Covid-19 vaccine: Bharat Biotech Initiates Phase-3 Trials In 26,000 Participants

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.