Covaxin gets DCGI nod for Phase 3 trial
NEW DELHI [Maha Media]: 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.
On October 2, Bharat Biotech had sought the DCGI’s permission to conduct phase 3 trial of its COVID-19 vaccine, but the vaccine maker was asked to submit the complete safety and immunogenicity data of the phase 2 trial, reported PTI.
The firm had presented data of phase 1 and 2 trials along with animal challenge data in two species including non-human primates (NHP) on the inactivated coronavirus vaccine (BBV152) along with the proposal to conduct event driven phase 3 clinical trial to assess the efficacy of the vaccine, the CDSCO recommendations stated.
In July, the DCGI had given permission to Bharat Biotech to conduct phase 1 and 2 clinical trials of its COVID-19 vaccine.
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.