Preclinical studies of the coronavirus candidate have demonstrated safety and immune response

Hyderabad based pharmaceutical firm Bharat Biotech has developed India's first vaccine candidate for coronavirus. The company got approvals for the vaccine after submitting results generated from preclinical studies, demonstrating safety and immune response against COVID-19

Hyderabad based Bharat Biotech, has successfully developed COVAXIN, India’s first vaccine candidate for COVID-19, in collaboration with the Indian Council of Medical Research (ICMR) and National Institute of Virology (NIV).

The SARS-CoV-2 strain was isolated in NIV, Pune and transferred to Bharat Biotech.

The indigenous, inactivated vaccine was 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- Central Drugs Standard Control Organisation and 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.

“COVAXIN is India’s first indigenous vaccine against COVID-19. 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. Our R&D and Manufacturing teams worked tirelessly to deploy our proprietary technologies towards this platform," said Dr Krishna Ella, Chairman and Managing Director of Bharat Biotech

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.

Joint Managing Director Suchitra Ella said that company’s ongoing research and expertise in forecasting epidemics enabled it to successfully manufacture a vaccine for the H1N1 pandemic.

Bharat Biotech in past has developed several vaccines for Polio, Rabies, Rotavirus, Japanese Encephalitis, Chikungunya and Zika.