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 to assess efficacy of the vaccine.
The SEC accorded approval for the Phase-III trials but subject to an amendment in the primary efficacy endpoint for symptomatic cases.
Bharat Biotech would cover 28,500 subjects aged 18 years and above in its Phase-III trials across 19 sites in the country. The company had received permission to conduct Phase-II clinical trials among 380 persons last month.