FDA Advisors Support Moderna’s Covid Booster For At-Risk Groups



A panel of high-level American scientists has recommended approving Moderna’s request to provide third injections of its Covid-19 vaccine, giving some impetus to the deployment of the booster in the United States.

U.S. Food and Drug Administration advisers voted Thursday to allow Moderna to provide third doses of its vaccine to people who received their second dose at least six months ago and are over 65 years of age , have underlying health problems or whose work puts them at high risk of contracting severe Covid-19. All 19 voting members voted in favor.

The FDA will make a final decision in the coming days on whether to give the green light for people to receive a third injection of the vaccine. If so, it will speed up the Biden administration’s plans for a widespread recall program, which President Joe Biden says will help reduce the high number of Covid-19 cases in the country.

The vote comes at a two-day meeting where the FDA panel will also consider whether to recommend a booster of Johnson & Johnson’s single-dose vaccine. They will also discuss the results of a preliminary study of a US trial of mixing Covid-19 vaccines as part of a booster program – a practice that some experts believe could boost a person’s immune response. and facilitate the logistical challenges associated with the deployment of recalls.

Scientists on the FDA committee expressed concerns about certain aspects of Moderna’s application, including whether there was enough evidence on how quickly protection from the initial two doses wanes, and what the impact of the use of half a dose for the booster.

They ultimately voted unanimously to approve the request in part because they had already done so for Pfizer.

Stanley Perlman, professor of microbiology and immunology at the University of Iowa, said: “I support this [application] because we have already approved it for Pfizer and I don’t see how we can not approve it for Moderna and most people in the US are not completely confused.

Patrick Moore, a professor at the Cancer Institute at the University of Pittsburgh, said: “The data itself is not solid, but it certainly points in a direction that supports this vote.”

Biden announced in August that every American adult would be offered a booster eight months after their initial vaccination ended.

But those plans ran into a hurdle last month when the FDA advisory committee rejected Pfizer’s request to provide all vaccinated Americans with additional doses, and instead chose to restrict eligibility criteria only to the elderly or to those at risk of severe Covid-19.

Committee members made it clear on Thursday that they were so far unconvinced by the case to offer reminders to all adults. Cody Meissner, professor of pediatrics at Tufts University School of Medicine, said: “Give a booster without a lot of [trial] participants and subjects may not be the best thing to do.

Biden said Thursday that more than a third of eligible people over the age of 65 had received a booster since the authorization from Pfizer. “We will continue to provide this extra protection for the elderly and others as we head into the holidays,” he said.

Just under 188 million people in the United States have now been fully vaccinated, according to the United States Centers for Disease Control and Prevention. Almost 9 million of them have also received booster doses, and data shows that more people are now receiving booster doses than receiving their first injections.

Moderna presented data showing a sudden increase in the proportion of vaccinated people receiving Covid-19 in July and August, seven months after the vaccine rolled out, which she said indicated the need for boosters.

People vaccinated earlier were significantly more likely to be infected than those who received their second dose later in the year, the company said.

Peter Marks, director of the Center for Biologics Evaluation and Research at the FDA, said: “There appears to be some decrease in protection against all of Covid-19. [infections]. We must take into account that mild and moderate Covid-19 can be associated with unwanted outcomes. “

Marks also attempted to address members’ concerns about small sample sizes in studies of the effectiveness of booster doses, saying the studies “are all pointing in the same direction.”

The FDA also showed members data indicating that a third shot did not cause stronger side effects than a second dose.

Once the FDA makes its final decision, it will be up to the CDC to make its own recommendations on who should receive the recalls.



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