Bharat Biotech has submitted Phase 3 clinical trial data for its Covid-19 vaccine, Covaxin, to the Drug Controller General of India (DCGI). Covaxin is among three vaccines being used in the nationwide drive against Covid-19. It was granted approval by the DCGI in January.
“We’ve received the data from phase 3 trials,” said a senior government official.
The DCGI’s Subject Expert Committee will take up the matter on June 2. Trial data for Phase-3 is crucial as it will provide details of the efficacy of the vaccine.
Earlier, the Hyderabad-based vaccine maker had stated that its coronavirus vaccine was 81 per cent effective in preventing the infection, according to early analysis of the results from late-stage trials.