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COVID-19 Vaccine key updates: ‘Covaxin’ commences Phase-3 Trial

India-developed corona virus vaccine Covaxin started its phase-three human clinical trial at AIIMS in New Delhi yesterday with Dr M V Padma Srivastava, the chief of Neurosciences Centre at the premier institute, and three other volunteers receiving the first dose.

Report said, “The first dose of 0.5 ml intramuscular injection was given to four volunteers. They were under observation for two hours and will be monitored for the next few days.” “Covaxin is the first indigenously-developed anti-coronavirus vaccine and on top of that, my institute is participating in the trial. I am honored 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,” Dr Srivastava said.

The safety and immunogenicity data of the phase one and two trials were hand over to the central drug regulator. The Hyderabad-based firm, while requesting for phase-three trial, declared that the vaccine was well-tolerated in all dose groups and no serious adverse events have been reported.

The phase-three randomized double-blind placebo-controlled multi-center trial would cover around 28,500 subjects aged 18 years and above. It would be organized in around 25 sites across 10 states. The trial has already began at a few sites.

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