India’s first COVID-19 vaccine gets DCGI approval for human trials
India's First Covid-19 Vaccine Developed By Bharat Biotech To Enter Human Trials From July
The COVID-19 Pandemic has brought the world to a standstill. As the positive cases are on an increase all over the globe there is also a race to develop the first vaccine to cure it. India’s ‘first’ indigenous COVID-19 vaccine has got the nod for human clinical trials from the Drug Controller General of India (DGCI).
Bharat Biotech India Ltd’s covid-19 vaccine ‘Covaxin’ has become the first candidate developed in India to receive the DGCI’s approval to enter human trials.
COVAXIN is developed by Hyderabad-based Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR) and the National Institute of Virology (NIV). The DGCI has approved the company’s application to conduct a Phase I and II clinical trial of Covaxin.
The statement released by the company says, The SARS-CoV-2 strain was isolated in NIV, Pune. It was then transferred to Bharat Biotech. The indigenous, inactivated vaccine has been developed and manufactured at Bharat Biotech’s BSL-3 (Bio-Safety Level 3) High Containment facility located in Genome Valley, Hyderabad, India.
Dr. Krishna Ella, Chairman, and Managing Director, Bharat Biotech 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. The proactive support and guidance from CDSCO have enabled approvals to this project. Our R&D and Manufacturing teams worked tirelessly to deploy our proprietary technologies towards this platform.”
According to the vaccine maker, human clinical trials of the experimental COVID-19 are scheduled to start across the country in July 2020.