COMIRNATY LP.8.1

August 27, 2026: Pfizer (NYSE: PFE) and BioNTech (NASDAQ: BNTX) said the FDA approved the supplemental BLA for the 2026-2027 COMIRNATY XFG (COVID-19 Vaccine, mRNA) formula targeting the XFG variant. The approval covers adults age 65 and older and individuals ages 5-64 with at least one underlying condition that increases risk for severe COVID-19.

The companies said the approval was based on previously submitted clinical, non-clinical, real-world, manufacturing/quality, and non-clinical immunogenicity data. They stated the XFG-adapted vaccine generated strong immune responses against circulating SARS-CoV-2 variants including XFG, XFG.1.1, NB.1.8.1, PQ.17, and PQ.2.8.1. The XFG strain selection follows FDA guidance for U.S. COVID-19 vaccines beginning in fall 2026.

Commercially, shipping will begin immediately, with availability in U.S. pharmacies, hospitals, and clinics in the coming days.