India’s first COVID-19 vaccine ‘COVAXIN’ gets DCGI approval for human trials
New Delhi: India’s first Covid-19 vaccine candidate Covaxin, developed by Hyderabad-based Bharat Biotech collaboration with the National Institute of Virology (NIV), has received Drug Controller General of India (DCGI) approval for phase I and II human trials.
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.
The Drug Controller General of India – CDSCO, Ministry of Health & Family Welfare, granted permission to initiate Phase I and II human trials after the company submitted results generated from preclinical studies, demonstrating safety and immune response.
The company accelerated its objective in completing the comprehensive preclinical studies. Results from these studies have been promising, showing extensive safety and effective immune responses.
Bharat Biotech’s track record in developing Vero cell culture platform technologies has been proven in several vaccines for polio, rabies, rotavirus, Japanese Encephalitis, Chikungunya and Zika.
Drug manufacturers around the world are racing to develop a vaccine against the novel coronavirus; a novel virus is one that has never previously been identified in humans, making the task of creating a vaccine that much harder.
India, a leading manufacturer of vaccines and generic medicines, is expected to play a key role in this race, with several institutes working on different drugs.