EMA has issued the Biologics Working Party (BWP) Ad hoc Influenza Working Group - Amended European Union recommendations for the seasonal influenza vaccine composition for the season 2021/2022 for the prevention of seasonal influenza from autumn 2021.

Manufacturers of egg-based or live attenuated trivalent vaccines for the 2021/2022 season should include these three virus strains:

  • an A/Victoria/2570/2019 (H1N1)pdm09-like virus;
  • an A/Cambodia/e0826360/2020 (H3N2)-like virus;
  • a B/Washington/02/2019 (B/Victoria lineage)-like virus

Manufacturers of cell-based trivalent vaccines for the 2021/2022 season should include these three virus strains:

  • an A/Wisconsin/588/2019 (H1N1)pdm09-like virus;
  • an A/Cambodia/e0826360/2020 (H3N2)-like virus;
  • a B/Washington/02/2019 (B/Victoria lineage)-like virus

For quadrivalent vaccines with two influenza B viruses, a B/Phuket/3073/2013-like virus should be added to the strains mentioned above.

These recommendations apply to the manufacture of both inactivated and live attenuated influenza vaccines.

Every year, EMA's ad hoc Influenza Working Group issues EU recommendations for the composition of seasonal influenza vaccines on the basis of observations by the World Health Organization. The recommendations for the influenza season 2021/2022 were endorsed by EMA's human medicines committee (CHMP) at its March 2021 meeting.

Influenza viruses continuously change and evolve. The periodic replacement of the virus strains contained in influenza vaccines is therefore necessary to keep them effective.

The Agency recommends that marketing authorisation holders submit applications to change the composition of centrally authorised seasonal flu vaccines by 14 June 2021.

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