POST 243. March 28, 2022. CORONAVIRUS. “…the US Food and Drug Administration is planning to authorize a fourth dose of the Pfizer and Moderna mRNA vaccines for adults over age 50 next week.”…”The decision to make fourth doses available now will bypass independent groups of scientific advisers for both the FDA and CDC, which would normally meet and publicly review the available science and then make recommendations to the agencies.”

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“The Biden administration will be giving elderly Americans a second COVID-19 booster shot, multiple people familiar with the plan told The New York Times.

Those above the age of 50 will be able to get a second booster of either the Pfizer-BioNTech or Moderna vaccines.

However, multiple issues complicate the plan as the administration has to calculate when the next COVID-19 wave could hit the U.S., sources told the Times. The administration will want to get the second booster to the elderly before another wave hits, but not too far before that protection could wane.

Other complications include how to explain the plan to the public and how long the second booster’s protection will remain strong, the Times noted.

White House adviser Anthony Fauci said last week that COVID-19 cases could begin increasing in the coming weeks.

“I would not be surprised if in the next few weeks we see somewhat of either a flattening of our diminution or maybe even an increase,” Fauci said on the ABC News podcast “Start Here.”

However, it is unclear how dangerous this wave could be compared to past increases as the BA.2 variant begins to become the dominant strand in the U.S.” (A)

“Major uncertainties have complicated the decision, including how long the protection from a second booster would last, how to explain the plan to the public and even whether the overall goal is to shield Americans from severe disease or from less serious infections as well, since they could lead to long Covid.

Much depends on when the next wave of Covid infections will hit, and how hard. Should the nation be hit by a virulent surge in the next few months, offering a second booster now for older Americans could arguably save thousands of lives and prevent tens of thousands of hospitalizations.

But if no major wave hits until the fall, extra shots now could turn out to be a questionable intervention that wastes vaccine doses, deepens vaccination fatigue and sows doubt about the government’s strategy. The highly contagious Omicron subvariant BA.2 is helping to drive another surge of coronavirus cases in Europe and is responsible for about a third of new cases in the United States, but health officials have said they do not anticipate a major surge caused by the subvariant.

Federal health officials have hotly debated the way forward, with some strongly in favor of a second booster now and others skeptical. But they have apparently coalesced around a plan to give everyone age 50 and up the option of an additional shot, in case infections surge again before the fall. In the fall, officials say, Americans of all ages, including anyone who gets a booster this spring, should get another shot…

A second booster is at best a stopgap measure. Many experts argue that the existing coronavirus vaccines need to be modified because the virus’s variants are diminishing their power; the question is how to reconfigure them. A surge in the fall is considered highly likely, whether it comes in the form of the Omicron variant, a subvariant like BA.2 or a new lineage entirely.” (B)

“The decision to make fourth doses available now will bypass independent groups of scientific advisers for both the FDA and CDC, which would normally meet and publicly review the available science and then make recommendations to the agencies.

Dr. Eric Topol, a cardiologist who is director of the Scripps Translational Research Institute in California, said the decision was expected next week, ahead of an April 6 meeting of the Vaccines and Related Biological Products Advisory Committee (VRBPAC), a group of independent experts who advise the FDA on its vaccine decisions. Boosters are on the agenda for discussion at that meeting, which will focus on future planning for boosters and variant-specific vaccines.

Topol, who was apprised of the FDA’s plans, said it was his understanding that the change would apply to both the Pfizer/BioNTech and Moderna vaccines.

Topol also said he was in favor of giving Americans the option of fourth doses.

“There are solid data from Israel for age 60+ (the only group reported on to date) for enhanced protection (vs severe illness) out to 3 months compared with 3 doses. It is reasonable to extend that and provide it as an option, since the 3rd dose has pronounced benefit in age 50+,” Topol wrote in an email to CNN.

Topol noted that the FDA’s move legitimizes what many Americans are doing anyway. Anyone who wants a fourth dose can go to a pharmacy and receive one just by saying that they need one because they are immunocompromised.

Others felt there wasn’t yet enough science available to support the decision.

Dr. Eric Rubin, editor in chief of The New England Journal of Medicine who sits on the FDA’s VRBPAC, said he hadn’t yet seen enough data on fourth doses to make a determination about whether they are needed for anyone beyond those who are already recommended to get them — adults who are severely immune deficient.

