The Hyderabad-based biotechnology firm Bharat Biotech has received the nod from the Drug Controller General of India for conducting phase I and II human clinical trials for India’s first COVID -19 vaccine candidate, code-named as COVAXIN. The trials for the vaccine are scheduled to begin across India in July.
This vaccine candidate was developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR) and the National Institute of Virology (NIV), Pune. The SARS-CoV-2 strain which was isolated in NIV was transferred to Bio-safety Level-III high containment facility at Bharat Biotech where the inactivated vaccine has been indigenously developed.
The permission for human clinical trials was granted by DCGI after the company submitted results from its preclinical studies, demonstrating safety and immune response of the vaccine. The results are expected to be out by October 2020, following which larger clinical trials will be conducted.