have already begun to emerge of Americans seeking testing only to find that their insurance was insufficient to the tune of thousands of dollars in medical bills. One such example is a man in Florida who faces a $3,270 medical bill after he went through his insurance when he was concerned he might have been exposed to coronavirus. He was confirmed negative for COVID-19 after testing positive for the flu via a standard flu test rather than the more expensive CT scan which has been proven to be the most consistent test in diagnosing coronavirus.

Others have undergone government-mandated treatment and found that, despite the procedure being required, they were the ones left to foot bills that totaled thousands of dollars. Experiences like this make it easy to see why a 2018 national poll conducted by West Institute and NORC at the University of Chicago found that 44% of Americans declined to see a doctor due to cost.

Notably, the U.S. is alone among other developed countries as the only one that doesn’t offer federally mandated paid sick leave. This makes it particularly difficult to follow the CDC’s current advice that people experiencing even mild respiratory symptoms should stay home, other than when getting medical care. Between a lack of mandated paid sick leave and approximately 27 million Americans currently without health insurance, the coronavirus outbreak is at risk of exhausting our already failing public health system.

Even among people with health insurance, 29% are underinsured, according to results from a 2018 Commonwealth’s Fund survey, meaning that even though they technically have an insurance plan, the copays and deductibles make seeking care unaffordable in relation to their income. Cases of the virus could go undetected and untreated simply because Americans cannot afford to be saddled with medical debt or go without pay to take sick leave (or both), thus encouraging a rapid spread of the virus as people attempt to “power through” in spite of symptoms.

And then there are the approximately 11 million undocumented U.S. residents: Many of these people are un- or under-insured, and also have to grapple with the justified fear of coming into contact with federal authorities, therefore preventing them from seeking medical care.

If further evidence is needed that our health care system has been crippled by privatization, government officials are not debating whether or not pharmaceutical companies should be allowed to profit from a vaccine, but are just figuring out by how much. Last week, the Department of Health and Human Service secretary, Alex Azar, would not commit to price controls on a coronavirus vaccine. “We need the private sector to invest… price controls won’t get us there,” said Azar.

House Speaker Nancy Pelosi responded directly to Azar’s comments. “This would be a vaccine that is developed with taxpayer dollars…We think that should be available to everyone—not dependent on ‘Big Pharma,’” she said in a press release on February 27. She described the vaccine as needing to be “affordable,” but what does that even mean? What is affordable to some is not affordable to all. 

Still, a vaccine – affordable or not – is a ways off. In a coronavirus task force briefing with Donald Trump on Monday, experts estimated that it would take a year to a year-and-a-half before a vaccine would be effective and safe for the public, reports CNN. Until then, the economic inequality that runs rampant in America is bound to be reflected in who can afford to survive this epidemic, and who can’t.

US may pay for uninsured coronavirus patients

Washington (AFP) – The US may invoke an emergency law to pay for uninsured patients who get infected with the new coronavirus, a senior health official said Tuesday.

Public health experts have warned that the country’s 27.5 million people who lack health coverage may be reluctant to seek treatment, placing themselves at greater risk and fueling the spread of the disease.

Robert Kadlec, a senior official with the Health and Human Services department told the Senate on Tuesday that talks were underway to declare a disaster under the Stafford Act, which would allow the patients’ costs to be met by the federal government.

Under this law, their health care providers would be reimbursed at 110 percent of the rate for Medicaid, a government insurance program for people with low income, he added.

“We’re in conversations, initial conversations with CMS (Centers for Medicare & Medicaid Services) to understand if that could be utilized in that way and be really impactful,” Kadlec told a Senate committee.

President Donald Trump also touched on the issue as he headed to a briefing on the coronavirus outbreak at the National Institutes of Health in Washington on Tuesday.

“We’re looking at that whole situation. There are many people without insurance,” Trump told reporters.

The number of Americans without health insurance began falling from a high of 46.5 million in 2010 following the passage of Obamacare (the Affordable Care Act).

It climbed again to 27.5 million in 2018, or 8.5 percent of the population, from 25.6 million the year before.

