FDA approves updated Pfizer-BioNTech COVID-19 vaccine targeting XFG variant

Pfizer and BioNTech said on August 27, 2026 that the FDA approved a supplemental Biologics License Application for their updated COVID-19 vaccine formula aimed at the XFG variant, branded COMIRNATY XFG, COVID-19 Vaccine, mRNA¹.

The clearance covers adults ages 65 years and older, as well as individuals ages 5 through 64 years who have at least one underlying condition that raises their risk of severe COVID-19 outcomes¹.

The companies said the FDA's decision drew on prior clinical, non-clinical, and real-world evidence for COMIRNATY, plus new manufacturing and non-clinical data indicating the XFG-adapted shot triggered robust immune responses against several circulating strains, among them XFG, XFG.1.1, NB.1.8.1, PQ.17, PQ.2.8.1 and other contemporary lineages¹.

According to the release, the choice of XFG as the target strain followed the FDA's recommendation on the preferred vaccine composition for the United States starting in fall 2026¹.

The companies said shipping would begin right away, with the vaccine reaching pharmacies, hospitals, and clinics across the U.S. within days¹.

The release also noted that more than five billion doses of COMIRNATY have been distributed worldwide to date¹, and that BioNTech serves as the Marketing Authorization Holder for the vaccine in the U.S., EU, UK, and other markets¹.

Standard safety information accompanied the release, including warnings about rare severe allergic reactions and cases of myocarditis and pericarditis reported mostly in males aged 12 to 24, with symptoms typically beginning within a week of vaccination¹.