Health Security最新文献

Scholars have called for ethical preparedness for public health practice and research to address the challenges of special ethical considerations under time and resource pressure during emergencies like the COVID-19 pandemic. We propose the idea of a rapid ethical assessment (REA) that aims to provide ethical justifications and policy recommendations for a specific public health policy, which is necessary for the ethical legitimacy of health policymaking and implementation. We suggest that an REA task force be established and incorporated into the administrative procedure to perform an REA in the early, middle, and terminal stages of a policy proposed by the health authority and to determine to what extent the tradeoffs between values and priorities required by the policy are ethically acceptable. The REA task force's role is consultative, with the final decisionmaking power and political responsibilities falling on the health authority. The REA task force should adopt 4 substantial ethical principles: utilitarianism, equity, human rights, and solidarity. The REA task force would consist of a multidisciplinary team of experts and a group of representatives from those who would be affected by the proposed policy. The REA task force would operate with a 5-step procedure of (1) convening, (2) investigation, (3) determination, (4) reporting and communication, and (5) decision and reassessment. We use 2 real incidents in Taiwan to demonstrate how the REA task force could work to enhance the ethical acceptance of a policy.

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.

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.

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.