The first indigenous vaccine candidate, developed by Bharat Biotech and ICMR-National Institute of Virology, has received the approval to conduct phase one and phase two human clinical trials in July. COVAXIN™ is India’s first vaccine candidate for COVID-19, developed from the SARS-CoV-2 strain that was isolated in NIV, Pune and transferred to Hyderabad-based Bharat Biotech.
“The indigenous, inactivated vaccine was developed and manufactured in Bharat Biotech’s BSL-3 (bio-safety level 3) high containment facility located in Genome Valley, Hyderabad, India,” the company said in a statement.
“The drug controller general of India, CDSCO, ministry of health & family welfare, granted permission to initiate Phase I & II human clinical trials after the company submitted results generated from preclinical studies, demonstrating safety and immune response,” the statement reads.
Before a company reaches this stage, the vaccine candidate is tested on animal models for safety .
Dr. Krishna Ella, chairman and managing director, Bharat Biotech, said, “We are proud to announce COVAXIN™, India’s first indigenous vaccine against COVID-19. The collaboration with ICMR and NIV was instrumental in the development of this vaccine. The proactive support and guidance from CDSCO have enabled approvals to this project. Our R&D and manufacturing teams worked tirelessly to deploy our proprietary technologies towards this platform.”
Expedited through national regulatory protocols, the company “accelerated” its objective in completing the comprehensive pre-clinical studies. Results from these studies have been promising and show extensive safety and effective immune responses, according to Bharat Biotech.