Coronavirus Vaccine in India: Bharat Biotech, together with the Indian Council for Medical Research (ICMR) and the National Institute of Virology (NIV), is developing the indigenous coronavirus vaccine Covaxin.
Coronavirus vaccine in India: Phase 3 human trials of the indigenous experimental vaccine Covaxin, a candidate for the coronavirus vaccine, are beginning, said manufacturer Bharat Biotech. COVAXIN’s large-scale advanced stage clinical trials will involve 26,000 volunteers across India. Phase 3 clinical trials of the Covaxin Covid-19 vaccine candidate are being conducted in collaboration with the Indian Council for Medical Research (ICMR), according to PTI report.
Human trials of Covaxin Phase 3 in India
The phase 3 human trials of Covaxin are the largest clinical trial conducted for a possible coronavirus vaccine in India. This is also India’s first phase 3 efficacy study for a Covid-19 vaccine, according to the Indian Express report.
During phase 3 human trials, volunteers will be inoculated with two intramuscular injections to be administered approximately 28 days apart.
Volunteers will be randomly selected to receive COVAXIN or placebo. The human trial of Covaxin is double blind. Researchers, volunteers, and the manufacturer will not know who is assigned to which group.
In October, Bharat Biotech said it had successfully completed an interim analysis of the phase I and II human trials of Covaxin, according to the PTI report.
During the phase 1 and phase 2 human trials of Covaxin, about 1000 volunteers were monitored for safety and immunogenicity data. Volunteers over 18 years of age must participate in human trials of Covaxin.
Bharat Biotech, together with the Indian Council for Medical Research (ICMR) and the National Institute of Virology (NIV), is developing the Covaxin vaccine against the indigenous coronavirus of India. Bharat Biotech President and Managing Director Krishna Ella said the company partnered with ICMR for phase 3 trials of the COVID-19 vaccine.
What is the significance of Covaxin Phase 3 human trials in India?
India hopes that “locally tested” coronavirus vaccines will help it control the coronavirus, as experimental Covid-19 vaccines developed by Pfizer-BioNTech and Moderna may not soon be available in large numbers, according to a Reuters report. One such potential coronavirus vaccine is Covaxin.
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