Vaccine advisers to the US Food and Drug Administration voted unanimously Thursday to recommend emergency use authorization of a booster dose of Moderna’s Covid-19 vaccine.
The FDA’s Vaccines and Related Biological Products Advisory Committee agreed use of a booster dose would be safe and effective in some people six months out from their primary series.
Moderna had asked for emergency use authorization (EUA) for a half dose of its vaccine to be used as a booster for certain people.
All 19 members of the committee supported the question:
Do available data support the safety and effectiveness of Moderna Covid-19 Vaccine for use under EUA as a booster dose (50 mcg mRNA-1273) at least six months after completion of a primary series in the following populations:
Individuals 65 years of age and older
Individuals 18 through 64 years of age at high risk of severe Covid-19, and
Individuals 19 through 64 years of age whose frequent institutional or occupational exposure to SARS-Covid-2 puts them at high risk of serious complications of Covid19 including severe Covid-19
What comes next: It will be up to FDA accept or reject the committee’s recommendation. Then vaccine advisers to the US Centers for Disease Control and Prevention meet Oct. 21 to decide on the recommendations.
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No need to expand booster recommendations to younger groups, FDA vaccine advisers say
From CNN’s Maggie Fox
Vaccine advisers to the US Food and Drug Administration declined to recommend expanding recommendations for booster doses of Covid-19 vaccines, and many expressed uneasiness with having recommended boosters at all Thursday.
The FDA’s Vaccines and Related Biological Products Advisory Committee voted unanimously to recommend half-dose booster shots for some people six months out from their first two doses of Moderna’s Covid-19 vaccine.
Their recommendation mirrors the emergency use authorization granted to Pfizer last month: people over 65 and those 18 and older at high risk of severe disease or whose work or living situation puts them at high risk of complications or severe disease.
After the vote, members were asked to discuss whether they’d consider recommend widening that group to younger ages. Several members said they were not even fully comfortable with having recommended boosters as widely as they already had.
“I don’t agree with doing this down to 18 years of age at all,” said Dr. Paul Offit, director of the Vaccine Education Center and a pediatrics professor at Children’s Hospital of Philadelphia.
“I am impressed by the fact that we continue to have excellent protection against moderate to severe disease in this country through Delta and for all age groups. And I just think we continue to send wrong messages out there by using terms like breakthrough and by making people feel like they’re not protected unless they’ve gotten a third dose,” he added.
“I am uncomfortable with how we just sort of tripped down the line here with the concept of a universal booster dose,” he said.
Dr. Michael Kurilla, director of the Division of Clinical Innovation at the National Center for Advancing Translation Sciences at the National Institutes of Health, agreed.
“I don’t see the need for a let-it-rip campaign for boosters,” Kurilla said.
Several members noted that the real need is to get unvaccinated people in the US vaccinated for the first time, not to get booster shots into people’s arms.
“I think we heard pretty loud and clearly that there was not much appetite for moving down the age range very significantly, if at all,” said Dr. Peter Marks, who heads the FDA’s vaccine arm, the Center for Biologics Evaluation and Research. Marks said the FDA was concerned about unexpected new waves of disease.