Knowledge base for the assessment of environmental risks by the use of genetically modified virus-vectored vaccines for domesticated animals
Report no: 2016: 49
The main potential environmental risks posed by the use of genetically modified virus vaccines in vaccinating livestock, is associated with the release of the virus from the target animal and its ability to survive and spread to other animals. This is from a report that the Scientific Committee for food safety (VKM) has delivered upon request from the Environment Agency.
VKM was requested to develop a knowledge base for evaluating environmental risks posed by the use of genetically modified viruses to vaccinate domesticated animals.
The report gives an overview of genetically modified virus vectors commonly used in vaccines in veterinary medicine. The VKM panel reviewed published literature in the field, assessed the environmental risks posed by the use of such vaccines, and have identified factors that may pose risk to the Norwegian environment.
The European Commission directive 2001/18, that regulates the deliberate release of genetically modified organisms into the environment, the European Union Regulation for approval of medicinal products (726/2004/EU), and other relevant guidelines from the European Medicines Agency (EMA) have served as reference documents.
VKMs review reveals that the main concern for environmental risks by using genetically modified virus vaccines relates to the potential release of infectious viruses into the environment. The risk of spread of infectious viruses can be reduced by the application of vaccines in physically isolated surroundings.
Genetically modified virus vaccines that contain viruses that are not infectious, pose less risk to the environment as opposed to infectious viruses. The spread of non- infectious viruses from vaccinated animals rarely occur.
Currently not used in Norway
Genetically modified viral-vectored vaccines are employed when no effective preventive measure or treatment exists for a particular disease. Pox-, herpes- and adenovirus are the most commonly used in veterinary medicine for vaccination of livestock.
Genetically modified virus vaccines for livestock are not currently in use in Norway. There is thus no experience related to environmental risks by the use of such vaccines under Norwegian conditions. Notably, in countries where genetically modified virus vaccines have been in use for a while, there is limited relevant information on the associated environmental risks.
VKMs Panel for Microbial Ecology has been responsible for this report.