Covaxin gets DCGI nod for human trial, India’s first Covid-19 vaccine by Bharat Biotech
- India's first COVID-19 vaccine candidate cleared for human trials
- Drug Controller General of India approves Bharat Biotech's Covaxin for clinical human trials
NEW DELHI: Bharat Biotech’s COVID-19 vaccine “Covaxin” has been approved for human trials, making it India’s first vaccine to get green signal from DCGI.
The vaccine is being developed in collaboration with ICMR and NIV , and got a nod for human trials from the Drug Controller General of India , the company said on Monday. The indigenous and inactivated vaccine has been developed at Bharat Biotech’s BSL-3(Biosafety Level 3)high containment facility located in Genome valley here , a release said.
CDSCO (The Central Drugs Standard Control Organisation), Ministry of Health & Family Welfare granted permission for Phase 1 and Phase 2 Human Clinical trials after successfully submitting demonstrations of safety and immune response. The trials will start across India from July 2020.
Chairman and Managing Director of the company Dr. Krishna Ella said “We are proud to announce COVAXIN, India’s first indigenous vaccine against COVID-19.”
“The proactive support and guidance from CDSCO has enabled approvals to this project. Our R&D and Manufacturing teams worked tirelessly to deploy our proprietary technologies towards this platform,” he said.
Apart from Bharat Biotech, at least five more companies in India are working on a vaccine for deadly coronavirus while other countries are also putting the same effort into the development race of vaccines.