The European Commission has authorized Pfizer and BioNTech’s updated COVID-19 vaccine formula for the 2026-2027 season, approving a version designed to target the XFG variant of SARS-CoV-2.

 

The authorization allows the vaccine to be used for active immunization against COVID-19 in individuals aged six months and older across all 27 European Union member states, as well as Iceland, Liechtenstein and Norway.

 

Pfizer and BioNTech said the updated monovalent XFG-adapted vaccine generated strong immune responses against currently circulating SARS-CoV-2 lineages, including XFG, XFG.1.1, NB.1.8.1, PQ.17 and PQ.2.8.1.

 

The companies have already begun manufacturing doses to ensure supply availability ahead of the upcoming respiratory disease season, when demand for COVID-19 vaccination is expected to rise.

 

The approval follows a recommendation from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP), which reviewed clinical, non-clinical and real-world data supporting the vaccine’s safety, efficacy and manufacturing quality.

 

The European Medicines Agency’s Emergency Task Force (ETF) recommended updating COVID-19 vaccines to target the XFG variant of the JN.1 lineage, stating that “the evidence suggests that targeting XFG would provide the best protection against COVID-19.”

 

Pfizer and BioNTech said the companies have also submitted data on the updated vaccine to regulatory authorities worldwide and will continue monitoring COVID-19 trends to support global vaccination needs.

 

The Pfizer-BioNTech COVID-19 vaccines, based on BioNTech’s proprietary mRNA technology, have been distributed more than five billion times globally.

 

Pfizer and BioNTech developed the vaccine through their ongoing partnership, with BioNTech serving as the Marketing Authorization Holder for the vaccine and adapted versions in the European Union, United States, United Kingdom and several other markets.

 

The companies said the updated vaccine maintains a favorable safety and efficacy profile, while continuing to address the evolving nature of SARS-CoV-2 variants.