This introductory paper gathers general considerations on the biosafety of virus-derived vectors that are used in
human gene therapy and/or vaccination. The importance to assess the potential risks for human health and the environment
related to the use of genetically modified organisms (GMO) in this case genetically modified viral vectors is highlighted
by several examples. This environmental risk assessment is one of the requirements within the European regulatory
framework covering the conduct of clinical trials using GMO. Risk assessment methodologies for the environmental
risk assessment of genetically modified virus-derived vectors have been developed.
Keywords: Biosafety, environmental risk assessment, gene therapy, genetically modified organisms, vaccination, viral vectors.
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