Session I-16: Alternatives for potency testing of rabies vaccines Session I -16: Oral presentations

Vaccines are subject to requirements that regulate their quality and safety. Due to their biological origin, vaccines are complex products which can be influenced by various factors. As a result, each batch of the finished product is tested on potency and safety. the use of animals in batch release testing is a regulatory obligation and represents around 80% of the total number of animals used in the vaccine industry. Over the last decades this heavy reliance on animal experimentation has met serious ethical, scientific and economic objections. However, despite the increase of 3R models to ensure vaccine quality and european legislation requiring the adoption of 3Rs alternatives where possible, the acceptance and use of 3Rs methods falls behind. this raises the question which factors influence the acceptance and use of 3R models for regulatory purposes and how should this process be optimised. the author aims at clarifying the mechanism of regulatory acceptance and implementation by defining the main obstacles and drivers influencing this process. For this purpose a case study on the rabies vaccine has been conducted that examines the acceptance of 3R models, such as a serology test developed by the PeI in Germany, to replace the regulatory required NIH potency test for veterinary rabies vaccines. The case study consists of literature research and interviews with regulatory authorities and vaccine manufacturers. In order to fully understand the mechanism of regulatory acceptance, the findings are put in the context of technology acceptance in the area of risk regulation. this study serves as input to the discussion between regulatory authorities and industry on how to optimise the process of acceptance of 3R models for quality control of vaccines in general and veterinary-rabies vaccines in particular. I-16-381 Drivers and barriers to acceptance and use of 3R models for the quality control of veterinary rabies vaccines M.-J. Schiffelers 1, C. Hendriksen 2, B. Blaauboer 3 and W. Bakker 1 1Utrecht University School of Governance, Utrecht, the Netherlands; 2Netherlands Vaccine Institute, Bilthoven, the Netherlands; 3Institute for Risk Assessment Sciences, Utrecht, the Netherlands