The Drugs Controller General Of India (DCGI) has ordered Serum Institute of India (SII) to suspend recruitment in its clinical trials for the Phase 2 and Phase 3 of the Oxford University's Covishield vaccine being manufactured by it along with pharma major AstraZeneca, local media reports said Saturday.
"The DCGI has also directed SII to increase the safety monitoring of the subjects who have already been vaccinated as part of the trial and submit the plan and report," local media quoted DCGI as having said.
The halt on new recruitment has been ordered until further orders.
"DCGI asked the firm to submit clearance from the Data and Safety Monitoring Board in the Britain as well as in India before resuming trials in the future," the report said.
On Thursday SII said it would pause Phase 3 trials that were to begin in India next week after AstraZeneca stopped vaccine trials across four nations as a precautionary measure. The pausing of trials by the pharma giant was linked to a British volunteer showing potentially adverse symptoms.
"We are reviewing the situation and pausing India trials till AstraZeneca restarts them. We are following DCGI's instructions and will not be able to comment further on the same," according to a brief statement from SII.
Reports said Phase 2 of the human trials of the vaccine started in Maharashtra's Pune on Aug. 27. It is not clear, however, how many volunteers received the dosage. Phase 3 of the trials was set to begin next week with 1,600 volunteers across 17 different sites.
India is in the grip of the ongoing COVID-19 pandemic and the cases are increasing with each passing day.
On Saturday the number of COVID-19 cases in the country has reached 4,659,984 including 77,472 deaths.
During the past 24 hours, 97,570 new COVID-19 cases and 1,201 related deaths were recorded in the country. Enditem
