The University of Oxford and AstraZeneca Plc have restarted a U.K. trial of an experimental Covid-19 vaccine after the study was halted over concerns about a participant who fell ill.
Oxford said in a statement that the U.K. regulator, the Medicines Health Regulatory Authority (MHRA), had recommended that the trials resume after an independent review of the safety data triggered a pause on Sept. 6. It declined to disclose any details about the participant’s illness.
“The U.K. committee has concluded its investigations and recommended to the MHRA that trials in the U.K. are safe to resume,” AstraZeneca said.
While temporary halts are common in vaccine trials, the interruption to the closely watched Astra-Oxford study had raised concerns about the viability of one of the fastest-moving experimental shots seeking protection from the pandemic.
The statements from Astra and Oxford on Saturday didn’t say anything about the status of tests outside the U.K.
AstraZeneca’s Chief Executive Officer Pascal Soriot said on Thursday that an independent safety review board was reviewing whether the participant’s illness had been caused by the vaccine or was unrelated. Oxford said some 18,000 people have received “study vaccines” as part of the trials.
“We cannot disclose medical information about the illness for reasons of participant confidentiality,” it 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.”
Culled from https://www.bloomberg.com/
