New Delhi, August 24
The phase-2 human medical trial of the Oxford COVID-19 vaccine candidate by Pune-based Serum Institute of India (SII) is about to start from Tuesday.
The observer-blind, randomised managed research to find out the protection and immunogenicity of ”Covishield” on wholesome Indian adults will start at Bharati Vidyapeeth Medical College and Hospital in Pune, sources stated.
The Serum Institute of India has partnered with British-Swedish pharma firm AstraZeneca for manufacturing the COVID-19 vaccine candidate, developed by the University of Oxford.
“We have gotten all approvals from the Central Drugs Standard Control Organisation (CDSCO). We are going to begin the human medical trial course of on 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, Additional Director, Government and Regulatory Affairs, Serum Institute of India (SII) stated.
As a fast regulatory response, the Drugs Controller General of India (DCGI) on August three had given nod to the Pune Serum Institute of India (SII) for conducting phase-2 and three human medical trials of the Oxford COVID-19 vaccine candidate within the nation.
The trials are to be carried out throughout 17 chosen websites, together with AIIMS Delhi, BJ Medical College in Pune, Rajendra Memorial Research Institute of Medical Sciences (RMRIMS) in Patna, Post-Graduate Institute of Medical Education and Research in Chandigarh, AIIMS-Jodhpur, Nehru Hospital in Gorakhpur, Andhra Medical College in Visakhapatnam and JSS Academy of Higher Education and Research in Mysore, SII sources had stated.
Around 1,600 individuals aged above 18 years are prone to take part within the trials. To introduce the vaccine, SII, the world’s largest vaccine maker by variety of doses produced and bought, has signed an settlement to fabricate the potential vaccine developed by the Jenner Institute (Oxford University) in collaboration with British-Swedish pharma firm AstraZeneca.
Initial outcomes of the primary two phases of trials of the vaccine carried out in 5 trial websites within the UK confirmed it has an appropriate security profile and homologous boosting elevated antibody responses, sources had stated. PTI