The European monographs allow for batch potency release of vaccines using a method based on antibody response if the assay is successfully validated against efficacy/ proof of concept tests for the vaccines in question. This approach will reduce the number of fish needed for in vivo testing in challenge trials.
VESO initiated in 2004 a PhD project with the aim to develop and validate a serological ELISA method to replace challenge tests in batch potency testing of vaccines. The project is a collaboration between VESO, the Norwegian School of Veterinary Science, The Norwegian Veterinary Institute, PHARMAQ AS, and Nord-Trøndelag University College. During the project, an ELISA assay has been developed to detect the antibody response against Aeromonas salmonicida after vaccination. The results are promising and may be used as an alternative to challenge tests for batch potency testing of Furunculosis vaccines in Atlantic salmon. For further information, please contact Anne Berit Romstad.