Genetically Engineered Virus-Vectored Vaccines – Environmental Risk Assessment and Management Challenges

Genetically engineered or modified viruses (GMVs) are being increasingly used as live vaccine vectors and their applications may have environmental implications that must be taken into account in risk assessment and management processes. In most legislative frameworks GMVs are treated as GMOs (genetically modified organisms), which require ERA (environmental risk assessment) in addition to the evaluation of the quality, safety and efficacy of the product before marketing authorization or clinical trial applications are submitted. The ERA is performed in order to identify the potential risks for public health and the environment that may arise due to the use and release of GMVs. If risks are identified and considered as not acceptable, the ERA process should go on to propose appropriate risk management strategies capable to reduce these risks (Anliker et al., 2010; Kühler et al, 2009).