Pune-based Serum Institute of India (SII) is set to start phase 2 human clinical trial of the Oxford University's covid-19 vaccine from Tuesday (25 August) after getting approval for the phase 2 and 3 trials from the Drug Controller General of India (DCGI) earlier this month, reports Times of India.
Serum Institute has 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 health Indian adults will begin at Bharati Vidyapeeth Medical College and Hospital in Pune.
The phase 2 and 3 trials of the Covishield will be conducted across 17 sites in India 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.
Earlier on 3 August, the DCGI has given its approval to the SII for conducting phase 2 and 3 human clinical trials of the Oxford Covid-19 vaccine candidate in India.
The Oxford Covid-19 vaccine has shown promise in its initial results of the first two-phases of the trials conducted in five trial sites in the UK. The Covid-19 vaccine candidate has shown acceptable safety profile and was able to generate immune response against the SARS-CoV-2, the virus that causes Covid-19.
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