COVID-19: Federal Efforts Accelerate Vaccine and Therapeutic Development, but More Transparency Needed on Emergency Use Authorizations, Report to Congressional Addressees   [open pdf - 2MB]

From the GAO (Government Accountability Office) Highlights: "The U.S. had about 10.3 million cumulative reported cases of COVID-19 [coronavirus disease 2019] and about 224,000 reported deaths as of November 12, 2020. Given this catastrophic loss of life as well as the pandemic's effects on the U.S. economy, effective and safe vaccines and therapeutics are more important than ever. The CARES [Coronavirus Aid, Relief, and Economic Security] Act includes a provision for GAO to report on its ongoing monitoring and oversight efforts related to the COVID-19 pandemic. This report examines, (1) efforts of Operation Warp Speed to accelerate COVID-19 vaccine and therapeutic development; and (2) FDA's use of EUAs [emergency use authorizations] for COVID-19 therapeutics and vaccines, among other objectives."