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Pages 18-36

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From page 19...
... Since the eradication of naturally occurring smallpox more than four decades ago, remaining collections of variola virus and advancements in genome amplification, sequencing, editing, and synthesis have presented both a danger to and safeguard of a world free from smallpox. Lessons learned from recent public health emergencies shed new light on vulnerabilities in the nation's readiness to swiftly contain emerging infectious disease threats, which calls into question the historical assumptions that underpin the smallpox medical countermeasures (MCMs)
From page 20...
... ACVVR oversees research using live variola virus and approves or rejects research proposals with live virus, discussed further in Chapter 3 (Box 3-1)
From page 21...
... 3. Explore the benefits and risks of scientific and technological advances on smallpox readiness and response and identify key priorities in research and development of smallpox MCMs.
From page 22...
... Study Scope The committee was asked to examine the utility of smallpox MCMs and implications for smallpox readiness and response considering lessons learned from recent public health emergencies. Further clarification during open session meetings with the sponsor tasked the committee to specifically consider strategic approaches for stockpiling smallpox MCMs and an enumeration of the ways in which research using live variola virus could provide benefits in a smallpox emergency (Sloane, 2023)
From page 23...
... Smallpox readiness and stockpiling decisions must account for the threat FIGURE 1-1  Public Health Emergency Medical Countermeasures Enterprise stakeholders and engagement.
From page 24...
... Chapter 2 introduces the MCMs developed to detect, prevent, and protect against smallpox in the post-eradication era, within the context of potential smallpox containment strategies. Chapter 3 discusses factors that may influence stockpiling considerations as well as other readiness planning decisions, including the impacts of orthopoxvirus characteristics, emerging technologies, and operational considerations on the development, testing, and deployment of smallpox MCMs.
From page 25...
... Smallpox Medical Countermeasures Stockpiles In 1980, WHA Resolution 33.4 recommended the establishment of a physical international reserve of smallpox vaccines, to be known as the Smallpox Vaccine Emergency Stockpile (SVES) , comprising remaining vaccine doses from the Smallpox Eradication Program and additional WHO Member State donations (WHO, 1980, 2017)
From page 26...
... . The United States has maintained its commitment to the global smallpox vaccine stockpile, having affirmed its pledged vaccines for 20 million people in 2024 in advance of the 154th session of the WHO Executive Board (Lewis, 2023)
From page 27...
... The U.S. pledge of smallpox vaccines to the WHO Smallpox Vaccine Emergency Stockpile (SVES)
From page 28...
... . In addition to the need for greater surge testing capacity, COVID-19 underscored the importance of maintaining a cadre of public health laboratory workforce and a dedicated supply chain for diagnostic test manufacturing, sample collection, and processing, (Behnam et al., 2020; Wolford et al., 2023)
From page 29...
... , and note an overall lack of revolutionary, intergovernmental effort on MCMs for emerging infectious diseases until the nation was in crisis (Bipartisan Commission on Biodefense, 2021)
From page 30...
... In marked contrast to the start of the COVID-19 pandemic, the U.S. government had stockpiled MCMs that would be effective to respond to the 2022 mpox multi-country outbreak through the SNS smallpox MCMs portoflio.
From page 31...
... Originally developed to address smallpox, it was also approved for an mpox indication by virtue of the vaccine challenge studies in animals having employed the monkeypox virus. Additionally, tecovirimat was made available during the mpox outbreak through a CDC investigational protocol and a National Institute of Allergy and Infectious Diseases clinical trial, as tecovirimat was not FDA approved for treating mpox (NLM, 2022; O'Laughlin et al., 2022)
From page 32...
... Therefore, global cooperation, information sharing and sharing financial and facility support for research to develop smallpox MCMs would be an essential first step in improving global readiness to a smallpox event. While this report focuses primarily on smallpox MCMs developed for use in the United States and maintained in the SNS, WHO Member States may benefit from, and in some cases depend on, U.S.
From page 33...
... OVERARCHING CONCLUSION Based on the evidence and findings on the implications of the U.S. smallpox MCM enterprise for potential global smallpox events, the committee drew the following overarching conclusion: In a smallpox event, the U.S.
From page 34...
... Accidental and Deliberate Release of Variola Virus Differences in exposure scenarios would impact the speed with which an immedi ate response would need to be scaled. In the event of a laboratory accident or dis covery of unofficial samples, direct and prolonged close contact would be needed for person-to-person transmission to continue to second- and third-generation smallpox cases.
From page 35...
... • Commercial manufacturing capability – Currently, there is a lack of com mercial market for smallpox MCMs and insufficient capacity to scale MCM production in the event of a large-scale smallpox event. The commercializa tion of cross-protective orthopoxvirus MCMs and emerging biotechnologies could provide capabilities to respond and deploy smallpox MCMs on demand, when and where needed.
From page 36...
... Washington, DC: Bipartisan Commission on Biodefense. https://biodefensec ommission.org/wp-content/uploads/2024/02/2024.02.20-Box-the-Pox.pdf  (accessed February 22, 2024)


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