Covaxin, the COVID-19 vaccine being developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR), has received the approval of Drugs Controller General of India (DCGI's) Expert Committee to start the final phase of trials. On October 2, the pharma company had applied to the Drugs Controller General of India (DCGI) asking its permission to conduct Phase 3 trials for its vaccine candidate.
"After detailed deliberation and based on the available evidences, the committee recommended for grant of permission to conduct Phase III clinical trial," the panel said in a statement.
The firm in its application had said that the study would cover 28,500 subjects aged 18 years and above and would be conducted in 19 sites -- including Delhi, Mumbai, Patna and Lucknow -- across 10 states, reported news agency PTI. Bharat Biotech had recently said in a report released last month that an animal study has shown its vaccine candidate has helped develop a strong immune response to COVID-19.
Besides, Bharat Biotech, indigenously developed vaccine candidate by Zydus Cadila Ltd is in Phase 2 of human clinical trials. 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 its candidate in India.
Meanwhile, more than 100 coronavirus vaccine candidates are in different stages all across the world.