Hazard Characterization of Modified Vaccinia Virus Ankara Vector: What Are the Knowledge Gaps?

Okeke, Malachy I.; Okoli, Arinze S.; Diaz, Diana; Offor, Collins; Oludotun, Taiwo G.; Tryland, Morten; Bøhn, Thomas; Moens, Ugo

Environmental risk assessment (ERA) is governed by regulatory instruments of different countries and regions. In the European Union (EU), the ERA is governed by Directive 2001/18/EC [14] and contains the guidelines and steps (in Annex 1 part IV of the Directive). The Directive stipulates a stepwise and case-by-case process in which hazards are identified and characterized, exposure pathways evaluated and potential risks characterized. A routine ERA procedure that is based on Directive 2001/18/EC involves the following 6 steps: hazard identification, hazard characterization, assessment of likelihood of hazard and risk level, risk characterization, risk management strategies and determination of overall risk and conclusion. The aim of the ERA is to assess the risk to humans and the environment of products derived from genetic modification and to proffer management and mitigation strategies. The environmental risks associated with GMVs have been widely published [15] [16] [17] [18] [19] . In general, hazards and potential risks to the environment of GMVs are linked to shedding, survivability, the nature and toxicity of transgenes, the dissemination and transfer of novel/foreign genes to wild-type viruses as well as contact with, and infection of, non-target individuals and animals in the environment.