The Drug Controller General of India on Sunday granted permission to the Serum Institute of India in Pune to conduct phase two and three human clinical trials of the coronavirus vaccine candidate developed by Oxford University and British-Swedish pharmaceutical firm AstraZeneca, PTI reported.
An unidentified official told the news agency that the Serum Institute of India will have to submit safety data to the Central Drugs Standard Control Organisation before moving to the third phase of human clinical trials.
“As per the study design, each subject will be administered two doses four weeks apart (first dose on day one and second dose on day 29) following which the safety and immunogenicity will be assessed at predefined intervals,” the official said.
Last week, the Serum Institute of India had submitted a revised proposal for conducting trials of the Oxford-AstraZeneca vaccine. The institute had suggested that 1,600 volunteers take part in the clinical trials across 17 sites in India, including the All India Institute of Medical Sciences in Delhi and the Post Graduate Institute of Medical Education and Research in Chandigarh.
The Serum Institute of India, which is the world’s largest vaccine maker in terms of the number of doses produced and sold globally, has partnered with AstraZeneca to mass-produce the Oxford vaccine.
Last month, the Centre identified five sites across the country for the third and final phase of the human trials of the vaccine. The five sites selected by the government were INCLEN Trust International in Palwal, Haryana, KEM Hospital in Pune, the Society for Health Allied Research in Hyderabad, the National Institute of Epidemiology in Chennai, and Christian Medical College in Vellore.
Oxford’s vaccine, called AZD1222, had produced an immune response against the coronavirus and proved to be safe in early-stage clinical trials, according to trial results published in The Lancet medical journal. The Oxford vaccine prompted an antibody response within 28 days and a T-cell response within 14 days. Neutralising antibodies, which can disable the virus, were detected in most participants after one shot, and in all of them after two.