AMN / New Delhi
The Serum Institute of India (SII) has paused the ongoing Phase 3 clinical trial of the Covishield vaccine in India till AstraZeneca restarts the trials after the Drugs Controller General of India (DCGI) issued a show-cause notice to the pharma giant.
“We are reviewing the situation and pausing India trials till AstraZeneca restarts the trials. We are following DCGI’s instructions and will not be able to comment further on trials,” the Serum Institute said in an official statement.
The DCGI in its letter to SII, which is conducting the trials in India, alleged that the institute had not informed the central licensing authority regarding pausing of a clinical trial carried out by AstraZeneca in other countries.
Earlier, the SII had said Indian trials are continuing as they have faced no issues at all. “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,” SII earlier said.
The Phase 3 study testing COVID-19 vaccine (Covishield) being developed by AstraZeneca and the University of Oxford at dozens of sites across the US have been put on hold due to a suspected serious adverse reaction in a participant in the United Kingdom.
The AstraZeneca said in a statement, “The company’s standard review process triggered a pause to vaccination to allow the review of safety data.” The notice to the Serum Institute has been issued by Drugs Regulator General of India Dr VG Somani.