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BusinessDrugs Controller General of India nod for Covaxin phase 3 trials

Drugs Controller General of India nod for Covaxin phase 3 trials

Published: 23rd Oct 2020 5:46 pm

Hyderabad: Covaxin, the Covid-19 vaccine being developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR) has been given approval for the third phase of clinical trials.

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

The DCGI granted permission to initiate Phase I & II human clinical trials in June this year, after the company submitted results generated from pre-clinical studies, demonstrating safety and immune response.


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