AstraZeneca started the week of March 22 announcing encouraging data from trial results for its COVID-19 vaccine and a push for that vaccine to be approved for use in the U.S. That data, however, is now coming under a new round of scrutiny that may affect public perception around the vaccine.
The New York Times reported that “a group of medical experts charged with monitoring the company’s clinical trial made a highly unusual accusation: AstraZeneca had essentially cherry-picked data to make its vaccine look better.”
The accusation prompted the National Institute of Allergy and Infectious Diseases to issue a statement just hours after it was issued, noting that the agency “expressed concern that AstraZeneca may have included outdated information from that trial, which may have provided an incomplete view of the efficacy data.”
The agency’s head, Dr. Anthony Fauci, said, via STAT News, “I was sort of stunned. The data and safety monitoring board were concerned that the data that went into the press release by [AstraZeneca] 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.”
That was a stunning reversal from Fauci, who heralded the original news by saying, “The data look good” and “The numbers don’t lie” before going on to tout its other advantages in the global battle against the pandemic.
The New York Times characterized the dispute as being “about the degree of effectiveness of a vaccine that is undisputably effective,” with the independent panel arguing for a 69-74% efficacy rate vs. the 79% efficacy that AstraZeneca claimed March 22.
The newspaper also wrote that the “public airing of a conflict between a pharmaceutical company and a board overseeing a clinical trial is almost unheard-of.”
“It is certain to trigger extra scrutiny of the vaccine by the Food and Drug Administration and other regulators if, as expected, AstraZeneca seeks their authorization to use it on an emergency basis in the United States,” the article observed.
CNBC added, “The company’s fumble was just the latest ‘self-inflicted wound’ in a series of missteps that threatens to erode public trust in its shot.” That article pointed to a September episode in which “the company failed to promptly notify Food and Drug Administration officials that it halted its trial globally after a participant in a study fell ill.”
The article also mentioned “criticism after volunteers in its trials were given an incorrect vaccine dosages and countries questioning whether its vaccine was appropriate for use in people over 65”—and, of course, the decision a number of nations made in mid-March to halt the vaccine’s use, which AstraZeneca and health organizations like the European Medicines Agency have since worked to dispel.