Target Animal Batch Safety Testing

Developed decades ago when vaccine production methods were much less precise than they are today, the target animal batch safety test (TABST) was intended to show that each batch of vaccine produced was safe in a specific (or target) animal species. Today, the consensus among the scientific community is that this test lacks specificity and is not reproducible. Such an unreliable test is especially inappropriate given the strict process controls that ensure consistent quality across batches in modern vaccine production.

Science Consortium members PETA US and PETA UK prompted the UK government to remove the fee that formerly disincentivised companies from seeking an exemption from compulsory TABST. Additionally, they ensured that the government established oversight procedures to promote and verify that this exemption was granted by the government. Ultimately, these Science Consortium members successfully petitioned the European Directorate for the Quality of Medicines & HealthCare to remove TABST from all veterinary vaccine monographs in the European Pharmacopoeia. To ensure that these successes are replicated elsewhere, including in the US and India, where the Science Consortium has supported the introduction of TABST waivers by government agencies, we continue to work on this issue with regulatory bodies, including VICH, a trilateral programme aimed at harmonising technical requirements for veterinary product registration among the EU, Japan, and the US.