The target animal safety test--is it still relevant?

In Europe, the target animal safety test (TAST) is stipulated by 52 European Pharmacopoeia monographs, by three European Union (EU) Directives and a number of EU guidelines as a routine test for veterinary immunologicals, to be carried out on the finished product. TAST data from seven European Official Member States Control Laboratories (OMCLs) and 14 manufacturers were retrospectively analysed. During 1994-1997, 11185 vaccine batches had been submitted for batch release, and the OMCLshad tested 670 batches in the TAST (665 passed, 4 passed after retesting, 1 failed). In total, 82 of these batches were not released; however, in only one case this was due to failure in the TAST. The data received from the 14 manufacturers covered the years from 1997 to 1999. 11386 batches were tested in the TAST,of which 215 passed after retesting and 7 failed. Although only 30% of the OMCLs provided data and the data of the manufacturers are not complete they clearly indicate that the TAST does not contribute to the safety of veterinary vaccines and should therefore not be required as a routine batch test. In cases, where it appears to be necessary, detailed guidance on the test design and evaluation should be given.