The next vaccination step will be discussed with FDA advisers: Shot

The Food and Drug Administration will meet with outside advisers to discuss the next steps in formulating a COVID-19 vaccination plan.

Through Dinendra Hariya / Sopa Image / Light Rocket Getty Images

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Through Dinendra Hariya / Sopa Image / Light Rocket Getty Images

The Food and Drug Administration will meet with outside advisers to discuss the next steps in formulating a COVID-19 vaccination plan.

Through Dinendra Hariya / Sopa Image / Light Rocket Getty Images

A top Food and Drug Administration official said Monday that most vaccinated people will probably need one more COVID-19 vaccine booster shot in the fall.

Dr. Peter Marks, director of the FDA’s Center, said: “At that time, with the further evolution of the virus, our immunity would be significantly reduced in combination with the return to the human body, where the coronavirus would spread more easily.” Biologics Evaluation and Research told NPR in an interview.

Marx said the United States should start planning now whether everyone needs another shot and if so, what kind of shot.

“We can basically wait until another wave arrives and then try to make another vaccine and try to deal with it, but I think we know it doesn’t work, because we can’t make and place the vaccine fast enough, “Marx said.

The FDA is calling a special meeting of the agency’s independent outside advisers on Wednesday for a day-long meeting to begin planning for the next round of booster.

The meeting took place a week after the agency’s fourth shot – a second booster – approved anyone aged 50 or older to increase immunity before a possible new wave of falls. A more contagious Omicron submarine known as BA.2, which has fueled uplift in other countries, is now dominant in the United States, raising fears of another increase.

Marx said the crucial part of determining what to do in the fall is determining which version of the coronavirus will be effective by then. It could be an omicron variant, but it could also be a whole new variant. This raises doubts about giving people a fifth shot of the current vaccine, he said.

“There is a definite diminishing return by giving the same vaccine repeatedly,” says Marx. “We’ve evolved enough of this virus to try to cover some of the genetic variation introduced into the mixture.”

One strategy is to give people a new vaccine that specifically targets one of Omicron or other forms, such as beta, says Marx. Another option would be a new vaccine that combines at least two strains into one vaccine, which could provide more comprehensive protection against any new forms that may arise.

“In this fall, we could be a new variant. It could be Sigma. It could be Tau. It could be something new that could be promoted that we have to deal with,” Marx said. “We need to make a good guess as to what might be most effective.”

This is how the flu vaccine is made every year, although the influenza virus is more predictable than the SARS-CoV-2, the coronavirus that causes COVID-19 disease.

So far, an omicron version of the COVID-19 vaccine has not yielded very promising results in initial tests. But scientists are waiting for more information about that shot and other newer versions of the vaccine that combine strains, such as Omicron and Real Strain, Omicron and Beta, or Delta and Omicron.

Another question is how often people have to continue getting vaccinated.

“Will it be something like the annual flu vaccine, or not?” White House science adviser Dr. Anthony Fawcett told NPR in an interview. “I have to emphasize: we don’t know the answer right now.”

Some experts are concerned that the FDA is simply assuming that another shot will be needed instead of focusing on the more important issue of encouraging immunization and unwinding.

“The FDA agenda implies that, without open, transparent scientific discussion, … that repeated boosting is the way to the future. Boosting and trade-off goals remain to be discussed,” said Dr. Celine Gounder, an infectious disease specialist and senior fellow at Kaiser Health News. Wrote in an email.

“People like to say we can walk and chew at the same time, but in a world of limited resources, there are choices and trade-offs for weights. What are we not doing at the expense of repeated boosts?” He says.

In a briefing document posted Monday, the FDA outlined a number of questions that the advisory committee will discuss on Wednesday. One issue is that the United States or the World Health Organization will lead the development of the next version of the vaccine, as it does with the annual flu shot.

Unlike flu shots, regulators will need specific new data that demonstrates that any new formulation of the vaccine is safe and effective, the FDA says.

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