Bharat Biotech, a leading vaccine maker that is developing India’s own vaccine for coronavirus will successfully completed the 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 byBharatBiotech in collaboration with the Indian Council of Medical Research (ICMR) – National Institute of Virology (NIV).
The primary efficacy endpoint is the outcome by which the effectiveness of treatments in a clinical trial is evaluated. A carefully chosen endpoint can ensure no bias. A primary efficacy endpoint needs to be specified before the start of the clinical trial. 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 multicenter trial of its COVID-19 vaccine, sources said.