Vaccine by Bharat Biotech first to get human trials nod

Newdelhi:india’sdrug controller has given approval for human clinical trials of the country’s first Covid-19 vaccine candidate, which has been developed by Bharat Biotech in collaboration with the ICMR and National Institute of Virology (NIV), the vaccine maker said on Monday.

The trials for the vaccine, named Covaxin, are likely to begin next month, the firm said. The strains of Sars-cov-2 that causes Covid was isolated by ICMR-NIV and transferred to Bharat Biotech in May. Scientists have managed to isolate and culture 11 strains that can be used to develop vaccines and aid research.

The indigenous and inactivated vaccine candidate was developed and manufactured at Bharat Biotech’s BSL-3 (Biosafety Level 3) High Containment facility located in Genome Valley, Hyderabad. “The Drug Controller

General of India… granted permission to initiate Phase I & II Human clinical trials after the company submitted results generated from preclinical studies, demonstrating safety and immune response. Human clinical trials are scheduled to start across India in July 2020,” the company said.

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 Central Drugs Standard Control Organisation has enabled approvals to this project. Our R&D and manufacturing teams worked tirelessly to deploy our proprietary technologies towards this platform.”

In the two phases, experts test if a vaccine is safe to be administered in humans and to establish trends of its efficacy.