Pfizer and BioNTech secure U.S. FDA approval for their XFG-adapted COVID-19 vaccine

Pfizer and BioNTech SE announced that the U.S. Food and Drug Administration has approved the supplemental Biologics License Application for their 2026 to 2027 COVID-19 vaccine formula, which targets the XFG variant, for use in adults 65 and older, as well as in individuals ages 5 through 64 who have at least one underlying condition placing them at higher risk of severe outcomes from COVID-19.

The FDA’s decision draws on the extensive body of evidence Pfizer and BioNTech have previously submitted, encompassing clinical, non-clinical, and real world data supporting the safety and effectiveness of COMIRNATY, along with manufacturing, quality, and non-clinical data showing that the XFG-adapted vaccine produced strong immune responses against currently circulating SARS-CoV-2 variants, including XFG, XFG.1.1, NB.1.8.1, PQ.17, PQ.2.8.1, and other present-day lineages.

The choice of the XFG variant follows FDA guidance identifying it as the preferred composition for COVID-19 vaccines used in the U.S. starting in fall 2026. This season’s vaccine from Pfizer and BioNTech will begin shipping right away, reaching pharmacies, hospitals, and clinics across the country within days.

More than five billion doses of COMIRNATY have now been distributed worldwide, and the vaccine continues to show a favorable safety and efficacy profile, backed by substantial real world evidence along with clinical, non-clinical, pharmacovigilance, and manufacturing data. The Pfizer-BioNTech COVID-19 vaccines rely on BioNTech’s proprietary mRNA technology and were jointly developed by both companies. BioNTech holds the Marketing Authorization for the Pfizer-BioNTech COVID-19 vaccine and its adapted versions in the United States, the EU, the United Kingdom, and other countries, and holds emergency use authorizations or their equivalents elsewhere.

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