European Commission Authorizes Pfizer and BioNTech COVID-19 Vaccine Adapted for XFG Variant

The European Commission has granted marketing authorization for Pfizer and BioNTech's updated COVID-19 vaccine, adapted to target the XFG variant. The authorization is valid across all 27 EU member states, as well as Iceland, Liechtenstein, and Norway. The vaccine is intended for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals aged 6 months and older.

The decision follows a recommendation from the European Medicines Agency's (EMA) Emergency Task Force (ETF) to update COVID-19 vaccines to target the XFG variant, part of the JN.1 lineage, for the 2026-2027 season. The ETF indicated that targeting XFG would provide the best protection against COVID-19. The Commission's authorization aligns with the EMA's Committee for Medicinal Products for Human Use (CHMP) recommendation on July 23, which was based on extensive clinical, non-clinical, and real-world data submitted by the companies.

Pfizer and BioNTech have already begun manufacturing the monovalent XFG-adapted COVID-19 vaccine at risk to ensure supply readiness for the upcoming respiratory disease season. The vaccine utilizes BioNTech's mRNA technology. The companies continue to monitor the evolving epidemiology of COVID-19 globally and have submitted data for the updated vaccine to regulatory authorities worldwide.

Pfizer and BioNTech have distributed more than five billion doses of their COVID-19 vaccines globally, and the vaccine has demonstrated a favorable safety and efficacy profile. Shipping of this season's vaccine is expected to begin shortly to ensure rapid access.