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NEW DELHI/ MUMBAI: Serum Institute of India stopped the Covishield trials, Oxford University-AstraZenecaCandidate for the Covid-19 vaccine, after a notice issued by the central drug regulator.
“We are reviewing the situation and stopping the trials in India until AstraZeneca restarts them. We are following the instructions of the Comptroller General of Drugs of India (DCGI) and we will not be able to comment further on them, ”said the Pune-based company.
The Serum Institute had said Wednesday that it had not faced any problems in its trials so far and that it was continuing its trials here.
However, the DCGI issued a demonstration cause notice to the vaccine manufacturer late Wednesday night asking why the company had not informed the regulator about the problems AstraZeneca was facing during the UK trials.
AstraZeneca had announced Tuesday that it would temporarily suspend its clinical trials. She said that a person participating in the studies had developed an “unexplained illness.” “The move was intended to give researchers time to examine safety data while maintaining the integrity of the trials,” the British-Swedish drugmaker had said.
In a notice of cause of the show to the SII, DCGI VG Somani He said one of the conditions for starting the trial was that “the clinical data generated in this trial will be considered in conjunction with the data from the Oxford University clinical trial.” She also asked “why the permission granted to you will not be suspended until patient safety is established.”
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