FDA Approves Pfizer-BioNTech's XFG-Adapted COVID-19 Vaccine for 2026-2027 Season

Pfizer and BioNTech announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental biologics license application for their 2026-2027 COVID-19 vaccine formula, Comirnaty XFG, which targets the XFG variant. The approval covers adults 65 years and older, as well as individuals ages 5 through 64 who have at least one underlying condition that puts them at high risk for severe COVID-19 outcomes.

The FDA based its approval on the companies’ existing body of clinical, nonclinical and real-world evidence supporting Comirnaty’s safety and effectiveness, along with manufacturing and nonclinical data showing the XFG-adapted formula generates strong immune responses against currently circulating variants, including XFG, XFG.1.1, NB.1.8.1, PQ.17 and PQ.2.8.1.

Why XFG Was Selected

The companies said their selection of the XFG variant follows FDA guidance identifying it as the preferred vaccine composition for the U.S. beginning in fall 2026. Shipping for the updated vaccine began immediately, with availability expected at pharmacies, hospitals and clinics across the country in the coming days.

Track Record and Technology

More than 5 billion doses of Comirnaty have been distributed globally to date, with the companies citing a continued favorable safety and efficacy profile supported by real-world evidence alongside clinical, nonclinical, pharmacovigilance and manufacturing data. The vaccine is built on BioNTech’s mRNA platform, with BioNTech serving as the marketing authorization holder for the Pfizer-BioNTech COVID-19 vaccine and its adapted formulas across the U.S., EU, U.K. and other markets.

Safety Considerations

Comirnaty carries important safety information, including the possibility of severe allergic reactions, which typically occur within minutes to an hour of vaccination. Myocarditis and pericarditis have also been reported following mRNA COVID-19 vaccination, most commonly in male individuals ages 12 through 24, with symptoms generally appearing within a week of vaccination. Individuals with weakened immune systems may have a reduced immune response to the vaccine, and it may not protect everyone who receives it. Commonly reported side effects include injection site reactions, fatigue, headache, muscle pain, chills, fever and nausea, among others.