<p>The country's 'first' indigenous Covid-19 vaccine COVAXIN, developed by city-based Bharat Biotech in collaboration with ICMR and NIV, has got the nod for human clinical trials from the Drug Controller General of India, the company said on Monday.</p>.<p>The Phase I and Phase II clinical trials of the vaccine for SARS-CoV-2, approved after pre-clinical studies demonstrated safety and immune response, would start across the country next month.</p>.<p><a href="https://www.deccanherald.com/national/coronavirus-news-live-updates-indias-tally-crosses-4-lakh-toll-jumps-to-12825-851629.html" target="_blank"><strong>For latest updates and live news on coronavirus, click here</strong></a></p>.<p>The 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.</p>.<p>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 here, a release said.</p>.<p>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.</p>.<p>Human clinical trials are scheduled to start across India in July 2020, the release said. 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.</p>.<p><strong>Follow: <a href="https://www.deccanherald.com/national/coronavirus-india-update-state-wise-total-number-of-confirmed-cases-deaths-on-june-29-854908.html" target="_blank">Coronavirus India update: State-wise total number of confirmed cases, deaths on June 29</a></strong></p>.<p>"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.</p>.<p>Expedited through the national regulatory protocols, the company accelerated its objective in completing the comprehensive pre-clinical studies.</p>.<p>Results from these studies have been promising and show extensive safety and effective immune responses, the released added. 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.</p>
<p>The country's 'first' indigenous Covid-19 vaccine COVAXIN, developed by city-based Bharat Biotech in collaboration with ICMR and NIV, has got the nod for human clinical trials from the Drug Controller General of India, the company said on Monday.</p>.<p>The Phase I and Phase II clinical trials of the vaccine for SARS-CoV-2, approved after pre-clinical studies demonstrated safety and immune response, would start across the country next month.</p>.<p><a href="https://www.deccanherald.com/national/coronavirus-news-live-updates-indias-tally-crosses-4-lakh-toll-jumps-to-12825-851629.html" target="_blank"><strong>For latest updates and live news on coronavirus, click here</strong></a></p>.<p>The 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.</p>.<p>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 here, a release said.</p>.<p>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.</p>.<p>Human clinical trials are scheduled to start across India in July 2020, the release said. 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.</p>.<p><strong>Follow: <a href="https://www.deccanherald.com/national/coronavirus-india-update-state-wise-total-number-of-confirmed-cases-deaths-on-june-29-854908.html" target="_blank">Coronavirus India update: State-wise total number of confirmed cases, deaths on June 29</a></strong></p>.<p>"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.</p>.<p>Expedited through the national regulatory protocols, the company accelerated its objective in completing the comprehensive pre-clinical studies.</p>.<p>Results from these studies have been promising and show extensive safety and effective immune responses, the released added. 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.</p>