EU Approves Pfizer-BioNTech's XFG-Adapted COVID-19 Vaccine For 2026-2027 Vaccination Season

Pfizer and BioNTech have received marketing authorisation from the European Commission (EC) for their XFG-adapted COVID-19 vaccine for the 2026–2027 immunisation season. The updated vaccine is approved for active immunisation against COVID-19 in individuals aged six months and older and is designed to target the XFG variant of the JN.1 SARS-CoV-2 lineage.

The approval follows the recommendation of the European Medicines Agency's (EMA) Emergency Task Force (ETF), which advised updating COVID-19 vaccines for the upcoming vaccination season to target the XFG variant. According to the task force, the available data indicate that the XFG-adapted formulation is expected to provide the best possible protection against currently circulating COVID-19 variants. The European Commission's decision also follows a positive opinion issued by the EMA's Committee for Medicinal Products for Human Use (CHMP) on 23 July 2026.

The marketing authorisation is valid across all 27 European Union member states as well as Iceland, Liechtenstein, and Norway. To ensure vaccine availability ahead of the upcoming cold and flu season, Pfizer and BioNTech have already begun manufacturing the updated monovalent vaccine at risk before receiving formal approval. Vaccine doses will be supplied to EU member states and Norway through the existing European Commission procurement agreement or through individual national procurement mechanisms.

The approval is supported by a comprehensive package of clinical, non-clinical, manufacturing, quality, and real-world data submitted by the two companies. According to the data, the updated vaccine generates strong immune responses against several currently circulating SARS-CoV-2 variants, including XFG, XFG.1.1, NB.1.8.1, PQ.17, PQ.2.8.1, and other related lineages. The findings also reinforce the established safety and effectiveness profile of Pfizer and BioNTech's COVID-19 vaccine platform.

Beyond Europe, Pfizer and BioNTech have submitted regulatory applications for the updated vaccine to health authorities in several other countries. The companies said they will continue monitoring the evolution of COVID-19 variants worldwide to ensure their vaccines remain aligned with changing public health needs and emerging viral strains.

The Pfizer-BioNTech COVID-19 vaccines are based on BioNTech's proprietary messenger RNA (mRNA) technology and have been jointly developed by the two companies since the start of the pandemic. The vaccine platform is currently authorised in multiple countries, including the United States, the European Union, the United Kingdom, and several other global markets, with additional emergency use authorisations and approvals supporting its worldwide availability.