Comirnaty is approved by the U.S. Food and Drug Administration (FDA) for active immunization to prevent coronavirus disease 2019 (COVID 19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 12 years of age and older.
Pfizer-BioNTech COVID-19 Vaccine (2023-2024 Formula) has not been approved or licensed by FDA, but has been authorized for emergency use by FDA, under an EUA to prevent COVID-19 for use in individuals 6 months through 11 years of age. The emergency use of this product is 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.