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Environmental Factor, October 2012

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Upcoming workshop on innovative safety tests for pertussis vaccines

By Debbie McCarley and Cathy Sprankle

NIEHS and U.S. Food and Drug Administration (FDA) scientists will join other scientific experts from around the world this fall to consider improved methods and approaches for safety testing of vaccines that protect against pertussis. The “International Workshop on Alternatives to the Murine Histamine Sensitization Test (HIST) for Acellular Pertussis Vaccines: State of the Science and the Path Forward” flyer will take place on Nov. 28-29 at the William H. Natcher Conference Center on the NIH campus in Bethesda, Md.

The NTP Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM), is organizing the workshop in collaboration with the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) and partner organizations in the International Cooperation on Alternative Test Methods. The organizing committee for the workshop includes NIEHS scientists and scientists from the FDA, international vaccine manufacturers, and international research and regulatory agencies. 


Pertussis is an important public health concern

Pertussis, also known as whooping cough, is a highly contagious bacterial disease that was once a major cause of childhood mortality. While widespread vaccination has substantially decreased the incidence of pertussis, recent outbreaks have led public health officials to recommend renewed and expanded vaccination efforts. For example, a sharp increase in the number of pertussis cases in early 2012, in central North Carolina, prompted the state health department to offer free pertussis vaccinations.

Regulatory authorities require testing of each production lot of a vaccine to ensure safety, potency, and purity. The murine HIST is a key safety test performed on pertussis vaccines to ensure that residual pertussis toxin has been effectively inactivated, to avoid adverse effects caused by the toxin. However, such testing requires large numbers of mice, some of which experience significant unrelieved pain and distress. An international workshop in 2010 identified the HIST as a priority for future research, development, and validation of alternative test methods that could reduce, refine, or replace animal use for pertussis vaccine safety testing.

“There is significant international interest in supporting innovation in this area,” notes Rear Adm. William Stokes, D.V.M., director of NICEATM, which administers and provides scientific support for ICCVAM. “In addition to animal welfare concerns, the HIST is time-consuming and technically challenging. Both vaccine manufacturers and regulators are actively working to develop and validate improved alternatives that can achieve acceptance and use.”

The ICCVAM Authorization Act of 2000 charges ICCVAM with coordinating the interagency evaluation of new testing methods that can replace or reduce the use of animals, and refine animal use to enhance animal well-being and lessen or avoid pain and distress. Vaccine testing uses significantly more animals, and results in more animals experiencing pain and distress than toxicity testing. Therefore, promoting improved alternative test methods for vaccine potency and safety testing is one of the highest priorities in ICCVAM’s five-year plan.

About the workshop

The upcoming workshop will provide a forum for participants to review protocols and available data from an ongoing international study of in vitro alternatives to the HIST. Participants will also review recent advances and innovations in science and technology that may provide greater accuracy, precision, and efficiency, and that are more humane and use fewer or no animals. Finally, the workshop will address the path to achieve validation, global acceptance, and implementation of new alternative methods.

Registration information and a workshop program are available on the NICEATM-ICCVAM website. NICEATM and ICCVAM also invite the submission of abstracts for scientific posters to be displayed during this workshop. Abstracts should be submitted by Oct. 12.

Stokes and Warren Casey, Ph.D., deputy director of NICEATM, are serving on the organizing committee for the workshop. The committee also includes Richard McFarland, Ph.D., M.D., co-chair of the ICCVAM Interagency Biologics Working Group, Juan Arciniega, D.Sc., and Lev Sirota, Ph.D., all from the FDA Center for Biologics Evaluation and Research.

(Debbie McCarley is a special assistant to Stokes. Cathy Sprankle is a communications specialist with ILS, Inc., support contractor for NICEATM.)

“International Workshop on Alternatives to the Murine Histamine Sensitization Test (HIST) for Acellular Pertussis Vaccines: State of the Science and the Path Forward” flyer

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