Developing an Ethics Framework for Allocating Remdesivir in the COVID-19 Pandemic.

7 When the FDA issued its EUA on May 1, based on unpublished data from the NIAID and Gilead trials, the agency stated that remdesivir was associated with a reduction in median time to recovery from 15 to 11 days in hospitalized patients with severe COVID-19, and there was potential for a reduction in mortality from 11.6% to 8% that did not reach statistical significance. 15 However, preliminary results from the NIAID trial were not published until May 22, 2020, 2 more than 2 weeks after MDH had to make the first allocation, and results from the Gilead trial were not published until May 27, 2020. 3 This paucity of evidence when the initial ethical framework for EUA allocation was needed created uncertainty about which patient populations would benefit from remdesivir.

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