Yesterday, early phase 3 data from Oxford-AstraZeneca was published and shared about the latest clinical trial on its COVID-19 vaccine including a study conducted in United States. Post here: https://publichealthdisasters.com/2021/03/22/worlds-vaccine-found-79-percent-effective/. Now a possible rebuke?
Today, US National Institutes of Health
Data and Safety Monitoring Board (DSMB) notified US National Institute of Allergy and Infectious Diseases, Biomedical Advanced Research and Development Authority (in U.S. Department of Health and Human Services) and AstraZeneca that there are concerns about the information released by AstraZeneca yesterday. In quite unusual & unprecedented move, DSMB calling out that yesterday’s data provided by AstraZeneca may be incomplete & urges the company to provide the entire dataset to provide a more complete view of the efficacy data.
Remember authorization and guidelines for use of the COVID-19 vaccine in United States will be determined by Food and Drug Administration and Centers for Disease Control and Prevention after thorough review of the data by independent advisory committees (not necessarily from DSMB). More information at Centers for Disease Control and Prevention’s website on vaccines approved for emergency usehttps://www.cdc.gov/coronavirus/2019-ncov/vaccines/different-vaccines.html