Comirnaty COVID-19 Vaccine Approved by the U.S. FDA

The U.S. Food and Drug Administration (FDA) announced today its Approval for the Comirnaty COVID-19 vaccine to prevent COVID-19 disease in individuals 16 years of age and older in the USA. 

The Approval was granted to BioNTech Manufacturing GmbH.

The Comirnaty vaccine continues to be available under FDA emergency use authorization, including for individuals 12 through 15 years of age and for the administration of the third vaccine dose in certain immunocompromised individuals.

The result of a person receiving this vaccine is that their immune system will ultimately react defensively to the SARS-CoV-2 betacoronavirus that causes COVID-19, says the FDA.

In the USA, the Comirnaty vaccine had been known as the Pfizer-BioNTech COVID-19 Vaccine.

FDA-approved vaccines undergo the agency’s standard process for reviewing medical products' quality, safety, and effectiveness. The FDA granted this vaccine application a Priority Review.

The FDA is based in Maryland and is an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices.