University of Oxford resumes vaccine trial

Published: 14-Sep-2020

In large trials such as this, the researchers have said, it's expected that some participants will become unwell

The ongoing randomised controlled clinical trials of the Oxford coronavirus vaccine ChAdOx1 nCoV-19 are set to resume across all UK clinical trial sites, following last week's pause.

Globally some 18,000 individuals have received study vaccines as part of the trial, and every case of illness must be carefully evaluated to ensure careful assessment of safety.

On the sixth September, 2020, Oxford's standard review process triggered a study pause to vaccination across all its global trials to allow the review of safety data by an independent safety review committee, and the national regulators. All routine follow-up appointments continued as normal during this period.

The independent review process has now concluded and, following the recommendations of both the independent safety review committee and the UK regulator, the MHRA, trials will recommence in the UK.

Regarding the patient illness that triggered the study pause, the researchers said: "We cannot disclose medical information about the illness for reasons of participant confidentiality."

"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," they added.

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