India's leading drug manufacturer of vaccines and generic medicines, that has been known to develop several vaccines including vaccines for Polio, Rabies, Rotavirus, Japanese Encephalitis, Chikungunya and Zika, has now entered the race for developing a COVID-19 vaccine. Bharat Biotech is expected to play a vital role in the discovery of COVID-19 vaccine, as this Hyderabad-based manufacturer has announced the successful development of a potential drug that it is calling COVAXIN.
COVAXIN, India's first potential vaccine for COVID-19, has been developed in collaboration with the Indian Council of Medical Research (ICMR) and National Institute of Virology (NIV).
Taking the development to the next level, the Drug Controller General of India and the Ministry of Health & Family Welfare have granted human clinical trial permissions for Phase I & II.
This approval has been given to the company after they submitted results generated from pre-clinical studies towards safety and immune response. Human clinical trials for COVAXIN are scheduled to begin in July 2020 across India and will be conducted in two-phases.
Speeding through national regulatory protocols, Bharat Biotech International Limited accelerated its objective about the successful completion of the comprehensive pre-clinical studies. The results and studies related to COVAXIN have shown promising results on the extensive safety and effective immune responses.
Announcing the COVAXIN vaccine development, Dr Krishna Ella, Chairman and Managing Director said: "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."
He further added, "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."
Speaking about Bharat Biotech's expertise, Suchitra Ella, Joint Managing Director said, "Our ongoing research and expertise in forecasting epidemics has enabled us to successfully manufacture a vaccine for the H1N1 pandemic."
She further added, "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."
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