On Aug. 23, 2021, the Food and Drug Administration (FDA) granted full approval to the Pfizer-BioNTech COVID-19 vaccine for use in individuals 16 years of age and older. This is the first COVID-19 vaccine and first mRNA to receive full approval and is being marketed as Comirnaty.

Pfizer-BioNTech's mRNA vaccine became the first COVID-19 vaccine to receive FDA's Emergency Use Authorization (EUA) on Dec. 11, 2020. The vaccine is currently authorized for emergency use in children ages 5-15.

Pfizer-BioNTech has also received an EUA for administration of a single COVID-19 vaccine booster dose for all individuals 12 years of age and older. The FDA has authorized the use of a single booster dose five months after completion of the primary vaccination series of the Pfizer-BioNTech COVID-19 vaccine. The Pfizer-BioNTech vaccine is also available to those who completed the Moderna primary series six months ago or those who completed the J&J primary vaccine two months ago.

The other authorized mRNA COVID-19 vaccine and booster dose available is produced by Moderna. Johnson & Johnson-owned Janssen Pharmaceuticals offers an authorized SARS-CoV-2 viral vector vaccine and booster dose, however, mRNA COVID-19 vaccines are preferred for the primary series and booster dose, over the J&J COVID-19 vaccine for the prevention of COVID-19 for those 18 years of age and older due to the risk of rare adverse events such as thrombosis with thrombocytopenia (TTS). 


Find clinical vaccine guidance from the U.S. Food and Drug Administration (FDA), Centers for Disease Control and Prevention (CDC) and other health organizations.

FDA

Learn more about FDA information on COVID-19 vaccines and the FDA's Vaccines and Related Biological Products Advisory Committee.

CDC

Learn more about the CDC's Advisory Committee on Immunization Practices. The CDC offers a guide on preparing for COVID-19 vaccination for health care professionals and a COVID-19 vaccination communications tool kit for medical centers, clinics and clinicians.


Explore featured AMA news and media about the Pfizer-BioNTech COVID-19 vaccine, including the AMA COVID-19 Video Update.

AMA COVID-19 Video Update

News highlights

Media coverage

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