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1 Introduction
Pages 19-40

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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...
... The U.S. Strategic National Stockpile, or SNS, contains smallpox vaccines, drugs, and related supplies and medical devices that the secretary of HHS can deploy to state, local, tribal, and territorial jurisdictions at their request in the event of a smallpox emergency (Kuiken and Gottron, 2023)
From page 21...
... Consider how the COVID-19 pandemic and the mpox multi-country outbreak can inform improvements to smallpox readiness and response, including the availability of smallpox MCMs and the ability to meet poten tial demand.
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...
... LESSONS LEARNED FROM RESPONDING TO COVID-19 AND MPOX ASPR asked the committee to consider lessons learned from COVID-19 and mpox in its thinking about how national smallpox MCM assets could be optimized. The initial response failures to COVID-19 in the United States have been attributed to "the nation's pre-existing structural and systemic features, which magnified the pandemic's impact" as well as failures in government at many levels "to generate reliable information, communicate it in a timely and consistent manner, and translate it into sound policy" (Yamey et al., 2024)
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...
... . On September 7, after an official declaration of a public health emergency, FDA issued EUA authorities to further expand in vitro diagnostic testing availability for monkeypox virus; the declaration was drafted broadly to include testing options that detect or diagnose infection with non-variola orthopoxvirus (FDA, 2023b)
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...
... Geographic Scope In the event of an accidental or deliberate smallpox outbreak, initial cases could be localized or across multiple locations. Regardless of the geographical scope, a smallpox outbreak of any size would likely constitute an international emergency, as it may indicate a nefarious actor with the motivation and capability to conduct subsequent attacks.
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...
... 2022. A hierarchy of medical countermeasures against biological threats.
From page 37...
... 2023. Smallpox medical countermeasures.
From page 38...
... Presentation at Meeting 3 of the Committee on Current State of Research, Development, and Stockpiling of Smallpox MCMs of the National Academies. December 14.
From page 39...
... 2021. Ensuring an effective Public Health Emergency Medical Countermeasures Enterprise.
From page 40...
... 2017. Operational framework for the deployment of the World Health Organization Smallpox Vaccine Emergency Stockpile in response to a smallpox event.


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