Pathogenic studies with recombinant Influenza A viruses

The COGEM has been asked to advice on a request to amendment an existing license IG 99-090. The applicant intends to perform laboratory handlings and animal studies with recombinant low- and high pathogenic influenza A viruses isolated from various hosts. The current license allows activities with a limited number of influenza viruses. The applicant requests to expand the research, whereby certain experiments will be performed under reduced containment levels (ML-II). The purpose of the study is to determine parts of the viral genome responsible for the virulence. The research is also focused on vaccine development. In COGEMs opinion, the intended laboratory experiments should be performed under containment level ML-III in accordance with the pathogen class 3 of the virus. Animal experiments must be conducted under containment level DM-III. Experiments intended for vaccine development using recombinant influenza viruses derived from non-virulent attenuated laboratory strains can be performed under containment level ML-II on specific conditions. COGEM is of the opinion that additional regulations are required to restrict the risk of spreading of the recombinant virus. In COGEMs opinion, the present experiments pose a negligible risk for human health and the environment, considering the containment restrictions and the mentioned additional regulations.