The U.S. Food and Drug Administration (FDA)-approved COMIRNATY (COVID-19 Vaccine, mRNA) and the two formulations of Pfizer-BioNTech COVID-19 Vaccine authorized for Emergency Use Authorization (EUA) for ages 12 years and older, when prepared according to their respective instructions for use, can be used interchangeably without presenting any safety or effectiveness concerns.

COMIRNATY (COVID-19 Vaccine, mRNA) is an FDA-approved COVID-19 vaccine that is approved as a 2-dose series for prevention of COVID-19 in individuals 16 years of age and older.  It is also authorized under EUA to provide a 2-dose primary series to individuals 12 through 15 years.

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.

Pfizer-BioNTech COVID-19 Vaccine has received EUA from FDA to provide a 2-dose primary series to individuals 5 through 11 years of age.

COMIRNATY and the Pfizer-BioNTech COVID-19 Vaccine are authorized under EUA to provide a third primary series dose in individuals 12 years of age and older who have been determined to have certain kinds of immunocompromise. The vaccines are also authorized as a single booster dose to individuals 18 years of age and older who have completed a primary series with Pfizer-BioNTech COVID-19 Vaccine or COMIRNATY and as a single booster dose to individuals 18 years of age and older who have completed primary vaccination with a different authorized COVID‑19 vaccine. The booster schedule is based on the labeling information of the vaccine used for the primary series.

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.