INDIA’S COVID-19 VACCINE, COVAXIN, GETS CLEARED FOR PHASE 3 TRIALS

The Hyderabad based firm had sought for permission to conduct its Phase 3 trials for the Covid-19 vaccine candidate. In an application written by the firm, it said that the study would cover 28, 500 subjects aged 18 years and above and would be conducting the trials in 19 different locations including Delhi, Mumbai, Patna and Lucknow – across 10 states.

The firm had earlier presented the 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.

In July, the DCGI had given permission to Bharat Biotech to conduct phase 1 and 2 clinical trials of its Covid-19 vaccine.

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