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Regulating Select Agent Chimeras: Defining the Problem(s) Through the Lens of SARS-CoV-1/SARS-CoV-2 Chimeric Viruses. 调节选择因子嵌合体:从严重急性呼吸系统综合征冠状病毒1/严重急性呼吸综合征冠状病毒2型嵌合体病毒的角度界定问题。
IF 3.3 4区 医学 Q3 PUBLIC, ENVIRONMENTAL & OCCUPATIONAL HEALTH Pub Date : 2023-09-01 Epub Date: 2023-09-13 DOI: 10.1089/hs.2023.0008
Elizabeth W Wells, Michael T Parker

In late 2021, the US Centers for Disease Control and Prevention (CDC) posted an interim final rule (86 FR 64075) to the federal register regulating the possession, use, and transfer of SARS-CoV-1/SARS-CoV-2 chimeric viruses. In doing so, the CDC provided the reasoning that viral chimeras combining the transmissibility of SARS-CoV-2 with the pathogenicity and lethality of SARS-CoV-1 pose a significant risk to public health and should thus be placed on the select agents and toxins list. However, 86 FR 64075 lacked clarity in its definitions and scope, some of which the CDC addressed in response to public comments in the final rule, 88 FR 13322, in early 2023. To evaluate these regulatory actions, we reviewed the existing select agent regulations to understand the landscape of chimeric virus regulation. Based on our findings, we first present clear definitions for the terms "chimeric virus," "viral chimera," and "virulence factor" and provide a list of SARS-CoV-1 virulence factors in an effort to aid researchers and federal rulemaking for these agents moving forward. We then provide suggestions for a combination of similarity and functional characteristic cutoffs that the government could use to enable researchers to distinguish between regulated and nonregulated chimeras. Finally, we discuss current select agent regulations and their overlaps with 86 FR 64075 and 88 FR 13322 and make suggestions for how to address chimera concerns within and/or without these regulations. Collectively, we believe that our findings fill important gaps in current federal regulations and provide forward-looking philosophical and practical analysis that can guide future decisionmaking.

2021年末,美国疾病控制与预防中心(CDC)向联邦登记册发布了一项临时最终规则(86 FR 64075),对严重急性呼吸系统综合征冠状病毒1/严重急性呼吸综合征冠状病毒2型嵌合病毒的拥有、使用和转移进行了监管。在这样做的过程中,美国疾病控制与预防中心提出了这样的理由,即将严重急性呼吸系统综合征冠状病毒2型的传播性与严重急性呼吸综合征冠状病毒1型的致病性和致死性相结合的病毒嵌合体对公众健康构成了重大风险,因此应将其列入选定的病原体和毒素名单。然而,86 FR 64075在定义和范围上缺乏明确性,其中一些定义和范围是美国疾病控制与预防中心在2023年初的最终规则88 FR 13322中回应公众意见时解决的。为了评估这些调控作用,我们回顾了现有的选择因子调控,以了解嵌合病毒调控的前景。基于我们的发现,我们首先对“嵌合病毒”、“病毒嵌合体”和“毒力因子”等术语提出了明确的定义,并提供了严重急性呼吸系统综合征冠状病毒1型毒力因子的列表,以帮助研究人员和联邦规则制定这些制剂。然后,我们提出了相似性和功能特征临界值的组合建议,政府可以利用这些建议使研究人员能够区分受调控和非受调控的嵌合体。最后,我们讨论了当前的选择代理法规及其与86 FR 64075和88 FR 13322的重叠,并就如何在这些法规内和/或不在这些法规下解决嵌合体问题提出了建议。总的来说,我们相信我们的发现填补了当前联邦法规中的重要空白,并提供了前瞻性的哲学和实践分析,可以指导未来的决策。
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引用次数: 0
A Modular-Incremental Approach to Improving Compliance Verification With the Biological Weapons Convention. 改进《生物武器公约》遵守情况核查的模块化递增办法。
IF 3.3 4区 医学 Q3 PUBLIC, ENVIRONMENTAL & OCCUPATIONAL HEALTH Pub Date : 2023-09-01 Epub Date: 2023-07-26 DOI: 10.1089/hs.2023.0078
Nicholas R Cropper, Shrestha Rath, Ryan J C Teo, Kelsey Lane Warmbrod, Mary J Lancaster
The Ninth Review Conference of the Biological Weapons Convention (BWC) concluded in December 2022 with the establishment of a working group that will make recommendations on, among other issues, verification and compliance, enabling discussion on a topic that was sidelined for over 2 decades. Unlike other major disarmament treaties, the BWC does not have an effective mechanism for verifying compliance among states parties. Verification is an essential function of many international disarmament treaties; however, there is little agreement among stakeholders about what form or function verification should take for the BWC. For the Chemical Weapons Convention or the Treaty on the Non-Proliferation of Nuclear Weapons, for example, verification is based on a framework driven by accounting that involves the meticulous documentation of facilities, tools, and raw materials of relevance to the fulfillment of state treaty obligations. Relying on this accounting approach alone is both technologically and practically infeasible in the context of the BWC. The dual-use nature of bioscience makes it difficult to differentiate between peaceful and offensive applications from an accounting-driven framework. Furthermore, the increased availability of and ever-widening access to biotechnology has increased the potential for misuse by a variety of nonstate actors. These new, distributed security risks present different verification challenges in the biological context, in contrast with the Chemical Weapons Convention or Treaty on the Non-Proliferation of Nuclear Weapons, and have led some experts to argue that compliance verification is currently impossible, although others have pointed out the opportunities that advances in biosciences bring to technical verification. This commentary offers solutions to some of the political and technical challenges that have led to this conclusion. No single verification activity can provide unambiguous evidence for assessing treaty compliance. A pragmatic approach to BWC compliance verification should leverage
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引用次数: 0
On the Mark: Modeling and Forecasting for Public Health Impact. 标记:公共卫生影响的建模和预测。
IF 3.3 4区 医学 Q3 PUBLIC, ENVIRONMENTAL & OCCUPATIONAL HEALTH Pub Date : 2023-09-01 DOI: 10.1089/hs.2023.0033
Mark J Panaggio, Shelby N Wilson, Jeremy D Ratcliff, Luke C Mullany, Jeffrey D Freeman, Kaitlin Rainwater-Lovett
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引用次数: 1
Chimeric Viruses Containing Select Agents: The Biology Behind Their Creation, Attenuation, and Exclusion From Regulation. 含有选择性试剂的嵌合病毒:其产生、衰减和排除在监管之外的生物学。
IF 3.3 4区 医学 Q3 PUBLIC, ENVIRONMENTAL & OCCUPATIONAL HEALTH Pub Date : 2023-09-01 Epub Date: 2023-09-13 DOI: 10.1089/hs.2023.0007
Elizabeth W Wells, Michael T Parker

