The Commission for the European Pharmacopoeia and the U. S. Department of Agriculture have agreed that the for years controversial discussed Abnormal Toxicity Test (ATT) for safety assessment of vaccine batches will be deleted from the regulations. From 2019 the test does not being used any longer in Europe.

In the "test for the absence of abnormal toxicity", mice or guinea pigs are a fixed concentration of the test vaccine is administered intravenously. There are two test versions in the European pharmacopoeia. In one version, mice are used: If two mice die within 24 hours, the batch has failed. If no animal dies, the batch can pass trough. Each batch is checked.

 

Since the mid-1990s, scientists at the Paul Ehrlich Institute questioned the relevance of this test. Positive results did not allow conclusions to be drawn about poor batch quality and the test does not allow conclusions for harmful reactions in target organism in a high degree of accuracy. The European Federation of Pharmaceutical Industries and Associations (efpia) had spoken for the abolition of this test in June 2017 because, among other things, there was no reliable evidence that conclusions can be drawn from this test.

In Europe, the "Abnormal Toxicity Test", which is used for batch safety testing of human vaccines, will be removed from all the pharmacopoeia monographs in 2019. In the United States, the authorities recently announced that they will authorise an animal-free replacement for the target animal batch safety test for quality control and production consistency of veterinary vaccines.

The Humane Society International reported that it is believed that up to 15 percent of the more than 100 million animals are used for batch releases of vaccines per year.

 

Sources:

 

Krämer, B., Nagel, M., Duchow, K., Schwanig, M. & Cussler, K. (1996): Is the abnormal toxicity test still relevant for the safety of vaccines, sera and immunoglobulins? ALTEX. 13(1): 7-16.

Cussler, K. (2015): The Scientific Relevance of the ATT – Today and from a historical Perspective. Vortrag EPAA – International Workshop “Towards global harmonization of 3Rs in biologicals” am 15-16 September 2015. https://circabc.europa.eu/sd/a/713b9d43-9383-4681-a46a-054c6249c40b/ihb%20sept%202015%205%20Case%20study%201_Klaus%20Cussler.PDF

Tellner, P. (2017): Deletion of test for abnormal toxicity from European pharmacopoeia. European Federation of Pharmaceutical Industries and Associations (efpia). 30/06/2017.
https://www.efpia.eu/media/219814/deletion-of-test-for-abnormal-toxicity-from-european-pharmacopoeia.pdf