Corona Vaccine: Drug Controller Issues Show Cause Notice To Serum Institute Over Suspension of COVISHIELD Trial By AstraZeneca

Pune, September 9, 2020: The Drug Controller General of India (DGCI) has issued a show-cause notice to the Pune-based Serum Institute of India asking the company why trial of Coronavirus disease (COVID19) vaccine, COVISHIELD, should not be stopped.

London-based pharma company AstraZeneca, which is developing the Corona vaccine (COVISHIELD) in collaboration with Oxford University, had to stop clinical trials. This decision had to be taken because a person involved in the trial got ill. The company gave this information on Tuesday and described it as routine action. They also said that the severity of the disease in the patient is not yet known.

The DCGI issued notice to Serum Institute after AstraZeneca stopped the trial. Regarding the show-cause notice issued by the DCGI, Serum Institute of India, said, “We are going by DCGI’s direction and so far we’re not told to pause the trials. If DCGI has any safety concerns, we will follow their instructions and abide by the standard protocols.”

Earlier in the day, the company had said, “We can’t comment much on the UK trials, but they have been paused for further review and they hope to restart soon. As far as Indian trials are concerned, it is continuing and we have faced no issues at all.”