The US Centers for Disease Control and Prevention (CDC), as part of the Federal Select Agent Program, and under the purview of 42 CFR §73.3, has the ability to regulate chimeric viruses that contain portions of pathogens that are part of the select agents and toxins list. In addition, the CDC is responsible for excluding pathogens from regulation, including chimeric viruses, that are sufficiently attenuated. Since 2003, the CDC has excluded over 20 chimeric viruses that contain portions of select agents. But in late 2021, the CDC proposed a regulatory first-the addition of a chimeric virus to the select agents and toxins list. To better understand the importance and applicability of this action, we surveyed the landscape of previous exclusions from select agent regulation. First, we reviewed the exclusion criteria used by the Intragovernmental Select Agents and Toxins Technical Advisory Committee in their advisement of the Federal Select Agent Program. We then reviewed the literature on chimeric viruses that contain portions of select agents and that have been excluded from regulation due to sufficient attenuation, focusing on chimeric alphaviruses and chimeric avian influenza viruses. By analyzing biological commonalities and patterns in the structure and methodology of the development of previously excluded chimeric viruses, we provide insight into how the CDC has used exclusion criteria in the past to regulate chimeric viruses. We conclude by contrasting previous exclusions with the recent addition of SARS-CoV-1/SARS-CoV-2 chimeric viruses to the select agents and toxins list, demonstrating that this addition strays from established, effective regulatory processes, and is thus a regulatory misstep.

