Sturm College of Law, University of Denver, Denver, Colorado, USA.
University of Chicago, Chicago, Illinois, USAand.
Clin Infect Dis. 2022 Aug 24;75(1):e529-e533. doi: 10.1093/cid/ciab1039.
The US Food and Drug Administration (FDA) has issued emergency use authorizations (EUAs) for monoclonal antibodies (mAbs) for nonhospitalized patients with mild or moderate coronavirus disease 2019 (COVID-19) disease and for individuals exposed to COVID-19 as postexposure prophylaxis. EUAs for oral antiviral drugs have also been issued. Due to increased demand because of the Delta variant, the federal government resumed control over the supply and asked states to ration doses. As future variants (eg, the Omicron variant) emerge, further rationing may be required. We identify relevant ethical principles (ie, benefiting people and preventing harm, equal concern, and mitigating health inequities) and priority groups for access to therapies based on an integrated approach to population health and medical factors (eg, urgently scarce healthcare workers, persons in disadvantaged communities hard hit by COVID-19). Using priority categories to allocate scarce therapies effectively operationalizes important ethical values. This strategy is preferable to the current approach of categorical exclusion or inclusion rules based on vaccination, immunocompromise status, or older age, or the ad hoc consideration of clinical risk factors.
美国食品和药物管理局（FDA）已为非住院的轻症或中度 2019 冠状病毒病（COVID-19）患者和 COVID-19 暴露后预防个体发布了单克隆抗体（mAb）的紧急使用授权（EUA）。也发布了口服抗病毒药物的 EUA。由于 Delta 变异株的需求增加，联邦政府恢复了对供应的控制，并要求各州配给剂量。随着未来变异株（例如，Omicron 变异株）的出现，可能需要进一步配给。我们根据综合的人口健康和医疗因素方法（例如，紧急缺乏医护人员、受 COVID-19 严重影响的弱势社区人群），确定了基于相关伦理原则（即，使人们受益和预防伤害、平等关注以及减轻健康不公平）和获得治疗的优先群体。使用优先级类别来有效分配稀缺的疗法可以使重要的伦理价值观付诸实践。与基于疫苗接种、免疫功能低下或年龄较大，或临时考虑临床危险因素的分类排除或纳入规则相比，这种策略更可取。
