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.
Some vaccine advisers to the US Food and Drug Administration said they were not entirely convinced the data showed a booster was necessary or that it increased protection, but noted a shortage of health care workers when discussing whether to recommend emergency use authorization of a booster dose of Moderna’s Covid-19 vaccine.
“The data are not perfect but these are extraordinary times and we have to work with imperfect data,” Dr. Eric Rubin, editor in chief of The New England Journal of Medicine and a professor at the Harvard TH Chan School of Public Health, said.
“We can’t afford to have health care workers, even if not sick, be positive and infected and have to stay home from work because in parts of the country there’s a shortage of health care workers and there’s burnout everywhere,” said Dr. Stanley Perlman, a professor of pediatrics at the University of California San Diego.
President Biden said the US Food and Drug Administration and outside experts of the US Centers for Disease Control and Prevention are set to make a decision on Covid-19 vaccine authorization for children’s ages 5 to 11 “in the next few weeks.”
“Now I know parents out there are anxiously waiting for vaccine for children ages 5 to 11. The good news is the FDA and outside experts in the CDC are set to make its determination as to whether the vaccination will be authorized for that age range in the next few weeks,” the President said in remarks from the White House.
Biden continued: “If authorized, we are ready. We have purchased enough vaccines for all children between the ages of 5 and 11 in the United States, and… it will be convenient for parents to get their children vaccinated at trusted locations, and families will be able to sleep easier at night knowing their kids are protected as well.”