The European Medicines Agency (EMA) has recommended granting a marketing authorisation in the European Union for Clynav, a DNA vaccine to protect Atlantic salmon from a life-threatening infectious disease.
Salmon Pancreas Disease causes damage to the heart, pancreas and skeletal muscle and can lead to the death of salmon. The disease has become established in some member states and outbreaks cause significant losses in salmon farms in the EU.
Clynav is the first DNA vaccine to be recommended for marketing authorisation in the EU. A DNA vaccine consists of a genetic sequence that triggers the production of proteins directly in the cells of the vaccinated animal. These proteins stimulate a protective immune response, in the case of Clynav against salmon alphavirus subtype 3, thereby preventing or reducing the impact of the disease should the fish subsequently be exposed to this virus.
The vaccine has been tested in fresh water and sea water trials that showed that an intramuscular injection reduces mortality and the damage to the heart, pancreas and muscle tissue that is associated with the disease. 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.
On the basis of a detailed environmental risk assessment, the committee was satisfied that any potential risk to the environment from use of the product in salmon was negligible. Likewise, as any vaccine residues are rapidly degraded in the gastrointestinal tract after ingestion, the committee concluded that vaccinated salmon are safe to eat.
The CVMP opinion will now be sent to the European Commission for the adoption of a decision on an EU-wide marketing authorisation.
