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 from August 25.
The observer-blind, randomised, controlled study to determine the safety and immunogenicity of “Covishield” on healthy Indian adults will begin at Bharati Vidyapeeth Medical College and Hospital in Pune.
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 atma nirbhar (self-reliant)’,” Prakash Kumar Singh, Additional Director, Government and Regulatory Affairs, Serum Institute of India (SII) told PTI.
As a rapid regulatory response, the Drugs Controller General of India (DCGI) on August 3 had given nod to the Pune Serum Institute of India (SII) for conducting phase 2 and 3 human clinical trials of the Oxford COVID-19 vaccine candidate in the country.
The trials are to be conducted across 17 selected sites, including AIIMS Delhi, B.J. 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 said.
Around 1,600 people aged above 18 years are likely to participate in the trials.
To introduce the vaccine, SII, the world’s largest vaccine maker by number of doses produced and sold, has signed an agreement to manufacture the potential vaccine developed by the Jenner Institute (Oxford University) in collaboration with British-Swedish pharma company AstraZeneca.
Initial results of the first two-phases of trials of the vaccine conducted in five trial sites in the U.K. showed it has an acceptable safety profile and homologous boosting increased antibody responses, sources had said.
