COVID-19 Vaccine: DCGI Gives Its Nod To Bharat Biotech’s Covaxin For Phase 3 Trial
New Delhi: The Bharat Biotech developed-vaccine in collaboration with the Indian Council of Medical Research (ICMR) — Covaxin — has got the approval for the third phase of clinical trials.
The Hyderabad-based vaccine maker on October 2 had applied to the Drugs Controller General of India (DCGI) and sought permission to conduct Phase 3 trials.
According to official reports, a Central Drugs Standard Control Organisation’s (CDSCO) expert panel recommended following its assessment about safety and immunogenicity data of phase 1 and 2 clinical trials. This was sent to the Drugs Controller General of India (DCGI) for final approval.
In its application, the firm 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, according to news agency PTI.