The Food and Drug Administration will meet with external advisors to talk about next steps in developing a COVID-19 vaccination plan.
Dinendra Haria / SOPA / LightRocket images via Getty Images
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Dinendra Haria / SOPA / LightRocket images via Getty Images
The Food and Drug Administration will meet with external advisors to talk about next steps in developing a COVID-19 vaccination plan.
Dinendra Haria / SOPA / LightRocket images via Getty Images
Most people who have been vaccinated will likely require an extra booster shot of the COVID-19 vaccine in the fall, a top Food and Drug Administration official said.
“That’s when we can have a reasonable amount of reduced immunity combined with the potential for further evolution of the virus, along with people going back inside,” where the coronavirus spreads more easily, Dr. Peter Marksdirector of the FDA’s Center for Biological Evaluation and Research, told NPR in an interview.
Marks says the US has to start planning now to see if people need another shot and if so, exactly what kind of shot.
“We can basically wait until another wave comes along and then try to make another vaccine and try to solve that problem, but I think we know,” Marks said. That doesn’t work, because we can’t produce and deploy a vaccine fast enough.” .
FDA is convening a special meeting of the agency’s independent external advisors on Wednesday for a day-long meeting to begin planning the next round of boosters.
The meeting comes about a week after the agency authorized a fourth shot – a second booster – for anyone 50 years of age or older to boost immunity against a possible new surge. early autumn. A more contagious omicron sub-variant known as BA.2, which has spurred increases in other countries, is now predominating in the US, raising fears of another increase.
The hard part of determining what to do in the fall, says Marks, is determining which version of the coronavirus will prevail. It could be the omicron variant, but it could also be an entirely new variant. That raises doubts about giving people only the fifth dose of the current vaccine, he said.
“There will be diminishing returns to multiple injections of the same vaccine,” says Marks. “We’ve had enough evolution for this virus that it makes sense to try to cover up some of the genetic diversity that’s been included in the mix.”
One strategy, says Marks, is to give people a new vaccine that specifically targets the omicron or one of the other variants, such as beta. Another option would be a new vaccine that combines at least two strains into one vaccine, which could provide broader protection against any new variants that may emerge.
“This fall, we might have a new variant. It could be sigma. It could be tau. There could be something new circulating that we’re going to have to deal with,” Marks said. . “We’ll have to guess exactly what might be most effective.”
That’s how the flu vaccine is made every year, although the flu virus is more predictable than SARS-CoV-2, the coronavirus that causes COVID-19.
So far, the omicron version of the COVID-19 vaccine has not produced promising results during initial testing. But scientists are waiting for more data on that shot and on other new versions of the vaccine that combine strains, such as omicron and original strain, omicron and beta, or delta and omicron.
Another question is how often people will have to keep vaccinated.
“Will it be like the annual flu vaccine, or not?” Dr. Anthony Fauci, the White House scientific adviser, told NPR in an interview. “I have to stress: We don’t know the answer to that right now.”
Some experts worry that the FDA is just assuming another shot will be needed, instead of focusing on the more important issue of immunizing the unvaccinated and boosting the unvaccinated. strains.
“The FDA agenda implies that, without open, transparent scientific discussion, … then iterative promotion is the way of the future. There is no discussion about it yet. motivational and trade-off goals,” Dr. Celine Gounderan infectious disease expert and senior member of Kaiser Health News, wrote in an email.
“People like to say we can walk and chew gum at the same time, but in a resource-constrained world, there are choices and trade-offs to consider. We don’t do anything with it. repeated promotion costs?” she speaks.
In a summary document posted Monday, the FDA raised many of the questions that the advisory committee will discuss Wednesday. One issue is whether the United States or the World Health Organization will take the lead in developing the next version of the vaccine, as the latter did with the annual flu vaccine.
Unlike the flu shot, regulators will need specific new data to demonstrate that any new vaccine formulation is safe and effective, the FDA said.
