EMA releases 2024/2025 seasonal influenza vaccine ingredient recommendations – Association

The European Medicines Agency (EMA) has issued recommendations on influenza strains that vaccine manufacturers should include in vaccines against seasonal influenza from autumn 2024.

Each year, the EMA publishes EU recommendations on the composition of seasonal influenza vaccines based on observations from the World Health Organization (WHO), which are based on regular activities to monitor the prevalence and characteristics of different influenza viruses around the world.

Based on these data, the EMA emergency working group issued a statement recommending a transition from the quadrivalent vaccine to the trivalent vaccine that does not contain the B/Yamagata component.

Since the B-Yamagata strain no longer appears to pose a threat to public health, the EMA has said there is no need to include it in flu vaccine formulations. Additionally, the ETF recommends that this strain should ideally be removed from all live-attenuated vaccines starting in the 2024/2025 season.

To ensure vaccine supply for the next vaccination campaign, the EMA said all other influenza vaccines should complete the transition to trivalent compositions by the 2025/2026 season.

Taking into account the ETF statement and the thoughts and advice of the WHO, the EMA Task Force on Influenza has issued the following strain recommendations for this year.

Manufacturers of live attenuated or trivalent egg vaccines must include the following three strains for the 2024/2025 season: viruses similar to A/Victoria/4897/2022 (H1N1)pdm09; viruses similar to A/Thailand/8/2022 (H3N2); viruses similar to B/Austria/1359417/2021 (B/Victoria lineage).

Likewise, manufacturers of trivalent cellular vaccines should include the following three strains for the 2024/2025 season: viruses similar to A/Wisconsin/67/2022 (H1N1)pdm09; viruses similar to A/Massachusetts/18/2022 (H3N2) Viruses; viruses similar to B/Austria/1359417/2021 (B/Victoria lineage).

Inactivated vaccine manufacturers may consider producing a quadrivalent vaccine containing two influenza B strains for the 2024/2025 season. In this case, in addition to the above-mentioned strains, viruses similar to B/Phuket/3073/2013 (B/Yamagata lineage) are considered suitable.

The EMA Committee for Medicinal Products for Human Use (CHMP) approved the recommendations for the 2024/2025 influenza season at its March 2024 meeting.

The EMA reminds that influenza viruses are constantly changing and evolving. Therefore, it is necessary to regularly change the strains of viruses contained in influenza vaccines to maintain the effectiveness of the vaccine.

Finally, EMA recommends that marketing authorization holders submit applications for changes to the centralized authorization of seasonal influenza vaccine ingredients by June 17, 2024.