Replacing the NIH test for rabies vaccine potency testing: a synopsis of drivers and barriers.
Approximately 70% of animal use is utilized to demonstrate quality control of vaccines. Especially rabies vaccine potency testing, using the NIH challenge test, involves objections in terms of scientific relevance, animal welfare concern and costs. Several 3R models have been proposed to refine, reduce or replace this test. Some are formally incorporated into regulatory requirements, but actual regulatory acceptance and use by industry lags behind, raising the question concerning which factors influence this process. This question is answered by a combination of literature review, interviews and a survey among 50 rabies vaccine experts. The findings are analyzed using the multilevel perspective on technology transition, which distinguishes 3 levels of factors influencing innovation acceptance. At the micro level (where 3R models are developed and validated) the dis-advantages of, and fractional experience with, 3R models, scarce data sharing and demanding validation processes exist. The meso level (existing regulatory regime) encloses the barriers of the 'gold standard', the lack of harmonization and the driving force of legislation stimulating 3Rs use. The macro level (the societal context) combines risk aversion and increased concern for animal welfare. Regulatory acceptance and use of 3R models requires dedicated stakeholder communication, cooperation and coordination at all three levels.
Utrecht University School of Governance, Bijlhouwerstraat 6, 3511 ZC Utrecht, The Netherlands. Electronic address: m.j.w.a.schiffelers@uu.nl.
Marie-Jeanne
MJ
Schiffelers
Utrecht University, Institute for Risk Assessment Sciences (IRAS), P.O. Box 80.178, 3508 TD Utrecht, The Netherlands.
Bas
B
Blaauboer
Utrecht University School of Governance, Bijlhouwerstraat 6, 3511 ZC Utrecht, The Netherlands.
Wieger
W
Bakker
Institute for Translational Vaccinology (InTraVacc), P.O. Box 450, 3720 AL Bilthoven, The Netherlands; Utrecht University, Faculty of Veterinary Medicine, Department Animals in Science and Society, The Netherlands.
Coenraad
C
Hendriksen
D000826:Animal Testing Alternatives / Q000592:standards; D000818:Animals; D003144:Communication Barriers; D006801:Humans; D062069:Inventions / Q000592:standards; D008962:Models, Theoretical; D009316:National Institutes of Health (U.S.); D012929:Psychological Distance; D011818:Rabies / Q000276:immunology; D011819:Rabies Vaccines / Q000276:immunology*; D018581:Technology Transfer; D014481:United States; D014611:Vaccination / Q000523:psychology / Q000662:veterinary; D064166:Vaccine Potency
D011819:Rabies Vaccines
3R models; Barriers and drivers; Multilevel innovation perspective; Potency testing; Rabies vaccines; Regulatory acceptance