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India’s first COVID-19 vaccine COVAXIN has got the Drug Controller General of India’s approval for phase I and II of human clinical trials. The two trials are designed to test whether the vaccine is safe, rather than whether it is effective.
The experimental vaccine has been developed by Hyderabad-based Bharat Biotech, in collaboration with the ICMR (Indian Council for Medical Research) and the National Institute of Virology (NIV). This could get underway across the country in July 2020. Results are expected to be out by October 2020, following which larger clinical trials will be conducted.
The trials are among many across the world. There are around 120 vaccine programmes under way worldwide. This is the first India-made vaccine and developed from a strain of the virus that was isolated locally and weakened under laboratory conditions.
Bharat Biotech, which has delivered more than 4 billion doses of vaccines worldwide, has developed vaccines for H1N1 and rotavirus, among other diseases.
The permission to initiate clinical trials came after the company submitted results that they had generated through pre-clinical studies, demonstrating safety and effective immune responses.
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