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NICEATM convenes international workshop on vaccine safety testing

By Debbie McCarley
October 2010

Rear Admiral Anne Schuchat, M.D.
In her keynote speech, Schuchat underscored the important role of safe and effective vaccinations in promoting public health. (Photo courtesy of William Stokes)

Rear Admiral William Stokes, D.V.M., D.A.C.L.A.M., and Karen Brown, Ph.D.
Stokes and Scientific Advisory Committee on Alternative Toxicological Methods (SACATM)( member Karen Brown, Ph.D., were among panelists at the workshop. (Photo courtesy of William Stokes)

NIEHS scientists Rear Admiral William Stokes, D.V.M. and Dr. Warren Casey, Ph.D. joined other scientists from around the world last month at 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." Nearly 200 scientists from 13 different countries gathered to review the current state of the science and to recommend future research, development and validation efforts needed to advance alternative methods that can reduce, refine (lessen or eliminate pain and distress), and replace the use of animals for human and veterinary vaccine post-licensing potency and safety testing. The workshop, which took place Sept. 14-16 at NIH in Bethesda, Md., was organized by the National Toxicology Program (NTP) Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM) and the Interagency Coordinating Committee on the Validation of Alternative Methods (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.

Vaccines are a vital and cost-effective public health tool in the prevention of a wide range of serious infectious diseases. In her remarks during the opening session of the workshop, Rear Admiral Anne Schuchat, M.D., director of the National Center for Immunization and Respiratory Diseases within the Centers for Disease Control and Prevention (CDC), noted the overwhelming impact of pediatric vaccines by stating, "For each birth cohort vaccinated with seven vaccines, direct health care costs are reduced by $9.9 billion, 33,000 lives are saved, and 14 million cases of disease are prevented." Similarly, James Roth, D.V.M., Ph.D., director of the Center for Food Security and Public Health at Iowa State University, emphasized in his presentation the importance of veterinary vaccines to both animal and human health. "Veterinary vaccines are essential for safe and effective food production, control of emerging and exotic diseases of animals and people, and reducing the transmission of foodborne diseases," Dr. Roth noted.

Scientists from the U.S. Food and Drug Administration (FDA) and U.S. Department of Agriculture (USDA) joined scientists from Health Canada, the United Kingdom, Japan, and the World Health Organization in a panel discussion of ways to increase international harmonization of differing vaccine testing procedures. Regulatory authorities require potency and safety testing of each vaccine production lot to ensure that it maintains the antigenic characteristics that make it effective and to prevent the release of vaccine lots that might cause serious adverse health effects. In his opening remarks, Stokes noted that while vaccines are vital for protecting human and animal health, the post-licensing testing required to ensure that each lot is safe and effective continues to require large numbers of animals for some vaccines. Annual research facility reports to the USDA also reveal that vaccine testing accounts for a significant number of animals experiencing unrelieved pain and distress. Accordingly, NICEATM and ICCVAM included vaccine testing as one of four highest priority areas in their 2008-2012 Five-Year Plan.

Workshop participants identified knowledge and data gaps that need to be addressed to develop methods that can further reduce, refine, and replace the use of animals in vaccine testing. Participants also identified and prioritized research, development, and validation activities needed to address these knowledge and data gaps, including the application of new science and technology to develop improved methods. They agreed that vaccines that use the largest number of animals, and that are associated with the greatest pain and distress, should be given the highest priority for development and validation of alternative test methods. Participants also emphasized the need to find ways to avoid or minimize testing with live viruses and bacteria that are hazardous to workers. Ways to promote the increased use of accepted methods were also discussed. Implementation of the workshop recommendations is expected to advance the availability and use of alternative methods for vaccine potency and safety testing, while ensuring continued protection of human and animal health.

The workshop provided a unique opportunity for stakeholders from the human and veterinary vaccine sectors to interact and gain important insights on similarities and differences in how potency and safety testing is currently conducted in each sector. Stokes, Casey, and 30 invited participants gave presentations, moderated sessions, and contributed to the breakout group discussions. Invited participants included scientists from the FDA, CDC, USDA, U.S. Department of Defense (DOD), National Institute of Allergy and Infectious Diseases (NIAID), 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.

