FDA outlines plan for annual Covid booster

The U.S. Food and Drug Administration announced on Monday that they could be offered a single dose of the Covid vaccine each fall, similar to the flu shot.

To simplify the composition and timing of immunizations, officials are also proposing to phase out the original vaccine. Provides only bivalent doses of primary and booster shotsaccording to a briefing document released Monday.

The proposal surprised some scientists, including some of the FDA’s own advisers. They plan to meet on Thursday to discuss the country’s vaccine strategy, including which doses should be delivered and on what schedule.

“I am choosing to believe that they are open to advice and have not yet made up their minds as to what they are going to do,” the Children’s Hospital of Philadelphia Center for Vaccine Education told FDA officials. about said:

Some advisers said there was little research to support the proposed plan.

“We would like data on the effect of dosing intervals, or at least observational data,” said Dr. Eric Rubin, one of the advisors and editors-in-chief of the New England Journal of Medicine. “And going forward, we want to collect data to determine if we are doing the right thing.”

Still, Dr. Rubin added, “I would definitely favor something simpler, as it makes people more likely to take it.”

only about 40 percent of adults Over the age of 65, only 16% of those over the age of 5 have received the latest Covid booster shot. Many experts, including federal officials, believe that for Americans at high risk of severe illness and death from Covid, including the elderly, immunocompromised people, pregnant women, and those with multiple underlying medical conditions. , stated that dose is of the utmost importance.

In its briefing document, FDA addressed different risks for people of different ages and health conditions.

“Most people can restore protective immunity for a period of time with just one dose of the approved or approved Covid-19 vaccine,” officials said. Very young children, the elderly and immunocompromised people who may not yet have the virus may need two doses, the document said.

But some scientists said there was little to suggest that low-risk Americans needed even one injection a year. It continues to protect against serious illness, and the benefits of annual boosters are unknown.

Kaiser Family Foundation Senior Fellow and infectious disease specialist Celine Gownder, Ph.D., said most people are “well protected from severe COVID-19 in the primary series without annual boosters.” said.

FDA advisers say they want to see detailed information about who is most vulnerable to the virus and use those data to make decisions about future vaccination strategies.

“How old are they? What are their comorbidities? When was the last dose of vaccine they received? Did they take antiviral medication?” said Dr. Offitt. . At the moment, the national strategy seems to be, ‘Okay, let’s dose everyone all the time,'” he said. “And it’s not for good reason.”

According to the FDA’s proposed plan, each June, the agency will select an annual vaccine composition aimed at combating any circulating variant.

But this year, Booster was quickly overtaken by a newly evolved variant. Some researchers say it may make more sense to develop a vaccine that targets parts of the coronavirus other than the so-called spike protein, which change less frequently.

They also criticized the agency’s proposal to use the current “bivalent” vaccine. It was designed to compete with both the original Wuhan variant and the BA.4 and BA.5 Omicron variants that were in circulation last summer. booster dose.

In some studies, combining both variants at booster doses resulted in impair their effectivenessBecause of a biological phenomenon called imprinting, preliminary studies suggest that bivalent vaccines induce stronger immune responses against ancestral variants than against newer variants.

A monovalent vaccine targeting only the new subspecies might have been more potent, experts say.

“This makes no sense, based on what we’ve learned from current bivalent vaccines and imprinting,” Dr. Gounder said of the FDA’s proposal. “Why not switch to the monovalent Omicron vaccine?”

FDA advisers said they hope Thursday’s meeting will be able to have a solid discussion of these issues. But others were more skeptical.

Poll questions are “structured in such a way as to force a particular outcome,” said Dr. Gounder.