U.S. FDA Approves Pfizer and BioNTech's XFG-Adapted COVID-19 Vaccine for 2026-2027 Season

The U.S. Food and Drug Administration (FDA) has approved Pfizer and BioNTech's supplemental Biologics License Application (sBLA) for their 2026-2027 COVID-19 vaccine formula. This updated vaccine targets the XFG variant and is approved for adults aged 65 years and older, as well as individuals aged 5 to 64 years with at least one underlying condition that places them at high risk for severe COVID-19 outcomes. The approval is based on clinical, non-clinical, and real-world data supporting the safety and effectiveness of COMIRNATY, showing strong immune responses against currently circulating SARS-CoV-2 variants.