An Indian biotech company has been granted permission to initiate phase I & II human clinical trials after submitting data from pre-clinical studies for developing the first COVID-19 vaccine late Monday.
Based in India‘s southeastern city of Hyderabad, 569 km east of Bengaluru, Bharat Biotech has developed this vaccine in collaboration with the two state-owned institutions — Indian Council of Medical Research (ICMR) and National Institute of Virology (NIV), and the human clinical trials are schedule to commence human clinical trials in July.
Bharat Biotech’s track record in developing Vero cell culture platform technologies has been proven in several vaccines for Polio, Rabies, Rotavirus, Japanese Encephalitis, Chikungunya, conjugated vaccine for Typhoid and Zika, and the comprehensive pre-clinical studies for COVID-19 vaccine have been promising and demonstrated extensive safety and effective immune responses, the statement said.
“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,” said Krishna Ella, chairman and managing director of Bharat Biotech. The CDSCO (Central Drugs Standard Control Organisation) is the national regulatory body for Indian pharmaceuticals and medical devices.
India, ranked fourth among all countries for number of confirmed COVID-19 cases, has 210,120 active cases with 16,475 deaths reported so far.