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The U.S. Food and Drug Administration (FDA) has approved the latest version of Pfizer and BioNTech's COVID-19 mRNA vaccine, specifically designed to target the dominant XFG variant, for use in adults 65 and older, as well as those ages 5 through 64 with at least one underlying health condition that raises their risk for severe illness. The companies announced the approval Thursday (August 27), highlighting that the new formula, known as COMIRNATY XFG, generated strong immune responses against several circulating variants, including XFG, XFG.1.1, NB.1.8.1, and PQ.17, in clinical and real-world studies.
According to the official Pfizer statement, the FDA's decision follows guidance recommending that this year's COVID-19 vaccines focus on the XFG variant for the 2026–2027 immunization season. The new vaccine is set to ship out immediately and will be available at pharmacies, hospitals, and clinics across the United States in the coming days.
The approval comes as part of a broader FDA move to authorize updated vaccines from Moderna, Novavax-Sanofi, and Pfizer-BioNTech, all aimed at protecting Americans from the now-dominant XFG variant. The advisory panel voted earlier this year to target XFG, and all manufacturers had stated they could provide updated doses for the fall season.
The Centers for Disease Control and Prevention (CDC) has not yet issued official recommendations for this year's COVID-19 vaccines, but medical organizations and insurers have indicated continued coverage for those eligible. Health experts say the vaccines should begin arriving in pharmacies and doctors' offices starting in September, ahead of the typical respiratory virus season. Recent CDC data shows the XFG.1.1 variant is the most common strain causing illness nationally, though overall COVID-19 cases and hospitalizations remain relatively low. However, the CDC notes a rising test positivity rate approaching five percent in mid-August.
The FDA continues to recommend that individuals consult with their healthcare providers to determine if vaccination is appropriate, especially for those with high-risk conditions such as asthma, heart, kidney, liver or lung disease, diabetes, obesity, or pregnancy, as outlined by the CDC.
The new vaccine formula is part of an ongoing effort by Pfizer and BioNTech to adapt COVID-19 vaccines in line with emerging variants and public health guidance. Since the start of the pandemic, more than five billion doses of COMIRNATY have been distributed globally, with ongoing monitoring for safety and effectiveness. Anyone experiencing side effects from the vaccine can report them to the Vaccine Adverse Event Reporting System (VAERS).
The CDC is expected to issue updated recommendations soon, and insurance coverage is anticipated to remain in place for those meeting eligibility criteria.