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January 2011

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Stokes presents at international meeting on alternatives for vaccine testing

January 2011

Seven meeting participants gathered together

Pictured above, left to right, are meeting participants Robin Levis, Ph.D., of the Food and Drug Administration's (FDA) Center for Biologics Evaluation and Research; NICEATM Director William Stokes, D.V.M.; Donna Gatewood, D.V.M., of the USDA Center for Veterinary Biologics; Juan Arciniega, D.Sc., of the U.S. Food and Drug Administration's Center for Biologics Evaluation and Research; Jean-Marc Spieser of the European Directorate for the Quality of Medicines and HealthCare; acting ICCVAM Chair Jodie Kulpa-Eddy, D.V.M.; and Carmen Jungback, D.V.M., of the Paul Ehrlich Institute. (Photo courtesy of William Stokes)

Rear Admiral William Stokes, D.V.M., the director of the National Toxicology Program (NTP) Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM(, traveled to Langen, Germany, in December to share recommendations for reducing, refining, and eventually replacing animal use for the purpose of testing vaccines.

Stokes presented conclusions and recommendations from the NICEATM-sponsored "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," which took place in September (see story(

He gave his presentation at a meeting titled, "Potency Testing of Veterinary Vaccines for Animals: The Way From In Vivo to In Vitro." The Dec. 1-3 meeting was sponsored by the Paul Ehrlich Institute( Exit NIEHS, an agency of the German Federal Ministry of Health that promotes the quality, efficacy, and safety of biological medicinal products. The meeting was co-sponsored by the International Association for Biologicals and the European Directorate for the Quality of Medicines and HealthCare( Exit NIEHS.

Vaccines are vital and cost-effective public health tools used to prevent a wide range of serious and potentially fatal infectious diseases in people and animals. However, prior to the release of each production lot of an approved vaccine, testing is required to ensure that the particular lot is safe and effective. Such testing requires the use of large numbers of animals, and can result in some animals experiencing significant pain and distress.

Efforts to reduce animal testing

In recent years, efforts have increased to develop and validate alternative methods that reduce, refine (decrease pain and distress), and replace the use of animals for vaccine potency and safety testing. These efforts are a high priority for NICEATM and the NICEATM-supported Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM).

Stokes' presentation pointed to priorities for future research and development efforts needed to advance alternatives for vaccine potency and safety testing, including:

  • Replacement alternatives such as in vitro protectiveantigen quantification assays
  • Refinement alternatives, including vaccination followed by in vitro antibody quantification, and developing earlier more humane endpoints for both safety and potency testing
  • Reduction alternatives, such as identifying and reducing sources of variation to allow for the use of fewer animals while still maintaining statistical power of the assay

Recommendations from the NICEATM-sponsored workshop also addressed how to expedite global progress in developing alternatives for human and veterinary vaccine testing, including improved dissemination and accessibility of information on new initiatives, documents, and guidances; international harmonization of principles for validation of alternative vaccine test methods; harmonizing testing procedures for individual protective antigens; encouraging product-specific validation of available alternative methods by vaccine manufacturers; and expanding support for research and development into new alternative methods.

NICEATM and ICCVAM have a commitment to building global partnerships to advance new alternative testing methods, and participation in events such as the recent Langen meeting are an important part of developing those partnerships. 

Highlights of the Langen meeting

In addition to presenting at the meeting, Stokes, who is a U.S. Public Health Service Commissioned Corps officer and an Assistant Surgeon General, served on the scientific committee for the meeting, along with experts in the fields of alternative methods development and vaccine testing from the United States and Europe.

Other presenters at the Langen meeting affiliated with ICCVAM or ICCVAM member agencies included: Jodie Kulpa-Eddy, D.V.M., of the U.S. Department of Agriculture (USDA), who is acting chair of ICCVAM; Juan Arciniega, D.Sc., of the U.S. Food and Drug Administration's Center for Biologics Evaluation and Research, a member of the ICCVAM Interagency Biologics Working Group; Donna Gatewood, D.V.M., of the USDA; and Karen Brown, Ph.D., of Pair O'Docs Enterprises, who is member of ICCVAM's scientific advisory committee and served as chair of a 2007 ICCVAM-sponsored independent peer review panel.

Proceedings of the Langen meeting will be published by the Paul Ehrlich Institute in 2011. Proceedings of the NICEATM-sponsored workshop will be also published in 2011 as a dedicated issue of Procedia in Vaccinology.

The ICCVAM Interagency Biologics Working Group is currently addressing implementation of the recommendations from the ICCVAM workshop. Presentation slides and more information about the ICCVAM workshop are available on the NICEATM-ICCVAM website(

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