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DCGI approves Bharat Biotech’s Covid-19 vaccine for human clinical trials

Our Bureau Hyderabad | Updated on June 30, 2020 Published on June 29, 2020

Bharat Biotech has developed India’s first vaccine candidate for Covid-19, Covaxin, in collaboration with the Indian Council of Medical Research (ICMR)-National Institute of Virology (NIV).

The Drug Controller General of India- CDSCO and Ministry of Health & Family Welfare have granted permission for the Hyderabad-based company to initiate Phase I & II human clinical trials which are scheduled to start across India in July.

“We are proud to announce Covaxin, India’s first indigenous vaccine against Covid-19,’’ Krishna Ella, Chairman and Managing Director, Bharat Biotech, said in a release issued here on Monday.

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, he added.

The SARS-CoV-2 strain was isolated in NIV, Pune and transferred to the Hyderabad-based Bharat Biotech. The indigenous, inactivated vaccine developed and manufactured in Bharat Biotech’s BSL-3 (Bio-Safety Level 3) High Containment facility located in Genome Valley, Hyderabad, India.

Bharat Biotech’s has so far developed several vaccines for polio, rabies, rotavirus, Japanese encephalitis, chikungunya and zika.

 

Published on June 29, 2020