The reasons include policies by Trump’s administration that made it harder to enroll in Medicaid — such as adding requirements to work — or to sign up for insurance under the marketplaces created by Obamacare.

The Republican-held Congress also repealed a penalty on people who lack insurance, which may have led people to voluntarily drop out.

The Centers for Disease Control and Prevention (CDC) has said patients who are advised by their health care providers to stay at home should do so for at least two weeks, but a work culture that emphasizes powering through while sick could compound the problem further.

The US is alone among advanced countries in not offering any federally mandated paid sick leave. While some states have passed their own laws, 25 percent of American workers lacking any whatsoever, according to official data.

Maia Majumder, an epidemiologist at Harvard, told AFP she was particularly concerned by low-wage workers in the service and hospitality sector, who cannot afford to take time off but could act as vectors to transmit the spread of the disease.

The latest coronavirus death rate is 3.4% — higher than earlier figures. Older patients face the highest risk.

The global death rate for the novel coronavirus based on the latest figures is 3.4% — higher than earlier figures of about 2%.

  • In contrast, the seasonal flu kills 0.1% of those infected.
  • A patient’s risk of death from COVID-19 varies depending on age and preexisting health conditions.
  • Though the latest numbers mark an increase in mortality, experts have predicted that the fatality rate of COVID-19 could decrease as the number of confirmed cases rises.

The latest global death rate for the novel coronavirus is 3.4% — higher than earlier figures of about 2%. 

The coronavirus outbreak that originated in Wuhan, China, has killed more than 3,100 people and infected nearly 93,000 as of Tuesday. The virus causes a disease known as COVID-19.

Speaking at a media briefing, the World Health Organization’s director-general, Tedros Adhanom Ghebreyesus, noted that the death rate was far higher than that of the seasonal flu, which kills about 0.1% of those infected.

The death rate is likely to change further as more cases are confirmed, though experts predict that the percentage of deaths will decrease in the longer term since milder cases of COVID-19 are probably going undiagnosed.

“There’s another whole cohort that is either asymptomatic or minimally symptomatic,” Anthony Fauci, the director of the US National Institute of Allergy and Infectious Diseases, said at a briefing last month. “We’re going to see a diminution in the overall death rate.”

‘It is a unique virus with unique characteristics’

Tedros noted differences between the novel coronavirus and other infectious diseases like MERS, SARS, and influenza. He said the data suggested that COVID-19 did not transmit as efficiently as the flu, which can be transmitted widely by people who are infected but not yet showing symptoms. 

He added, however, that COVID-19 caused a “more severe disease” than the seasonal flu and explained that while people around the world may have built up an immunity to the flu over time, the newness of the COVID-19 meant no one yet had immunity and more people were susceptible to infection. 

“It is a unique virus with unique characteristics,” he said. 

Tedros said last week that the mortality rate of the disease could differ too based on the place where a patient receives a diagnosis and is treated. He added that people with mild cases of the disease recovered in about two weeks but severe cases may take three to six weeks to recover.

Older patients face the highest risk 

A patient’s risk of dying from COVID-19 varies based on several factors, including where they are treated, their age, and any preexisting health conditions.

COVID-19 cases have been reported in at least 76 countries, with a vast majority in China. 

A study conducted last month from the Chinese Center for Disease Control and Prevention showed that the virus most seriously affected older people with preexisting health problems. The data suggests a person’s chances of dying from the disease increase with age.

Notably, the research showed that patients ages 10 to 19 had the same chance of dying from COVID-19 as patients in their 20s and 30s, but the disease appeared to be much more fatal in people ages 50 and over. 

About 80% of COVID-19 cases are mild, the research showed, and experts think many mild cases haven’t been reported because some people aren’t going to the doctor or hospitals for treatment. 

CDC reports 108 cases of coronavirus, including presumed infections; 4 more deaths

The Centers for Disease Control and Prevention (CDC) on Tuesday confirmed 17 new cases of the coronavirus and four more deaths due to the outbreak, bringing the total number of U.S. cases to 108, including among repatriated citizens.