美国疾病控制与预防中心(CDC)作为联邦选择制剂计划的一部分,在《美国联邦法规》第42卷第73.3节的管辖范围内,有能力调节含有部分病原体的嵌合病毒,这些病原体属于选择制剂和毒素清单的一部分。此外,美国疾病控制与预防中心负责将病原体排除在监管之外,包括充分减毒的嵌合病毒。自2003年以来,美国疾病控制与预防中心已经排除了20多种含有部分选择性试剂的嵌合病毒。但在2021年末,美国疾病控制与预防中心首次提出了监管建议,将嵌合病毒添加到选定的制剂和毒素列表中。为了更好地理解这一行动的重要性和适用性,我们调查了以前被排除在选择性代理人监管之外的情况。首先,我们审查了政府内部选择制剂和毒素技术咨询委员会在其对联邦选择制剂计划的建议中使用的排除标准。然后,我们回顾了关于嵌合病毒的文献,这些病毒含有部分选择试剂,并且由于足够的衰减而被排除在调节之外,重点是嵌合α病毒和嵌合禽流感病毒。通过分析先前被排除的嵌合病毒的结构和开发方法中的生物学共性和模式,我们深入了解了美国疾病控制与预防中心过去是如何使用排除标准来调节嵌合病毒的。最后,我们将之前的排除与最近将严重急性呼吸系统综合征冠状病毒1/严重急性呼吸综合征冠状病毒2型嵌合病毒添加到选择试剂和毒素列表中进行了对比,表明这种添加偏离了既定的有效监管过程,因此是监管失误。
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引用次数: 0
A Multisite Investigation of Areas for Improvement in COVID-19 Surge Capacity Management. 新冠肺炎激增能力管理改进领域的多站点调查。
IF 3.3 4区 医学 Q3 PUBLIC, ENVIRONMENTAL & OCCUPATIONAL HEALTH Pub Date : 2023-09-01 Epub Date: 2023-08-07 DOI: 10.1089/hs.2023.0019
Emily R Post, Reena Sethi, Adeteju A Adeniji, Clark J Lee, Sophia Shea, Rebecca Metcalf, Jamie Gaynes, Kila Tripp, Thomas D Kirsch

The congressionally authorized National Disaster Medical System Pilot Program was created in December 2019 to strengthen the medical surge capability, capacity, and interoperability of affiliated healthcare facilities in 5 regions across the United States. The COVID-19 pandemic provided an unprecedented opportunity to learn how participating healthcare facilities handled medical surge events during an active public health emergency. We applied a modified version of the Barbisch and Koenig 4-S framework (staff, stuff, space, systems) to analyze COVID-19 surge management practices implemented by healthcare stakeholders at 5 pilot sites. In total, 32 notable practices were identified to increase surge capacity during the COVID-19 pandemic that have potential applications for other healthcare facilities. We found that systems was the most prevalent domain of surge capacity among the identified practices. Systems and staff were discussed across all 5 pilot sites and were the 2 domains co-occurring most often within each surge management practice. These results can inform strategies for scaling up and optimizing medical surge capability, capacity, and interoperability of healthcare facilities nationwide. This study also specifies areas of surge capacity worthy of strategic focus in the pilot's planning and implementation efforts while more broadly informing the US healthcare system's response to future large-scale, medical surge events.

国会授权的国家灾难医疗系统试点项目成立于2019年12月,旨在加强美国5个地区附属医疗机构的医疗激增能力、能力和互操作性。新冠肺炎大流行提供了一个前所未有的机会来了解参与的医疗机构如何在活跃的公共卫生紧急情况下处理医疗激增事件。我们应用Barbisch和Koenig 4-S框架的修改版本(员工、材料、空间、系统)来分析医疗保健利益相关者在5个试点点实施的新冠肺炎激增管理实践。在新冠肺炎大流行期间,总共确定了32种显著的做法来提高激增能力,这些做法有可能应用于其他医疗机构。我们发现,在已确定的做法中,系统是最普遍的激增能力领域。对所有5个试点地点的系统和工作人员进行了讨论,这是每个激增管理实践中最常见的两个领域。这些结果可以为扩大和优化全国医疗机构的医疗激增能力、能力和互操作性的战略提供信息。这项研究还指定了在试点计划和实施工作中值得战略关注的激增能力领域,同时更广泛地为美国医疗系统应对未来大规模医疗激增事件提供信息。
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引用次数: 1
Reimagining Preparedness Through Systems Approaches. 通过系统方法重塑准备。
IF 3.3 4区 医学 Q3 PUBLIC, ENVIRONMENTAL & OCCUPATIONAL HEALTH Pub Date : 2023-09-01 DOI: 10.1089/hs.2023.0133
Eric S Toner
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引用次数: 0
Reimagining Incident Management Systems for Public Health Responses. 重塑公共卫生响应事件管理系统。
IF 3.3 4区 医学 Q3 PUBLIC, ENVIRONMENTAL & OCCUPATIONAL HEALTH Pub Date : 2023-09-01 Epub Date: 2023-09-21 DOI: 10.1089/hs.2023.0037
Regina W Hawkins, Kimberly Y Ma, Andrew D Pickett, Gerrit Bakker, Steven S Kipp, Alysia Mihalakos, Paul E Petersen
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引用次数: 1
"Boosting" Surveillance for a More Impactful Public Health Response During Protracted and Evolving Infectious Disease Threats: Insights From the COVID-19 Pandemic. 在长期和不断演变的传染病威胁期间,“加强”监测以更有效地应对公共卫生:新冠肺炎大流行的见解。
IF 2.1 4区 医学 Q3 PUBLIC, ENVIRONMENTAL & OCCUPATIONAL HEALTH Pub Date : 2023-09-01 Epub Date: 2023-08-29 DOI: 10.1089/hs.2023.0046
Saba A Qasmieh, McKaylee M Robertson, Denis Nash
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引用次数: 0
New York State, New York City, New Jersey, Puerto Rico, and the US Virgin Islands' Health Department Experiences Promoting Health Equity During the Initial COVID-19 Omicron Variant Period, 2021-2022. 2021-2022年新冠肺炎奥密克戎变异株初期,纽约州、纽约市、新泽西州、波多黎各和美属维尔京群岛卫生部在促进卫生公平方面的经验。
IF 2.1 4区 医学 Q3 PUBLIC, ENVIRONMENTAL & OCCUPATIONAL HEALTH Pub Date : 2023-09-01 Epub Date: 2023-08-17 DOI: 10.1089/hs.2023.0001
Heidi Cox, Yonathan Gebru, Libby Horter, Francisco S Palomeque, Kristopher Myers, Daniel Stowell, Torian Easterling, Nayeli Salazar de Noguera, Amanda Medina-Forrester, Josely Bravo, Siomara Pérez, Jaikiz Chaparro, Lisa La Place Ekpo, Hannah Cranford, Scott Santibañez, Diana Valencia

