Coronavirus vaccine in India: The phase 3 human trials of India’s indigenous experimental Coronavirus vaccine candidate Covaxin is beginning, manufacturer Bharat Biotech has said. The large-scale late-stage clinical trials of COVAXIN will involve 26,000 volunteers across India. The phase 3 clinical trials of Covaxin Covid-19 vaccine candidate are being done in collaboration with the Indian Council of Medical Research (ICMR), according to PTI report
Covaxin Phase 3 human trials in India
Phase 3 human trials of Covaxin is the largest clinical trial conducted for a potential Coronavirus vaccine in India. This is also India’s first phase 3 efficacy study for a Covid-19 vaccine, as per Indian Express report.
During phase 3 human trials, volunteers will be inoculated with two intramuscular injections which will be administered around 28 days apart.
Volunteers will be randomly selected to receive COVAXIN or placebo. The human trial of Covaxin is double-blinded. The investigators, 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 Phase I and II human trials of Covaxin, as per PTI report.
During phase 1 and Phase 2 human trials of Covaxin, around 1000 volunteers were monitored for safety and immunogenicity data. Volunteers aged over 18 must participate in human trials of Covaxin.
India’s indigenous Coronavirus vaccine Covaxin is being developed by Bharat Biotech along with the Indian Council of Medical Research (ICMR) and the National Institute of Virology (NIV). Bharat Biotech Chairman and Managing Director Krishna Ella said that the firm tied up with ICMR for COVID-19 vaccine phase 3 trials.
What is the importance of Covaxin Phase 3 human trials in India
India is hoping the “locally-tested” Coronavirus vaccines will help it to control Coronavirus, as the experimental Covid-19 vaccines developed by Pfizer-BioNTech and Moderna may not be available to it in big quantities soon, as per a Reuters report. One of these potential Coronavirus vaccines is Covaxin.
