Chennai: Covaxin, the Coronavirus vaccine being developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR), has been cleared for the third phase of clinical trials.
Drugs Controller General of India (DCGI’s) Subject Expert Committee (SEC) recommended granting of permission to conduct Phase III clinical trials for Covaxin.
“In continuation of the SEC meeting dated 05.10.2020, 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,” the panel said in a statement.
The Hyderabad-based vaccine maker had applied to the Drugs Controller General of India (DCGI) on 2 October, seeking its permission to conduct Phase 3 trials for its Covid-19 vaccine candidate.
In its application, the firm said that the study would cover 28,500 subjects aged 18 years and above and would be conducted in 19 sites – including Delhi, Mumbai, Patna and Lucknow – across 10 States.