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Tools for Safety Assessment: Vaccinia-derived recomibnant rabies vaccine

Download here: Tools for Safety Assessment: Vaccinia-derived recomibnant rabies vaccine ( pdf 750 Kb) D. Omlin

The vaccinia - rabies glycoprotein (VRG) recombinant virus vaccine (Raboral®) is a live viral vaccine presently used in France, Belgium and in the U.S.A. for the oral vaccination of wild animals against rabies. Target animals for vaccination programmes are the main vectors transmitting the disease: foxes in Europe; raccoons and skunks in the U.S.A. There are plans to use this vaccine in Switzerland; the recombinant viral vaccine would be the first transgenic microorganism released on Swiss soil. The prospect of this release, along with a general public wariness of genetic engineering, has fostered a multitude of on-going discussions dealing with political, ecological, economical, social and ethical issues. In order to meet the need for readily accessible information, the agency for Biosafety Research and Assessment of Technology Impacts (BATS) of the Swiss Priority Programme Biotechnology, funded by the Swiss National Science Foundation, has taken on the task of rigourously reviewing and analysing the available safety-related data concerning VRG. This undertaking was performed in a systematic manner, with emphasis on the phenotype of the transgenic organism rather than on the technique used to produce it. Data concerning possible impact aspects of the environmental release were compiled from existing knowledge of the recombinant virus, VRG; of the inserted glycoprotein G of the ERA rabies strain; of the wild-type vaccinia virus (especially strain Copenhagen, which is the parental strain) and tk--vaccinia virus (the thymidine kinase gene of vaccinia virus is insertionally inactivated in VRG); and knowledge of (ortho)poxviruses.
It was the aim of this work to make available as much pertinent information as possible related to the safety aspects of VRG. This publication is the assembly of existing data and information into an efficient tool for safety assessment. An extensive list of references is also provided. Both qualitative and quantitative data are presented, and the report attempts to remain impartial regarding sensitive issues where there exist no absolute answers. Some of these more controversial topics include: the probability of VRG persistence in the environment with its related consequences; the overall significance of rare adverse events expected in persons having accidental contact with vaccine fluid. The risks involved with the use of any rabies vaccine, whether recombinant or not, must always be weighed against the health danger arising from uncontrolled rabies for animals and humans.