The FDA-approved COMIRNATY (COVID-19 Vaccine, mRNA) and the formulations of Pfizer-BioNTech COVID-19 Vaccine authorized under 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 is FDA-approved as a 2-dose primary series for prevention of COVID-19 in individuals 12 years of age and older. Comirnaty and the Pfizer-BioNTech COVID-19 Vaccine have received EUA from FDA 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 and as a first booster dose in individuals 12 years of age and older who have completed a primary series with Pfizer-BioNTech COVID-19 Vaccine or COMIRNATY.  The vaccines are also authorized as a first booster dose to individuals 18 years of age and older who have completed primary vaccination with another authorized or approved COVID-19 vaccine.  The vaccines are also authorized as a second booster dose to individuals 50 years of age and older who have received a first booster dose of any authorized or approved COVID-19 vaccine and as a second booster dose to individuals 12 years of age and older with certain kinds of immunocompromise and who have received a first booster dose of any authorized or approved COVID-19 vaccine.  The Pfizer-BioNTech COVID-19 Vaccine has received EUA from FDA to provide a 3-dose primary series to individuals 6 months through 4 years of age and to provide: a two-dose primary series to individuals 5 through 11 years of age; a third primary series dose to individuals 5 through 11 years of age with certain kinds of immunocompromise; and a single booster dose to individuals 5 through 11 years of age who have completed a primary series with Pfizer-BioNTech COVID-19 Vaccine. 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.