Coronavirus is making some Republicans reconsider the merits of free health care

Tim O’Donnell reported that the Coronavirus has a lot of people re-thinking things. That apparently includes Republicans and government-funded health care.

With the possibility of an outbreak of the respiratory virus in the United States looming, the government is still trying to piece together its response. And it sounds like free testing could be on the table. Rep. Ted Yoho (R-Fla.), at least, thinks it’s really the only option. Yoho is normally known for opposing the Affordable Care Act, and certainly doesn’t seem likely to advocate for Medicare-for-All anytime soon. But he’s willing to blur the lines when an unforeseen circumstance like coronavirus comes to town and is even ok if you want call it “socialized medicine.”

Truly stunning to hear some Republicans advocate for free Coronavirus testing and treatment for the uninsured.

Rep. Ted Yoho (R-Fla.), one of the most anti-ACA members:

“You can look at it as socialized medicine, but in the face of an outbreak, a pandemic, what’s your options?”

The Trump administration, meanwhile, is contemplating funding doctors and hospitals so they can care for people who don’t have insurance should they become infected with the virus, a person familiar with the conversation told The Wall Street Journal. Read more at The Wall Street Journal.

The Coronavirus Outbreak Could Finally Make Telemedicine Mainstream in the U.S.

Time’s reporter, Jamie Ducharme noted that for years, telemedicine has been pitched as a way to democratize medicine by driving down costs, increasing access to care and making appointments more efficient. It sounds great—until you look at the data, and find that only about 10% of Americans have actually used telemedicine to make a virtual visit, according to one 2019 survey.

An outbreak of the novel coronavirus COVID-19 could change that. If extreme measures like mass quarantines come to pass, telehealth could finally have its bittersweet moment in the spotlight, potentially generating momentum that proponents hope will continue once life returns to normal.

“Something like having to stay home could springboard telehealth tremendously, because when we get over this—and we will—people will have had that experience, and they’ll be saying, ‘Well, why can’t I do other aspects of my health care that way?’” says Dr. Joe Kvedar, president-elect of the American Telemedicine Association (ATA).

As of March 3, more than 92,000 people worldwide have been sickened by the virus that causes COVID-19, including more than 100 in the U.S. As both numbers trend upward, the U.S. Centers for Disease Control and Prevention (CDC) has warned that increased person-to-person spread in U.S. communities is likely, and that containment measures may become increasingly disruptive to daily life. If the situation reaches the point where public health officials are encouraging or requiring people to stay home, the health care system may have to offer many medical appointments via telehealth services, the CDC’s Dr. Nancy Messonnier said during a Feb. 26 press briefing.

Kvedar says telehealth tools offered by health plans, private companies and pharmacies are ready and waiting for that possibility. There are some limitations to telehealth’s utility for COVID-19 testing—you can’t take a chest x-ray or collect a sample for lab testing remotely, after all—but Kvedar says it could be used for initial symptom assessment and questioning, as well as non-virus-related appointments that couldn’t happen in person due to precautions. If a patient turned up at an emergency room with possible COVID-19 symptoms, doctors could also do initial intake via virtual platforms, while keeping the patient in isolation to minimize spread within the vulnerable health care environment, he says.

Telehealth giants like Amwell and Teladoc are now advertising their availability for coronavirus-related appointments, and Teladoc’s stock prices spiked in late February. XRHealth, a company that makes health-focused virtual reality applications, is this week providing Israel’s Sheba Medical Center with VR headsets that will both allow doctors to monitor COVID-19 patients remotely, and enable quarantined patients to “travel” beyond their rooms using VR, says XRHealth CEO Eran Orr. The company will next week begin working with hospitals to deploy the technology in the U.S., Orr says.

All of these solutions seem logical. But in practice, there’s a “thicket of state laws and regulations that make telemedicine very complex…to implement broadly,” says Dr. Michael Barnett, an assistant professor of health policy and management at the Harvard T.H. Chan School of Public Health. Insurers—especially Medicare—don’t always cover telehealth visits, and, since medical licenses are state-specific, there could be legal issues if a doctor is located in a different state than the patient they’re treating, Barnett says. Drug prescription and privacy laws can also complicate regulation, according to the American Hospital Association.

