Bharat Biotech’s coronavirus vaccine ‘Covaxin’, which is being developed in collaboration with the Indian Council of Medical Research (ICMR), has been cleared for the third phase of clinical trials.
The biotechnology company, on October 2, had applied to the Drugs Controller General of India (DCGI) seeking its permission to conduct Phase 3 trials for its vaccine candidate.
In its application, the firm said that the study would cover 28,500 subjects aged 18 years and above and would be conducted across 10 states including Delhi, Mumbai Patna and Lucknow.
Three months back in July, the firm was allowed to hold phase 1 and phase 2 of the human clinical trials. With the clearance of phase 1 and 2, phase 3 is scheduled to take place in the coming month.
Covaxin is the first indigenous vaccine candidate by India to fight against the novel coronavirus.
Besides, Bharat Biotech, an indigenously developed vaccine candidate by Zydus Cadila Ltd is also in Phase 2 of human clinical trials.