|"We need this virus research"|
Some professional groups and scientists think it's a good idea to classify highly pathogenic avian (HPAI) H5N1 influenza viruses as "select agents" requiring special research precautions, while others say the step is unnecessary and would impede research, according to comments they have filed with the US Department of Health and Human Services (HHS). For example, the Infectious Diseases Society of America (IDSA), a physician organization, says H5N1 viruses should be in the select agent category, whereas the American Society for Microbiology (ASM) argues against the idea, noting that circulating H5N1 viruses have poor transmissibility in humans. Several vaccine manufacturers recommend that the attenuated H5N1 strains used to make vaccines should not be included in any select agent designation, because that could slow vaccine development if an H5N1 strain gained greater human transmissibility. Aside from the select agent question, the IDSA and some scientists suggest that H5N1 vaccination should be required for lab workers who handle H5N1 strains that can spread among mammals.
In mid-October HHS asked the public to comment on whether H5N1 should be designated an HHS special agent, which means that labs handling it would have to register with the agency and meet special requirements for physical security and personnel screening and training. The department also asked for comments on whether special safety and containment measures are needed for research involving H5N1 strains with increased transmissibility in mammals. The request followed the publication earlier this year of two controversial studies describing genetically modified H5 strains that were capable of aerosol transmission in ferrets. Officials originally had set a Dec 17 deadline for commenting, but last week they extended the deadline to Jan 31, 2013. Because of the threat they pose to poultry, HPAI H5N1 viruses are already listed as select agents in the US Department of Agriculture's (USDA's) Select Agent Program. But the viruses are not on HHS's select agent list.
HHS's request for comments followed a determination by a federal interagency committee that H5N1 viruses may pose a severe threat to human health and safety. The finding came from the Centers for Disease Control and Prevention's (CDC's) Intragovernmental Select Agents and Toxins Technical Advisory Committee (ISATTAC), which includes members from various HHS and USDA agencies and the departments of Homeland Security and Defense. The committee considered the findings concerning the transmissibility of genetically modified H5N1 viruses among ferrets, along with the virus's virulence and the low level of immunity in the population.
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