The phase 2 human clinical trial of the Oxford Covid-19 vaccine candidate in the country by Pune-based Serum Institute of India (SII) is set to begin.
Serum Institute of India has partnered with British-Swedish pharma company AstraZeneca for manufacturing the Covid-19 vaccine candidate, developed by the University of Oxford.
“We have got all approvals from the Central Drugs Standard Control Organisation (CDSCO). We are going to start the human clinical trial process at the Bharati Vidyapeeth (Deemed to be University) Medical College and Hospital from August 25.
“We are sure that in line with the philosophy of our group, we are going to make available a world class Covid-19 vaccine for people of our country and make our country ‘AatmaNirbhar’,” Prakash Kumar Singh, Government and Regulatory Affairs, Serum Institute of India told PTI.
SII said, “The phase-3 trials for the Oxford-AstraZeneca vaccine are still underway. And only once the vaccine is proven immunogenic and efficacious, SII will confirm its availability, officially. COVISHIELD will be commercialized once the trials are proven successful and all the requisite regulatory approvals are in place. …Presently, the government has granted us permission to only manufacture the vaccine and stockpile it for future use.”
