COVID-19: India’s First Coronavirus Vaccine Candidate Gets Nod For Human Clinical Trials

Ministry of Health and Family Welfare (MoHFW) granted permission to initiate Phase I and II human clinical trials of COVAXIN by Bharat Biotech International.

Jessica David

July 2, 2020

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India’s first COVID-19 vaccine developed by Bharat Biotech International (BBI) got the nod of approval for human clinical trials by the Drug Controller General of India (DCGI) on Monday (June 29).  COVAXIN has been developed in collaboration with the Indian Council of Medical Research (ICMR) and the National Institute of Virology (NIV). Bharat Biotech stated the 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 in Hyderabad, Telangana.

“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,” said Bharat Biotech. According to the Union Health Ministry, India has witnessed a total of 6,04,641 COVID-19 infections, out of which 2,26,947 are still active. There are 17,834 people who have succumbed to the virus.

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