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October 11-13, 2011
U.S. Department of Agriculture Center for Veterinary Biologics
National Centers for Animal Health
1920 Dayton Ave, Ames, Iowa, 50010 USA
View workshop summary [PDF]
USDA Seeks Comment on Guidance Document Incorporating Workshop Recommendations
The U.S. Department of Agriculture Center for Veterinary Biologics
Draft Notice 465, which is currently available for
comment, provides proposed guidance on the use of humane endpoints and methods in animal testing of
biological products. The draft document includes specific guidance regarding the use of humane
endpoints in biological products testing, including guidance on humane endpoints for the rabies
challenge test. The draft guidance also strongly encourages the use of anesthesia for intracerebral
inoculation of mice during rabies vaccine testing. This guidance reflects
recommendations for refinement of rabies vaccine testing made by
participants at the October 2011 workshop.
Comments on the draft proposed guidance document should be submitted to
the Center for Veterinary Biologics by April 23, 2012.
View draft proposed guidance documents and additional information about
submitting comments on the USDA website 
View workshop agenda [PDF]
View workshop plenary session presentations
View poster session abstracts [PDF]
View breakout group introductions and questions [PDF]
Read article about the workshop in the November 2011 issue of the
NIEHS Environmental Factor newsletter
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
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Workshop Overview
View printable version of Workshop Overview [PDF]
Rabies in humans is a uniformly fatal disease, with infections killing over 70,000 people
worldwide each year. Rabies vaccines serve a vital role in preventing further deaths and controlling
the disease in certain animal populations. According to the World Health Organization, an
estimated 15 million people receive post-exposure
vaccine prophylaxis annually due to actual or suspected exposures to the rabies virus. In
the U.S. and other developed countries, rabies vaccines have effectively eliminated domestic canine
rabies virus strains. However, determining the safety and effectiveness of rabies vaccines requires
large numbers of laboratory animals and involves significant pain and distress. New methods and
approaches are sought that: 1) are more humane and use fewer or no animals, 2) are faster, cheaper,
and more accurate, and 3) are safer for laboratory workers.
A recent international workshop organized by NICEATM, ICCVAM, and its international partners
identified rabies vaccines as one of the three highest priorities for future research, development,
and validation of alternative test methods that could further refine, reduce, and ultimately replace
animal use for potency and safety testing. One of the highest priority implementation activities was
organization of an international workshop on alternative methods for rabies vaccine potency testing.
Based on recent scientific and technological advances, several alternative approaches have been
proposed or are currently available. For example, scientists at the Paul-Ehrlich-Institut recently
conducted an international collaborative study for the validation of a serological potency assay for
rabies vaccine (inactivated) for veterinary use. A single-dilution assay that
significantly reduces the number of mice utilized for the current in vivo NIH test is available for
human and veterinary rabies vaccine potency testing. Protective antigen quantification methods that
do not require animals or the use of live rabies virus are now available and may be applicable to
batch release testing for rabies vaccines. This workshop brought together international scientific experts from government, industry, and academia to review
these methods and to define efforts necessary to achieve global acceptance and implementation.
Federal Register notice announcing workshop (76 FR 50221, August 12, 2011)
[PDF - HTM]
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