EDQM welcomes WHO recommendation to end innocuity test in vaccines, biologicals

The European Directorate for the Quality of Medicines & HealthCare (EDQM) has welcomed the recommendation of the WHO Expert Committee on Biological Standardization (ECBS) to omit the abnormal toxicity test (also called the innocuity test) in all future WHO documents on vaccines and other biological products, and to disregard the inclusion of this test in previously published WHO Technical Report Series documents. The ECBS bases its recommendations on the consideration that the omission of the abnormal toxicity test would not compromise the quality and safety of vaccines and other biological products. Animal tests such as the abnormal toxicity test were developed for the safety testing of human vaccines at a time when limited scientific knowledge for the quality control of biological products existed. Over the past decades, researchers have identified viable alternatives, and current manufacturing processes, including the Good Manufacturing Practices (GMP) and in-process quality controls, can ensure a more appropriate level of quality and safety for vaccines and other biological products than the abnormal toxicity test. More info: www.edqm.eu/sites/default/files/press_release_edqm_welcomes_recommendation_on_innocuity_test_november_2018.pdf