FDA Approves Updated COVID-19 Vaccines Targeting XFG Variant for 2026–2027
The U.S. FDA has approved updated COVID-19 vaccines for the 2026–2027 season, formulated to target the currently dominant XFG variant of SARS-CoV-2. The approved vaccines include formulations from Moderna, Pfizer-BioNTech, and Novavax through its commercial partners Sanofi and Takeda.
The updated vaccines are intended to provide protection against circulating XFG-lineage variants and will offer options using both mRNA and protein-based vaccine platforms. The approvals come ahead of the upcoming respiratory-virus season as XFG continues to circulate widely.
The FDA approval is based on the cumulative body of evidence previously submitted by Pfizer and BioNTech that includes clinical, non-clinical and real-world data supporting the safety and effectiveness of COMIRNATY, as well as manufacturing/quality and non-clinical data showing that the XFG-adapted COVID-19 vaccine generated 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 contemporary lineages.
The selection of the XFG variant is based on guidance from the FDA as the preferred composition of COVID-19 vaccines for use in the U.S. beginning in fall 2026.3 This season’s Pfizer and BioNTech COVID-19 vaccine will begin shipping immediately and will be available in pharmacies, hospitals, and clinics across the U.S. in the coming days.
To date, more than five billion doses of COMIRNATY have been distributed globally, and it continues to demonstrate a favorable safety and efficacy profile supported by extensive real-world evidence as well as clinical, non-clinical, pharmacovigilance, and manufacturing data.
The COVID-19 vaccines by Pfizer and BioNTech are based on BioNTech’s proprietary mRNA technology and were developed by both companies. BioNTech is the Marketing Authorization Holder for the Pfizer-BioNTech COVID-19 vaccine and its adapted vaccines in the United States, the EU, the United Kingdom, and other countries, and the holder of emergency use authorizations or equivalents in other countries.
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