Clinical trials testing a potential COVID-19 vaccine developed by AstraZeneca and the University of Oxford are set to resume after a six-day pause due to “potentially unexplained illness” in the United Kingdom.
An independent safety review was conducted Sept. 6 during what was referred to as a “routine action” to maintain the “integrity of the trials.” It concluded on Saturday.
In a release sent to Global News, Oxford University said the study vaccines had been administered to some 18,000 patients as part of the trial.
AstraZeneca pauses COVID-19 vaccine trial after unexplained illness in U.K.
“In large trials such as this, it is expected that some participants will become unwell and every case must be carefully evaluated to ensure careful assessment of safety,” the release said, adding they were unable to disclose the patient’s medical information due to “participant confidentiality.”
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On Thursday, a spokesperson for AstraZeneca said the brief pause was triggered after one woman developed “severe neurological symptoms” after taking the experimental COVID-19 vaccine.
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AstraZeneca said the company’s “standard review process triggered a study pause to vaccination across all of our global trials to allow the review of safety data by an independent safety review committee, and the national regulators.”
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“All routine follow-up appointments continued as normal during this period,” they said.
“We are committed to the safety of our participants and the highest standards of conduct in our studies and will continue to monitor safety closely.”
More to come.
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