These regulatory issues, as well as a lack of patient awareness, have kept telehealth from being as widely adopted as it could be, Barnett says. COVID-19 could be “a good use case” for telemedicine, he says, but it will partially depend on lawmakers’ willingness to relax, or at least streamline, regulation.

The wheels are already in motion. On Feb. 28, telehealth groups including the ATA, the Personal Connected Health Alliance and the eHealth Initiative sent a letter to Congressional leaders, urging them to expand access to telehealth and to grant the Department of Health and Human Services the power to let Medicare cover telemedicine appointments during emergency situations. On March 3, Arizona Rep. Ruben Gallego announced he was introducing a bill that would allow Medicaid to cover all COVID-19-related charges, including virtual appointments.

That’s a good step, but Julia Adler-Milstein, director of the University of California, San Francisco’s Center for Clinical Informatics and Improvement Research, says there are still logistical challenges.

She says larger health systems that have invested heavily in telehealth, like Kaiser Permanente, have seen benefits from it, but providers with a less built-out infrastructure will have to grapple in real-time with questions like, “How do we know which patients are well-suited to telehealth?” and “How do we get their information into the doctor’s hands?” These issues are especially salient for patients with complex medical histories, who may have choose between seeing their regular doctor in person, potentially risking infection, or seeing a doctor virtually who does not have access to their medical records, she says.

Kvedar acknowledges that widespread adoption of telehealth during the COVID-19 outbreak may require some goodwill on the part of companies and doctors. Companies like CVS and Walgreens could waive fees for the use of their telemedicine services during the crisis, Kvedar suggests, or doctors could offer to see patients virtually for free for a few hours a week. “People pull together for all sorts of things,” he says.

Barnett is less optimistic that providers can seamlessly overcome regulations, but says patients and doctors will find a way through the outbreak with or without telemedicine, even if it means conducting many appointments over the old-fashioned telephone. “We have more pressing needs in this epidemic,” he says, “than telehealth availability.”

15 Italian tourists test positive for Covid-19, India springs into battle mode

Niharika Sharma reported that fifteen Italian tourists in India have been reportedly tested positive for the dreaded coronavirus, perhaps finally bringing home the full scale of the seriousness of the global health crisis to the country.

This is besides the six others who have been diagnosed with Covid-19 across the country, prompting India to take massive preventive measures.

The Italian tourists have been quarantined at a camp of the paramilitary, Indo-Tibetan Police Force, media reports said.

Fear and anxiety gripped India’s national capital region (NCR) after a 45-year-old man was diagnosed with the novel coronavirus infection in the city yesterday (March 3). This prompted authorities to step up the vigil.

Over 40 people in Delhi NCR, who came in contact with the patient, are under surveillance. Another 13 people have been screened in Uttar Pradesh’s Agra where he visited his family.

The man who self-reported at Delhi’s Ram Manohar Lohia Hospital had organised his son’s birthday party at Hyatt Regency on Feb. 28. The five-star hotel has asked staffers, who were on duty that day, to stay at home. “The hotel has also started to conduct daily temperature checks for all colleagues and contractors when they enter and exit the building,” the hotel said in a statement yesterday (March 3).

The school in Noida where the infected man’s son attended classes has been shut for the rest of the week, and five students are being screened.

Besides the Delhi man, an Italian tourist, and a person in Hyderabad, who travelled from Dubai to Bengaluru on Feb. 20 on an IndiGo flight, have also tested positive for the virus. ”We’re following all prescribed Airport Health Organisation guidelines,” IndiGo said in a statement yesterday. The airline has asked its four cabin crew who were on the aircraft to stay at home.

