The European Commission authorized Pfizer and BioNTech’s XFG-adapted COVID-19 vaccine on July 29, 2026, clearing the updated 2026-2027 formula for use across the European Union and three additional countries for individuals 6 months of age and older.
The authorization covers all 27 EU Member States as well as Iceland, Liechtenstein, and Norway. The vaccine targets the XFG variant of the JN.1 lineage, which the European Medicines Agency’s Emergency Task Force identified as the preferred choice for the upcoming respiratory season.
The European Commission’s decision followed a positive recommendation from the EMA’s Committee for Medicinal Products for Human Use (CHMP) on July 23, 2026. That recommendation was based on cumulative clinical, non-clinical, and real-world data showing the monovalent XFG-adapted vaccine generated strong immune responses against multiple circulating SARS-CoV-2 lineages, including XFG, XFG.1.1, NB.1.8.1, PQ.17, PQ.2.8.1, and other contemporary variants, according to the Pfizer press release.
Pfizer and BioNTech have already begun manufacturing the vaccine at risk to ensure supply readiness ahead of the fall respiratory disease season. The companies said shipping will begin soon to enable rapid access across EU member states and other eligible countries.

This authorization follows a similar regulatory pathway established in 2025. The EMA’s CHMP recommended Pfizer-BioNTech’s LP.8.1-adapted COVID-19 vaccine for the 2025-2026 season on July 25, 2025, and the European Commission granted marketing authorization shortly after for deployment in fall 2025. The accelerated approval process for variant-adapted COVID vaccines reflects the EU’s amended regulatory procedure designed to speed authorizations as the virus evolves.
The EMA’s Emergency Task Force stated that “the evidence suggests that targeting XFG would provide the best protection against COVID-19” for the 2026-2027 season. The vaccine is formulated as a monovalent preparation, meaning it targets a single variant rather than multiple strains simultaneously.

According to Pfizer, more than five billion doses of Pfizer-BioNTech COVID-19 vaccines have been distributed globally since the vaccine’s initial authorization in December 2020. The companies are continuing to submit data for the updated 2026-2027 vaccine to regulatory authorities worldwide as they monitor the evolving epidemiology of COVID-19.
Sources
- Pfizer — press release announcing European Commission authorization for XFG-adapted COVID-19 vaccine for 2026-2027 season, data on immune response, manufacturing plans, and global distribution figures
- Reuters — EMA recommendation that vaccines target XFG variant for 2026-2027 season, issued May 29, 2026
- RTT News — confirmation of CHMP recommendation on July 23, 2026, and EC approval process
- Clinical Trial Vanguard — confirmation of cross-reactive immunity data against JN.1 lineage variants











