FDA Approval of the Pfizer-BioNtech COVID-19 Vaccine: Frequently Asked Questions [Updated September 29, 2021] [open pdf - 1MB]
From the Document: "In August 23, 2021, the U.S. Food and Drug Administration (FDA) approved the Coronavirus Disease 2019 (COVID-19) vaccine manufactured by Pfizer and BioNTech for individuals 16 years of age or older. The Pfizer-BioNTech COVID-19 vaccine is the first COVID-19 vaccine--and the first vaccine based on messenger RNA (mRNA) technology-- to be licensed by FDA. Pfizer and BioNTech will market their licensed COVID-19 vaccine under the brand name Comirnaty (pronounced koe-MIR-na-tee). [...] FDA's approval of Comirnaty has caused some confusion about the scope of FDA's approval, the relationship between Comirnaty and the Pfizer-BioNTech COVID-19 vaccine, and other issues. This report addresses some common questions about FDA's approval of Comirnaty."
CRS Report for Congress, R46913
Congressional Research Service: https://crsreports.congress.gov/