COVAXIN Enters Phase-II Trials As Bharat Biotech Received DCGI Nod
COVAXIN vaccine, India’s indigenous Covid-19 vaccine by Bharat Biotech enters Phase II human clinical trials after receiving approval from the Drugs Controller General of India.
In order to conduct Phase II human clinical trials of Bharat Biotech’s indigenously developed Covaxin, Bharat Biotech received a nod from the Drugs Controller General of India (DCGI), according to a report by The Indian Express.
The report informed that the trial will be conducted on 380 participants as recommended by the subject expert committee (SEC). The company has been notified about this through a letter dated September 3 from Dr. S Eswara Reddy, the Joint Drugs Controller.
India’s first indigenous Covid-19 vaccine’s clinical trials were conducted in 12 institutes selected by the ICMR. In collaboration with the National Institute of Virology (NIV) and ICMR, the Hyderabad-based Bharat Biotech developed the COVID-19 vaccine, Covaxin successfully. After the company had submitted results generated from preclinical studies, which demonstrated the safety and immune response of the vaccine candidate, the Drug regulatory bodies of India had granted permission to initiate Phase I & II Human clinical trials.
Earlier, Principal investigators conducting the trials of the Covid-19 vaccine, Covaxin, developed by Bharat Biotech and ICMR said that the preliminary results of phase 1 clinical trials of the vaccine suggest that the vaccine is safe. Across 12 sites with over 375 participants, the first phase of the Covaxin trial was carried out. The principal investigator, Savita Verma has said that at their site, they have not observed any adverse events in any of the volunteers, the vaccine has shown to be safe.
In India, Serum Institute of India and Zydus Cadila have also begun conducting phase II trials for the vaccines Covishield (by Oxford-AstraZeneca) and ZyCoV-D.
COVAXIN Enters Phase-II trials as Bharat Biotech received DCGI nod