Future State of Smallpox Medical Countermeasures (2024) / Chapter Skim
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In other words, the destruction of known variola virus collections would no longer eliminate the threat of smallpox reemergence as a public health threat. It therefore remains important to maintain robust public health and health system capacities and readiness to rapidly identify -- and effectively respond to -- a potential smallpox outbreak.
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. Additionally, the committee considered the future research and development that would be needed to improve existing smallpox MCMs, including research with live variola virus (Chapter 4)
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OVERARCHING CONCLUSIONS ON MEDICAL COUNTERMEASURES READINESS State of Smallpox MCM Readiness A variety of MCMs have been developed to detect (diagnostics) , prevent (vaccines)
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, envelope protein required Expanded Access IND, Emergency for envelopment and IND (not FDA approved) excretion of extracellular - STOMP/A5418 (Study of forms of the virus.
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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)
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Furthermore, the mpox outbreak highlighted gaps in the smallpox therapeutic options, specifically on the reliance on challenge studies in animals and animal model data for understanding potential efficacy in humans and predicting antiviral resistance, and on a lack of diverse therapeutic options with distinct mechanisms of action. For these reasons, the committee drew the following overarching conclusion: 1.
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; (3) vaccinia immune globulin intravenous (VIGIV)
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For these reasons, the committee drew the following overarching conclusion: 3. A comprehensive and ongoing risk–benefit analysis is needed for smallpox MCMs research using emerging technologies as well as ongoing careful oversight to mitigate the risks of this research and ensure the risk–benefit balance is maintained.
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In Chapter 4, Table 4-2 shows smallpox MCM readiness as a function of research with live variola and non-variola orthopoxviruses. It maps the potential for using these viruses or their components against specific knowledge gaps and MCM goals that could support improved public health benefit.
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(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.
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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.
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The successes of the mpox response were tempered by major challenges, especially the short supply of immediately available third generation licensed smallpox/mpox vaccine doses, as well as by concerns over needed changes in dosing and route of administration strategies not included in the vaccine's label for use during the outbreak response, inequitable access to vaccines and laboratory testing for patients, and overall federal, state, and local coordination. To aid SNS administrators in their review of the future of the SNS smallpox MCM portfolio, the committee poses the considerations offered in Box S-1 (adapted from Box 4-2 in Chapter 4)
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• 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.
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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)
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Specific conclusions in Chapter 1 on the implications of the U.S. smallpox MCM enterprise for potential global smallpox events (1-1, 1-2)
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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.
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• Emerging Technologies – Ongoing risk/benefit analysis conducted periodically for smallpox MCM research and development using emerging technologies. Systems Readiness • Operational Considerations – Periodic assessment of implementation and operational factors that might influence smallpox readiness and response, including manufacturing capacity, frontline readiness, risk communication, and regulatory readiness.
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