FDA Approves First COVID-19 Vaccine 8/23/21

The FDA approved the first COVID-19 vaccine for the prevention of COVID-19 disease in individuals 16 years of age and older on August 23, 2021.

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

“The FDA’s approval of this vaccine is a milestone as we continue to battle the COVID-19 pandemic,” said Acting FDA Commissioner Dr. Janet Woodcock.

“Our scientific and medical experts conducted an incredibly thorough and thoughtful evaluation of this vaccine,” said Dr. Peter Marks, Director of the Center for Biologics Evaluation and Research. “Although we approved this vaccine expeditiously, it was fully in keeping with our existing high standards for vaccines in the U.S.”

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