ABLE member Bharat Biotech gets regulatory nod for India’s first COVID-19 vaccine human trials
- by Team ABLE - 30 Jun, 2020
Hyderabad-based Bharat Biotech India Ltd’s covid-19 vaccine ‘Covaxin’ has become the first candidate developed in India to receive the Drug Controller General of India’s approval to enter human trials. The regulator has approved Bharat Biotech’s application to conduct a phase I and II clinical trial of its vaccine candidate Covaxin.
“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 has enabled approvals to this project," Bharat Biotech chairman and managing director Krishna Ella said. Bharat Biotech is a member of ABLE.
The indigenous, inactivated vaccine was developed and manufactured in Bharat Biotech’s facility located in Genome Valley in Hyderabad and human clinical trials are scheduled to start across India in July, the company said.
Covaxin is one of the more than 200 vaccine candidates undergoing various stages of trials against COVID-19 virus in the world.
Covaxin is the first home made vaccine to reach this stage of clinical trials in humans. The vaccine has been developed in collaboration with ICMR-National Institute fo Virology, Pune.