Phase 3 clinical trial of Bharat Biotech's indigenously-developed COVID-19 vaccine - Covaxin - began at AIIMS Delhi on November 26. Three volunteers and Dr MV Padma Srivastava, the chief of Neurosciences Centre at AIIMS Delhi received the first dose of vaccine.
Covaxin, being developed jointly by Bharat Biotech and Indian Council of Medical Research (ICMR), will be administered to around 15,000 volunteers at the AIIMS over the next few days.
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"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," a source told PTI.
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."
Covaxin phase 3 trial also began at Sola Civil Hospital in Gujarat's Ahmedabad on November 26. On the first day, five healthy volunteers were given the first dose of the vaccine. The second dose will be given after 28 days, said Principal Investigator, Sola Civil, Dr Parul Bhatt.
Meanwhile, Sir JJ Hospital in Mumbai is also likely to commence the phase 3 trial soon. The ICMR completed paperwork on November 25 and enrolment of suitable volunteers, following the norms, is likely to begin from November 27.
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According to the dean of Sir JJ Hospital, Dr Ranjit Mankeshwar, it is expected to enrol at least 1,000 people for the trial of the coronavirus vaccine candidate.
The phase-three randomised double-blind placebo-controlled multi-centre trial would cover around 28,500 subjects aged 18 years and above. It would be conducted in around 25 sites across 10 states.
Read: COVID-19 update | Covaxin's phase-3 trials commences in Ahmedabad hospital
Besides Covaxin, four other vaccines are under different phases of clinical trial in India with the Serum Institute of India conducting the phase-three trial of the Oxford-Astrazeneca COVID-19 vaccine, while the indigenously developed vaccine by Zydus Cadila has completed the phase-two clinical trial.
Dr Reddy's Laboratories will soon start combined phase 2 and 3 clinical trials of the Russian COVID-19 vaccine Sputnik V in India.
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