Covaxin: Bharat Biotech gets DCGI nod for Phase 3 trial of its coronavirus vaccine

Mangalore Today News Network

New Delhi, Oct 23, 2020: The coronavirus vaccine being developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR) Covaxin, 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 permission to conduct Phase 3 trials.

As per official reports, the recommendation was given by an expert panel at the Central Drugs Standard Control Organisation (CDSCO) after assessing the safety and immunogenicity data of phase 1 and 2 clinical trials and have been sent to the Drugs Controller General of India (DCGI) for final approval.

The firm in its application said that the study would cover around 28,500 subjects aged 18 years and above and would be conducted in 19 sites - including Delhi, Mumbai, Patna and Lucknow - across 10 states.


courtesy: Zeenews