FDA advisory committee recommends EUA for booster dose of Moderna’s COVID-19 vaccine

Oct. 15, 2021

The U.S. Food and Drug Administration’s (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) recommended that the FDA grant an emergency use authorization (EUA) for a booster dose of the Moderna COVID-19 vaccine (mRNA-1273) at the 50-µg dose level, according to a news release from Moderna.

The recommendation is for people aged 65 and older, people aged 18 to 64 who are at high risk of severe COVID-19, and people aged 18 to 64 whose exposure to COVID-19 puts them at risk for COVID-19 complications or severe illness, according to a news release from Moderna.

The positive vote was unanimous with 19 VRBPAC members recommending EUA. The booster dose is to be administered at least six months after completion of the primary series.

FDA advisory committeesprovide non-binding recommendations. The FDA will take the VRBPAC’s recommendation into consideration in making a final decision on authorization.

Visit Moderna for more news