COVID-19 Vaccine: Bharat Biotech to Conduct Phase-3 Trials of Covaxin in 26,000 Volunteers
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.
Hyderabad, October 23: Bharat Biotech,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. COVID-19 Vaccine Update: Covaxin By Bharat Biotech Cleared For Phase 3 Trials By The Drugs Controller General Of India (DCGI).
Covaxin is being developed by Bharat Biotech 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.
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