EU Authorizes Pfizer-BioNTech XFG-Adapted COVID-19 Vaccine for Ages 6 Months and Up

The European Commission on Tuesday authorized Pfizer and BioNTech’s updated COVID-19 vaccine targeting the XFG variant for people 6 months and older, clearing the way for countries across Europe to use the shot ahead of the 2026-27 respiratory virus season.

The marketing authorization, granted July 29, applies across the European Union’s 27 member states under the bloc’s centralized drug approval system. It is also valid in Iceland, Liechtenstein and Norway. Pfizer and BioNTech said the decision followed a positive recommendation issued July 23 by the European Medicines Agency’s Committee for Medicinal Products for Human Use, the agency panel that evaluates medicines for use in the EU.

The newly authorized shot is Pfizer and BioNTech’s 2026-27 monovalent COVID-19 vaccine, meaning it targets a single strain. It has been adapted to the XFG variant, which the companies describe as a descendant of the JN.1 lineage of Omicron-related SARS-CoV-2 variants. The authorization covers active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals ages 6 months and older.

The update reflects regulators’ effort to better match vaccines to the variants now circulating. The European Medicines Agency’s Emergency Task Force had recommended that COVID-19 vaccines for the 2026-27 season be updated to target XFG, part of the JN.1 family of Omicron descendants. In Pfizer and BioNTech’s July 29 release, the task force was quoted as saying that “the evidence suggests that targeting XFG would provide the best protection against COVID-19.”

Pfizer and BioNTech said data submitted to regulators showed the updated vaccine generated strong immune responses against currently circulating lineages and supported a favorable safety and efficacy profile. Those findings were described by the companies in announcing the authorization.

The companies also said they had begun at-risk manufacturing of the XFG-adapted vaccine in preparation for supply. They said EU member states and Norway would receive doses either through a European Commission contract or under individual national government policies.

The EU-wide authorization is a regulatory green light, but it does not by itself determine who will be offered the updated shot or when campaigns will begin. Those decisions will be made by national health authorities, which set vaccination recommendations and rollout plans in each country.