Late Monday, the Data and Safety Monitoring Board (DSMB) notified NIAID, BARDA, and AstraZeneca that it was concerned by information released by AstraZeneca on initial data from its COVID-19 vaccine clinical trial.
Earlier on Monday, AstraZeneca released Phase 3 data that found its SARS-CoV-2 vaccine was 79% effective at preventing symptomatic COVID-19 and 100% effective at preventing severe disease and hospitalization.
The DSMB expressed concern that AstraZeneca may have included outdated information from that trial, which may have provided an incomplete view of the efficacy data.
“We urge the company to work with the DSMB to review the efficacy data and ensure the most accurate, up-to-date efficacy data be made public as quickly as possible,” the NIAID said in an advisory.
According to the Department of Health and Human Services, the DSMB is a group of individuals with pertinent expertise that regularly reviews accumulating data from one or more ongoing clinical trials. A DSMB functions as a monitor of the trial to ensure the safety of study subjects and validity and integrity of the data.
Authorization and guidelines for use of the vaccine in the United States will be determined by the Food and Drug Administration and Centers for Disease Control and Prevention after thorough review of the data by independent advisory committees.
