HYDERABAD: The Subject Expert Committee (SEC) under Central Drugs Standard Control Organisation (CDSCO) has given the nod to Hyderabad-based firm Bharat Biotech to conduct Phase-III trials of Covaxin, the vaccine for COVID-19. The permission was accorded at the SEC meeting held in New Delhi on Tuesday.
At the meeting, Bharat Biotech presented data from Phase I and II trials, along with animal challenge data in two species including non-human primates (NHP), on its inactivated Coronavirus vaccine, along with the proposal to conduct Phase-III clinical trials.
The SEC accorded approval for the trials but subject to an amendment in the primary efficacy endpoint for symptomatic cases. The firm would cover 28,500 subjects aged 18 and above in its trials across 19 sites in the country.