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India’s very first vaccine candidate against the novel coronavirus, COVAXIN, has received a nod in the Drug Controller General of India (DCGI) for further clinical trials Stage I and two in infected men and women. The vaccine is under development by Hyderbad-based biotechnology firm Bharat Biotech in cooperation with the Indian Council of Medical Research (ICMR) and the National Institute of Virology (NIV).
The clinical trials of the experimental COVID-19 vaccine in people are scheduled to begin in July 2020, Bharat Biotech stated in a note. COVAXIN has been expedited through national regulatory protocols, and subjected to”comprehensive pre-clinical studies” according to the company, which reports that the results are”promising” and”show extensive safety and powerful immune responses”.
Dr Krishna Ella, Chairman and Managing Director of Bharat Biotech, stated,”The cooperation with ICMR and NIV was instrumental in the development of this vaccine. The educated support and guidance from CDSCO has enabled approvals for this project. We worked tirelessly to set up our proprietary technology towards this platform”
First COVID19 vaccine candidate COVAXIN out of India gets DCGI approval for individual trials
“The SARS-CoV-2 strain was isolated in NIV, Pune and moved to Bharat Biotech. The indigenous, inactivated vaccine has been designed and manufactured in Bharat Biotech’s BSL-3 (Bio-Safety Level 3) High Containment facility located in Genome Valley, Hyderabad,” the company added.
