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Reduction of animal tests: EURL ECVAM contributed to the recently adopted VICH guideline on "Harmonization of criteria to waive the target animal batch safety testing for inactivated vaccines for veterinary use"

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Apr 16, 2013
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The new guideline on "Harmonization of criteria to waive the target batch animal safety testing for inactivated vaccines for veterinary use" (VICH GL50) was recently adopted by the Committee for Medicinal Products for Veterinary Use of the European Medicines Agency (EMA).

Since 2008, EURL ECVAM has been working on behalf of EMA with VICH  experts on the development of this guideline. Its implementation (from 1st March 2014 onwards) is a major step towards international harmonisation and will reduce the number of animals used for batch release testing.

How does this guideline contribute to the reduction of animal tests?

Each batch of a vaccine has to undergo strict quality control before it is released on the market. Some of these batch release tests are carried out in animals, for example the target animal batch safety test (TABST). Since 1st April 2013, the TABST is no longer required in Europe and has been deleted from the European Pharmacopoeia monographs for veterinary vaccines. However, outside of Europe and European Pharmacopoeia countries the TABST is still requested for batch release. With the new VICH GL50 European manufacturers have the possibility to apply for a waiver of the TABST when exporting to the other VICH regions (Japan, North America) or countries following the VICH guidelines.

Role of EURL ECVAM

EURL ECVAM had been a driving force for this change by addressing questions  on the relevance of the target animal batch safety test, which were raised  for many years by European control authorities and manufacturers. EURL ECVAM launched in 1997 a retrospective study analysing target animal batch safety test data provided by manufacturers and control authorities. The ECVAM Scientific Advisory Committee peer reviewed the results of the study and stated in 2002 that the target animal batch safety test is no longer relevant and should be omitted for routine batch control.

This had been incorporated into the European Pharmacopoeia and from 2004 onwards (until its deletion) manufacturers had the possibility to waive the TABST provided that their vaccines fulfilled the waiving criteria, i.e. the manufacturer had to demonstrate to the control authorities that at least 10 batches of his product had not failed the TABST.

After successful finalisation of the VICH guideline for inactivated veterinary vaccines, EURL ECVAM will now support the development of a comparable guideline for live vaccines.

Background to the TABST

The TABST was introduced several decades ago during the development of the first veterinary vaccines and became a mandatory batch release test in 1970s. It is a general safety test which should demonstrate that a vaccine does not cause abnormal local or systemic reactions. However, over the last 20 years, the relevance of the TABST for the safety of a vaccine was questioned by European control authorities and manufacturers. The introduction of good manufacturing practice and more specific safety tests have significantly improved the quality and safety of vaccines.