AstraZeneca may have used “outdated information” in the results of a large-scale COVID-19 vaccine trial, a U.S. health agency said on Tuesday, casting fresh doubt on the shot, its potential U.S. rollout and plunging its developers, once again, into controversy, Reuters reported.
The highly unusual rebuke from federal health officials comes just one day after interim data from the drugmaker showed better-than-expected results from the U.S. trial which had been seen as a scientific counter to concerns that have dogged the shot since late last year.
The vaccine developed with partner Oxford University was 79% effective in preventing symptomatic illness in the large trial that also took place in Chile and Peru, according to the data. It was also 100% effective against severe or critical forms of the disease and hospitalisation, and posed no increased risk of blood clots.
The Data Safety Monitoring Board (DSMB), an independent committee overseeing the trial, has “expressed concern that AstraZeneca may have included outdated information from that trial, which may have provided an incomplete view of the efficacy data,” the U.S. National Institute of Allergy and Infectious Diseases (NIAID) said in a statement released after midnight in the United States.
“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,” it said, adding that the DSMB had informed AstraZeneca of its concerns.
NIAID is headed by U.S. infectious diseases expert Anthony Fauci and is part of the National Institutes of Health. The DSMB is organised by NIAID, according to a document outlining the trial design. The board’s role is to provide study oversight and evaluate clinical data to ensure safe and ethical conduct of the study.
Authorization and guidelines for use of the vaccine in the United States will be determined after thorough review of the data by independent advisory committees, the statement added.
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