COVID-19 : Federal Efforts Accelerate Vaccine and Therapeutic Development, but More Transparency Needed on Emergency Use Authorizations : report to congressional addressees.

Format:

Book

Government document

Author/Creator:

United States. Government Accountability Office, author.

Denigan-Macauley, Mary, author.

Hundrup, Alyssa M., author.

Language:

English

Subjects (All):

United States. Food and Drug Administration--Rules and practice--Evaluation.

United States.

United States. Food and Drug Administration.

COVID-19 (Disease)--Prevention--Government policy--United States.

COVID-19 (Disease).

COVID-19 (Disease)--Treatment--Government policy--United States.

COVID-19 (Disease)--Research--Government policy--United States.

Emergency management--United States.

Emergency management.

Transparency (Ethics) in government--United States.

Transparency (Ethics) in government.

COVID-19 (Disease)--Prevention--Government policy.

Physical Description:

1 online resource (ii, 46 pages) : color illustrations

Place of Publication:

Washington, DC : United States Government Accountability Office, 2020.

Summary:

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. This report examines, (1) efforts of Operation Warp Speed to accelerate COVID-19 vaccine and therapeutic development; and (2) FDA's use of EUAs for COVID- 19 therapeutics and vaccines, among other objectives. FDA should identify ways to uniformly disclose to the public the information from its scientific review of safety and effectiveness data when issuing EUAs for therapeutics and vaccines.

Contents:

Background.

Operation Warp Speed partnership leads federal efforts to accelerate developing and manufacturing COVID-19 vaccine and therapeutics.

FDA clarified expected evidence for COVID-19 vaccine EAUs, but the evidence to support its COVID-19 therapeutic EUA decisions is not always transparent.

Stakeholders indicate initial planning documents are helpful, but seek additional information on federal plans for vaccine distribution.

Conclusions.

Recommendation for executive action.

Agency comments and our evaluation.

Appendices.

Notes:

"November 2020."

"GAO-21-207."

Includes bibliographical references.

Description based on online resource; title from PDF cover page (GAO, viewed on Jan. 24, 2022).

OCLC:

1236944902