The drama surrounding AstraZeneca‘s (NASDAQ: AZN) coronavirus vaccine seems to be never-ending. First there were issues with half doses, then with reporting data that was combined from multiple clinical trials. Now the company appears to have released interim data from a trial in the U.S. when final data was pending.
The National Institutes of Health’s National Institute of Allergy and Infectious Diseases (NIAID) reported on Tuesday that it had been told by the Data and Safety Monitoring Board (DSMB) for AstraZeneca’s U.S. clinical trial that the board “expressed concern that AstraZeneca may have included outdated information from that trial, which may have provided an incomplete view of the efficacy data.”
A clinical trial’s DSMB is an independent group that reviews the data and makes recommendations to the clinical trial’s sponsor about whether to continue the study, stop it early because of positive data, or stop it early due to futility or safety issues. By using an intermediary, the sponsoring company can remain blinded to the data as the clinical trial continues.