“The only data that I’ve seen has been for participants followed for just a few weeks. The most important information is going to be how well a fourth dose protects highly vulnerable people against serious disease and death, and I don’t know when that will be available,” Rubin said in an email to CNN. Rubin said the FDA might have access to that data, but he had not seen it yet.” (C)

In order to authorize a fourth shot, the FDA will consider still emerging data that don’t paint a definitive picture about whether an additional dose is necessary for most people. One the one hand, there are troubling signs that the immunity provided by the vaccines is starting to wane, which could make people more vulnerable to COVID-19’s more severe effects…

On the other hand, another small study published in the New England Journal of Medicine among younger health care workers in Isreal showed that adding a fourth dose for people vaccinated and boosted with the Pfizer-BioNTech shot may only have “marginal benefits,” according to the researchers. While the additional dose raised levels of antibodies that can neutralize the virus, including Omicron, slightly, those levels were relatively similar to peak amounts of antibodies people generated after the first booster, or third dose. The study did not focus on elderly people or those with compromised immune systems…

But whether everyone needs an additional vaccine dose, and whether or not we can anticipate getting one every year or every few years, depends on what we want the vaccines to accomplish. The vaccines were not designed to prevent people from getting infected by the virus, but to protect them from getting extremely sick with COVID-19, and to keep them from needing hospitalization and intensive care. Remembering that goal, says Dr. Paul Offit, director of the Vaccine Education Center and professor of pediatrics at Children’s Hospital of Philadelphia, is useful when thinking about whether a fourth dose is necessary for most people.

“We got hung up using the word ‘breakthrough’ in describing mild illness,” he says, referring to the term for any infection occurring among vaccinated and boosted people (most of which were mild or even asymptomatic). “But that’s a win—it meant the vaccine was working for you and protected you from serious illness. We have developed a zero tolerance strategy that we are going to have to get over: the idea that it’s not okay to have mild illness after you’ve been vaccinated.”

If the goal of a COVID-19 vaccine is to protect people from severe disease, Offit says that there is still insufficient data supporting the need for a booster for most healthy adults. “I think we have to accept the notion that this is a three-dose vaccine in certain groups and a two-dose vaccine in others,” Offit says.

Offit, who serves on the FDA vaccine advisory committee of independent experts that reviews data and makes recommendations to the FDA about whether or not a vaccine is safe and effective, says that trying to protect the world’s population from mild disease with continued booster doses isn’t a realistic or practical public health goal. The question becomes one of balancing any marginal benefit in protecting against mild illness against potential side effects, which for the mRNA vaccines include the risk of inflammation of heart tissue. “Everything has costs, including boosting,” he says. “If it doesn’t benefit you in terms of protection against serious illness, then you have to consider the side effects.” (D)

“When the vaccines were first launched in December 2020, emphasis was placed on their ability to protect against COVID-19 infection. But now, with the passage of time and emergence of new variants, many vaccine experts argue this was always an impossibly high standard to maintain, and moving forward, the emphasis should be on their ability to protect against severe disease.

Now, more than a year later, data shows that boosters may shore up the body’s defenses against mild infections — but only temporarily.

“These vaccines continue to demonstrate high protection against hospitalization and severe disease,” Durbin agreed. “Prevention of infection, in my opinion, is not the metric that we should use.”

“We’re going to have to learn to live with mild disease at some point,” said Offit. Frequent boosting “is not a reasonable thing to do, and it’s not something most people will do anyway.”

A better approach, said Durbin, would be to roll out a tweaked vaccine that is a better match against the new omicron variant. Vaccine makers agree, with Pfizer and Moderna both studying new versions of their vaccines they hope will work better and offer more durable protection against current and future variants.

“We can’t have vaccines every five, six months,” said Pfizer CEO Albert Bourla, speaking on CNBC. But until they have new-and-improved boosters ready to go, Pfizer and Moderna executives argue fourth doses will be needed by at least some older Americans soon.

In the United States, vaccination rates have stalled. Roughly a quarter of eligible adults have yet to receive their first vaccine doses, while about half of vaccinated adults have yet to receive their first boosters…

“I do think three doses will be enough for some individuals,” said Goepfert, “but it depends on the new variants that will come next.” (E)

“And this is where the latest COVID-19 booster debate gets complicated. It’s not just about whether another round of shots is needed. It’s whether a booster should be based on the original Wuhan strain of the virus (as our current vaccines are) or on the omicron variant. It also has to do with timing: Are boosters needed right now? Will we need a round of shots in the fall, as suggested by Moderna’s Bancel?

Then there’s the very American question of how it’s all going to get paid for. White House officials say there is only enough COVID-19 funding to allow the immunocompromised and seniors to get a fourth dose unless Congress agrees to provide more pandemic funds. (The Kaiser Family Foundation said Friday that there are only enough doses for 70% of seniors to get a fourth dose at this time.)

“Without more funding, we can’t procure the necessary vaccine supply to support fourth shots for all Americans,” Jeff Zients, the White House’s COVID-19 response coordinator until April 5, said at the same briefing. “Furthermore, if things change and there’s a need for a new vaccine, a new formulation — for example, a variant-specific vaccine — we won’t be able to secure doses for the American people.”

