F.D.A. Outlines a plan for annual Covid reminders

Ahead of a science meeting Thursday, officials proposed offering new vaccines to Americans each fall, a strategy long employed against the flu.

< p class="css-at9mc1 evys1bk0">Americans could be offered a single dose of a Covid vaccine each fall, just as they receive flu shots, the Food and Drug Administration announced Monday.

To simplify the composition and timing of injections, the agency also proposes to withdraw the original vaccines and only offer bivalent doses for primary and booster injections , according to briefing papers released Monday.

The proposal surprised some scientists, including a few of the F.D.A.'s own advisers. They are due to meet on Thursday to discuss the country's vaccine strategy, including doses to offer and timing.

"I choose to believe they are open to advice and they haven't decided exactly what they're going to do yet," said Dr. Paul Offit, one of the advisers and director of the Vaccine Education Center at Children's Hospital of Philadelphia. /p>

There was little research to support the suggested plan, some advisers said.

"I would like to see data on the effect of the dosing interval, at least observational data,” said Dr. Eric Rubin, one of the New England Journal of Medicine's advisors and editor. "And in the future, I'd like to see data collected to try to say if we're doing the right thing."

Yet Dr. Rubin added: " I would certainly favor something simpler, as it would make it more likely that people could take it, and only 16% of people aged 5 and over received the last Covid booster shot.Many experts, including federal officials, said the doses are most important for Americans at high risk of serious illness and death from Covid: the elderly, immunocompromised people, pregnant women, and people with multiple under-the-hood conditions. diseases.

In its disclosure documents, the F.D.A. has discussed the different risks for people of different ages and health conditions.

< p class="css-at9mc1 evys1bk0">"Most individuals may only need recevo ir only a single dose of an approved or licensed Covid-19 vaccine to restore protective immunity for a period of time,” the agency said. Very young children who may not yet have been infected with the virus, as well as older adults and immunocompromised people, may need two injections, the documents say.

But some scientists said there's little to suggest that low-risk Americans even need a single annual vaccine. The original vaccines continue to protect young, healthy people against serious diseases, and the benefit of annual boosters is unclear.

Most people are "well protected against severe Covid illness with a primary series and no annual boosters," said Dr. Celine Gounder, infectious disease physician and senior researcher at the Kaiser Family Foundation.

F.D.A. advisers said they would like to see detailed information about who is most vulnerable to the virus and make decisions about future vaccination strategy based on that data.

"How old are they? What are their comorbidities? When was the last dose of vaccine they received? Did they take antiviral drugs? said Dr. Offit. At the moment, the national strategy seems to be, "'OK, well, let's administer everyone all the time,'" he said. "And that's just not a good reason."

Under the plan suggested by the F.D.A., officials would choose the composition of the annual vaccine each June, aiming to combat any circulating variant.

But this year the booster was quickly overtaken by newly evolved variants. It might make more sense to develop vaccines that target parts of the coronavirus other than the so-called spike protein, which changes less frequently, some researchers have said.