FDA Authorizes Moderna, Pfizer-BioNTech Boosters

FDA 8/31 authorized Moderna’s and Pfizer-BioNTech’s updated (bivalent) Covid-19 vaccines for use as a single booster dose at least two months following primary or booster vaccination. The bivalent vaccines “contain two messenger RNA (mRNA) components of SARS-CoV-2 virus, one of the original strain of SARS-CoV-2 and the other one in common between the BA.4 and BA.5 lineages of the omicron variant of SARS-CoV-2, an agency release says. Moderna’s shot is authorized for use in individuals 18 years of age and older, whereas the Pfizer-BioNTech shot is authorized in individuals 12 years of age and older.

The CDC was expecting a positive agency decision on the boosters this week and its Advisory Committee on Immunization Practices has already scheduled meetings on 9/1-2 to review the boosters, after which CDC director Rochelle Walensky must sign off on the updated boosters before they can be administered to the public.