The U.S. Food and Drug Administration (FDA) approved Pfizer and BioNTech’s supplemental Biologics License Application for an updated COVID-19 vaccine. This new formula targets the circulating XFG variant for the 2026-2027 autumn season.
The approval applies to adults aged 65 and older. It also covers individuals aged 5 to 64 with underlying conditions that increase the risk of severe COVID-19 outcomes.
Regulators based the decision on clinical, non-clinical, and real-world data supporting the safety of the COMIRNATY platform. The updated vaccines will soon be available at pharmacies and clinics across the U.S.