Live Variola Virus Considerations for Continuing Research (2009) / Chapter Skim
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convened a consensus committee to explore scientific needs for the live virus. The IOM committee reached a number of conclusions, focused in particular on the need to develop medical countermeasures for smallpox and the role of the live virus in meeting this need (see Box S-1)
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2. The most compelling reason for long-term retention of live variola virus stocks is their essential role in the identification and development of antiviral agents for use in anticipation of a large outbreak of smallpox.
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The conclusions and recommendations will inform policy discussions in the United States and within the world community regarding the continued need to retain the official stocks of live variola virus for research purposes, and would provide a major review of completed, ongoing and planned research activities that should be undertaken. The committee shall specifically consider and offer recommendations perti nent to the utility of live variola virus in addressing potential unmet requirements including: • Advanced development through licensure and post-licensure of antivirals for use in treatment of variola virus infections.
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Finally, based on experience with other pathogens, the threat of drug resistance remains a real possibility, and drug TABLE S-1 Overview of Essential Versus Useful Scientific Needs for Live Variola Virus Need Requires Use of Live Virus Does Not Require Live Virus Essential • Development of therapeutics • Development of first- and second and assessment of resistance generation vaccines that produce a take • Development of vaccines that • Development of methods for detection do not manifest a take and diagnosis Useful • Functional genomics-based • Variola genome sequence analysis research • Discovery research
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However, second-generation vaccines use the same strain of vaccinia virus as the first-generation vaccines; validation with live variola virus has not been necessary; and efficacy can be assessed through the manifestation of "take" -- a cutaneous lesion that forms at the site of inoculation. Nonreplicating and subunit third-generation vaccines do not present a take; therefore, an estimate of their potential efficacy requires vaccination and challenge with live variola virus in animal models, as well as testing of the immune responses of human vaccine recipients with methods that show activity against the live virus.
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Beyond the genome, analysis of functional pathways and expressed proteins would yield even deeper understanding. The committee concludes that live variola virus is not needed for variola genome sequence analysis, as long as specimens contain ing viral DNA of adequate quantity and quality are available.
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A more precise nonhuman primate model is essential for correct characterization of the efficacy of new therapeutics and vaccines. It is important to optimize approaches to infecting nonhuman primates so as to best recapitulate variola pathogenesis as it occurs in the human host, for example, by testing aerosol or intratracheal delivery as well as intravenous inoculation.
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The committee recommends that WHO explore the use of func tional genomics approaches to improve understanding of variola pathogenesis and advance the development of novel strategies for therapeutic intervention. REFERENCE IOM (Institute of Medicine)
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