FDA Authorizes First Covid-19 Vaccine

Late last week, the U.S. Food and Drug Administration issued the first Emergency Use Authorization (EUA) for a COVID-19 vaccine in the United States. The vaccine is manufactured by Pfizer Inc. and BioNTech SE. It consists of two doses taken three weeks apart, and is indicated for use in individuals 16 years of age and older.

The official authorization follows Thursday's meeting of FDA's Vaccines and Related Biological Products Advisory Committee to review and discuss information about the vaccine. The external advisory panel voted to recommend that FDA grant authorization, agreeing that the benefits of the vaccine outweigh its risks for use. While it did not ultimately have to follow the Committee's recommendation, FDA officially did so on Friday.