AstraZeneca said clinical trials for the AstraZeneca Oxford Covid vaccine had resumed in UK following confirmation by the Medicines Health Regulatory Authority that trials were safe.
Oxford said the UK health regulator approved resuming the trials after review of the safety data triggered a pause on 6 September. It declined to disclose details about the participant’s illness.
AstraZeneca CEO Pascal Soriot sought to reassure investors after the Oxford vaccine trial was halted due to a person in the UK falling sick, triggering a review of safety data.
The AstraZeneca Plc paused the trial of its leading candidate, developed with Oxford University, to study a volunteer's illness. This pause shows the system is working as it should.
DCGI issued a show-cause notice to Serum Institute following reports that human trials of the Oxford vaccine were paused in UK after a candidate had an adverse reaction.
Suspension of the trial is a routine action whenever there is a potentially unexplained illness to ensure we maintain integrity of trials, AstraZeneca says.
The protocol will now be moved to DCGI V.G. Somani, who is likely to take a ‘decision by the end of the week’ given the urgency of the Covid challenge.
The Serum Institute of India will start manufacturing the vaccine even before the final nod so it is ready with sizeable volumes once the vaccine gets all permissions.
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