Drugs Controller General of India or DCGI on Friday ordered Bharath Biotech to submit outrights of phase 2 before proceeding the latter.
Bharat Biotech has informed the phase 3 study would cover 28,500 volunteers aged 18 and above set to conduct in 19 sites – including Delhi, Mumbai, Patna, and Lucknow – across 10 states. The phase-3 clinical trial application proposed a dose of 0.5 ml on days 0 and 28- sources told.
The vaccine is being under development in collaboration with the nation’s apex medical research body — the Indian Council of Medical Research (ICMR). The Pune Serum Institute located in Mumbai is the only one been approved for phase 3 study.