Pfizer Inc. and BioNTech SE have received marketing authorisation from the European Commission (EC) for their updated 2026–2027 COVID-19 vaccine targeting the XFG variant of SARS-CoV-2. The approval covers active immunisation for individuals aged six months and older to prevent COVID-19 and will be valid across all 27 European Union Member States, as well as Iceland, Liechtenstein and Norway.

The updated vaccine follows the recommendation of the European Medicines Agency's (EMA) Emergency Task Force (ETF), which advised that COVID-19 vaccines for the 2026–2027 vaccination season should target the XFG variant within the JN.1 lineage. According to the ETF, available evidence indicates that an XFG-targeted vaccine is expected to provide the most effective protection against circulating COVID-19 strains.

The European Commission's decision came shortly after the EMA's Committee for Medicinal Products for Human Use (CHMP) issued a positive recommendation on July 23, 2026. The recommendation was based on a comprehensive body of clinical, non-clinical and real-world evidence demonstrating the safety and effectiveness of the Pfizer-BioNTech COVID-19 vaccine, alongside manufacturing and quality data supporting the updated formulation.

Studies submitted to regulators showed that the monovalent XFG-adapted vaccine generated strong immune responses against several currently circulating SARS-CoV-2 lineages, including XFG, XFG.1.1, NB.1.8.1, PQ.17, PQ.2.8.1 and other contemporary variants.

To ensure timely availability ahead of the expected rise in respiratory infections, Pfizer and BioNTech have already initiated at-risk manufacturing of the updated vaccine. Distribution to European Union Member States and Norway will take place through the existing European Commission procurement agreement or according to individual national vaccination policies.

The companies have also submitted regulatory applications for the updated vaccine in multiple international markets and continue to monitor the evolving epidemiology of COVID-19 to support global vaccination strategies.

Pfizer and BioNTech stated that the updated vaccine demonstrates a favourable safety and efficacy profile while providing strong immune protection against emerging SARS-CoV-2 variants. Shipments are expected to begin shortly to facilitate rapid access before the 2026–2027 respiratory disease season.

The Pfizer-BioNTech COVID-19 vaccines are based on BioNTech's proprietary mRNA technology and have been jointly developed by the two companies. To date, more than five billion doses of the Pfizer-BioNTech COVID-19 vaccine have been distributed worldwide. BioNTech remains the marketing authorisation holder for the vaccine and its adapted formulations in the United States, European Union, United Kingdom and several other countries, while also holding emergency use authorisations or equivalent approvals in additional global markets.