On guard

Authorities appear to be working overtime to track the footprints of all the patients and screen everyone who came in contact with them. “Our officers even visit the homes individually, taking necessary precautions, to check listed people for symptoms,” an official of the Integrated Disease Surveillance Programme (IDSP) under the health ministry told Hindustan Times on condition of anonymity. “For asymptomatic people, home quarantine for a stipulated period of time is good enough, but those who develop symptoms are moved to a hospital as per protocol.”

But the process could be tedious as the 69-year-old Italian tourist, who was tested positive in Jaipur on March 3,had travelled to six districts in India before arriving at Rajasthan. He and his wife, who has also tested positive, were part of a 21-member group, which landed in Delhi on Feb. 21. The rest of the group is in Agra, according to a Hindustan Times report.

The health ministry has now issued a travel advisory, suspending all regular visas/e-visas granted on or before March 3 to nationals of Italy, Iran, South Korea, and Japan, who have not yet entered India. The advisory also suspends visa on arrival issued until March 3 to Japanese and South Korean nationals who have not yet entered India.

The government has also made it mandatory for passengers entering India from other countries affected by coronavirus to fill forms with personal details and travel history to the health and immigration officials at 21 airports across the country and 12 major and 65 minor seaports.

Aviation watchdog Directorate General of Civil Aviation has also asked carriers to ensure that adequate protective gears like surgical masks and gloves are available in flight for passengers.

In Delhi, the Kejriwal government has reserved 230 beds in isolation wards at 25 hospitals and also sent advisories to schools mentioning precautions to tackle the situation.

On March 3, the information ministry asked all private radio and TV channels to give “adequate publicity” to the travel advisory issued by the health ministry in the wake of the coronavirus outbreak.

The health ministry has also launched a series of TV commercials as part of its awareness program against the outbreak.

Here’s what you must keep in mind:

In addition, the Narendra Modi government has asked the army, the navy and the air force to prepared quarantine facilities for over 2,500 in coming days, as per the sources quoted by various media reports.

Preventive measures

Several events, where foreign delegates were expected to participate, have been cancelled or postponed.

The Indian Navy called off a multilateral naval exercise that was scheduled from March 18 in Visakhapatnam due to coronavirus. Around 30 countries were expected to take part in the event.

On March 3, Chinese smartphone maker Xiaomi said it is cancelling all upcoming on-ground launch events in India to reduce exposure risk in the wake of Covid-19.

Italy could have more than 100,000 coronavirus cases, expert warns

Reporter Will Taylor of the Yahoo News noted that Italy could have more than 100,000 cases of coronavirus, an expert has revealed.

Professor Neil Ferguson, of Imperial College London’s faculty of medicine, said he estimates there are “at least” 50,000 to 100,000 cases of the virus in the country, which is one of the worst affected by the virus.

Italy has 2,500 confirmed cases and has suffered 79 deaths.

Prof Ferguson told the BBC’s Today programme that he expects to see measures to tackle the virus rolled out in a matter of days.

“[Italy has] I think it’s over 50 deaths now,” he said, “so those people were probably infected three weeks ago, and for every person who dies we think there might be 100, maybe even 200 people infected.

“The lethality of this virus is not completely determined but it’s in that order… so the epidemic is probably doubling every week or so in Italy, so when you put those numbers together, we’d estimate somewhere between 50,000 and 100,000 cases at the moment in Italy.

“At least, it could even be higher, cases may still be being missed even in severe cases.”

He said the UK is “several weeks” behind Italy and is in an earlier stage of an epidemic.

Authorities will be looking to slow the spread of the virus to try to relieve pressure on health systems and the UK government yesterday announced measures to tackle the virus.

Prof Ferguson said screening air passengers is imperfect and pointed out that Spanish flu spread around the world in the days before commercial air travel.

His figures mean the total number of Italy’s cases could outstrip the total number confirmed worldwide. Just over 93,000 have been reported globally as of Wednesday morning.

After mainland China – where the virus originated – South Korea is the next worst hit with 5,328 confirmed cases and 28 deaths.

Iran reports 77 deaths from its 2,300 officially reported cases.

