Symptoms that prompted the University of Oxford and partner AstraZeneca Plc to pause trials evaluating their experimental coronavirus vaccine probably weren’t related to the shot itself, according to documents sent to participants.
Safety reviews were carried out when volunteers in the Oxford study developed unexplained neurological symptoms including limb weakness or “changed sensation,” a participant information sheet posted online by Oxford shows.
“After independent review, these illnesses were either considered unlikely to be associated with the vaccine or there was insufficient evidence to say for certain that the illnesses were or were not related to the vaccine,” the letter reads. “In each of these cases, after considering the information, the independent reviewers recommended that vaccinations should continue.”
The details shed more light on an episode reported last week in the U.K. trial and the safety data that triggered the halt. AstraZeneca and Oxford have continued to face questions about the event, and their vaccine study remains on hold in the U.S. pending a regulatory review, federal officials said. It’s the first indication from Oxford as to the nature of the illness, which sparked widespread concerns about vaccine safety.
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