On Jun. 29, 2020, Bharat Biotech announced it had successfully developed COVAXIN, India’s 1st vaccine candidate for COVID-19, in collaboration with the Indian Council of Medical Research (ICMR) -National Institute of Virology (NIV). The SARS-CoV-2 strain was isolated in NIV, Pune and transferred to Bharat Biotech. The indigenous, inactivated vaccine developed and manufactured in Bharat Biotech’s BSL-3 (Bio-Safety Level 3) High Containment facility located in Genome Valley, Hyderabad, India.

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. Human clinical trials are scheduled to start across India in July 2020.

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.