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Pages 3-17

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From page 3...
... OVERARCHING CONCLUSIONS ON MEDICAL COUNTERMEASURES READINESS State of Smallpox MCM Readiness A variety of MCMs have been developed to detect (diagnostics) , prevent (vaccines)
From page 4...
... Tecovirimat for Human Mpox Virus) a - STOMP sub-study of open label tecovirimatb - Other Use: STOMP sub-study: Tecovirimat for Orthopox Virus Exposurec • No serious adverse events reported.
From page 5...
... Food and Drug Administration; IND = investigational new drug; OPXV = orthopoxvirus; VARV = variola virus. a NIH/NIAID-sponsored: Phase 3 randomized, placebo-controlled, double-blind study to establish the efficacy of tecovirimat for the treatment of people with laboratory-confirmed or presumptive human monkeypox virus disease (HMPXV)
From page 6...
... The development of novel smallpox vaccines using multi-vaccine platforms (i.e., use common vaccine vectors, manufacturing ingredients, and processes) would
From page 7...
... In addition to smallpox readiness, research should continue to be used to enhance readiness and response for other orthopoxviruses, this includes supporting the validation, approval and licensure, and commercialization of existing and next-generation MCMs for use in the management of non-variola orthopoxviruses as an ef ficient way to expand readiness more broadly by enabling vendor managed inventory approaches to stockpiling. Conclusions in Chapter 2 (2-4)
From page 8...
... Conclusions in Chapter 3 on the implications of scientific and technological advancements on available smallpox MCMs (3-4, 3-5) include: (3-4)
From page 9...
... on a smallpox research agenda, including the utility of live variola virus research and clinical trial readiness (4-3) , include: (3-2)
From page 10...
... (4-2) Discovery research and pathogenesis research with live variola virus has merit as biomedical research without an immediate obvious connection to smallpox readiness and response.
From page 11...
... are: (3-6) The small number of manufacturers of smallpox MCMs is a readiness and response vulnerability -- and it is clear there is insufficient capacity to scale MCM production in the event of a large-scale smallpox outbreak especially one of international scope.
From page 12...
... for smallpox medical countermeasures could be developed (or in the case of smallpox vaccine, refined)
From page 13...
... • Examining the potential uses of and implications for currently stockpiled MCMs for other orthopoxvirus outbreaks. Consider the threat of other orthopoxviruses that stockpiled smallpox MCMs could be used for, and furthermore, if mpox becomes a more serious global health problem, consider the risk of further depletion of stockpiled smallpox MCMs.
From page 14...
... The scientific and technological opportunity for innovative and improved smallpox MCMs supports a transitional phase for the smallpox MCM portfolio, in which investments made to date are sustained to ensure a ready stockpile -- while leveraging collaborations and partnerships with other nations and organiza tions to build a diversified smallpox MCM stockpile and an agile, on-demand, distributed MCM response network of the future. Conclusions in Chapter 4 on strategies for smallpox MCM portfolio planning (4-4, 4-5, 4-6)
From page 15...
... Specific conclusions in Chapter 1 on the implications of the U.S. smallpox MCM enterprise for potential global smallpox events (1-1, 1-2)
From page 16...
... The United States maintains a national MCM stockpile and plans to diagnose, prevent, and treat smallpox. Despite the research done over recent decades and the fact that there are more smallpox MCMs available now than there were in the pre-eradication period, the nation's readiness and response posture to a smallpox event could be strengthened.
From page 17...
... • Strategic National Stockpile – Transition plan for the smallpox MCM portfolio, in which investments made to date are sustained to ensure a ready stockpile -- while working with other nations and organizations to build a diversified smallpox MCM stockpile and an agile, on-demand, distributed re sponse MCM network of the future. Budgetary stress on stockpile purchases and maintenance could be reduced through the commercialization of these smallpox MCMs for non-variola orthopoxviruses.


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