Pune: The Phase 2 of human clinical trial of the Oxford COVID-19 vaccine within the country coordinated by Pune-based blood serum Institute of Asian country (SII) is about to start.
The observer-blind, randomised controlled study to determine the safety and immunogenicity of “Covishield” on healthy Indian adults will be undertaken at Bharati Vidyapeeth Medical faculty and Hospital in Pune.
Serum Institute of India has partnered with British-Swedish pharmaceutical company AstraZeneca for producing the COVID-19 vaccinum candidate, developed at 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, Additional Director, Government and Regulatory Affairs, Serum Institute of India (SII) said.
As a fast restrictive response, the medicine Controller General of {india|India|Republic of Asian country|Bharat|Asian country|Asian nation} (DCGI) on August three had given nod to the Pune blood serum Institute of
India (SII) for conducting a pair of and three human clinical trials of the Oxford COVID-19 vaccinum candidate within the country.
The trials to be conducted across seventeen hand-picked sites, together with AIIMS urban center, B.J.
Medical faculty in Pune, Rajendra Memorial analysis Institute of Medical Sciences (RMRIMS) in Patna, Post Graduate Institute of Medical Education and analysis in Chandigarh, AIIMS-Jodhpur, national leader Hospital in
Gorakhpur, Andhra Medical faculty in Visakhapatnam and JSS Academy of upper Education and analysis in Mysore, SII sources had aforementioned.
Around 1,600 people aged over 18 years are likely to participate within the trials.