Drug Controller General of India (DGCI), the country’s top drug regulator has given permission to Bharat Biotech India to conduct human clinical trials or first indigenous COVID-19 vaccine COVAXIN.
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 in July, a PTI report 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.
“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.
The vaccine has been developed by Hyderabad-based Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR) and the National Institute of Virology (NIV). It has been developed at Bharat Biotech’s BSL-3 (Bio-Safety Level 3) high containment facility located in the Genome Valley in Hyderabad.
At a time when Corona virus has created, causing death of millions of people, countries across the globe are trying all possible ways to come up with vaccine for COVID-19. Though many companies have achieved positive results, the vaccine is yet to see the light of the day.