COVID-19 (retired 3/10/2023)

On August 23, 2021, FDA announced the first approval of a COVID-19 vaccine. The vaccine has been known as the Pfizer-BioNTech COVID-19 Vaccine, and will now be marketed as Comirnaty, for the prevention of COVID-19 in individuals 16 years of age and older. Pfizer-BioNTech COVID-19 Vaccine is authorized for emergency use and is available under the EUA as a two-dose primary series for individuals 5 years of age and older, as a third primary series dose for individuals 5 years of age and older who have been determined to have certain kinds of immunocompromise, and as a single booster dose for individuals 12 years of age and older at least five months after completing a primary series of the vaccine. The Pfizer-BioNTech COVID-19 Vaccine is also authorized for use as a heterologous (or “mix and match”) single booster dose for individuals 18 years of age and older following completion of primary vaccination with a different available COVID-19 vaccine. For example, Moderna and Janssen COVID-19 vaccine recipients 18 years of age and older may receive a single booster dose of the Pfizer-BioNTech COVID-19 Vaccine. On November 17, 2021, CDC, in consultation with FDA, issued emergency use instructions to provide information about the use of the vaccine as an additional primary series dose or as a booster dose in certain individuals who completed vaccination with certain non-FDA-authorized or -approved COVID-19 vaccines.

On January 31, 2022, the FDA announced the second approval of a COVID-19 vaccine. The vaccine has been known as the Moderna COVID-19 Vaccine, and will now be marketed as Spikevax, for the prevention of COVID-19 in individuals 18 years of age and older. Spikevax has the same formulation as the EUA Moderna COVID-19 Vaccine and is administered as a primary series of two doses, one month apart. Spikevax can be used interchangeably with the EUA Moderna COVID-19 Vaccine to provide the COVID-19 vaccination series.

Moderna COVID-19 Vaccine is available under EUA as a two-dose primary series for individuals 18 years of age and older, as a third primary series dose for individuals 18 years of age and older who have been determined to have certain kinds of immunocompromise, and as a single booster dose for individuals 18 years of age and older at least five months after completing a primary series of the vaccine.

The Moderna COVID-19 Vaccine is also authorized for use as a heterologous (or “mix and match”) single booster dose for individuals 18 years of age and older following completion of primary vaccination with a different available COVID-19 vaccine. For example, Pfizer-BioNTech COVID-19 Vaccine and Janssen COVID-19 vaccine recipients 18 years of age and older may receive a single booster dose of the Moderna COVID-19 Vaccine.

On August 23, 2021, FDA announced the first approval of a COVID-19 vaccine. The vaccine has been known as the Pfizer-BioNTech COVID-19 Vaccine, and will now be marketed as Comirnaty, for the prevention of COVID-19 in individuals 16 years of age and older.

Pfizer-BioNTech COVID-19 Vaccine is authorized for emergency use and is available under the EUA as a two-dose primary series for individuals 5 years of age and older, as a third primary series dose for individuals 5 years of age and older who have been determined to have certain kinds of immunocompromise, and as a single booster dose for individuals 12 years of age and older at least five months after completing a primary series of the vaccine.

The Pfizer-BioNTech COVID-19 Vaccine is also authorized for use as a heterologous (or “mix and match”) single booster dose for individuals 18 years of age and older following completion of primary vaccination with a different available COVID-19 vaccine. For example, Moderna and Janssen COVID-19 vaccine recipients 18 years of age and older may receive a single booster dose of the Pfizer-BioNTech COVID-19 Vaccine.

On November 17, 2021, CDC, in consultation with FDA, issued emergency use instructions to provide information about the use of the vaccine as an additional primary series dose or as a booster dose in certain individuals who completed vaccination with certain non-FDA-authorized or -approved COVID-19 vaccines.