FDA Approves First COVID-19 Vaccine

On August 23, 2021, the Food and Drug Administration (FDA) released an announcement that the Pfizer-BioNTech COVID-19 Vaccine, now marketed as Comirnaty (koe-mir’-na-tee), has been approved for use for individuals 16 years of age and older to help with the prevention of the COVID-19 disease.

The vaccine also continues to be available under emergency use authorization (EUA) for individuals 12 through 15 years of age and for the administration of a third dose in certain immunocompromised individuals.

FDA-approved vaccines undergo the agency’s standard process for reviewing the quality, safety and effectiveness of medical products.

For all vaccines, the FDA evaluates data and information included in the manufacturer’s submission of a biologics license application (BLA). For Comirnaty, the BLA builds on the extensive data and information previously submitted that supported the EUA. The agency conducts its own analyses of the information to make sure the vaccine is safe and effective and meets the FDA’s standards for approval.

Read the full release on the FDA website.