Elimination of abnormal toxicity test for sera and certain vaccines in the European Pharmacopoeia

This is in response to a letter from Gupta on the utility of the abnormal toxicity test (ATT) for vaccines. We agree with his comments and suggestions that this test is not necessary for vaccines. In this report, we summarize the current status of ATT in the European Pharmacopoeia (Eur. Pharm.). The ATT of the Eur. Pharm. does, in principle, have the same implications as similar tests in the United States Code of Federal Regulations (CFR) and the World Health Organization (WHO) requirements. The purpose of the tests is to detect any toxicity unrelated to the product. The differences between the tests are listed. In 1994 the Paul-Ehrlich Institute (PEI), Federal Agency for Sera and Vaccines in Germany, circulated a detailed questionnaire to all manufacturers which have vaccines licensed in Germany. The manufacturers who answered this questionnaire were: Behringwerke AG (Germany), Connaught (CLL, Canada and CLI, USA), Evans/Wellcome (UK), Lederle/Praxis (USA), Pasteur/Merieux (France), MSD Merck Sharp and Dome (USA), SmithKline Biologicals (Belgium), Biocine/Sclavo (Italy), through the Instituto Superiore di Sanita in Rome. These companies represent the majority of European and North American vaccine manufacturers, both in terms of numbers of manufacturers and amount of vaccine produced.