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Genetically Modified Organisms - Medicinal Products

Risk assessment of a Genetically Modified Virus (Vector) Vaccine

Commissioned: 06.11.2024

Publishing: 27.01.2025

Key message:

The Norwegian Environment Agency has requested the Scientific Committee for Food and Environment (VKM) to carry out an environmental risk assessment of the vaccine Recombitek C4 intended for use in the national breeding program of Arctic foxes. The program is administered by the Norwegian Institute for Nature Research (NINA).

The application for use of the vaccine is due to an outbreak of infectious hepatitis at the breeding station in Oppdal, where four pups have succumbed to the disease.

VKM will evaluate whether the documentation in the application is sufficient for a risk assessment and whether additional information is required. VKM will also assess whether the use of the vaccine at the breeding station may pose a risk to the environment, other animals, or humans.

VKM received this assignment from the Norwegian Environment Agency on 6 November 2024.

Four VKM committee members form the project group conducting the risk assessment. The final report will be reviewed and approved by the VKM Panel on GMO-Medicinal Products.

Deadline 27 January 2025.

Project Group

Espen Rimstad, Panel on GMO-Medicinal Products (Chair)

Jan E. Brinchmann, Panel on GMO-Medicinal Products

Åsa Frostegård, Panel on Microbial Ecology and Panel on GMO-Medicinal Products

Ragnhild Tønnessen, Panel on GMO-Medicinal Products

Ville Erling Sipinen, VKM Secretariat (Project Manager)

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