Serum pauses trials of Oxford vaccine after DCGI’s notice – Times of India

NEW DELHI/ MUMBAI: Serum Institute of India paused the trials of Covishield, Oxford University-AstraZeneca’s Covid-19 vaccine candidate, following a notice issued by the central drug regulator.
“We are reviewing the situation and pausing India trials till AstraZeneca restarts them. We are following the Drug Controller General of India’s (DCGI) instructions and will not be able to comment further on the same,” the Pune-based company said.
Serum Institute had said on Wednesday that it had not faced any issues in its trials so far and that it was continuing with its trials here.
However, the DCGI issued a show cause notice to the vaccine manufacturer late on Wednesday evening asking why the company had not informed the regulator about the issues faced by AstraZeneca during trials in the UK.
AstraZeneca had announced on Tuesday that it was temporarily halting its clinical trials. It said 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 Swedish-British drugmaker had said.
In a show cause notice to SII, DCGI V G Somani said one of the conditions to start the trial was that “the clinical data generated in this trial shall be considered along with the data from Oxford University clinical trial”. It also asked “why the permission granted to you shall not be suspended till patient safety is established”.