FDA approves Pfizer and BioNTech's updated COMIRNATY XFG

Pfizer and BioNTech announced on August 27 that the US Food and Drug Administration approved their supplemental Biologics License Application for their 2026–2027 COVID-19 vaccine formula, COMIRNATY XFG. The updated formula targets the XFG variant.

The authorization covers adults aged 65 and older, as well as individuals aged 5 to 64 with high-risk underlying conditions. The approval aligns with FDA strain guidance for fall 2026, supported by clinical, real-world, and manufacturing data demonstrating strong immune responses against circulating strains.

For Pfizer, the seasonal clearance helps stabilize recurring cash flows as it funds its non-COVID pipeline in oncology, obesity, and immunology, while managing elevated debt levels ahead of upcoming patent expirations.