F.D.A. Outlines a Plan for Annual Covid Boosters

Americans could be given a single dose of the Covid vaccine each fall, just as they would get a flu shot, the Food and Drug Administration announced Monday.

To simplify makeup and injection times, the agency is also proposing to eliminate the original vaccines and give only primary and booster doses of dual chemotherapyaccording to summary documents published on Monday.

The proposal surprised a number of scientists, including some of the FDA’s own advisors. They are scheduled to meet on Thursday to discuss the country’s vaccine strategy, including what doses should be given and what schedule.

“I choose to believe that they are open to advice and that they have yet to decide exactly what they are going to do,” said Dr. Paul Offit, one of the program’s advisors and director. The Vaccine Education Center at Children’s Hospital of Philadelphia, said FDA officials.

Some advisers say there is little research to support the proposed plan.

“I wanted to see some data on the effect of dosing interval, at least observational data,” said Dr. Eric Rubin, one of the advisors and editor-in-chief of the New England Journal of Medicine. “And in the future, I’d like to see the data being collected to try to know if we’re doing the right thing.”

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

just about 40 percent of adults 65 years of age or older, and only 16% of those 5 years and older received the latest Covid booster shot. Many experts, including federal officials, have said that dosage is most important for Americans at high risk of severe illness and death from Covid: the elderly, the immunocompromised. , pregnant women and people with multiple medical conditions.

In its summary documents, the FDA addressed the different risks for people of different ages and health conditions.

“Most individuals can probably only need one dose of the approved or authorized Covid-19 vaccine to restore protective immunity over a period of time,” the agency said. The documents say young children who may not have been infected with the virus, as well as older adults and immunocompromised people, may need two shots.

But some scientists say there is little indication that low-risk Americans need even once a year. The primary vaccines continue to protect young and healthy people from serious illness, and the benefit of yearly booster shots is unclear.

Dr Céline Gounder, infectious disease physician and senior fellow at the Kaiser Family Foundation, said most people “are well protected against severe Covid disease with a range of basic medications and no annual boosters.” “.

FDA advisers say they want to see insights into who is most vulnerable to the virus and make decisions about future vaccination strategies based on those data.

“How old are they? What are their comorbidities? When was the last dose of vaccine they had? Do they take antiviral medication?” Dr. Offit said. Right now, the national strategy seems to be, “’OK, fine, let’s always get people on drugs,’” he said. .”

Under the FDA’s proposed plan, officials would select the vaccine composition annually in June each year, aiming to combat any circulating variants.

But this year, the booster was quickly overtaken by newly developed variants. It may make more sense to develop a vaccine that targets parts of the coronavirus, some researchers say, rather than the so-called spike protein, which changes less frequently.

They also criticized the agency’s proposal to use the current “bivalent” vaccine, designed to fight both the original Wuhan variant and the BA.4 and BA.5 Omicron variants. was in circulation last summer, when the agency decided to give the vaccine a makeover. booster doses.

Several studies have suggested that combining both variants in the booster dose can weaken their effectiveness. Because of a biological phenomenon called imprinting, preliminary research suggests that bivalent vaccines induce a stronger immune response to the ancestral variant than to newer variants.

A monovalent vaccine that targets only newer variants could be more potent, experts say.

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

FDA advisers said they hope Thursday’s meeting will allow for vigorous discussion of those questions. But others were more skeptical.

Dr Gounder said the voting questions were “arranged in such a way as to produce a certain outcome”.


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