Hyderabad: 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 centres across India,” the vaccine maker said in a communication.
Covaxin is being developed byBharatBiotech 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 randomised double-blind placebo-controlled multi centre 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.