Bharat Biotech’s COVID-19 vaccine first in India to receive nod for human trials

Bharat Biotech India Ltd’s COVID-19 vaccine ‘COVAXIN’ has become the first candidate developed in India to receive the Drug Controller General of India’s approval to enter human trials. The indigenous, inactivated vaccine is developed and manufactured in Bharat Biotech’s BSL-3 (Bio-Safety Level 3) High Containment facility located in Genome Valley, Hyderabad.

Hyderabad: Leading vaccine maker Bharat Biotech on Monday announced that it 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 is developed and manufactured in Bharat Biotech's BSL-3 (Bio-Safety Level 3) High Containment facility located in Genome Valley, Hyderabad, the company said in a statement.

The Drug Controller General of India - Central Drugs Standard Control Organisation (CDSCO), Ministry of Health & Family Welfare granted permission to initiate Phase I and 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 next month.

Announcing the vaccine development milestone, Dr Krishna Ella, Chairman and Managing Director, Bharat Biotech, said, "We are proud to announce COVAXIN, India's first indigenous vaccine against COVID-19. The collaboration with the ICMR and the NIV was instrumental in the development of this vaccine. The proactive support and guidance from the CDSCO has enabled approvals to this project. Our R&D and Manufacturing teams worked tirelessly to deploy our proprietary technologies towards this platform."

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.

Speaking about Bharat Biotech’s prowess, Suchitra Ella, Joint Managing Director, Bharat Biotech said, "Our ongoing research and expertise in forecasting epidemics has enabled us to successfully manufacture a vaccine for the H1N1 pandemic. 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."

It is to be noted that 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.