Government infectious disease experts said early Tuesday that AstraZeneca was not forthcoming about the trial results of its coronavirus vaccine, presenting a new snag for the approval process for the shots.
The National Institutes of Health’s committee of clinical trial analysts “expressed concern that AstraZeneca may have included outdated information from that trial, which may have provided an incomplete view of the efficacy data,” according to a message from the government-run National Institute of Allergy and Infectious Diseases.
ASTRAZENECA COVID-19 VACCINE 100% EFFECTIVE AT PREVENTING HOSPITALIZATIONS, COMPANY SAYS
The announcement early Tuesday morning came just hours after the company released data from its massive U.S.-based trial of its two-dose COVID-19 vaccine that showed it performed better than in previous trials based in other countries. AstraZeneca reported that its vaccine, developed with Oxford University, was 79% effective overall in preventing symptomatic illness and 100% effective in preventing deaths and hospitalizations.
Dr. Anthony Fauci told Stat on Tuesday that he was “sort of stunned” when the agency’s independent data safety monitoring board raised concerns about the suspiciously positive results.
“The data safety and 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,” Fauci said. “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.”
Tuesday’s announcement will likely complicate the company’s efforts to rebuild public confidence in its vaccine that has already been authorized and put to use in over 70 other countries. Even though it has been in use for months in Europe, the vaccine has now suffered several setbacks in the United States. AstraZeneca has not yet submitted a petition for emergency use authorization to the Food and Drug Administration but is expected to do so “in the coming weeks.”
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Reports earlier this month of more than 30 cases of severe blood clots, some fatal, in European vaccine recipients caused several member states, including Germany and Italy, to suspend use of the drug, further slowing the bloc’s already sluggish vaccine rollout. Most countries resumed administering the vaccine last week after the European Medicines Agency announced it had deemed the shots safe and efficacious.
