Pfizer-BioNTech COVID-19 Vaccine - FDA Briefing Document - December 10, 2020

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.

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