The phase-three human clinical trial of India developed anti-coronavirus vaccine candidate Covaxin began at the AIIMS on Thursday. Dr M V Padma Srivastava, the chief of Neurosciences Centre at the premier institute, and three other volunteers received the first dose. Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR) has developed the 'Covaxin'.
The trials will be given to around 15,000 volunteers at the AIIMS over the next few days, sources said. The first dose of 0.5 ml intramuscular injection was given to four volunteers. After injection they were under observation for two hours and will be monitored for the next few days, an institute source said. The test volunteer Dr. Srivastava said, "Covaxin is the first indigenously-developed anti-coronavirus vaccine and on top of that, my institute is participating in the trial. I am honoured to be the first volunteer to receive the shot. I am happy to be a part of such a great cause. I am perfectly fine and I'm working."
The trial process involves two doses, one each on day 0 and day 28. The phase-three randomised double-blind placebo-controlled multi-centre trial would cover around 28,500 subjects aged 18 years and above, in 25 sites across 10 states. Drugs Controller General of India (DCGI) has given permission for conducting phase-3 human clinical trials of the Covaxin to the Bharat Biotech.
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