Bharat Biotech has obtained the approvals from the Drug Controller General of India (DCGI) to initiate Phase I and II clinical trials for a COVID-19 vaccine candidate it developed in collaboration with the Indian Council of Medical Research's National Institute of Virology (NIV), reported The Economic Times.
The clinical trials are scheduled to start across India in July, said the company in a statement.
According to the news source, Bharat Biotech has developed an inactivated vaccine at its biosafety level-3 high containment facility located in Genome Valley in the outskirts of Hyderabad.
The DCGI granted permission to Bharat Biotech to initiate the clinical testing after the vaccine maker submitted results generated from preclinical studies, demonstrating safety and immune response.
Announcing the development milestone for the first indigenous vaccine candidate Covaxin, Bharat Biotech chairman Krishna Ella said "the collaboration with ICMR and NIV was instrumental in the development of this vaccine."
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