Pfizer-BioNTech COVID-19 Vaccine Gets Full FDA Approval: What to Know

• The United States reaches another pandemic milestone, with a COVID-19 vaccine fully approved by the Food and Drug Administration.
• The full approval is for use of the two-dose vaccine to prevent COVID-19 in people 16 years and older.
• However, children younger than 12 years old still do not have access to a vaccine yet.

The Food and Drug Administration (FDA) granted full approval to Pfizer-BioNTech’s COVID-19 vaccine, making it the first vaccine of its kind to reach this regulatory milestone in the United States.

This replaces the emergency use authorization (EUA) that the agency issued last December.

The full approval is for use of the two-dose vaccine to prevent COVID-19 in people 16 years and older. The vaccine will be marketed with the brand name Comirnaty.

The vaccine is still available for 12- to 15-year-olds and as a third dose for certain people with weakened immune systems through the existing emergency approval.

“While this and other vaccines have met the FDA’s rigorous, scientific standards for emergency use authorization, as the first FDA-approved COVID-19 vaccine, the public can be very confident that this vaccine meets the high standards for safety, effectiveness, and manufacturing quality the FDA requires of an approved product,” Acting FDA Commissioner Dr. Janet Woodcock said in a statement.