Emergency uses of the vaccines have not been approved or licensed by U.S. Food and Drug Administration (FDA), but have been authorized by 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 12 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. 

12 Years of Age and Older

The FDA-approved COMIRNATY (COVID-19 Vaccine, mRNA) and the Pfizer-BioNTech COVID-19 Vaccine authorized under EUA 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.  The Pfizer-BioNTech COVID-19 Vaccine, Bivalent is made in the same way as COMIRNATY and Pfizer-BioNTech COVID-19 Vaccine but it also contains an Omicron component to help prevent COVID-19 caused by the Omicron variant of SARS-CoV-2. 

COMIRNATY (COVID-19 Vaccine, mRNA) is an FDA-approved COVID-19 vaccine as a 2-dose series for prevention of COVID-19 in individuals 12 years of age and older. It is also authorized under EUA to provide a third primary series dose to individuals 12 years of age and older with certain kinds of immunocompromise.  The Pfizer-BioNTech COVID-19 Vaccine has received EUA from FDA to provide: a 2-dose primary series to individuals 12 years of age and older; and a third primary series dose to individuals 12 years of age and older with certain kinds of immunocompromise. 

The Pfizer-BioNTech COVID-19 Vaccine, Bivalent has received EUA from FDA to provide either: a single booster dose to individuals 12 years of age and older at least 2 months after completion of primary vaccination with any authorized or approved monovalent3 COVID-19 vaccine; or a single booster dose to individuals 12 years of age and older at least 2 months after receipt of the most recent booster dose with any authorized or approved monovalent COVID-19 vaccine. 

5 through 11 Years of Age

The Pfizer-BioNTech COVID-19 Vaccine has received EUA from the FDA to provide: a two-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. 

 The Pfizer-BioNTech COVID-19 Vaccine, Bivalent has received EUA from FDA to provide either: a single booster dose to individuals 5 through 11 years of age at least 2 months after completion of primary vaccination with any authorized or approved monovalent COVID-19 vaccine; or a single booster dose to individuals 5 through 11 years of age and older at least 2 months after receipt of the most recent booster dose with any authorized or approved monovalent COVID-19 vaccine. 

6 Months through 4 Years of Age

The Pfizer-BioNTech COVID-19 Vaccine has received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) to provide a 3-dose primary series to individuals 6 months through 4 years of age.