Three Rs Approaches in the Production and Quality Control of Fish Vaccines

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

Estrogen receptor binds to the salmon GnRH gene in a region with long palindromic sequences

International audienc

Northern blot analysis of the Na+, K+-ATPase alpha subunit in salmonids

A 450-bp long fragment of the gene encoding the Na+, K+-ATPase alpha-subunit was PCR (polymerase chain reaction)-amplified from the rainbow trout (Oncorhynchus mykiss) genome. The protein coding sequence of the cloned PCR product shared 85 and 73% identity with Na+, K+-ATPase alpha-subunit-encoding sequences of the rat (alpha(2)-isoform) and the teleost species of the white sucker (Carostomus commersoni), respectively. Northern blot analysis demonstrated that the fragment hybridized to a major transcript of about 3.7 kb in several salmonid and non-salmonid species. The observed changes in Na+, K+-ATPase mRNA levels in osmoregulatory organs of seawater- and freshwater-adapted fish further confirm the specificity of the probe

Three Rs approaches in the production and quality control of fish vaccines

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.JRC.DG.I.3-In-vitro method