Experts Marvel at US Government’s ‘Extraordinary Public Rebuke’ of AstraZenaca Trial Data

 

Medical experts were left shocked after the government publicly rebuked the results of the United States AstraZeneca trial, claiming the data may have included “outdated information.”

The National Institute of Allergy and Infectious Diseases (NIAID) released a statement on AstraZeneca via the NIH early Tuesday morning, causing quite the stir in the medical world.

“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,” read the statement.

“The DSMB expressed concern that AstraZeneca may have included outdated information from that trial, which may have provided an incomplete view of the efficacy data.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.”

Just Monday, AstraZeneca had announced that a largely U.S. study of 32,000 people showed its vaccine was 79 percent effective, also stressing that there were no severe illnesses reported among the trail’s volunteers.

The NIAID released the statement after an independent panel of medical experts, tasked with overseeing the vaccine’s clinical trial, sent a two-page letter to AstraZeneca and federal authorities on Monday, accusing the company of skewing data.

“The DSMB is concerned that AstraZeneca chose to use data that was already outdated and potentially misleading in their press release,” read the letter, obtained by the Washington Post. “The point that is clear to the board is that the [vaccine efficacy number] . . . they chose to release was the most favorable for the study as opposed to the most recent and most complete. Decisions like this are what erode public trust in the scientific process.”

AstraZeneca released its own statement following the NIAID’s, writing, “We have reviewed the preliminary assessment of the primary analysis and the results were consistent with the interim analysis. We are now completing the validation of the statistical analysis.”

“We will immediately engage with the independent data safety monitoring board (DSMB) to share our primary analysis with the most up to date efficacy data,” the statement continued. “We intend to issue results of the primary analysis within 48 hours.”

Experts have begun to weight in on the very public spat — pointing to the fact that it is causing the public to question the safety of a vaccine amid a global pandemic.

Former FDA vaccine chief and Georgetown University professor, Dr. Jesse Goodman, for example, told the Post, “It would seem that whatever this communication misstep is, at the end of the day the data will have to stand for itself.”

While, Adrian Hill, one of the Oxford scientists who developed the AstraZeneca vaccine, labeled the data and safety board’s move as “extraordinary behavior.”

“Talk about efforts to maintain confidence in vaccines,” Hill wrote in an email. “What is going on?!”

NIAID director Dr. Anthony Fauci, despite the statement issued by his own institution, claimed AstraZeneca “is likely a very good vaccine,” adding, “It really is unfortunate that this happened. You know this is really what you call an unforced error.”

“If you look at it, the data really are quite good but when they put it into the press release it wasn’t completely accurate,” he said while on Good Morning America on Tuesday.

Other medical experts, baffled by the U.S. government’s unprecedented rebuke of the vaccine trial, weighed in on Twitter:

Watch above, via MSNBC.

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