The US Food and Drug Administration (FDA) has approved updated COVID-19 vaccines for the 2026–27 vaccination season, with the new formulations designed to target the XFG variant of SARS-CoV-2.
The updated vaccines include products from Pfizer-BioNTech, Moderna and Novavax, providing vaccine options based on both mRNA and protein-based technologies.
New COVID Vaccine Approved By FDA
The approvals come ahead of the upcoming respiratory virus season, as SARS-CoV-2 continues to evolve and newer variants circulate globally.
The updated formulations have been developed to generate an immune response against XFG and other contemporary SARS-CoV-2 lineages.
According to data submitted to the FDA, the updated Pfizer-BioNTech vaccine generated immune responses against several currently circulating variants, including XFG, XFG.1.1, NB.1.8.1, PQ.17 and PQ.2.8.1.
XFG Variant Included in Updated COVID-19 Vaccine Formulation
The FDA’s decision follows its guidance for the 2026–27 season, which called for COVID-19 vaccines to be updated to better match the SARS-CoV-2 variants currently in circulation.
The periodic updating of COVID-19 vaccines is intended to maintain their effectiveness as the virus continues to undergo genetic changes and new lineages emerge.
Pfizer-BioNTech Updated COVID-19 Vaccine to Roll Out in US
Pfizer and BioNTech said their updated COVID-19 vaccine will begin distribution in the US, with doses expected to become available through pharmacies, hospitals and healthcare clinics.
The companies said the updated vaccine is supported by previously submitted clinical, non-clinical and real-world data, along with manufacturing and safety information.
Following approval, the vaccines will continue to be monitored through established pharmacovigilance systems to assess their safety and performance in the wider population.
COVID-19 vaccines have undergone multiple updates since the beginning of the pandemic, with vaccine compositions revised periodically in response to changes in the circulating virus.
The latest approvals are aimed at ensuring that vaccines available during the 2026–27 season are better aligned with the current SARS-CoV-2 landscape and continue to provide protection against COVID-19.
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