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Genetically Modified Organisms - Medicinal Products

No increased environmental risk with the use of a GMO vaccine

Commissioned: 06.11.2024

Report no: VKM Bulletin 2025:02

Published: 27.01.2025

Key message:

There is no increased environmental risk related to the genetically modified vaccine Recombitek®C4 compared to similar approved vaccines.

This is the conclusion in the risk assessment VKM has carried out for the Norwegian Environment Agency.

Background

The Norwegian Environment Agency has received an application under the Gene Technology Act for the use of the vaccine Recombitek®C4 in the national breeding program of Arctic foxes (Vulpes lagopus). The Arctic fox is classified as an endangered species in Norway. The breeding program is part of the preservation effort and is run by the Norwegian Institute for Nature Research (NINA). Due to an outbreak of infectious hepatitis (hepatitis contagiosa canis (HCC)) at the breeding station in Oppdal where four pups have succumbed to the disease, the use of Recombitek®C4 has been requested to prevent further infection.

Available alternative vaccines to Recombitek®C4 do exist, but these contain a weakened (for dogs) but live distemper virus (CDV) which can cause disease in arctic foxes and are therefore unsuitable.

Recombitek®C4 is currently not approved in Norway or in the EU but has been in regular use for vaccination of dogs for over 20 years, including in the USA and Canada.

The Norwegian Environment Agency has asked VKM to carry out an environmental risk assessment of the Recombitek®C4 vaccine in accordance with the Gene Technology Act.

VKM's assessment

The Recombitek®C4 vaccine contains a canarypox virus vector called ALVAC. ALVAC is based on the Canarypox virus (CNPV), which primarily causes disease in passeriform birds, such as canaries. The disease is characterised by cutaneous and diphtheria-like symptoms with possible high mortality.

ALVAC is a genetically engineered, attenuated derivative of CNPV, designed for use in vaccines. Neither the vector nor the virus can produce or spread new viruses between mammals. Thus, the most plausible path to the environment will be via transmission to wild birds. The breeding station in Oppdal reports some interaction between Arctic foxes and birds, such as eagles, ravens and crows, e.g. around feed placements. To minimise the possibility of contact, feeding boxes and designed "eagle structures" are used in the enclosures. Still, even if eagles or other birds were to be exposed to ALVAC during the period when the foxes are vaccinated, the risk of infection, disease and spread among birds is considered highly unlikely.

Several vaccines containing ALVAC are approved for use in animals in Norway, e.g. in vaccines for cats and horses.

Conclusion

VKM concludes that use of Recombitek®C4 in the national breeding program of endangered Arctic foxes, does not represent an increased environmental risk compared to other vaccines containing the ALVAC vector already in use for other species in Norway.

The risk assessment is approved by the VKM panel on Genetically Modified Organisms - Medicinal Products.

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Contact

Liten bilde av Erling Rimstad

Espen Rimstad

Chair of the project group, member of the VKM Scientific Steering Committee and Chair of the Panel on Genetically Modified Organisms – Medicinal Products.

M: 922 13 719

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