A Coronavirus Guide for Older Adults (And Their Family Advocates)

Jeffrey Kluger noted that it’s hard enough getting old, what with all of the creeping ailments—diabetes, COPD, dementia, heart disease—that come along with age. Now add a novel coronavirus to the mix. There are more than 91,000 COVID-19 cases and 3,100 deaths as of writing, but the virus doesn’t hit all demographics equally hard—and seniors are the most vulnerable.

A late February study in the Journal of the American Medical Association showed that children 10 and under accounted for just 1% of all COVID-19 cases, for example, while adults in the 30-79 age groups represented a whopping 87%. The World Health Organization (WHO) found something similar in China, with 78% of patients falling between the ages of 30 and 69.

The older you get, the likelier you are not only to contract a SARS-CoV-2 infection (the virus that causes COVID-19), but to suffer a severe or fatal case. One study out of China found that the average age of COVID-19 patients who developed acute respiratory distress syndrome—a severe shortness of breath often caused by fluid in the lungs and requiring a ventilator—is 61. As early as January, Chinese health authorities were already reporting that the median age range for people who died of the disease was 75.

“Older people are more likely to be infected, especially older people with underlying lung disease,” says Dr. Teena Chopra, medical director of infection prevention and hospital epidemiology at Wayne State University. “For this population, mortality rates for COVID-19 are about 15%.”

In this sense, COVID-19 behaves a lot like seasonal flu. From 70% to 85% of all flu deaths and 50% to 70% of flu-related hospitalizations occur among people in the 65-plus age group, according to the United States Centers for Disease Control and Prevention (CDC). The 2002-2003 SARS outbreak similarly proved lethal for more than 50% of people over 60 who contracted the disease..

None of this is a surprise of course. With their higher risk of underlying health conditions, older people are already under physical stress, and their immune systems, even if not significantly compromised, simply do not have the same “ability to fight viruses and bacteria,” says Dr. Steven Gambert, professor of medicine and director of geriatrics at the University of Maryland School of Medicine.

What’s more, seniors’ risk of exposure to any pathogen is often higher than that of other adults. There are 48 million seniors overall in the U.S., and while only about 3% of them reside in assisted living facilities, that still factors out to more than 1.4 million already at-risk people living in communal environments in which disease can spread quickly.

“People living in long care facilities have common meetings, they share common rooms,” says Chopra. Common meetings and common rooms can too often mean common pathogens.

In the event of coronavirus infection in a residential facility, Gambert says, those living there should avoid communal rooms and even meals, and, if possible, eat in their own rooms.

Even older people living at home face communal risks, since many of them regularly visit community senior centers, which are great places for socialization and provide a means to stay active and engaged, but can serve as pathogenic petri dishes. Gambert recommends being proactive in these situations, asking the staff of the senior center if they have had any cases of coronavirus, and if so, avoid those facilities.

The health system itself may be playing a significant role in putting seniors at risk. People with multiple medical conditions typically visit multiple specialists, and every such visit means entering a health care environment that can be teeming with viruses and bacteria. For now, Chopra advises older patients to postpone doctor visits that aren’t absolutely essential, like “their annual eye visit. Dental cleaning can be avoided too.” Telemedicine—conducting doctor visits that don’t require hands-on treatment online—can be helpful too, as can e-prescribing, with drugs being delivered straight to patients, sparing them exposure to pharmacies.

Staying current on vaccines—especially flu and pneumonia—can also be critical. Patients—or their family advocates—should ask doctors if they are up to date on their vaccines, or if they need a booster, especially since vaccine formulations change and improve over time. “If you haven’t had a pneumonia vaccine now is the time to get one,” says Gambert. “Even if you have had one in the past, ask your primary care provider if you need a newer one.”

Finally, it’s important to remember that the way COVID-19 presents itself in a younger person is not always the way it presents itself in someone who’s older. “Old people may not get a fever so just checking their temperature may not reveal the infection,” says Gambert.

Instead, he says, families and seniors should be alert for “atypical presentation” of COVID-19. A fall or forgetfulness, for example, might be a sign of infection, even if other, more common symptoms aren’t in evidence. “Any reason you don’t feel the same as you usually do should not be dismissed,” Gambert says.

