Bharat Biotech India Ltd’s covid-19 vaccine ‘Covaxin’ has become the first candidate developed in India to receive the Drug Controller General of India’s approval to enter human trials.
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Key-Points
DGCI has approved the company’s application to conduct a phase I and II clinical trial of its vaccine candidate ‘Covaxin’, which it developed in in collaboration with the Indian Council of Medical Research’s National Institute of Virology (NIV).
COVAXIN is an inactivated vaccine, created from a strain of the infectious SARS-CoV-2 virus that has shown promise in preclinical studies, demonstrating extensive safety and effective immune responses.
COVAXIN has been developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR) and the National Institute of Virology (NIV).
The SARS-CoV-2 strain was isolated in NIV, Pune and transferred to Bharat Biotech. The indigenous, inactivated vaccine will be developed and manufactured by Bharat Biotech’s BSL-3 (Bio-Safety Level 3) High Containment facility located in Genome Valley, Hyderabad, India.
Human clinical trials of the experimental COVID-19 are scheduled to start across the country in July 2020.
The indigenous, inactivated vaccine was developed and manufactured in Bharat Biotech’s facility located in Genome Valley in Hyderabad and human clinical trials are scheduled to start across India in July.
