Workshop on Alternative Methods for Rabies Vaccine Testing
NICEATM and the International Alliance for Biological Standardization co-organized an October 2018 workshop on "Implementing Nonanimal Approaches to Human and Veterinary Vaccine Testing: Achieving Scientific and Regulatory Success for Rabies and Beyond"
October 11-13, 2011
U.S. Department of Agriculture Center for Veterinary Biologics
National Centers for Animal Health
Ames, Iowa, USA
This workshop brought together over 70 international experts from government, industry, and academia to
- Review the available methods and approaches that reduce, refine, and replace animals used in human and veterinary rabies vaccine potency testing
- Develop an implementation strategy to achieve global acceptance and use of these alternatives
The U.S. Department of Agriculture Center for Veterinary Biologics and the International Alliance for Biological Standardization were sponsors of the workshop.
USDA Issues Policies Incorporating Workshop Recommendations
The U.S. Department of Agriculture (USDA) Center for Veterinary Biologics (CVB) Notice 12-12 (May 2012) provides guidance on the use of humane endpoints and methods in animal testing of biological products, refining animal use for this purpose. Key provisions include:
- Clarification of the humane endpoint for all animal challenge potency tests codified in 9 CFR 113
- Guidance on establishing humane endpoints for potency test that do not follow standard requirements
- Statement encouraging the use of anesthesia for intracranial inoculation of mice
CVB Notice 13-10 (July 2013) eliminates the upper limit LD50 for a valid challenge test as a validity requirement when conducting the rabies virus potency test. Tests in which the challenge LD50 is greater than the upper limit are now acceptable. This is expected to reduce the number of animals used for rabies vaccine testing.
Video on Humane Endpoints to Replace Lethal Parameters in Batch Potency Tests of Rabies Vaccines
This video, discussed at the October 2011 rabies vaccine workshop and the September 2010 ICCVAM vaccine workshop, is available on the Humane Endpoints in Laboratory Animal Experimentation website, which is administered by the Netherlands Center for Alternatives to Animal Use. Please note that the video is on the secured section of the website, which requires the user to register and receive approval for access.
Video credit: Klaus Cussler, Tamara Folz, Joachim Hartinger, Coenraad F.M. Hendriksen, Bjorn V.L. Steen and David A. Morton. The HELP Group (Humane Endpoints – Lethal Parameters), Bilthoven, The Netherlands, 2001.