Covaxin, the coronavirus vaccine 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 October 2, seeking its permission to conduct Phase 3 trials for its COVID-19 vaccine candidate.
The firm in its application 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.
Besides, Bharat Biotech, an indigenously developed vaccine candidate by Zydus Cadila Ltd is also 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 the candidate in India.
In a report last month, Bharat Biotech had said that an animal study has shown its vaccine candidate has helped develop a strong immune response to the highly infectious coronavirus.