The European Commission has granted marketing authorization for Pfizer and BioNTech’s 2026-2027 COVID-19 vaccine formula targeting the XFG variant, clearing the shot for active immunization against COVID-19 caused by SARS-CoV-2 in people 6 months and older. The authorization is valid across all 27 European Union member states as well as Iceland, Liechtenstein and Norway.
Pfizer and BioNTech said the updated monovalent vaccine was designed for the upcoming respiratory disease season and is already being manufactured at risk to help ensure supply readiness. Shipping is expected to begin soon so doses can reach markets quickly ahead of seasonal demand.
The companies said the decision follows a recommendation from the European Medicines Agency’s Emergency Task Force, which advised updating COVID-19 vaccines to target the XFG variant of the JN.1 lineage for the 2026-2027 season. The task force said the evidence suggests targeting XFG would provide the best protection against COVID-19.
Pfizer and BioNTech said the authorization is supported by a cumulative package of clinical, non-clinical and real-world data, along with manufacturing and quality data showing the 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 said the vaccine also demonstrated a favorable safety and efficacy profile.
The firms said more than five billion doses of their COVID-19 vaccines have been distributed globally. They added that they continue to monitor the evolving epidemiology of COVID-19 and have submitted updated vaccine data to regulators around the world as they prepare to meet global public health needs.
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