Serum Institute of India (SII) gets DCGI's nod to conduct human trials of Oxford-AstraZeneca coronavirus vaccine in India.
Serum Institute of India (SII) has been granted permission by Drugs Controller of General of India (DCGI) to conduct Phase 2, 3 human trials of Oxford-AstraZeneca coronavirus vaccine in India, a government official has said. The vaccine will be called Covishield in India. Serum Institute is already preparing to produce 20 crore -- 200 million -- doses of Covishield.
Serum Institute has been given DCGI nod to conduct human trials of Oxford's coronavirus vaccine after it was asked by an expert committee to resubmit a revised protocol of carrying the clinical trials of the vaccine. SII has partnered with AstraZeneca which has got the license of manufacturing Oxford's vaccine.
After a thorough evaluation, the DCGI has given approval to SII to perform phase 2, 3 clinical trial based on the recommendation of the Subject Expert Committee (SEC), a source told ANI.
As a rapid regulatory response, the proposal was deliberated in the SEC through a virtual meeting earlier this week. And after considering the data generated on the vaccine in phase 1, 2 of the Oxford University trial, the committee recommended granting permission to conduct phase 2, 3 clinical trials of COVISHIELD (SII-ChAdOx1nCov-19) healthy adult subjects at risk in the country," officials said.
Hope to launch Covishield by 2020 end: Poonawalla
Serum Institute CEO Adar Poonawalla said Oxford-AstraZeneca coronavirus vaccine will be branded as Covishield and they are hopeful that it will be an efficacious, immunogenic vaccine, viable for mass use. Poonawalla said they hope to launch it by the end of 2020 and by first quarter Covishield will start reaching masses.
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