India's first COVID-19 vaccine gets DCGI's approval for human trials: Report
Hyderabad/IBNS: India's first homegrown Covid-19 vaccine candidate COVAXIN has received approval from Drug Controller General of India (DCGI) to conduct Phase I and II human trials, said a media report.
COVAXIN has been developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR) and the National Institute of Virology (NIV), a Times Now report said.
The SARS-CoV-2 strain was isolated at the National Institute of Virology (NIV) and transferred to Bharat Biotech.
The inactivated vaccine will be manufactured and developed by Bharat Biotech’s BSL-3 (Bio-Safety Level 3) High Containment facility located in Genome Valley in Hyderabad, said the report.
The Drug Controller General of India - CDSCO, Ministry of Health & Family Welfare, granted permission to start phase I and phase II of human trials after the company showed the preclinical studies, demonstrating safety and effective immune response.
“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,” said Dr Krishna Ella, Chairman and Managing Director, Bharat Biotech, announcing the vaccine development milestone, reported Times Now.
The company said the results from preclinical tests showed extensive safety and effective immune responses.
“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,” the report quoted Mrs Suchitra Ella, Joint Managing Director as saying.
The company has a proven track record in developing vaccines for polio, rabies, rotavirus, Japanese Encephalitis, Chikungunya and Zika.
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