FDA approves first COVID-19 vaccine, but was it pushed into speedy action?

The US Food and Drug Administration late Friday issued the first emergency use authorization (EUA) for a vaccine for the prevention of coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 16 years of age and older.

The emergency use authorization allows US pharma giant Pfizer (NYSE: PFE) and German partner BioNTech’s (Nasdaq: BNTX) vaccine, dubbed BNT162b2, to be distributed in the USA. The decision follows a 17-4 vote by a panel of FDA exports to recommend approval of the vaccine on Thursday.

The FDA has determined that the Pfizer-BioNTech COVID-19 vaccine has met the statutory criteria for issuance of an EUA. The totality of the available data provides clear evidence that the Pfizer-BioNTech vaccine may be effective in preventing COVID-19. The data also support that the known and potential benefits outweigh the known and potential risks, supporting the vaccine’s use in millions of people 16 years of age and older, including healthy individuals.