COVID-19 Vaccine: India’s COVAXIN Gets DCGI Approval To Begin Human Clinical Trials

The Drug Controller General of India (DCGI) has allowed Bharat Biotech International (BBI) to conduct human clinical trials for COVAXIN, a potential vaccine.

Jessica David

July 1, 2020

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Hyderabad-based Bharat Biotech International (BBI) announced that it has successfully developed ‘COVAXIN’, India’s first vaccine candidate for COVID-19, in collaboration with the Indian Council of Medical Research (ICMR) and National Institute of Virology (NIV). The Drug Controller General of India (DCGI) – Central Drugs Standard Control Organisation (CDSCO), Ministry of Health and Family Welfare (MoHFW) granted permission to initiate Phase I and 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 SARS-CoV-2 strain was isolated in NIV, Pune and transferred to Bharat Biotech. The indigenous, inactivated vaccine developed and manufactured in the company’s Bio-Safety Level 3 (BSL-3) High Containment facility located in Genome Valley, Hyderabad. Announcing the vaccine development milestone, Dr Krishna Ella, Chairman and Managing Director 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.”

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