The FDA has granted Emergency Use Authorization for Pfizer-BioNTech COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5), as a single booster dose for eligible people 12 years of age and older.
It is now available as a single booster dose administered at least 2 months after:
- Completion of primary vaccination with any authorized or approved monovalent†
- Receipt of the most recent booster dose with any authorized or approved monovalent†
The vaccine may not protect everyone.
†Monovalent refers to any authorized or approved
Emergency Use Authorization
Emergency uses of Pfizer-BioNTech COVID-19 Vaccine, Bivalent have not been approved or licensed by FDA but have been authorized by FDA under an Emergency Use Authorization (EUA) to prevent Coronavirus Disease 2019 (COVID-19) in individuals aged 12 years and older. The emergency uses are only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of the medical product under Section 564(b)(1) of the FD&C Act unless the declaration is terminated or authorization revoked sooner.