HSR&D Citation Abstract
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Allocation of Remdesivir if Demand Outstrips Supply
Black H, Buhr RG, Cederquist L, Dastur C, Dicker R, Doucet J, Edwards S, Fairman N, Godat L, Hemphill C, Kheriaty A, Koenig B, Mittal A, Narayana S, Navarro JN, Rajczi A, Turnbull J, Wenger N, Nelson Z, Nosowsky R. Allocation of Remdesivir if Demand Outstrips Supply. University of California Critical Care Bioethics Working Group. Los Angeles, CA: University of California; 2020 Jun 26.
On May 1, 2020, the Federal Drug Administration (FDA) issued an Emergency Use Authorization (EUA) for the use of remdesivir in the treatment of patients with COVID-19. Remdesivir, an antiviral drug which targets RNA dependent polymerase in SARS-CoV2, has been shown in a recent NIH sponsored trial to hasten the time to recovery by 31% compared with placebo (11 v 15 days) among patients with COVID-19 infection.
The EUA allows for the treatment of COVID-19 in adults and children who are hospitalized with severe disease as defined by a room air oxygen saturation of 94%. Because of the limited distribution, and because pregnant women and children may receive remdesivir from Gilead through the Compassionate Use Program, the California Department of Public Health (CDPH) has determined that the EUA supply be reserved for non-pregnant adults at this time. If there is delay in receiving remdesivir through this program, pregnant people and children should be included in the EUA allocation.
The data on remdesivir remains new and evolving. Therefore, additional therapies through controlled trials should also be considered, as well as opportunities for therapies through compassionate use (e.g. convalescent plasma). Additionally, the administration of remdesivir through existing trials should be supported if available and if patient qualifies and consents. However, there may be a patient who may not have the opportunity for a clinical trial or may not consent, for whom EUA remdesivir may be utilized.