August 23, 2021 – The U.S. Food and Drug Administration (FDA) this morning formally approved Pfizer’s COVID-19 vaccine. The widely anticipated decision replaces the emergency use authorization (EUA) granted by the agency last December.
This is the first COVID-19 vaccine to be subject to a full review by the U.S. regulator and to get an approval that puts the vaccine at the same level as other marketed vaccines.
The FDA’s full approval applies to people 16 and older. Those between ages 12 through 15 can still receive the vaccine under the existing EUA.
According to NPR, the full approval could make it easier for employers, the military and universities to mandate vaccination and may reassure those who are hesitant about the safety of taking vaccine that was not fully approved.
According to CDC data, as of Sunday, 73% of adults have had at least one dose of the Pfizer, Moderna, or Johnson & Johnson vaccine. Pfizer’s vaccine is most commonly administered, accounting for about 56% of the doses administered overall.
Moderna’s COVID-19 vaccine remains under FDA’s review, but its approval is expected to follow in the near future.