Covid-19 Vaccine: Bharat Biotech To Conduct Phase-3 Trials For Covaxin
BharatBiotech, which is into developing Covaxin, a vaccine candidate for Covid-19,on Friday said it has successfully completed 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 by BharatBiotech in collaboration with the Indian Council of Medical Research - National Institute of Virology. The city-based vaccine maker had on Oct. 2 sought the Drug Controller General of India 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.