The U.S. Food and Drug Administration (FDA) has approved the 2026–2027 XFG-adapted COVID-19 vaccine developed by Pfizer and BioNTech. The updated COMIRNATY XFG vaccine is approved for adults aged 65 and older, as well as individuals aged 5 to 64 with at least one underlying condition that increases their risk of severe COVID-19.
The approval follows FDA guidance recommending an XFG-based vaccine composition for the upcoming fall 2026 season. Data submitted by Pfizer and BioNTech showed strong immune responses against XFG and other currently circulating SARS-CoV-2 variants.
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Shipments of the updated vaccine will begin immediately, with availability expected at pharmacies, hospitals and clinics across the U.S. in the coming days. The vaccine uses BioNTech’s mRNA technology and has been jointly developed by Pfizer and BioNTech. More than five billion doses of COMIRNATY have been distributed globally to date.
