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First COVID-19 vaccine clinical trial approved in India

Indian authorities have given the green light to test Bharat Biotech’s COVID-19 vaccine in Phase I and Phase II clinical trials.

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India’s first potential COVID-19 vaccine has been given approval for Phase I and Phase II clinical trials. Named COVAXIN™, the vaccine was developed by Bharat Biotech and has been granted approval from the Drugs Controller General of India (DCGI). Human clinical trials are scheduled to start across India in July 2020.

Bharat Biotech created COVAXIN in collaboration with the Indian Council of Medical Research (ICMR) and National Institute of Virology (NIV). According to the company, the SARS-CoV-2 strain was isolated in NIV, Pune and transferred to Bharat Biotech. The indigenous, inactivated vaccine was developed and manufactured in Bharat Biotech’s facility located in Hyderabad, India.

The DCGI granted permission to initiate Phase I and II human clinical trials after the company submitted results generated from pre-clinical studies, demonstrating “promising” and “extensive” safety and immune responses.

Dr Krishna Ella, Chairman and Managing Director of Bharat Biotech, 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. The proactive support and guidance from CDSCO has enabled approvals to this project. Our R&D and manufacturing teams worked tirelessly to deploy our proprietary technologies towards this platform.”

Expedited through national regulatory protocols, the company accelerated its objective in completing the comprehensive pre-clinical studies. 

Mrs Suchitra Ella, Joint Managing Director of Bharat Biotech said the company “is committed to advancing vaccine development as a matter of national importance to demonstrate India’s strength in handling future pandemics.”

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