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India’s Serum Institute has paused clinical trials of Covid-19 vaccine developed by University of Oxford and AstraZeneca Plc in India, till the UK-based company resumes it. The Indian vaccine manufacturer took the following decision on the instructions of the Drug Controller General of India, V.G. Somani.
“We are reviewing the situation and pausing India trials till AstraZeneca restarts them. We are following DCGI’s instructions and will not be able to comment further on the same,” said the Serum Institute of India.
Late on Tuesday AstraZeneca had paused its trials, after observing “a single event of an unexplained illness that occurred in the UK Phase III trial”. At the same time, AstraZeneca on Wednesday in its statement has not given the details on the nature of the adverse event.
As reported by Bloomberg, Francis Collins Director of US National Institute of Health told a Senate committee that the trial had been halted because of a “spinal cord problem” in the vaccine candidate.
In June, AstraZeneca Plc has signed a pact with Serum Institute for manufacturing a billion doses of vaccine at its facility in Pune. Serum Institute is also inducting trials of Phase- II and III vaccines on 1,600 patients across 17 sites in India.
The trials of the vaccines have to be reconsidered after Somani shot a show-cause notice to the Pune-based firm late Wednesday, asking the firm to explain why it was not informed about the pausing of AstraZeneca’s clinical trial of the Oxford coronavirus vaccine on the participant.
Somani in the notice sought an immediate explanation, failing which “action deemed fit will be taken” against the company that will result in the withdrawal of permission granted to Serum Institute for conducting the trials of the vaccine until the patient safety is established.
