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The Pfizer-BioNTech COVID-19 Vaccine is also known as COMIRNATY (COVID-19 Vaccine, mRNA).
Comirnaty is U.S. Food and Drug Administration (FDA)-approved as a 2-dose series for prevention of COVID-19 in individuals 16 years of age and older. It is also authorized under Emergency Use Authorization (EUA) to provide a two-dose primary series in individuals 12 through 15 years.
Pfizer-BioNTech COVID-19 Vaccine has received EUA from FDA to provide a two-dose primary series 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 single booster dose in the following individuals who have completed a primary series with Pfizer-BioNTech COVID-19 Vaccine or Comirnaty: 65 years of age and older, 18 through 64 years of age at high risk of severe COVID-19, and 18 through 64 years of age with frequent institutional or occupational exposure to SARS-CoV-2. The vaccines are also authorized as a single booster dose to eligible individuals who have completed primary vaccination with a different authorized COVID-19 vaccine. The eligible population(s) and dosing interval for the heterologous booster dose are the same as those authorized for a booster dose of the vaccine used for primary vaccination.
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.
The FDA-approved Comirnaty (COVID-19 Vaccine, mRNA) and the EUA-authorized Pfizer-BioNTech COVID-19 Vaccine have the same formulation and can be used interchangeably to provide doses for COVID-19 primary vaccination or a booster dose.