FDA Approves 2026-2027 Pfizer-BioNTech COVID-19 Vaccine

The FDA has approved a supplemental Biologics License Application from Pfizer and BioNTech for Comirnaty XFG, the companies' 2026-2027 COVID-19 vaccine formula targeting the XFG variant.¹ The vaccine is indicated for adults 65 years and older, as well as individuals ages five through 64 years with at least one underlying condition placing them at high risk for severe COVID-19 outcomes.¹

Selection of XFG follows FDA guidance identifying it as the preferred vaccine composition for the United States beginning fall 2026.¹ The approval rests on a cumulative body of evidence already submitted for Comirnaty, spanning clinical, non-clinical, and real-world data, along with manufacturing and quality information.¹

Non-clinical data specific to the XFG-adapted formula showed strong immune responses against XFG and against several other currently circulating SARS-CoV-2 lineages, including XFG11, NB181, PQ17, and PQ281.¹ Pfizer and BioNTech say this breadth of coverage supports protection against contemporary variants beyond XFG itself.

Shipping of the updated vaccine began immediately following approval, with doses expected to reach pharmacies, hospitals, and clinics nationwide within days.¹ The companies say rapid distribution is intended to ensure access ahead of the fall respiratory virus season.

More than five billion doses of Comirnaty have been distributed globally to date.¹ Pfizer and BioNTech describe the vaccine's safety and efficacy profile as favorable, citing extensive real-world evidence alongside clinical, non-clinical, pharmacovigilance, and manufacturing data collected since the original vaccine's authorization.

BioNTech remains the Marketing Authorization Holder for the Pfizer-BioNTech COVID-19 vaccine and its adapted formulas in the United States, the European Union, the United Kingdom, and other markets, and holds emergency use authorizations or equivalents elsewhere.

References

1.Pfizer and BioNTech receive US FDA approval for XFG-adapted COVID-19 vaccine. Pfizer Inc, BioNTech SE. news release. August 27, 2026. Accessed August 27, 2026. https://www.pfizer.com/news/press-release/press-release-detail/pfizer-and-biontech-receive-us-fda-approval-xfg-adapted