The European Medicines Agency has issued its annual recommendations for the influenza strains to be included in seasonal vaccines from autumn 2026, with separate guidance for egg-based, cell-based, and live-attenuated platforms.
Manufacturers of live-attenuated and egg-based vaccines should include three strains: an A/Missouri/11/2025 (H1N1)pdm09-like virus, an A/Darwin/1454/2025 (H3N2)-like virus, and a B/Tokyo/EIS13-175/2025 (B/Victoria lineage)-like virus. For cell-based vaccines, the H3N2 component shifts to an A/Darwin/1415/2025-like virus, and the B strain to a B/Pennsylvania/14/2025 (B/Victoria lineage)-like virus.
The recommendations continue the transition away from quadrivalent vaccines. The B/Yamagata influenza lineage, previously included as a fourth strain, has not been detected in circulation since March 2020 and is no longer considered a public health threat. For regions that have not yet completed the transition, manufacturers may still produce quadrivalent formulations using the WHO-recommended B/Phuket/3073/2013 (B/Yamagata lineage)-like virus.
EMA formulates its recommendations annually based on worldwide surveillance data collected by the WHO. Influenza viruses evolve continuously, making regular strain updates essential for maintaining vaccine effectiveness. Alongside the strain recommendations, EMA updated specifications for the reagents used in vaccine quality control.
Marketing authorization holders must submit applications to update the composition of centrally authorized seasonal influenza vaccines by June 15, 2026.
Source: EMA News