The Drugs Controller General of India (DGCI) on Wednesday issued a show-cause notice to Serum Institute of India (SII) as the trial of Oxford University’s Covishield vaccine paused.
The notice was served to SII after reports that the human trial of the COVID19 vaccine candidate, being developed by the University of Oxford, was put on hold after a volunteer from the United Kingdom, showed some adverse reactions.
The DGCI asked the firm why it should not suspend permission granted for conducting Phase 2 and 3 clinical trials of the vaccine candidate in the country until patient safety is established.
After the adverse reactions during the trial, AstraZeneca, which jointly developed the vaccine with Oxford University, has temporarily stopped the vaccine’s clinical trials in four nations as a precautionary measure.
In its notice, the DGCI VG Somani questioned SII about the reason for still proceeding with the trials and why it has not sent a detailed report about the patient in the UK.
On Wednesday, the SII said it was following the instructions issued by the DGCI and it has not been asked to stop the vaccine trials till now.
“We were going by DCGI’s direction and were not instructed to pause the trials. If DCGI has any safety concerns, we will adhere to their instructions and abide by the standard protocols,” the SII said in a statement.
In a statement earlier in the day, the Pune-based vaccine manufacturer said that it cannot comment about the UK trials which have been paused for review.
“We can’t comment on reports of AstraZeneca pausing the trials in the UK, other than that they have been paused for review and shall restart soon. The Indian trials are continuing and we have faced no issues at all,” it said.
The notice from the DGCI came at a time when the trials of the Covishield vaccine are going on in seventeen sites across the country.
Meanwhile, India’s COVID19 tally increased to 44,65,864 after 95,735 new cases and 1,172 deaths were reported in the last 24 hours.
