BharatBiotech, which is into developing Covaxin, a vaccine candidate for Covid-19, on Friday said it has successfully completed an interim analysis of Phase I and II trials and is initiating Phase-III trials in 26,000 participants.
"After successful completion of the interim analysis from the Phase 1 & 2 clinical trials of Covaxin, Bharat Biotech received DCGI approval for Phase 3 clinical trials in 26,000 participants in over 25 centers across India," the vaccine maker said in a communication.
Covaxin is being developed by BharatBiotech in collaboration with the Indian Council of Medical Research (ICMR) - National Institute of Virology (NIV).
The city-based vaccine maker had on October 2 sought the Drug Controller General of India (DCGI)'s permission to conduct Phase 3 randomized double-blind placebo-controlled multicentre trial of its Covid-19 vaccine, sources said.
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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