Breaking! India’s first coronavirus vaccine candidate approved for human trials; details inside

India’s first vaccine candidate against COVID-19, named COVAXIN, has received approval from the Drug Controller General of India (DCGI) to conduct Phase I and Phase II trials on human beings. The potential COVID-19 vaccine has been developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR) and the National Institute of Virology (NIV).

According to a statement released by the firm on Monday, a strain of the infectious SARS-CoV-2 virus was isolated in NIV, Pune and transferred to Bharat Biotech. After it showed promise in preclinical studies, demonstrated extensive safety and exhibited effective immune responses, the Drug Controller General of India – CDSCO, Ministry of Health & Family Welfare, granted permission to initiate Phase I and II human trials. The potential vaccine was developed and manufactured at Bharat Biotech’s BSL-3 (Bio-Safety Level 3) High Containment facility located in Genome Valley, Hyderabad, India.

“We are proud to announce COVAXIN, 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 have enabled approvals to this project. Our R&D and manufacturing teams worked tirelessly to deploy our proprietary technologies towards this platform,” Dr. Krishna Ella, Chairman and Managing Director of Bharat Biotech mentioned in a statement.

“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 the future pandemics,” Mrs. Suchitra Ella, Joint Managing Director of the firm stated.

As on June 28, a total of 548k cases have been registered across India and 16475 people have died. Tamil Nadu has reported 82275 cases and 1079 deaths.