COVID-19: Federal Efforts Accelerate Vaccine and Therapeutic Development, but More Transparency Needed on Emergency Use Authorizations
Abstract
The U.S. had about 10.3 million cumulative reported cases of COVID-19 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 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-19vaccine and therapeutic development; and (2) FDA's use of EUAs for COVID-19 therapeutics and vaccines, among other objectives. GAO reviewed federal laws and agency documents, including HHS and DOD information on vaccine and therapeutic development and EUAs as of November 2020. GAO interviewed or received written responses from HHS and DOD officials, and interviewed representatives from vaccine developers and manufacturers, as well as select public health stakeholders and provider groups covering a range of provider types.
Document Details
- Document Type
- Technical Report
- Publication Date
- Nov 01, 2020
- Accession Number
- AD1149375
Entities
People
- Alyssa M. Hundrup
- Mary Denigan-macauley
Organizations
- United States Government Accountability Office