Late Monday, the Data and Safety Monitoring Board (DSMB) notified the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), BARDA, and AstraZeneca that it was concerned by information released by AstraZeneca on initial data from its COVID-19 vaccine clinical trial, announced NIH.
The DSMB expressed concern that AstraZeneca may have included outdated information from that trial, which may have provided an incomplete view of the efficacy data.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.
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.
Earlier results had been reported that from a large clinical trial in the United States and South America indicate that AstraZeneca’s COVID-19 vaccine, AZD1222, is well-tolerated and protects against symptomatic COVID-19 disease, including severe disease or hospitalization. The independent Data and Safety Monitoring Board (DSMB) overseeing the trial identified no safety concerns related to the vaccine. The United Kingdom-based global biopharmaceutical company AstraZeneca developed the vaccine and led the trial as regulatory sponsor.
