Covid Vaccine: Bharat Biotech To Conduct Phase 3 Trials Of Covaxin On 26,000 People Across 25 Centres

Drug Controller General of India (DGCI) has also given Bharat Biotech the permission to go ahead with the Phase III trials after successful completion of Phase I and Phase II clinical trials.

(Representative Image/ Getty)

New Delhi: The Bharat Biotech, which is into developing Covaxin - a vaccine candidate for COVID-19, on Friday said that it will now be conducting Phase III trials in 25 centres across the country with a total of 26,000 people participating in the trials. Bharat Biotech successfully completed interim analysis of Phase I and II trials of Covaxin. According to report, the Drug Controller General of India (DGCI) has also given Bharat Biotech the permission to go ahead with the Phase III trials after successful completion of Phase I and Phase II clinical trials. "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 an official communication. An expert panel at the Central Drugs Standard Control Organisation (CDSCO) has recommended granting permission for conducting phase 3 clinical trials of its indigenously developed COVID-19 vaccine with certain conditions. The phase 3 clinical trial application has proposed a dose of 0.5 ml on day 0 and 28. Covaxin is being developed by BharatBiotech in collaboration with the Indian Council of Medical Research (ICMR) - National Institute of Virology (NIV). As per sources close to news agency PTI, the Hyderabad-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. But it was asked to submit the complete safety and immunogenicity data of the phase 2 trial besides providing some clarifications before proceeding to the next stage. The firm in its application has said that the study would cover 28,500 subjects aged 18 years and above and would be conducted in 19 sites across 10 states including places like Delhi, Mumbai, Patna and Lucknow.