Successful Initiative by the Paul-Ehrlich-Instituts: Fewer Animal Experiments in Vaccine Testing

In a few day's time, as from 1st July 2002, the European Pharmacopeia will require considerably fewer animal tests than previously for regular vaccine testing. The decisive initiative for such a change originates from work by the Paul-Ehrlich-Institut performed between 1993 and 1995. This work was supported by the Federal German Ministry for Education and Research. The objective of the trials at the Paul-Ehrlich-Institut was to establish ways to save animals in the quality control of immunobiologicals within a scientifically acceptable framework. "We have submitted concrete suggestions from this project as suggestions for change - i.e. so-called "requests for revision" - at the European Pharmacopoeia Commission", declares Prof. Johannes Löwer, the President of the Paul-Ehrlich-Institut. Following this, the applications had to be discussed in the appropriate expert group of the European Pharmacopoeia, in which a representative of the Paul-Ehrlich-Institut is also a member. After the European Pharmacopoeia accepted the applications of the Paul-Ehrlich-Institut in its 110th session in June 2001, the appropriately changed testing specifications will now come into force in the whole of Europe on 1st July 2002.

As Prof. Löwer says concerning this: "We are proud of the success by the Paul-Ehrlich-Institut which was so extensive, even in the whole of Europe. Being the President of a testing authority, I am particularly pleased that we could prove that the high demands made on the safety and quality of vaccines can be fulfilled even if considerably fewer animals than before are used today".

The changes recently decided upon particularly refer to toxicity and efficacy tests in guinea pigs and mice.

• Two types of animal tests previously required for diphtheria and tetanus vaccine assays in the finished product (toxicity) have been eliminated without replacement.
• Two more tests for diphtheria vaccines will be replaced by a cell culture test (toxicity).
• The arrangement of the assay will be modified in five other tests for the toxicity and efficacy of diphtheria, tetanus and pertussis. This can reduce the requirement for animals pr vaccine batch by 40 to 60%.

For batch testing of vaccines to be sold in Germany, this alone will save roughly 5000 guinea pigs and mice per year.

Efforts have also been made to modify the cost decree of the Paul-Ehrlich-Institut in such a way as to reduce animal experiments wherever possible. The current version of the decree has been applicable since 1st May 2002 (published in the Federal Law Gazette No I, page 1483). In contrast to the previous decree, it allows the Paul-Ehrlich-Institut to renounce charging fees in the event of notifications of change which lead to a replacement or the avoidance of animal experiments.

Animal protection was adopted as part of the Grundgesetz (German constitution) a few days ago. The above examples show that the Paul-Ehrlich-Institut has been taking this issue seriously and has been making efforts to promote it for years.

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