Pfizer, BioNTech’s COVID-19 Vaccine on Brink of Full FDA Approval
According to people familiar with the matter, the FDA is expected to grant full approval to Pfizer and BioNTech’s COVID-19 vaccine BNT162b2 as soon as Monday, The New York Times reported. The sources suggested that the agency was aiming to complete the process by August 20, but was still working through a large amount of paperwork, as well as continuing negotiations with the companies.
BNT162b2 first received an emergency-use authorization (EUA) last December for people 16 and up, with the EUA expanded more recently to include preventing COVID-19 in adolescents 12 through 15 years of age.
