AstraZeneca missteps threaten to further erode trust as company seeks

U.S. health officials released a bizarre statement early Tuesday that AstraZeneca may have based its Covid-19 vaccine trial results on outdated information.

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, experts on public health and vaccines told CNBC.

On Monday, AstraZeneca announced the long-awaited results of its phase three clinical trial of the Covid-19 vaccine it developed with the University of Oxford, saying it was 79% effective in preventing symptomatic illness and 100% effective against severe disease and hospitalization. The analysis was based on 32,449 participants across 88 trial centers in the U.S., Peru and Chile, according to the company.

The National Institute of Allergy and Infectious Diseases threw the accuracy of those results into question early Tuesday when it said it was informed by the data and safety monitoring board overseeing the trial that the U.K.-based company may have included information in its U.S. vaccine trial results that 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,” the NIAID said in a statement.

NIAID Director Dr. Anthony Fauci said the DSMB, an independent group of experts who oversee U.S. clinical trials, raised concerns with the agency because it felt the results in AstraZeneca’s press release looked more favorable than more recent data from the vaccine study had shown, according to STAT News. “I was sort of stunned,” Fauci told STAT, adding that the agency could not remain silent.

The statement from the NIAID, which is part of the National Institutes of Health, was highly unusual, health experts said. The last time a statement from the U.S. agency caused such a stir was in September when one of its panels said there was “insufficient data” to show convalescent plasma works against the coronavirus, contradicting claims made by then-FDA Commissioner Dr. Stephen Hahn.

AstraZeneca’s data hiccup is just the latest example in a series of blunders by the company that could affect people’s willingness to take the vaccine, which may be authorized for use in the U.S. as early as next month, said Isaac Bogoch, an infectious disease expert who has sat on numerous data and safety monitoring boards.

The problems first began in September after 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, according to the New York Times. The company would later face more issues, including criticism after volunteers in its trials were given an incorrect vaccine dosages…