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Laboratory Animals in Bacterial Vaccine Control and Some Opportunities for Replacement, Reduction and Refinement

In recent years, there has been a growing interest in alternatives to animal experimentation. Public attention was, and still is, focused on potential alternatives in toxicology in particular, probably because of the moral implications of testing some chemical products (e.g. cosmetics) by means of in vivo procedures such as the Draize eye test. In contrast, the use of laboratory animals for quality control of biological products such as vaccines is scarcely criticised. Nevertheless, the use of animals for that purpose is extensive and alternatives are urgently needed for several reasons. The development of models which can reduce the number of animals used or refine the experimental procedures used is receiving attention at several institutions. This paper outlines the activities of the Laboratory for the Control of Bacterial Vaccines of the National Institute of Public Health and Environmental Protection (RIVM) in the Netherlands, especially with regard to the testing of diphtheria and tetanus vaccines.