The Paul-Ehrlich-Institut (PEI) has already released 19.9 million doses of influenza vaccine for the 2024/2025 season before the end of October 2024. This means that doctors' offices and pharmacies in Germany have sufficient vaccines available in time to meet the demand for influenza vaccinations. Additional vaccine batches are under review and will be released for the German market on an ongoing basis.
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For many years, influenza vaccines have contained four influenza strains recommended by the World Health Organization (WHO). Tetravalent influenza vaccines (also called quadrivalent) with these four strains were used for vaccination. WHO has recommended switching from tetravalent to trivalent influenza vaccines without the B/Yamagata line since September 2023, as there has been little evidence of a naturally occurring case of influenza caused by B/Yamagata since March 2020. That lack of evidence suggests that there is no longer any international circulation of this strain. The B/Yamagata virus component should be removed from influenza vaccines as soon as possible to avoid the theoretical risk of B/Yamagata viruses spreading again through the use of live attenuated vaccines. Dead vaccines will also transition to three strains, so trivalent vaccines will be the universal option. The European Medicines Agency (EMA) followed this recommendation in March 2024.
Since it was not possible for many manufacturers to transition to the trivalent vaccines at short notice, there will only be one trivalent live attenuated vaccine available for the 2024/2025 season. All other flu vaccines with approved strain updates have "tetra" added to their name. Inactivated tetravalent vaccines can still be used during the transitional period (until the 2025/2026 season at the latest) according to the recommendation of the Standing Committee on Vaccination (Ständige Impfkommission, STIKO) at the Robert Koch-Institut (RKI).
The following influenza vaccines will be marketed in Germany in the 2024/2025 season:
The Paul-Ehrlich-Institut's list of influenza vaccines also includes two trivalent flu vaccines with strain updates, however, these vaccines will not be marketed in Germany in the 2024/2025 season.
An annual flu vaccination is particularly recommended by the STIKO for high-risk groups such as the elderly, pregnant women, and people with chronic diseases. Since influenza viruses are constantly changing, regular vaccination is necessary to ensure optimal protection against the circulating strains. Vaccinations should be administered annually in autumn so that protection is established at the beginning of the flu season.
In Germany, all influenza vaccines are subject to federal batch testing. This testing is carried out by Official Medicines Control Laboratories (OMCLs), such as the Paul-Ehrlich-Institut. Randomly selected doses (test samples) of each production batch are tested. The Institute also checks the manufacturing documents and the results of the manufacturer's quality control examinations. Batch release will only be granted if all the criteria set out in the marketing authorisation have been met. If another European OMCL takes over the examination, the Paul-Ehrlich-Institut examines the certificate and issues the batch release for Germany.
Updated: 25.10.2024
