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.