USA – Pfizer-BioNTech COVID-19 Vaccine : official FDA assessment result

On November 20, 2020, Pfizer and BioNTech (the Sponsor) submitted an Emergency Use
Authorization (EUA) request to FDA for an investigational COVID-19 vaccine (BNT162b2)
intended to prevent COVID-19 caused by severe acute respiratory syndrome coronavirus 2
(SARS-CoV-2). The vaccine is based on the SARS-CoV-2 spike glycoprotein (S) antigen
encoded by RNA and formulated in lipid nanoparticles (LNPs). The proposed use under an EUA is “for active immunization for the prevention of COVID-19 caused by SARS-CoV-2 in
individuals 16 years of age and older.” The proposed dosing regimen is 2 doses, 30 µg each, administered 21 days apart…