FDA Approves Pfizer-BioNTech COVID-19 Vaccine

The U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) for Pfizer Inc. and BioNTech SE’s 2026-2027 COVID-19 vaccine formula targeting the XFG variant (COMIRNATY XFG) for use in adults ages 65 years and older, as well as in individuals ages 5 through 64 years with at least one underlying condition that puts them at high risk for severe outcomes from COVID-19.

The FDA approval is based on the cumulative body of evidence previously submitted by Pfizer and BioNTech that includes clinical, non-clinical and real-world data supporting the safety and effectiveness of COMIRNATY, as well as manufacturing/quality and non-clinical data showing that the XFG-adapted COVID-19 vaccine generated strong immune responses against currently circulating SARS-CoV-2 variants, including XFG, XFG.1.1, NB.1.8.1, PQ.17, PQ.2.8.1 and other contemporary lineages.

The selection of the XFG variant is based on guidance from the FDA as the preferred composition of COVID-19 vaccines for use in the U.S. beginning in fall 2026. This season’s Pfizer and BioNTech COVID-19 vaccine will begin shipping immediately and will be available in pharmacies, hospitals, and clinics across the U.S. in the coming days.