International Workshop on Alternative Methods to Reduce, Refine, and Replace the Use of Animals in Vaccine Potency and Safety Testing

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The National Toxicology Program Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM) announces availability of the report on 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».

The report was published as a dedicated issue of the journal Procedia in Vaccinology (Volume 5, pp 1-266, 2011) and is publicly available on the journal’s website at http://www.sciencedirect.com/science/journal/1877282X. A limited number of CD and paper copies of the report are available from NICEATM (see contact information below).

Background

Regulatory authorities require testing of vaccines to ensure their safety and effectiveness. However, such testing requires large numbers of animals and accounts for the majority of animals reported to the USDA with unrelieved pain and distress. Accordingly, identification and promotion of alternative methods that can reduce, refine (enhance animal well-being and lessen or avoid pain and distress), and replace the use of animals for vaccine potency and safety testing is one of the four highest priorities of the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM), an interagency committee of the Federal government administered by NICEATM.

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 in September 2010 to review the state of the science of available alternative methods for human and veterinary vaccine potency and safety testing and to identify specific R&D activities necessary to advance test methods with the potential to further reduce, refine, and replace animal use for vaccine testing.

Workshop Report and Outcomes

The workshop report is comprised of 27 papers that summarize plenary session presentations and the conclusions and recommendations developed by the workshop participants during six breakout group sessions. The report recommends vaccines that should have the highest priority for future reduction, refinement, and replacement efforts. Other key recommendations include:

  • Procedures such as earlier humane endpoints should be developed and implemented immediately to reduce or avoid the pain and distress experienced by animals for vaccines that still require live-agent challenge testing. Until non-animal tests are available, development of serological assays should also be considered as a way to avoid challenge testing.
  • Specific non-animal approaches that have successfully replaced animals for some vaccine potency testing should be developed for vaccines currently requiring animals through identification, purification, and characterization of vaccine protective antigens.
  • International harmonization and cooperation efforts and closer collaborations between human and veterinary vaccine researchers should be enhanced to support more rapid progress towards reduction, refinement, and replacement of animal use for vaccine testing.

The workshop was organized by NICEATM and ICCVAM and sponsored by the National Institute of Environmental Health Sciences and the National Toxicology Program. It was cosponsored by the European Centre for the Validation of Alternative Methods, the Japanese Center for the Validation of Alternative Methods, and Health Canada, along with the Society of Toxicology.

Information about the workshop can be found on the NICEATM-ICCVAM website at http://iccvam.niehs.nih.gov/meetings/BiologicsWksp-2010/BiologicsWksp.htm. This page also contains a link to the online workshop report, which is available to the public.

Copies of the workshop report can also be obtained by contacting NICEATM at niceatm@niehs.nih.gov.