The FDA officially approved the Pfizer-BioNTech COVID-19 vaccine in late August. This is the first FDA-approved vaccine for the prevention of COVID-19 and potentially serious outcomes including hospitalization and death. Prior to this approval, COVID-19 vaccines had only received emergency use authorization (EUAs) – declarations that circumstances exist to justify the emergency use of drugs that have not been FDA-approved, particularly when no effective alternatives are available. Full FDA approval means that a drug has undergone the FDA’s full standard process for reviewing the quality, safety, and effectiveness of medical products. Based on results from the clinical trial, the vaccine was 91% effective in preventing COVID-19 disease.