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 USDA, and Richard McFarland, Ph.D., M.D., of the FDA. Dr. Kulpa-Eddy is also currently acting chair of ICCVAM. In addition to FDA and USDA, the BWG includes scientists from the CDC, DOD, U.S. Department of the Interior, NIEHS, and NIAID. Drs. Stokes and Casey are the NIEHS representatives on the BWG.

Presentations from the workshop will soon be available on the NICEATM-ICCVAM Web site ( Complete proceedings of the workshop, including manuscripts from speakers and breakout group sessions, will be published next year as a dedicated issue of Procedia in Vaccinology. An article summarizing the workshop discussions and conclusions will also be published in the journal Biologicals. The conclusions and recommendations resulting from the workshop will be provided to ICCVAM for prioritization of future research, development, and validation activities for alternative test methods that reduce, refine, and replace the use of animals in vaccine potency and safety testing.

(Debbie McCarley is the special assistant to Rear Admiral William Stokes, D.V.M., D.A.C.L.A.M., director of the NTP Interagency Center for the Evaluation of Alternative Toxicological Methods.)

Several of the organizers posed for a group shot during a break in the workshop.
Several of the organizers posed for a group shot during a break in the workshop. In front, left to right, are Yoshinobu Horiuchi, Ph.D., Pharmaceuticals and Medical Devices Agency, Japan; Theresa Finn, Ph.D., FDA; Jodie Kulpa-Eddy, D.V.M., USDA; Stokes; and Richard McFarland, M.D., Ph.D., FDA. In the second row, left to right, are Juan Arciniega, D.Sc.; and Steven Rubin, Ph.D., FDA. In the third row, left to right, are Marlies Halder, V.M.D., Institute for Health and Consumer Protection; Robin Levis, Ph.D., FDA; Johan Descamps, Ph.D., GlaxoSmithKline, Belgium; Geetha Srinivas, D.V.M., Ph.D., USDA; and Jeffrey Galvin, Ph.D., Pfizer Animal Health. Shown in the fourth row, left to right, are Janet Skerry, U.S. Army Medical Research Institute of Infectious Diseases; Dorothea Sesardic, Ph.D., National Institute for Biological Standards and Control, U.K.; and Hajime Kojima, Ph.D., director, Japanese Center for the Validation of Alternative Methods. In the top row, left to right, are Paul Stickings, Ph.D., National Institute for Biological Standards and Control, U.K.; Ivo Claassen, Ph.D., Central Veterinary Institute, The Netherlands; Michael Schmitt, Ph.D., FDA; Richard Isbrucker, Ph.D., Health Canada; Casey; and Coenraad Hendriksen, D.V.M., Ph.D., Netherlands Vaccine Institute. (Photo courtesy of Steve McCaw)

NICEATM is organizing workshops on accepted alternative methods in 2011

A series of workshops to be organized by NICEATM on "Best Practices for Regulatory Safety Testing" will focus on methods currently accepted or endorsed by regulatory agencies that can reduce, refine, or replace animal use for common safety testing applications. The first two of these will be held early next year: "Assessing the Potential for Chemically Induced Eye Injuries" will take place on January 19, 2011, and "Assessing the Potential for Chemically Induced Allergic Contact Dermatitis (ACD)" will take place on January 20, 2011.

These one-day workshops will help participants gain a practical understanding of the theory and application of available methods that can be used to evaluate the hazard potential of chemicals and products, while minimizing animal use and avoiding pain and distress. Participants will learn the strengths and weaknesses of available alternative test methods, become familiar with the types of data they provide, and learn how to use these data in regulatory safety assessments.  Scientists from industry, government, and academia that have an interest in learning more about the available alternative test methods for assessing potential eye injury or ACD hazards are encouraged to attend the workshops.

The workshops will be held on the campus of the National Institutes of Health in Bethesda, Md. Each workshop is free and open to the public with attendance limited only by the space available. Those interested may register for one or both workshops. Individuals who plan to attend are asked to register with NICEATM by January 6, 2011. Registration information, a tentative agenda for each workshop, and additional meeting information are available on the NICEATM-ICCVAM Web site( Information is also available upon request from NICEATM (phone: 919-541-2384, email:

The workshop series is being organized by NICEATM and ICCVAM, and is co-sponsored by the Society of Toxicology.

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