A potential COVID-19 vaccine, Covaxin, the first to be developed in India, has been given Drug Controller General of India (DCGI) approval for Phase I and II human clinical trials that are scheduled to start across the country in July. The vaccine is under development by Hyderbad-based biotechnology firm Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR) and the National Institute of Virology (NIV).
The clinical trials of the experimental COVID-19 vaccine in humans are scheduled to begin in July 2020, Bharat Biotech said in a note. COVAXIN has been expedited through national regulatory protocols, and subjected to “comprehensive pre-clinical studies” according to the company, which reports that the results are “promising” and “show extensive safety and effective immune responses”.
Dr Krishna Ella, Chairman and Managing Director of Bharat Biotech, said, “The collaboration with ICMR and NIV was instrumental in the development of this vaccine. The proactive support and guidance from CDSCO has enabled approvals to this project. We worked tirelessly to deploy our proprietary technologies towards this platform.”