The Paul-Ehrlich-Institut, Federal Institute for Vaccines and Biomedicines started the annual batch release testing of influenza vaccines on 31 July 2020. In the meantime, 24 million doses have been released for German market. The batch testing is based on the strain adaptations approved by the Federal Institute or the EU Commission for the 2020/21 season. The Paul-Ehrlich-Institut publishes the number of vaccine doses released for the German market after batch release on a weekly basis at www.pei.de/influenza-vaccine-batch-release.
As different influenza viruses circulate each influenza season, vaccines against influenza (viral flu) must be adapted each year to the virus variants likely to circulate. The World Health Organization (WHO) and the European Medicines Agency (EMA) make annual their recommendation on this which form the basis for the production of influenza vaccines for the respective season.
For 2020/21 the Paul-Ehrlich-Institut has approved the strain adaptations for all influenza vaccines which have been granted a national marketing authorisation. The approval of the strain adaptation for vaccines centrally authorised in the EU was granted by the EU Commission. A total of seven tetravalent vaccines are available for use in Germany. In addition, the Paul-Ehrlich-Institut has approved the strain composition of three trivalent vaccines, which, however, are not marketed in Germany.
The governmental testing of vaccine batches prior to marketing is a legal requirement in Germany. Each batch (production unit) of an influenza vaccine is therefore released by the Paul-Ehrlich-Institut before it is marketed in Germany. To this end, experts from the Institute check the manufacturing documents and the results of the quality controls. In addition, the Paul-Ehrlich-Institut or another Official Medicines Control Laboratory (OMCL) in another European country examines the test samples from the manufactured batch experimentally to ensure the high quality of the influenza vaccines. The Paul-Ehrlich-Institut will only grant the batch release if the criteria specified in the marketing authorisation for the vaccine are fulfilled. Persons who have been vaccinated can be sure that the vaccines administered in Germany are safe and effective.
Updated: 23.11.2020