Putting aside the question of federal funding, there are still many unknowns about what the next phase of a pandemic vaccination program could look like in the U.S.

When about 275 health care workers at a medical center in Israel were given a second booster, it only slightly increased their protection against omicron, according to correspondence published March 16 in the New England Journal of Medicine. The workers were immunized with either the Comirnaty or Spikevax booster four months after getting their third shot of the BioNTech/Pfizer vaccine.

“We observed low vaccine efficacy against infections in health care workers, as well as relatively high viral loads suggesting that those who were infected were infectious,” the researchers concluded. “Thus, a fourth vaccination of healthy young health care workers may have only marginal benefits.”

Research like this can help inform pandemic policy makers. It can also raise additional questions, including: Will the current COVID-19 boosters continue to protect people against the BA.2 subvariant if they get a fourth dose now? Will the omicron-specific or pan-SARS-CoV-2 vaccines in development do a better job protecting against the variants that are currently in circulation?

“The problem is the vaccines were developed against the original Wuhan strain,” said Dr. Carlos del Rio, an infectious-disease physician and executive associate dean of the Emory School of Medicine, told MarketWatch last month. “As variants have evolved, we’ve seen a decrease in the efficacy of vaccines. The vaccines stay the same, but the variants are changing. You can start doing a vaccine for specific variants, but then as the virus evolves, there’ll be more variants. More strategically and more important is to develop a pan-coronavirus vaccine.” (F)

“There’s a 1 in 5 chance that there will be a dangerous new coronavirus variant in the near future, Moderna CEO Stephane Bancel told Bloomberg Thursday.

Driving the news: Bancel said that the new variant would be considerably more troublesome than the current versions of the coronavirus.

Why it matters: According to Bancel, this would require vulnerable populations to receive another round of coronavirus vaccines and annual booster shots to stay safe.

What he said: “I think there’s an 80% chance that the variants that we’re going to see in the future are manageable from a severity standpoint and vaccine production,” Bancel told Bloomberg.

“But I think we should always be very cautious, because there’s a 20% chance that something happens in some of the new variants that is very virulent.”

Flashback: Scientists told Newsweek in August 2021 that there was a potential “doomsday COVID variant” that would be worse than the delta variant. Not long after, the omicron variant arrived, causing widespread cases across the United States.”

“There’s simply no way you can have such low rates of vaccination around the world with the virus ping-ponging between vaccinated and unvaccinated people. I’m an immunologist. The probability of us seeing a vaccine-resistant strain is very high,” he said, according to Fortune.” (G)

“Up until late February, the CDC based its rankings of a county’s level of risk on the amount of virus spreading there and what portion of lab tests were found to be positive. The new framework instead focuses on the situation in hospitals — how many people are being admitted for COVID-19 and how much capacity is left.

Critics of CDC’s new approach say the agency seems to have moved the goalposts to justify the political imperative to let people get back to their normal lives.

“What it looks like is quite literally a changing of thresholds in order to justify a policy that I think assumes way too much risk,” says Jessica Malaty Rivera, an epidemiologist at the Pandemic Prevention Institute.

Experts in public health and infectious disease NPR interviewed say that for the average American trying to decide on behaviors like going to restaurants, the CDC’s new blueprint for navigating the pandemic leave them with an incomplete picture of their individual risk.

It also moves the U.S. away from collective response where members of a community join together in shared precautions, instead leaving vulnerable people to fend for themselves.

The debate over how to measure a given county’s COVID-19 level may seem academic, given that cases are in dramatic decline across the U.S. But the question is what the metrics will mean for how well communities predict and avert future surges — and how much life is lost.

The rationale behind the CDC’s new formula is that hospital capacity serves as a signal for how bad a local outbreak is.

“We want to prevent hospitalizations, we want to prevent our hospitals from becoming overwhelmed – so our metrics were really [developed] with that in mind,” CDC director Rochelle Walensky said while presenting the new map last month…

In its guidance, CDC does note that some people may want to be more cautious, including those who are immunocompromised or at high risk of severe disease; they’re advised to talk to their doctor about wearing a facemask or getting treatment, even if the risk level is “low” or “medium” where they live.

But this approach seems to abandon a fundamental goal of public health — to keep everyone safe through collective action, says Jason Salemi, an epidemiologist at the University of South Florida College of Public Health. Even with cases declining, he says, many people are still at high risk of severe disease, including the immunocompromised, unvaccinated kids and the elderly.

“They’re shifting from a community-wide response to really putting the onus on individuals and particularly individuals who have already borne the disproportionate burden of this pandemic,” he says…

The CDC undertook an exceedingly difficult task when it revamped its guidance: Give the U.S. a simple way of understanding COVID-19 risk.

