Press release

Tuesday 23 March 2021

On Monday evening, the Data and Safety Oversight Board (DSMB) notified NIAID, BARDA and AstraZeneca that it was concerned about information released by AstraZeneca on initial data from its clinical trial of the COVID-19 vaccine. The DSMB expressed concern that AstraZeneca may have included outdated information from this trial, which may have provided an incomplete view of efficacy data. We urge the company to work with the DSMB to review efficacy data and ensure that the most accurate and up-to-date efficacy data is released to the public as quickly as possible.

Authorization and guidelines for use of the vaccine in the United States will be determined by the Food and Drug Administration and the Centers for Disease Control and Prevention after a thorough review of the data by independent advisory committees.

About the National Institutes of Health (NIH):NIH, the nation’s medical research agency, comprises 27 institutes and centers and is a component of the US Department of Health and Human Services. The NIH is the principal federal agency that conducts and supports basic, clinical, and translational medical research, and studies the causes, treatments, and cures for common and rare diseases. For more information about NIH and its programs, visit www.nih.gov.

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