In this case study, we aim to understand how health departments in 5 US jurisdictions addressed health inequities and implemented strategies to reach populations disproportionately affected by COVID-19 during the initial Omicron variant period. We used qualitative methods to examine health department experiences during the initial Omicron surge, from November 2021 to April 2022, assessing successful interventions, barriers, and lessons learned from efforts to promote health equity. Our findings indicate that government leadership supported prioritizing health equity from the beginning of the pandemic, seeing it as a need and vital part of the response framework. All jurisdictions acknowledged the historical trauma and distrust of the government. Health departments found that collaborating and communicating with trusted community leaders helped mitigate public distrust. Having partnerships, resources, and infrastructure in place before the pandemic facilitated the establishment of equity-focused COVID-19 response activities. Finally, misinformation about COVID-19 was a challenge for all jurisdictions. Addressing the needs of diverse populations involves community-informed decisionmaking, diversity of thought, and delivery measures that are tailored to the community. It is imperative to expand efforts to reduce and eliminate health inequities to ensure that individuals and communities recover equitably from the effects of COVID-19.

在本案例研究中,我们旨在了解美国5个司法管辖区的卫生部门如何解决卫生不平等问题,并实施战略,以在最初的奥密克戎变异株时期接触受新冠肺炎不成比例影响的人群。我们使用定性方法研究了2021年11月至2022年4月奥密克戎最初激增期间卫生部门的经验,评估了成功的干预措施、障碍以及从促进卫生公平的努力中吸取的教训。我们的研究结果表明,政府领导层从疫情一开始就支持优先考虑卫生公平,将其视为应对框架的一个需求和重要组成部分。所有司法管辖区都承认历史创伤和对政府的不信任。卫生部门发现,与值得信赖的社区领导人合作和沟通有助于减轻公众的不信任。在大流行之前建立伙伴关系、资源和基础设施有助于建立以公平为重点的新冠肺炎应对活动。最后,关于新冠肺炎的错误信息对所有司法管辖区来说都是一个挑战。满足不同人群的需求涉及社区知情决策、思想多样性和针对社区的交付措施。当务之急是扩大减少和消除卫生不平等的努力,以确保个人和社区公平地从新冠肺炎的影响中恢复。
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引用次数: 0
Strengths, Weaknesses, and Catharsis: The Role of Information Sharing in Public Health After the COVID-19 Response. 优势、劣势和传染病:新冠肺炎应对后信息共享在公共卫生中的作用。
IF 3.3 4区 医学 Q3 PUBLIC, ENVIRONMENTAL & OCCUPATIONAL HEALTH Pub Date : 2023-09-01 DOI: 10.1089/hs.2023.0034
Andrew D Pickett
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引用次数: 1
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Health Security
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