On This Day: FDA fully approves the Pfizer COVID-19 vaccine

On August 23, 2021, the Food and Drug Administration (FDA) fully approves the Pfizer-BioNTech COVID-19 vaccine for people aged 16 and older, following a manufacturing review and analysis of the company’s expanded clinical trial, which included approximately 44,000 participants and found the vaccine to be 91% effective in preventing COVID-19 disease. 

The Pfizer-BioNTech vaccine was the first COVID-19 vaccination to receive full review and approval from the U.S. regulatory agency. (FDA approval for the vaccine’s use in children aged 5 through 11 followed in October 2021.)

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