The Drug Controller General of India (DCGI)- 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.
Human clinical trials are scheduled to start across India in July 2020.
“Continuing our focus on creating the only BSL-3 containment facilities for manufacturing and testing in India, Bharat Biotech is committed to advancing vaccine development as a matter of national importance to demonstrate India’s strength in handling future pandemics,” she added.
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 and Zika.
