AstraZeneca Plc and the University of Oxford have resumed the British clinical trials of its Covid-19 vaccine, after the initial suspension over concerns with a participant who fell ill.
University of Oxford, in a statement, said that the UK regulator, Medicines Health Regulatory Authority (MHRA), had recommended a restart of the trials, after an independent review of the safety data triggered a pause on September 6.
It revealed some 18,000 people have received ‘study vaccines’ as part of the trials, but declined to disclose any details about the participant’s illness, for confidentiality reasons.
AstraZeneca Plc said, “The UK committee has concluded its investigations and recommended to the MHRA that trials in the UK are safe to resume.”
The statements from both AstraZeneca Plc and the University of Oxford did not make any disclosure about the status of tests outside the UK.
The CEO of AstraZeneca, Pascal Soriot, disclosed on Thursday, that an independent safety review board was reviewing whether the participant’s illness had been caused by the vaccine or was unrelated.
“We cannot disclose medical information about the illness for reasons of participant confidentiality. We are committed to the safety of our participants, the highest standards of conduct in our studies, and will continue to monitor safety closely,” he said.