Publication Date
7-2022
Document Type
Article
Organizational Units
Sturm College of Law
Keywords
COVID, Bioethics, FDA, Emergency use authorization, Monoclonal antibodies
Abstract
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 (e.g., the Omicron variant) emerge, further rationing may be required. We identify relevant ethical principles (i.e., 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, immunocompromised status, or older age, or the ad hoc consideration of clinical risk factors.
Copyright Date
2022
Copyright Statement / License for Reuse
This work is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License
Publication Statement
Copyright is held by the author. User is responsible for all copyright compliance.
File Format
application/pdf
Recommended Citation
Govind Persad, Monica E. Peek & Seema K. Shah, Fair Allocation of Scarce Therapies for Coronavirus Disease 2019 (COVID-19), 75 Clinical Infectious Diseases e529 (2022).