The phase 2 clinical trial of the Oxford University’s COVID-19 vaccine by the Pune-based Serum Institute of India (SII) is set to start from Tuesday (25 August).
This is an important step towards finding a cure for the Wuhan virus and approval for the phase 2 and 3 trials has been received from the Drug Controller General of India (DCGI) earlier this month, reported Times of India.
Serum Institute is a manufacturer of immunobiological drugs including vaccines in India and they have partnered with British-Swedish pharma company AstraZeneca to manufacture the potential Covid-19 vaccine, which has been developed by the Oxford University.
According to the report, the observer-blind, randomised controlled study of the Serum’s ‘Covishield’ on the health of Indian adults will begin at Bharati Vidyapeeth Medical College and Hospital in Pune.
Across 17 sites in India, phase 2 and 3 trials of the Covishield will be conducted on 1,600 healthy adults.
The testing sites include 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.
“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 25 August,” Prakash Kumar Singh, additional director, government and regulatory affairs, SII was quoted as saying.