The truth is no single metric can accomplish that.” (H)

“Experts, however, cautioned that the available data is still preliminary and has not yet shown how long the benefits of a fourth dose will last.

If the shots are authorized for seniors, how should they think about timing them?

Experts tracking Covid-19 are careful not to give specific advice on when to get a fourth dose when the safety and efficacy data are still limited.

If another surge is just around the corner, for instance, seniors may benefit from getting an extra shot as soon as it’s authorized. But if the next wave doesn’t occur until the summer or even the fall, getting a booster now could backfire because the recipients’ immunity might start to wane by the time they need protection the most. Current vaccines are based on the original strain of the coronavirus, so getting a booster now may also do little to protect against future variants.

“It would be great if we knew exactly when the next wave was going to be so we could vaccinate people beforehand,” said Dr. Amy Sherman, an infectious disease physician at Brigham and Women’s Hospital in Boston. “But I think we’re not quite at the point where we know a clear seasonality, and we know the exact tempo and dynamics of Covid and newer variants.”

That being said, if a fourth shot is authorized for adults over 65, and it has already been several months since they got their first booster, “I would start thinking about whether I need a booster now,” Dr. del Rio said.

What does this mean for everyone else?

For people younger than 65, who are otherwise healthy, most experts agree that three doses are most likely enough for now. Those in their 20s and 30s who have already received three shots of the vaccine, for instance, will only see marginal benefits in protection from an additional shot, Dr. Gaebler said.

“Fourth doses might turn out to be advisable,” he said, “but at this point I think the focus should be on administering third doses.”

Dr. del Rio agreed. “I’m more concerned about the millions of Americans who are not vaccinated or are only partially vaccinated,” he said. “That, to me, is where we need to put our major focus.” Getting more people vaccinated, nationally and globally, could potentially have a bigger effect on reducing virus transmission and curtailing new variants so that everyone can return to normal life, Dr. del Rio said.

And there is hope that better vaccines and treatments are on the way. Pfizer and Moderna are testing new Omicron-specific versions of the Covid booster. And other researchers are investigating vaccines that boost mucosal immunity in the nose, as well as protein-based shots that may be better at protecting against the coronavirus in the future.

“We have to really think carefully about our vaccine strategies,” Dr. Sherman said. “We have to think as a society about what our goal is with repeated boosters and vaccines because none of our existing vaccines completely prevent transmission or prevent all disease. And so at what point are we comfortable with asymptomatic or mild infection in the population while still being able to protect those who are vulnerable?” (I)

With a potential second booster on the horizon for vulnerable groups, the Biden administration is still struggling to drum up American public interest in additional shots – and funding from Congress to pay for Covid initiatives.

“We’re out of money pretty much for the pandemic spending, which is terrifying because we don’t know what’s coming around the corner,” said Katrine Wallace, an epidemiologist at the University of Illinois Chicago.

Pfizer-BioNtech asked the US Food and Drug Administration (FDA) on 15 March for another round of boosters for those 65 and up, while Moderna went a step further and asked on 17 March for more boosters among those 18 and up to give the FDA “flexibility” in considering who would benefit from additional shots, including vulnerable younger people, the company said.

The doses in question would be the original formulation of the vaccines. Omicron-specific vaccines are still in the trial phase, but scientists believe updating the vaccines as the virus evolves could broaden immune responses to future variants.

A $15bn funding package for testing, treatment, vaccines and more was cut unexpectedly from an omnibus spending bill in Congress on 9 March.

Health officials spoke to Democratic senators about the urgent need for Covid funding in a meeting on Wednesday, Politico reports, but the plan may meet with opposition: Republicans, who were not at the meeting, say the White House’s $22.5bn request must be accompanied with equal cuts to government spending elsewhere.

There is enough funding to give fourth doses of the vaccines to immunocompromised people, who already qualify for the shots, and for those over 65, if the shot is authorized for them in coming weeks, the coronavirus response coordinator, Jeff Zients, said at a White House briefing on Wednesday.

But wider booster campaigns would not have funding under the current budget shortfalls, and first- and second-shot campaigns could also be affected in the longer term.

The funding collapse may also affect future research on updated vaccines and treatments. “Maybe we will see a new variant that’s escaped all of these, and we need a new vaccine,” Wallace said. Without funding to create and then distribute the updated vaccines, “that is going to be an issue”. (J)

“As the White House pleads with Republicans in Congress for emergency aid to fight the coronavirus, the federal government said that a fund established to reimburse doctors for care for uninsured Covid patients was no longer accepting claims for testing and treatment “due to lack of sufficient funds.”

Some U.S. health care providers are informing uninsured people they can no longer be tested for the virus free of charge, and will have to pay for the service.” (K)


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