European Journal of Epidemiology

, Volume 10, Issue 4, pp 513–514 | Cite as

Licensing and control authority batch release of influenza vaccine in Germany in accordance with EEC regulations

  • M. Weeke-Lüttmann
Third Session: Social And Regulatory Aspects Of Management Of A Pandemic


The epidemiological situation calls for almost yearly changes in the antigenic composition of influenza vaccine, thus necessitating fresh licensing procedures. Since the time for bringing a new vaccine onto the market should be relatively short, the following work of all parties involved must be done expeditiously: 1) WHO recommendations on new virus strains and their subsequent adaptation by the EEC (February/March); 2) Distribution of the new virus strains to the International Reference Centers for Influenza in the UK and USA (February/ March); the centers later issue reference materials for the determination of the haemagglutinin antigen concentration (April/May); 3) Production and testing of seed virus by manufacturers, as well as validation of the producer's inactivation process for the new virus strains (May/June); 4) Licensing of the vaccines by the National Control Authority (Paul-Ehrlich-Institute) (June/July); in the case of previously licensed products, the procedure is limited essentially to the approval of the detailed protocol of production and tests on the new virus strains, clinical studies not being required before licensing because of a lack of time; 5) Paul-Ehrlich-Institute's test for batch release, according to Directive 89/342/EEC, besides protocol approval, conducts material testing of the endotoxin and antigen content of each vaccine lot; the assay for the antigen quantification is especially laborious and sometimes must be repeated because of test invalidity.

Key words

Batch release Inactivation process Influenza vaccine Licensing seed virus 

Copyright information

© Kluwer Academic Publishers 1994

Authors and Affiliations

  • M. Weeke-Lüttmann
    • 1
  1. 1.Paul-Ehrlich-InstitutLangenGermany

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