Vaccine by Bharat Biotech first to get human trials nod
NEW DELHI : India’sdrug controller has given approval for human clinical trials of the country’s first coronavirus disease (Covid-19) vaccine candidate, which has been developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (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-19 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.
In the two phases, experts test if a vaccine is safe to be administered in humans and to establish trends of its efficacy.