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AstraZeneca Plc announced it has paused a late-stage trial of one of the leading COVID-19 vaccine candidates after an unexplained illness in a study participant.
“Our standard review process was triggered, and we voluntarily paused vaccination to allow review of safety data by an independent committee,” company spokeswoman Michele Meixell said in an emailed statement.
The study is testing a COVID-19 vaccine being developed by AstraZeneca and University of Oxford researchers at various sites, including the United Kingdom, where the illness was reported.
The nature of the case and when it happened were not detailed, although the participant is expected to recover, according to Stat News, which first reported the trial was halted due to a “suspected serious adverse reaction.” The U.S. Food and Drug Administration defines that as an adverse event in which evidence suggests a possible relationship to the drug being tested.
The suspension of the trial has impacted other AstraZeneca vaccine trials – as well as clinical trials being conducted by other vaccine makers, which are looking for signs of similar reactions, Stat said.