FDA grants full approval to Pfizer-BioNTech COVID-19 vaccine

Aug. 24, 2021

The U.S. Food and Drug Administration (FDA) granted full approval to the COVID-19 vaccine from Pfizer-BioNTech for people 16 years of age and older.

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

The FDA first approved an EUA for the Pfizer-BioNTech COVID-19 vaccine for people 16 years of age and older on December 11, 2020, and then expanded the authorization to include individuals 12-15 years old on May 10, 2021.

As part of the process for granting full approval of the 2-dose regimen in people 16 years and older, the agency analyzed effectiveness data from approximately 22,000 people who received the vaccine and 22,000 people who received a placebo. Based on results from the clinical trial, the vaccine was 91% effective in preventing COVID-19 disease.

Pfizer and BioNTech said they plan to seek FDA approval for a third, booster dose of the vaccine for people 16 years of age and older. The companies also plan apply for full FDA approval of the vaccine for use in individuals 12-15 years of age once the required data are available.

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