DCGI nod for Covaxin human trials


Bharat Biotech gained an edge in the race among a few entities in the country and several more globally to ready a vaccine for COVID-19 when the Drug Controller General of India (DCGI) cleared its product for human clinical trials.

The collaboration with the Indian Council of Medical Research (ICMR)-National Institute of Virology (NIV) was instrumental in the development of the vaccine, Chairman and Managing Director Krishna Ella said on Monday. The trials of Covaxin, the vaccine, will begin next month.

The proactive support and guidance from the Central Drugs Standard Control Organization (CDSCO) had enabled approvals for the project, Mr. Ella said in a statement.The indigenous, inactivated vaccine has been developed and manufactured in Bharat Biotech’s Bio-Safety Level 3 (BSL-3) High Containment facility located in Hyderbad’s Genome Valley.

‘National importance’

Bharat Biotech is committed to advancing vaccine development as a matter of national importance to demonstrate India’s strength in handling future pandemics, Joint Managing Director Suchitra Ella, was quoted as saying in the statement.

Bharat Biotech’s track record in developing vero cell culture platform technologies has been proven in several vaccines for Polio, Rabies, Rotavirus, Japanese Encephalitis, Chikungunya and Zika. The company is proficient in conducting extensive multi-centre clinical trials, having completed more than 75 trials in over 300,000 subjects globally, the release said.

The company is also involved in the development of CoroFlu, a nasal vaccine for COVID-19, as part of an international collaboration of virologists at the University of Wisconsin–Madison and vaccine firm FluGen.

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