India's Covid-19 vaccine candidate 'Covaxin' gets clearance for Phase 3 clinical trials
New Delhi/IBNS: In a ray of hope, India's coronavirus vaccine named 'Covaxin', being developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR), has been cleared for the third phase of clinical trials.
The Hyderabad-based vaccine maker had applied to the Drugs Controller General of India (DCGI) on Oct 2 seeking permission to conduct the Phase 3 trials for its COVID-19 vaccine candidate.
In its third phase trials, the study would be conducted on 28,500 subjects aged 18 years and above across 9 sites including Delhi, Mumbai, Patna and Lucknow.
In a report last month, Bharat Biotech had said that the study conducted on animals showed the vaccine candidate was able to develop strong immune responses to the highly infectious coronavirus.
"To summarise, the vaccine candidate was found to generate robust immune responses. Thus, preventing infection and disease in the primates upon high amounts of exposure to live SARS-CoV-2 virus," Bharat Biotech posted on its website.
Besides Covaxin, another indigenously developed vaccine candidate by Zydus Cadila Ltd is also in the Phase 2 trials on human beings.
The Pune-based Serum Institute of India, which has partnered with AstraZeneca for manufacturing the Oxford COVID-19 vaccine candidate, is also conducting Phase 2 and 3 human clinical trials of the candidate in India.