Paul-Ehrlich-Institut

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In­fluen­za Sea­son 2021/2022 – First In­fluen­za Vac­cine Batch­es Re­leased

The Paul-Ehrlich-Institut (PEI), Federal Institute for Vaccines and Biomedical Products, has started this year's batch testing of influenza vaccines and released the first 10.7 million doses for the German market up to and including 29 August 2021. The batch tests are based on the strain adjustments approved by the Paul-Ehrlich-Institut or the EU Commission for the 2021/2022 season. The Paul-Ehrlich-Institut publishes the number of influenza vaccine doses it has released for the German market after batch testing on a weekly basis at www.pei.de/influenza-vaccine-batch-release.

Batch testing vaccines (Source: gopixa/shutterstock.com)

Strain Adjustment for 2021/2022 Completed

Different influenza virus variants circulate in each influenza season. Therefore, influenza (viral flu) vaccines must be adapted each year to the virus variants that are expected to circulate. The World Health Organization (WHO), confirmed for the EU by the European Medicines Agency (EMA), make recommendations on this every year, which form the basis for the production of influenza vaccines for the respective season.

For 2021/2022, the Paul-Ehrlich-Institut has approved the strain adjustments for all nationally licensed influenza vaccines applied for. The EU Commission has approved the master adjustments for the vaccines centrally authorised in the EU. In total, nine tetravalent vaccines are available for use in Germany this year. In addition, the Paul-Ehrlich-Institut has approved the strain composition of one trivalent vaccine, which, however, will not be marketed in Germany.

Tetravalent Vaccines (for Marketing in Germany)

  • Afluria Tetra 2021/2022
  • Efluelda 2021/2022
  • Fluad Tetra 2021/2022
  • Flucelvax Tetra 2021/2022
  • Fluenz Tetra 2021/2022
  • Influsplit Tetra 2021/2022
  • Influvac Tetra 2021/2022
  • Vaxigrip Tetra 2021/2022
  • Xanaflu Tetra 2021/2022

Trivalent Vaccine (not Marketed in Germany)

  • Influvac 2021/2022

High Quality through Batch Testing

The official batch testing of vaccines before marketing is required by law in Germany. Therefore, each batch (production unit) of influenza vaccine is approved by the Paul-Ehrlich-Institut before it is marketed in Germany. Experts from the Institute check the manufacturing documents and the results of the quality controls for this purpose. In addition, the Paul-Ehrlich-Institut or another Official Medicines Control Laboratory (OMCL) in another European country examines the test samples of the manufactured batches experimentally to ensure the high quality of the influenza vaccines. Only if the criteria specified in the approval of the vaccine with regard to its quality are met, the Paul-Ehrlich-Institut will issue the batch release. People who get vaccinated can rest assured that the vaccines administered in Germany are safe and effective.

Updated: 31.08.2021