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Three Rs Approaches in the Production and Quality Control of Fish Vaccines
  • Paul J. Midtlyng, Center for Veterinary Biologics
  • Coenraad F.M. Hendriksen, Netherlands Vaccine Institute
  • Elisabeth Balks, Paul-Ehrlich-Institut
  • Lukas Bruckner, Institut für Viruskrankheiten und Immunprophylaxe
  • Lawrence Elsken, Center for Veterinary Biologics
  • Øystein Evensen, Norwegian School of Veterinary Science
  • Kjetil Fyrand, PHARMAQ
  • Allison Guy, Canadian Council on Animal Care
  • Marlies Halder, Joint Research Centre European Commission
  • Penny Hawkins, Royal Society for the Prevention of Cruelty to Animals
  • Gunn Kisen, Norwegian Medicines Agency
  • Anne Berit Romstad, Nord-Trondelag University College
  • Kira Salonius, Novartis Animal Health Canada Inc.
  • Patrick Smith, Schering Plough Animal Health
  • Lynne U. Sneddon, University of Liverpool
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The workshop on Three Rs Approaches in the Production and Quality Control of Fish Vaccines aimed a) to identify animal tests currently stipulated for the production and quality control of fish vaccines and to highlight animal welfare concerns associated with these tests; b) to identify viable options to replace, reduce, and refine animal use for fish vaccine testing; and c) to discuss the way forward and set out how the Three Rs may be implemented without jeopardizing the quality of the vaccines. The workshop participants -- experts from academia, regulatory authorities, a scientific animal welfare organization, and the fish vaccine industry -- agreed that efforts should be undertaken to replace the vaccination challenge batch potency testing with tests based on antigen quantification or antibody response tests. Regulatory requirements of questionable scientific value and relevance for the quality of fish vaccines, such as the re-testing of batches produced outside Europe, or the double-dose batch safety test, should be re-considered. As an immediate measure the design of the current animal tests should be evaluated and modified in the light of refinement and reduction, for example, the number of unprotected control fish in vaccination-challenge tests should be reduced to the minimum.


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Citation Information
Midtlyng, P. J., Hendriksen, C., Balks, E., Bruckner, L., Elsken, L., Evensen, Ø., ... & Sneddon, L. U. (2011). Three Rs approaches in the production and quality control of fish vaccines. Biologicals, 39(2), 117-128.