Clin Infect Dis. 2021 Dec 18:ciab1039. doi: 10.1093/cid/ciab1039. Online ahead of print.
The U.S. FDA has issued emergency use authorizations (EUAs) for monoclonal antibodies (mAbs) for non-hospitalized patients with mild or moderate COVID-19 disease and for individuals exposed to COVID-19 as post-exposure prophylaxis. One EUA for an oral antiviral drug, molnupiravir, has also been recommended by FDA's Antimicrobial Drugs Advisory Committee, and others appear likely in the near future. 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 with increased infectivity and/or severity (e.g., potentially 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 (e.g. 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 rules based on vaccination, immunocompromise status, or older age, or the ad hoc consideration of clinical risk factors.