The coronavirus epidemic is not going away any time soon. That means continued vigilance for our own health and special vigilance for that of seniors. The people who looked after us when we were younger need the favor returned now that they are older.

AOC says that ensuring access to free coronavirus testing and treatment is ‘absolutely’ an ‘argument for Medicare for All’

According to Joseph Zeballos-Roig AOC told the Huffington Post that the government is taking steps to guarantee free coronavirus testing and medical treatment.

“What this crisis has taught us is that, our health care system and our public health are only as strong as the sickest person in this country,” she told the outlet.

Concerns are increasing that the expensive nature of American healthcare could discourage people from seeking medical treatment if they are infected with the coronavirus.

Democratic Rep. Alexandria Ocasio-Cortez  said in an interview published Tuesday that ensuring free coronavirus testing and medical treatment is “absolutely” an “argument for Medicare for All.”

The New York congresswoman told the Huffington Post that if the government took steps to guarantee public access to testing and treatments by paying for it, “then what makes coronavirus different from so many other diseases, particularly ones that are transmissible?”

“What this crisis has taught us is that, our health care system and our public health are only as strong as the sickest person in this country,” she told the outlet.

Medicare for All is the signature plan of Sen. Bernie Sanders, a leading Democratic presidential candidate that Ocasio-Cortez has thrown her support behind. It would provide comprehensive health coverage and do away with deductibles, premiums, and other out-of-pocket spending. Private insurance would be eliminated as well.

As of Wednesday, the coronavirus has infected more than 94,000 people in at least 80 countries beyond China, its point of origin. The death toll from the respiratory disease it causes, COVID-19, has killed more than 3,200 people, mostly in China. There are at least 128 confirmed cases in the US.

Over the last week, concerns have mounted that the skyrocketing costs of healthcare could form a barrier discouraging people from getting tested and receiving treatment for the virus.

Business Insider recently analyzed the medical bill of a Miami resident who tested negative for the coronavirus but still racked up a $1,400 in costs, though he was insured. The majority of it came from an emergency room visit.

The Trump administration announced on Monday it was reviewing what products and services it would cover for coronavirus under Medicare and Medicaid, the two biggest federal health insurance programs.

Vice President Mike Pence said a day later the programs would insure diagnostic testing, making it free for patients. But it was not immediately clear what additional medical care would be paid for by the government.

“People who are subject to cost sharing — they are less likely to use medical care, even if they need it,” John Cogan, a health-law expert at the University of Connecticut, previously told Business Insider.

The White House is also reportedly considering reimbursing hospitals and doctors for treating uninsured coronavirus patients. In 2018, 27.5 million Americans had no health insurance, an increase from 25.2 million the year before.

The Most Common Coronavirus Symptoms to Look Out for, According to Experts Coronavirus symptoms are similar to those associated with the flu. 

Unless you get a lab test, you can’t really distinguish between coronavirus COVID-19 and a typical cold or the flu. Dr. Wesley Long, Houston Methodist Director of Diagnostic Microbiology The severity of coronavirus

symptoms varies from person to person, Dr. Long notes. In more serious cases, the infection may lead to pneumonia, severe acute

respiratory syndrome, kidney failure, and even death, says Dr. Neal Shipley. Those most at risk of severe illness from coronavirus include the very young, the very old, and people with generally weakened or impaired immune systems. It’s difficult to pinpoint how long it takes

for coronavirus symptoms to appear. “The generally accepted window from exposure to onset of symptoms is 2-14 days,” says Dr. Long. To be clear, there’s still a lot that experts don’t know about COVID-19. And, you can only contract it if you’ve come into contact with someone who already has it.

So, rather than cause continual promotion of more fear we should all be prepared using good hand washing, cleaning surfaces with appropriate products, if you are sick seek assistance with your medical physician or nurse practitioner offices regarding the need to be tested, etc. The question looms out there, not if you will become sick with this virus, but when and how you care for yourself!

Stay well!!