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Environmental Factor, January 2012

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NICEATM workshop report on vaccine testing now available

By Debbie McCarley and Cathy Sprankle

Jodie Kulpa-Eddy, D.V.M.

As acting chair of ICCVAM, Jodie Kulpa-Eddy, D.V.M., of the U.S. Department of Agriculture, welcomed participants to the workshop. (Photo courtesy of William Stokes)

Rear Adm. Anne Schuchat, M.D.

In her keynote speech, Rear Adm. Anne Schuchat, M.D., director of the National Center for Immunization and Respiratory Diseases within the CDC, underscored the important role of safe and effective vaccinations in promoting public health. (Photo courtesy of William Stokes)

A workshop organized last year by the NTP Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM) and the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) is the subject of the current issue of the journal Procedia in Vaccinology.

The International Workshop on Alternative Methods to Reduce, Refine, and Replace the Use of Animals in Vaccine Potency and Safety Testing: State of the Science and Future Directions was convened to review the state of the science of available alternative methods for human and veterinary vaccine potency and safety testing. Workshop participants also identified specific activities that will be needed to advance test methods with the potential to reduce, refine and replace animal use for vaccine testing.

Identifying high priority vaccines for alternative testing

The workshop described in the current Procedia in Vaccinology was held Sept. 14-16, 2010, at NIH in Bethesda, Md. Nearly 200 scientists from 13 countries attended the workshop. Over 30 invited participants included scientists from U.S. government research and regulatory agencies as well as representatives from the governments of Japan, Canada, the United Kingdom, the Netherlands, and the European Union. National and multinational corporations and research institutions were also represented. The workshop report is comprised of 27 manuscripts and summarizes the plenary session speaker presentations as well as the conclusions and recommendations developed by the workshop participants.

“One of the key accomplishments of this workshop was the identification of the highest priority vaccines for future reduction, refinement, and replacement efforts,” noted Rear Adm. William Stokes, D.V.M., director of NICEATM. “Targeting specific vaccines will help focus research and validation efforts that can have a real impact on animal use and animal welfare.” He added that rabies vaccines were identified as one of the high priority vaccines. Reduction, refinement, and replacement of animal use for rabies vaccine potency testing was the subject of a recent workshop in October organized by NICEATM and ICCVAM.

Recommending alternative methods

Vaccines improve animal and human health by preventing infectious diseases in people and animals. As a result of widespread human vaccination, smallpox has been globally eradicated, and many other diseases such as polio, measles, and rubella now occur only rarely in North America. Veterinary vaccines prevent a wide range of diseases in many animal populations, and contribute to human health by controlling diseases such as rabies that can be transmitted from animals to humans. However, testing necessary to ensure vaccine effectiveness and safety can involve large numbers of animals, and result in significant animal pain and distress. NICEATM and ICCVAM, whose mission is to promote alternative methods that can reduce, refine (enhance animal well-being, or lessen or avoid pain and distress), and replace animal use in testing, identified alternative test methods for vaccine potency and safety testing as one its highest priorities in a issued in 2008.

In addition to prioritizing specific vaccines for future efforts, recommendations made by the participants of the September 2010 workshop included:

  • Specific non-animal antigen quantification approaches that have successfully replaced animals for potency testing for some vaccines should be expanded for use with other vaccines through identification, purification, and characterization of vaccine protective antigens.
  • Procedures should be implemented to reduce both the numbers of animals used and the pain and distress experienced by animals while and where animal testing is still needed.
  • Efforts should be made to facilitate international harmonization and cooperation, as well as closer collaboration between human and veterinary vaccine researchers, as this will allow faster progress towards reduction, refinement, and replacement of animal use.

The workshop was organized by NICEATM and ICCVAM in partnership with the European Centre for the Validation of Alternative Methods, the Japanese Center for the Validation of Alternative Methods, and Health Canada. The workshop was co-sponsored by the Society of Toxicology.

(Debbie McCarley is the special assistant to Rear Adm. William Stokes, D.V.M., director of NICEATM. Cathy Sprankle is a communications specialist with ILS, Inc., support contractor for NICEATM.)

Workshop organizers

NICEATM and the ICCVAM Biologics Working Group (BWG) were primarily responsible for organizing the workshop. The BWG is co-chaired by Jodie Kulpa-Eddy, D.V.M., of the U.S. Department of Agriculture (USDA), and Richard McFarland, M.D., Ph.D., of the Center for Biologics Evaluation and Research at the U.S. Food and Drug Administration (FDA). Kulpa-Eddy is also currently chair of ICCVAM. In addition to FDA and USDA, the BWG includes scientists from the Centers for Disease Control and Prevention (CDC), U.S. Department of Defense, U.S. Department of the Interior, NIEHS, and the National Institute of Allergy and Infectious Diseases. Stokes and Warren Casey, Ph.D., deputy director of NICEATM, are the NIEHS representatives on the BWG.

Materials from the workshop, including the agenda, presentations from the workshop, and abstracts of posters presented at the workshop poster session, are available on the NICEATM-ICCVAM website.

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