FDA authorizes Omicron-specific boosters

Aug. 31, 2022

The U.S. FDA has amended the emergency use authorizations for the Moderna COVID-19 vaccine and the Pfizer-BioNTech COVID-19 vaccine to authorize the new, bivalent formulations for use as booster doses.

The updated boosters contain two mRNA components of SARS-CoV-2 virus — one of the original strain and one in common between the BA.4 and BA.5 lineages of the omicron variant.

The Moderna booster is authorized for individuals 18 years of age and older, while the Pfizer-BioNTech one is authorized for individuals 12 years of age and older. Pfizer plans to submit an application for the Omicron-adapted bivalent vaccine for children 5 through 11 in early October.

The updated authorization means that the original EUAs granted have been revised to remove the use of the monovalent vaccines as boosters.