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International news agency Reuters on Saturday reported that clinical trials for AstraZeneca and Oxford University coronavirus vaccine have resumed following confirmation by the Medicines Health Regulatory Authority (MHRA) that it was safe to do so, the company said.
An unexpected and serious adverse reaction in a participant in the UK had put the trials on hold earlier this week. The Phase 3 study testing the vaccine at dozens of sites across the US was halted when a participant showed serious reactions after being administered a booster dose of Covishield, the vaccine candidate developed jointly by the pharma giant AstraZeneca and University of Oxford.
It is to be noted that the vaccine being developed by AstraZeneca and Oxford was a frontrunner in the race for a Covid-19 vaccine. A spokesperson of AstraZeneca had then said that the company's "standard review process triggered a pause to vaccination to allow review of safety data."
The US trial is currently taking place at 62 sites across the country, according to clinicaltrials.gov, a government registry, though some have not yet started enrolling participants. Phase 2/3 trials were previously started in the UK, Brazil, and South Africa.
But What About That One Case Which Halted The Trails?
Though the details of the case has not been officially released by AstraZeneca or Oxford University, keeping up with the participant confidentiality, Medicines Health Regulatory Authority has given a green signal to the trials.
A report in Stat News said that the illness occurred in a woman who was in the vaccine arm of the U.K. trial. It cited AstraZeneca CEO Pascal Soriot as telling a group of investors that her symptoms were consistent with transverse myelitis, a serious condition involving inflammation of the spinal cord that can cause muscle weakness, paralysis, pain and bladder problems.
Serum Institute paused trials in India:
Following the suit, the Serum Institute of India (SII) which was conducting the India trials for the coronavirus vaccine being developed by Oxford University, paused the clinical trials of the vaccine in India. SII is reviewing the situation and has paused India trials till AstraZeneca restarts the trials. Following, the update on resumption in UK, it said once DCGI (Drugs Controller General of India) gives us permission to restart the trials in India, we will resume the trials.