U.S. health officials have expressed concerns that AstraZeneca may have included “outdated information” from its coronavirus vaccine trial that may have provided an “incomplete view” of efficacy data.
The statement comes barely a day after AstraZeneca announced that its US study indicated that its vaccine, developed with the University of Oxford, was safe and effective.
The study aimed to address any concerns in the United States, which has yet to approve the jab. But Tuesday’s statement from the U.S. National Institute of Allergy and Infectious Diseases (NIAID) cast doubt that the United States would imminently give the green light..
In the statement, NIAID said the Data and Safety Oversight Board (DSMB), which oversees clinical trials, notified the agency on Monday that it was concerned about information released by AstraZeneca on the data. initials of its clinical trial on the COVID-19 vaccine. . ”
“The DSMB has expressed concern that AstraZeneca may have included outdated information from this trial, which may have provided an incomplete view of the efficacy data,” NIAID said.
The institute urged AstraZeneca to work with the oversight committee to review efficacy data and ensure that the most accurate and up-to-date data is made public “as quickly as possible.”
The U.S. clinical trial for the vaccine was suspended for more than a month last year after illnesses that were unexplained in the study.