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Pages 128-137

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From page 128...
... TABLE 4-2 Continued 128 Element Replicationof MCM Opportunity for MCM Knowledge Gaps and Non-VARV Defective Live VARV in Live VARV in Readiness Improvement Research Possibilities Orthopoxviruses VARV Tissue Culture Animal Models Vaccines • Vaccines against smallpox Advancing research on Essential for No use Useful for Arguably with improved efficacy, orthopoxvirus replication, almost every measuring essential safety, utility, and pathogenesis, host aspect of vaccine functional for optimal scalability. interactions, and immune development immune verification of • Ancillary benefits of responses to improve with vaccinia response (e.g., potential efficacy vaccinia-based vaccines understanding of virus virus neutralization)
From page 129...
... . antivirals: humans • Viral evolution, including genomic mutations from orthopoxvirus patients • Transmission • Pathogenesis and host interaction • Mechanisms of entry and receptors, DNA replication, transcription, membrane assembly, virion assembly and egress, and resistance • Viral protein functions and functional interactions • Major targets of neutralizing antibodies • Factors that determine host range • Cellular mechanisms promoting zoonotic infection continued 129
From page 130...
... human surrogate NOTE: VARV = variola virus.
From page 131...
... . Decentralizing and taking clinical trials closer to the community has the potential to also reduce social inequities and logistical barriers in research participation (Petrini et al., 2022)
From page 132...
... (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 133...
... . These threats remain substantive drivers of the SNS budget, and there is limited flexibility in terms of what other MCMs can be purchased with current appropriations, due to the portion of the budget allocated to anthrax and smallpox MCMs (GAO, 2022)
From page 134...
... The description of BARDA's investment in smallpox MCMs includes funding to support sustained investment in a lyophilized formulation of MVABN, manufacturing of additional doses of MVA-BN to bolster domestic supply, and procurement of oral and intravenous tecovirimat to replenish products used to respond to the mpox outbreak. Sustainment of stockpiled assets is a prudent course, given the years and billions of dollars that have gone into developing and procuring these assets.
From page 135...
... An important question raised from the mpox experience is whether the dual indications for both a national security threat and an emerging infectious disease will remain an outlier, or whether it can 2 Public Law: Project BioShield Act of 2004, Public Law 108-276, 108th Cong., 2d. sess.
From page 136...
... . Unlike ACAM2000, the smallpox vaccine intended for the general population and thus stored in the large quantities, MVA-BN was intended for use in a subset of the population.
From page 137...
... to all-hazards and emerging infectious diseases) but in a resourceconstrained environment that requires making prioritization decisions, or in some cases, decisions as if there were no costs involved at all (GAO, 2022)


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