FDA outlines plan for annual Covid recalls

Americans could be offered a single dose of a Covid vaccine each fall, much like they receive flu shots, the Food and Drug Administration announced Monday.

To simplify the composition and timing of injections, the agency is also proposing to remove the original vaccines and offer only bivalent doses for primary and booster injectionsaccording to briefing documents released on Monday.

The proposal took some scientists by surprise, including some of the FDA’s own advisers. They are due to meet on Thursday to discuss the country’s vaccine strategy, including the doses to be offered and according to what schedule.

“I choose to believe that they are open to advice and have not yet decided exactly what they are going to do,” said Dr. Paul Offit, one of the advisers and director of the Vaccine Education Center. from Children’s Hospital of Philadelphia, FDA officials said.

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.”

Still, Dr Rubin added: “I would definitely favor something simpler because it would make it more likely that people would take it.”

Only about 40% of adults aged 65 and over, and only 16% of those aged 5 and over received the last Covid booster shot. Many experts, including federal officials, have said the doses are most important for Americans at high risk of serious illness and death from Covid: the elderly, the immunocompromised, pregnant women and people with multiple underlying conditions.

In its briefing materials, the FDA has addressed the varying risks for people of different ages and health conditions.

“Most individuals may only need to receive 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 have already 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 was little to suggest low-risk Americans even needed just one 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, an infectious disease physician and senior researcher at the Kaiser Family Foundation.

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

“How old are they? What are their co-morbidities? When was the last dose of vaccine they received? Have they taken antiviral drugs? says Dr Offit. “‘OK, well, let’s administer everyone all the time,'” he said, “And that’s just not a good reason.”

According to the plan suggested by the FDA, 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.

They also criticized the agency’s proposal to use the current “bivalent” vaccine, which was designed to counter both the original Wuhan variant and the BA.4 and BA.5 Omicron variants that were circulating last summer. , when the agency decided on the composition of the booster doses.

Some studies have suggested that combining the two variants in the booster dose has undermined their effectiveness. Due to a biological phenomenon called imprinting, preliminary research suggests that the bivalent vaccine elicits a stronger immune response to the ancestral variant than to newer variants.

A monovalent vaccine targeted only at new variants could have been more potent, experts said.

“It doesn’t make sense, based on what we’ve learned from the current bivalent vaccine and the footprint,” Dr. Gounder said of the FDA proposal. “Why not switch to a monovalent Omicron vaccine?”

FDA advisers said they hoped Thursday’s meeting would allow for a thorough discussion of these issues. But others were more skeptical.

Voting questions “are phrased in such a way as to force a certain outcome”, Dr Gounder said.