FDA approves XFG-adapted COVID-19 vaccine
The 2026 to 2027 formulation aligns with FDA guidance on the preferred composition for COVID-19 vaccines beginning this fall.
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By
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Kathryn Wighton
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August 28, 2026
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The FDA approved Pfizer and BioNTech’s XFG-adapted COVID-19 vaccine for adults 65 and older and high-risk patients aged 5 to 64.
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The approval is for the 2026 to 2027 formulation targeting the XFG variant, based on FDA guidance.
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The vaccine demonstrated immune responses against various circulating SARS-CoV-2 variants, including XFG and others.
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COMIRNATY should not be given to individuals with a history of severe allergic reactions to the vaccine or its components.
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Reported adverse events include injection-site reactions, fatigue, headache, and rare cases of myocarditis and pericarditis.