Scientific advice on the suitability of data for the assessment of DNA integration into the fish genome of a genetically modified DNA plasmid-based veterinary vaccine


European Food Safety Authority
EFSA Journal
EFSA Journal 2013;11(5):3232 [8 pp.].

EFSA wishes to thank Hermann Broll, Ana Gomes, Matthew Ramon and Elisabeth Waigmann (GMO unit) and Franck Berthe, Per Have and Frank Verdonck (AHAW unit) for the support provided to this scientific output.

Statement of EFSA
On request from
European Commission
Question Number
17 May 2013
Published in the EFSA Journal
30 May 2013
European Food Safety Authority (EFSA), Parma, Italy

Pancreas disease caused by salmonid alphavirus in farmed Atlantic salmon (Salmo salar) leads to high mortality rates post infection and histopathological lesions in several organs. As protection against pancreas disease, Novartis developed a prophylactic DNA plasmid-based vaccine to be administered to salmon as naked plasmid in a single intramuscular injection. In order to assess the legal status of the fish vaccinated with this new vaccine with regard to the legislation on genetically modified organisms, the European Commission suggested that the company carry out a scientific study on the integration/non-integration of the plasmid DNA into the fish genome. Subsequently, the European Commission requested EFSA to give scientific advice on the study design and the conclusions drawn by the company. PCR based analysis of genomic DNA from muscle samples, taken from at or around the injection site 436 days post vaccination, led the company to conclude that integration of plasmid DNA into the fish genome is extremely unlikely. After an assessment of the study, EFSA considers that the study presented by Novartis Animal Health on the integration/non-integration of DNA plasmid-based vaccine into the salmon genomic DNA provides insufficient information on the potential integration of plasmid DNA fragments into the fish genome due to a limited coverage of the plasmid DNA by the detection method provided, the limited number of samples analysed and an insufficient limit of detection and method validation. Therefore, EFSA is of the opinion that the results from the integration/non-integration study submitted by Novartis Animal Health are not sufficient to support the conclusion of non-integration of plasmid DNA into the fish genome drawn by the company.

DNA plasmid-based vaccine, genomic DNA, salmon, study design, DNA integration, genetically modified organisms, Directive 2001/18/EC
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