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 (DCGI) 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.
Story Source- www.abplive.in