The adverse events that led to a pause in trials evaluating AstraZeneca Plc’s Covid-19 vaccine candidate would possibly not have been associated with the vaccine itself, according to a document outlining participant information that used to be posted online by the Oxford University.
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Enrollment in the British drugmaker’s global trials of the vaccine, which it is developing with researchers at Oxford University, used to be paused on Sept. 6, after a participant in its U.K. trial had a serious side effect regarded as a infrequent spinal inflammatory disorder called transverse myelitis.
Safety reviews were conducted when volunteers in the trials for testing the vaccine candidate, called AZD1222 or ChAdOx1 nCoV-19, developed unexplained neurological symptoms including changed sensation or limb weakness, and the study used to be paused while a safety review took place, according to the document.
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“After independent review, these illnesses were either thought to be unlikely to be associated with the vaccine or there used to be inadequate evidence to say for sure that the illnesses were or were not related to the vaccine,” the document said.
The vaccine trials have resumed in Britain, Brazil and South Africa, but not yet in the USA.
AstraZeneca and Oxford University did not immediately respond to Reuters requests for remark.