The country's 'first' indigenous COVID-19 vaccine COVAXIN, developed by Bharat Biotech has got the nod to conduct human clinical trials.
The COVAXIN vaccine has received?approval from?the Drug Controller General of India (DCGI) to conduct Phase I and 2?human trials. According to the vaccine maker, clinical trials of the experimental COVID-19 vaccine are scheduled to start across the country in July 2020.
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Collaboration with Indian Council of Medical Research (ICMR) and the National Institute of Virology (NIV) was instrumental in the development of the vaccine, the company said in a release.??
The indigenous and inactivated vaccine has been developed at Bharat Biotechs BSL-3 (Bio-Safety Level 3) high containment facility located in the Genome Valley, Hyderabad.?
The Drug Controller General of India CDSCO (The Central Drugs Standard Control Organisation), Ministry of Health & Family Welfare, granted permission to initiate Phase I & II human clinical trials, after the company submitted results generated from pre-clinical studies, demonstrating safety and immune response.?
Chairman and Managing Director of the company Dr. Krishna Ella said, "We are proud to announce COVAXIN, Indias first indigenous vaccine against COVID-19. The collaboration with ICMR and NIV was instrumental in the development of this vaccine."
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"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," he said.?
Expedited through the 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, the release added.?
¡°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,¡± said Mrs Suchitra Ella, Joint Managing Director.
Besides Bharat Biotech, at least five other Indian companies are working on a vaccine for the deadly coronavirus while similar efforts are underway in different countries.
SOURCE: PTI