EMA issues 2025/2026 influenza vaccine composition update :- Medznat
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EMA issues flu vaccine composition guidance for 2025/2026 season

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EMA recommends updated trivalent influenza vaccines for the 2025/2026 season, selecting strains based on global surveillance data and excluding B/Yamagata due to its continued absence since 2020.

In a proactive move to ascertain efficient influenza prevention across Europe, the European Medicines Agency (EMA) has released its official recommendations on 1 April 2025 for the viral strains to be included in the seasonal flu vaccines for the 2025/2026 season. These guidelines help vaccine manufacturers tailor formulations that align with circulating strains, supporting public health efforts to minimize flu-related illness and hospitalization.

Updated Recommendations

The EMA advises including three specific influenza virus strains in trivalent vaccines, based on data from the World Health Organization’s (WHO) Global Influenza Surveillance and Response System. This recommendation reflects the agency's decision to shift focus from quadrivalent to trivalent formulations, given the continued global absence of the B/Yamagata lineage since early 2020.

For egg-based or live attenuated trivalent vaccines, the suggested strains are:

  • A/Victoria/4897/2022 (H1N1)pdm09-like virus
  • A/Croatia/10136RV/2023 (H3N2)-like virus
  • B/Austria/1359417/2021 (B/Victoria lineage)-like virus

For cell-based trivalent vaccines, the suggested strains are:

  • A/Wisconsin/67/2022 (H1N1)pdm09-like virus
  • A/District of Columbia/27/2023 (H3N2)-like virus
  • B/Austria/1359417/2021 (B/Victoria lineage)-like virus

Although the EMA now advocates a return to trivalent vaccines, manufacturers choosing to continue quadrivalent production may encompass a B/Yamagata-like strain, specifically B/Phuket/3073/2013.

Understanding the Shift Towards Trivalent Vaccines

The decision to drop the B/Yamagata lineage from standard flu vaccines stems from the lack of evidence of its circulation since the COVID-19 pandemic began. This absence, noted for over 4 years, allows health authorities to streamline vaccine production and focus resources on the most relevant virus types—two influenza A subtypes and one B lineage (Victoria).

Next Steps for Manufacturers

The EMA has set a deadline of 9 June 2025 for vaccine manufacturers with centrally authorized influenza products to submit updated strain compositions for the 2025/2026 season. This ensures timely review, approval, and distribution ahead of the autumn vaccination campaigns across Europe.

Ensuring Preparedness for the Flu Season

Seasonal influenza continues to pose a substantial health threat, particularly to older adults, young children, pregnant women, and those with underlying health ailments. By aligning annual vaccine formulations with global surveillance data, the EMA aims to maximize protection and curtail the burden of flu-linked complications and deaths.

Source:

European Medicines Agency

Article:

EU recommendations for 2025/2026 seasonal flu vaccine composition

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