Clynav is the first DNA vaccine to be given the go-ahead for use in Europe by the European Commission, and this week cleared its final hurdle when the Norwegian Medicines Agency (NoMA) certified its use in Norway, despite serious reservations.
NoMA said: “Clinical safety and efficacy has been studied only in some limited laboratory studies and there are no field trials with this vaccine. It therefore also lacks field data on efficacy and safety in combination with other vaccines that are required to use for salmon in Norway.
“Pancreas disease is one of the most serious diseases in Norwegian salmon farming, both [in terms of] animal welfare and economic [impact]. NoMA therefore believes that the vaccine should not be taken into general use until you have results from controlled field trials.”
Elanco, however, has now said it is increasing production to meet demand.
The company's European spokesperson, Karin Gerbens, told fishfarmingexpert's sister website, kyst.no: "Elanco is pleased to have received a marketing authorisation from the authorities in Norway and the EU. EMA’s Committee for Veterinary Medical Products (CVMP) considered that the protection provided by the vaccination is clinically relevant and provides direct benefit to the salmon in terms of improved health and welfare. In addition, the benefit risk assessment of CVMP has sufficiently established the efficacy and safety of the vaccine. Elanco will review and assess NoMA’s recommendation for field trials with the various stakeholders in Norway and NoMA.
"We are committed to ensuring that this vaccine is available at the earliest opportunity.
"We are scaling up production to ensure we have sufficient supply to meet demand, and further announcements will be made when dates become available."
Clynav is specifically designed as a vaccine against salmonid alphavirus subtype 3 (SAV 3), a virus variant only present in Norway. SAV 1, 4, 5 and 6 are found in salmon in Scotland, with SAV 1 being the biggest problem.
Nonetheless, Ronnie Soutar, president of the Fish Veterinary Society and head of fish health and welfare at fish vaccination specialists Aqualife Services, has previously said it would be “an addition to the tools in the fish vet toolbox” and could open the door to more DNA and RNA vaccines.
He said at the time: “I think the cross-protection issue – will SAV 3 vaccine protect against other strains – is one we will be looking to Elanco for answers to in the near future.”
He pointed out that Clynav was the first DNA vaccine for any species to gain approval, adding: “We would certainly hope that this heralds a new generation of DNA and RNA vaccines, as they have been successfully used against other viruses in North America.”