The Phase-1 human clinical trials for Covaxin, a vaccine candidate for COVID-19 developed by city-based Bharat Biotech, began at the state-run Nizams Institute of Medical Sciences (NIMS) here on Monday. We started phase-1 human clinical trials today.
The vaccine was given to two volunteers. Both of them are stable, a doctor, associated with the exercise, said. The process for conducting the clinical trials for Covaxin began on July 7 at the NIMS. It has also been started at Rohtak’s Post-Graduate Institute of Medical Sciences last week. The phase I and II clinical trials of the vaccine for SARS-CoV-2 by Bharat Biotech have been approved by the Indian drug regulator after pre-clinical studies demonstrated safety and immune response.
The company has developed the vaccine in collaboration with the Indian Council of Medical Research (ICMR) and the National Institute of Virology (NIV).
The ICMR had identified 12 clinical trial sites such as medical institutions and hospitals, including NIMS, and asked their principal investigators to ensure that the subject enrollment is initiated no later than July 7.