The volunteers will be counselled first followed by medical tests. If the reports of the volunteers are normal then they will be given the first dose.
The phase-III trial of the first indigenous coronavirus vaccine of India, Covaxin, started in Madhya Pradesh on Friday. Covaxin is being developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR).
After getting the green signal, the process of trial of volunteers has started for Bharat Biotech's Covaxin. The volunteers will be counselled first, followed by medical tests. If the reports of the volunteers are normal then they will be given the first dose of the vaccine.
After that, they will be monitored for 28 days, following which the second dose will be given. In the next step, they will be observed for six months after giving both the doses. All types of permission have been taken for this.
On November 16, Bharat Biotech had announced the commencement of phase III trials of the COVID-19 vaccine, Covaxin. It is the largest clinical trial conducted for a COVID-19 vaccine in India.
The phase III trials will involve 26,000 volunteers across 25 centres in India, being conducted in partnership with ICMR. This is India’s first phase 3 efficacy study for a COVID-19 vaccine, and the largest phase III efficacy trial ever conducted in India.
The safety and immunogenicity data of the phase one and two trials were submitted to the central drug regulator. The Hyderabad-based firm, while applying for phase-three trial, stated that the vaccine was well-tolerated in all dose groups and no serious adverse events have been reported.
The most common adverse event was pain at the injection site, which resolved transiently, the vaccine manufacturer said.
Bharat Biotech has been given the permission for conducting phase-III human clinical trials of the Covaxin from the Drugs Controller General of India (DCGI).
The third trial may be completed by early 2021. The most important thing is that India works on an affordable biotech vaccine, so it is expected that the Covaxin may be the cheapest vaccine in the world.
Besides, Covaxin, four other vaccines are under different phases of clinical trial in India with the Serum Institute of India conducting phase-three trial of the Oxford-AstraZeneca COVID-19 vaccine while the indigenously developed vaccine by Zydus Cadila has completed phase-two clinical trial in the country.
Dr Reddy's Laboratories will soon start combined phase two and and three clinical trials of the Russian COVID-19 vaccine Sputnik V in India.
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 "Bharat Biotech starts phase III trials of Covaxin in Bhopal")
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