AstraZeneca may have used ’outdated information’ on vaccine - STAT
▻https://www.statnews.com/2021/03/23/astrazeneca-may-have-used-outdated-information-in-announcing-covid19-vacci
U.S. health officials raised concerns early Tuesday that positive results that AstraZeneca announced Monday for its Covid-19 vaccine may have been based on “an incomplete view of the efficacy data” from a clinical trial and relied on “outdated information,” throwing another curveball in the saga of the company’s vaccine.
In a statement issued soon after midnight Tuesday morning, the National Institute of Allergy and Infectious Diseases said it had been informed about the data questions by the data and safety monitoring board auditing the trial. DSMBs consist of independent medical experts who review data produced from clinical trials.
“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,” NIAID said.
In an interview Tuesday morning with STAT, Anthony Fauci, the head of the NIAID, said the DSMB raised concerns because it felt the results in a AstraZeneca press release Monday looked more favorable than more recent data from the vaccine study had shown.
“I was sort of stunned,” Fauci said. “The data and safety monitoring board were concerned that the data that went into the press release by AZ was not the most accurate and up-to-date data. That is what the DSMB communicated to AZ in a rather harsh note. Having seen that letter we could not just let it go unanswered.”
Asked why NIAID released its unusual statement, Fauci said, “We just felt we could not remain silent. Because if we did remain silent, we could be understandably accused of covering something up. And we definitely didn’t want to be in that position.”
He added: “In my mind, it’s an unforced error by the company.”