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[Application of the 3 R]

This report describes the various ways in which animal experiments were replaced, reduced or refined by the manufacturer in the quality control of the tick-borne encephalitis (TBE) vaccine over the past fifteen years. The total number of test animals was reduced from 4.278 to 2.011 per vaccine lot. This involves a reduction of 34.005 test animals per year. If a further planned change submitted to the regulatory authorities is approved, the number of animals used will be further reduced to 961 per vaccine lot. This will result in a total saving of 49.755 animals per year. A newly developed TBE vaccine, which will be submitted to the EC regulatory authorities in 1997, will involve even further reductions in the number of test animals required for quality control. Only 531 test animals will be required per lot for this newly developed vaccine i. e. almost 90% reduction compared to the numbers required for the original vaccine. It has been possible to convince the national regulatory authority that only a minimal amount of animal tests are essential for the quality control of this vaccine. This has been made possible by the intensive search for replacement tests and by the high standard of validation of these tests. It will probably not be possible to totally eliminate animal tests for vaccine quality control in the future. However, the vigorous implementation of the 3R"s will certainly lead to a reduction in the number of animals required and the reduction of animal suffering. The aim of this policy must be seen not only as a reduction in the number of animals used, but primarily a reduction in suffering to the lowest possible levels for the animals still required.