Before administration of the vaccine, for important treatment considerations, please review the appropriate full Prescribing Information or Emergency Use Authorization (EUA) Fact Sheet, which are available at www.pfizermedicalinformation.com/en-us/pfizer-biontech-covid-19-vaccine.
Emergency uses of the vaccines have not been approved or licensed by FDA, but have been authorized by the U.S. Food and Drug Administration (FDA), under an Emergency Use Authorization (EUA) to prevent Coronavirus Disease 2019 (COVID-19) in individuals aged 6 months and older for the Pfizer-BioNTech COVID-19 Vaccine and 5 years and older for the Pfizer-BioNTech COVID-19 Vaccine, Bivalent. 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.
Pfizer-BioNTech COVID-19 Vaccine, Bivalent (Original and Omicron BA.4/BA.5) is authorized for emergency use in individuals 5 years of age and older as a single booster dose administered at least 2 months after either: completion of primary vaccination with any authorized or approved monovalent* COVID-19 vaccine, or receipt of the most recent booster dose with any authorized or approved monovalent* COVID-19 vaccine.
The Pfizer-BioNTech COVID-19 Vaccine, Bivalent for individuals 12 years of age and older is supplied in vials with gray caps and labels with gray borders; for individuals 5 through 11 years of age, it is supplied in vials with orange caps and labels with orange borders. Please be aware of label similarities to the vaccines used for primary series (described below).
Original [Monovalent] Vaccines
Comirnaty (COVID-19 Vaccine, mRNA) is an FDA-approved COVID-19 vaccine that is indicated for active immunization to prevent COVID-19 in individuals 12 years of age and older. It is approved for use as a 2-dose primary series for the prevention of COVID-19 in individuals 12 years of age and older. Comirnaty and Pfizer-BioNTech COVID-19 Vaccine are also authorized for emergency use to provide a third primary series dose to individuals 12 years of age and older with certain kinds of immunocompromise. The formulation for use as a primary series in individuals 12 years of age and older has a gray cap and label with a gray border.
The FDA-approved Comirnaty (COVID-19 Vaccine, mRNA) and the EUA‑authorized Pfizer-BioNTech COVID-19 Vaccine for individuals 12 years of age and older when prepared according to their respective instructions for use can be used interchangeably without presenting any safety or effectiveness concerns.
Pfizer-BioNTech COVID-19 Vaccine supplied in vials with an orange cap and labels with an orange border is authorized for use to provide: a 2-dose primary series to individuals 5 through 11 years of age; and a third primary series dose to individuals 5 through 11 years of age with certain kinds of immunocompromise.
Pfizer-BioNTech COVID-19 Vaccine supplied in vials with a maroon cap and labels with a maroon border is authorized for use to provide a 3-dose primary series to individuals 6 months through 4 years of age.
*Monovalent refers to any authorized or approved COVID-19 vaccine that contains or encodes the spike protein of only the Original SARS-CoV-2.