FDA, EMA and WHO guidance on updating COVID-19 vaccines for winter 2025/26

As the northern hemisphere prepares for the 2025/26 respiratory virus season, both the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), as well as the World Health Organization (WHO), have issued new recommendations for updating the antigenic composition of COVID19 vaccines. These updates are based on the latest surveillance data, immunogenicity studies, and the evolving landscape of SARS-CoV-2 variants. FDA recommendations (United States) On May 22, 2025, the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) unanimously recommended that all COVID19 vaccines for the 2025-2026 season be updated to a monovalent formulation based on the JN.1 lineage, with a preference for the LP.8.1 subvariant if feasible. This recommendation follows a comprehensive review of: Current variant circulation, with LP 8.1 now dominant in the U.S. Vaccine effectiveness data showing continued benefit from JN.1-lineage vaccines. Immunogenicity and antigenic characterization studies indicate robust protection against emerging subvariants. The FDA has advised vaccine manufacturers—Moderna, Pfizer/BioNTech,...