Vaccines and Biologics

PETA Science Consortium International works to replace the use of animals in the development and regulatory testing of human and veterinary vaccines, antitoxins, and other biologics. To advance the development and use of non-animal methods in biologic drug manufacturing and assessment, Science Consortium members collaborate with companies that manufacture these products as well as international regulatory agencies and standards organisations, including the European Directorate for the Quality of Medicines & HealthCare, the US Food and Drug Administration, the US Department of Agriculture, the US Pharmacopeia, India’s Central Drugs Standard Control Organisation, and the Indian Pharmacopoeia Commission. Once non-animal test methods gain regulatory approval in one region, the Science Consortium engages with other stakeholders to ensure that testing policies and official methods are revised and harmonised internationally.

The Science Consortium is currently working to accelerate the replacement of live hamsters in leptospirosis veterinary vaccine potency testing in the US with an in vitro test method. This in vitro test has been shown to be equal to the in vivo test at assessing potency, is less time-consuming (completed in days instead of the weeks needed for the animal-based test), and costs approximately 50% less than the in vivo test. Despite these advantages, hamsters are still used to test leptospirosis vaccines.

In 2022, the Science Consortium co-authored a publication assessing the progress made since a 2012 international workshop that summarised the barriers faced by industry and regulatory agencies interested in adopting the non-animal replacement method. While the total number of hamsters used to test these vaccines decreased by 55% between 2014 and 2020, an estimated 49,000 hamsters are still used each year despite successful efforts to resolve some of the issues raised in the 2012 workshop. The Science Consortium will work with the US Department of Agriculture and leptospirosis vaccine manufacturers to help implement and optimise the in vitro method with the ultimate aim of completely eliminating the use of hamsters to test these products. For questions about our work on leptospirosis vaccine potency testing, please contact Jeffrey Brown at [email protected].