European Commission authorizes Pfizer and BioNTech XFG-adapted COVID-19 vaccine in the European Union

Pfizer and BioNTech SE announced that the European Commission (EC) has granted marketing authorization for the companies’ 2026-2027 COVID-19 vaccine formula, targeting the XFG variant, for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 6 months of age and older. The adaptation is based on the recommendation from the Emergency Task Force (ETF) of the European Medicines Agency (EMA) to update COVID-19 vaccines to target the XFG variant of the JN.1 lineage for the 2026-2027 season. The ETF stated that “the evidence suggests that targeting XFG would provide the best protection against COVID-19.”

The marketing authorization is valid in all 27 European Union (“EU”) Member States, as well as Iceland, Liechtenstein and Norway. Pfizer and BioNTech have already initiated manufacturing of the monovalent XFG-adapted COVID-19 vaccine at risk to ensure supply readiness in anticipation of the respiratory disease season, when the demand for COVID-19 vaccination is expected to increase. EU Member States as well as Norway, will be supplied either via the EC contract or according to individual country government policies.

The EC approval follows the EMA’s Committee for Medicinal Products for Human Use (CHMP) recommendation from July 23, 2026 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 efficacy of the Pfizer and BioNTech COVID-19 vaccine as well as manufacturing/quality and non-clinical data showing that the monovalent XFG-adapted COVID-19 vaccine generated strong immune responses against currently circulating SARS-CoV-2 lineages, including XFG, XFG.1.1, NB.1.8.1, PQ.17, PQ.2.8.1 and other contemporary lineages.2

The companies have also submitted data for the updated COVID-19 vaccine to regulatory authorities around the world. The companies are continuing to monitor the evolving epidemiology of COVID-19 in preparation to meet global public health needs.

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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