The Paul-Ehrlich-Institut (PEI), the Federal Institute for Vaccines and Biomedicines, is once again prepared for this year's influenza vaccine demand. This year it is possible to be vaccinated with an adapted COVID-19 vaccine and the influenza vaccine at the same time and thus obtain immune protection against both viral diseases.
As of late September 2023, the Paul-Ehrlich-Institut had already released over 20 million doses of influenza vaccine.
Influenza viruses are constantly changing. Different influenza virus subtypes circulate in the population during each influenza season. This means that the antigens in the influenza vaccines need to be adapted each year to the expected circulating virus variants (known as the seasonal strain update) in order to ensure protection against influenza. The World Health Organization (WHO) makes annual recommendations for influenza vaccine composition. Those recommendations form the basis for the influenza vaccine strain adjustment for the upcoming influenza vaccination season in the northern hemisphere. The WHO recommendations are based on observations of influenza virus variant circulation in the southern hemisphere, where the influenza season takes place half a year before our season in the northern hemisphere. With the participation of the Paul-Ehrlich-Institut, the Committee for Human Medicinal Products (CHMP) at the European Medicines Agency (EMA) confirms the WHO’s recommendations, which makes them binding for the EU.
For the influenza season 2023/2024, there are nine tetravalent (containing four antigens of different influenza virus variants) influenza vaccine products that will be available for use in Germany having completed the approved seasonal strain update. This is the same amount of vaccines as were available in the previous season.
Most flu vaccines are authorised for individuals from six months or two years of age. However, there are also vaccine products that have been specially developed for certain age groups. Examples are the high-dose vaccine and the vaccine with an adjuvant for the elderly as well as the live attenuated vaccine for children and adolescents, which was developed as a nasal spray.
Federal batch testing by an Official Medicines Control Laboratory (OMCL), such as the Paul-Ehrlich-Institut, is required by law for all vaccines used in Germany. Randomly selected doses (test samples) of each batch (production unit) of each influenza vaccine product are tested by the Paul-Ehrlich-Institut or an OMCL in another European country. Experts check the manufacturing documents as well as the results of the manufacturer's quality control examinations to ensure the high quality of each batch of influenza vaccines. The Paul-Ehrlich-Institut will only grant federal batch release for Germany if the quality criteria specified in each vaccine product's marketing authorisation have been met and all specifications have been complied with.
Federal batch release for Germany is always issued by the Paul-Ehrlich-Institut. If another European OMCL has taken over the batch testing, the Paul-Ehrlich-Institut evaluates the certificate issued and issues the federal batch release on this basis. Conversely, the Paul-Ehrlich-Institut issues certificates for the authorities of other Member States if the batch testing is carried out on-site at the Paul-Ehrlich-Institut.
Updated: 26.09.2023
