In another major update for coronavirus vaccine in India, Covaxin - the drug developed by Hyderabad-based Bharat Biotech in collaboration with Indian Council of Medical Research (ICMR) has been granted permission to conduct the third phase of clinical trials.
The Subject Expert Committee of Drugs Controller General of India (DCGI) recommended that permission should be granted to the vaccine maker to conduct the trials. Bharat Biotech had applied to the DGCI on October 2 and sought its permission.
The recommendation was given by the panel at the Central Drugs Standard Control Organisation (CDSCO) after assessing the data of phase 1 and 2 clinical trials as well as animal challenge study.
"In continuation of the SEC meeting dated 05.10.2020, the firm presented their data from Phase I and II along with animal challenge data in two species including NHP on the Inactivated Corona Virus Vaccine (BBV152) along with the proposal to conduct event driven Phase III clinical trial to assess the efficacy of the vaccine," a statement from the expert panel read.
In its application, the pharma major 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.
It also 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, Bharat Biotech had received DCGI nod to conduct phase 1 and 2 clinical trials of an indigenous vaccine for COVID-19.
Another indigenously developed vaccine candidate by Zydus Cadila Ltd is also in Phase 2 of human clinical trials.