Indigenously Developed ‘COVAXIN’ gets DCGI approval for Human Clinical Trials
The Drug Controller General of India (DCGI) has given approval for Phase I and Phase II human clinical trials for COVID-19 vaccine ‘COVAXIN’. In association with the Indian Council of Medical Research (ICMR) and the National Institute of Virology (NIV), COVAXIN is developed by Hyderabad based vaccine & bio-therapeutics manufacturer-Bharat Biotech. At NIV Pune, the strain of SARS-CoV-2 was isolated before being transferred to Bharat Biotech.
COVAXIN is the first indigenously developed COVID-19 vaccine to be approved for Human Clinical Trials. The approval was granted based on the results from the pre-clinical studies of the vaccine. During preclinical studies, the vaccine has demonstrated safety and effective immune response.
The vaccine is developed at the high containment facility of Bharat Biotech- BSL-3 (Bio Safety Level 3). Human trials are expected to begin from the month of July in a phased manner.
Bharat Biotech has developed several vaccines over the last decades such as Polio, Rabies, Chikungunya, Rotavirus, Zika.
Last month, the Indian Government has announced that for developing a vaccine for the COVID-19 virus, as many as 30 Indian Companies are working on it.