India's first COVID-19 vaccine candidate 'COVAXIN' gets DCGI approval for human clinical trials
The permission for human clinical trials was granted by DCGI after the company submitted results generated from preclinical studies, demonstrating safety and immune response.
Published: 29th June 2020 10:06 PM | Last Updated: 30th June 2020 09:27 AM | A+A A-
It was developed and manufactured at the company's Bio-safety Level-III high containment facility at Genome Valley in the city. (Photo | Special Arrangement)
HYDERABAD: Hyderabad-based vaccine manufacturer Bharat Biotech has been accorded permission by the Drug Controller General of India (DCGI) to initiate Phase I&II human clinical trials for India’s first vaccine candidate against Covid-19.
The vaccine has been developed and manufactured at the company’s Bio-safety Level-III high containment facility at Genome Valley in the city.
The human clinical trials are scheduled to start across India in July, 2020. Results are expected to be out by October 2020, following which larger clinical trials will be conducted.
The indigenously developed vaccine has been named as Covaxin and is an inactivated vaccine. It has been developed after National Institute of Virology, Pune isolated a strain of the novel Coronavirus known as SARS-CoV-2 and transferred it to the company.
The permission for human clinical trials was granted by DCGI after the company submitted results generated from preclinical studies, demonstrating safety and immune response.
Dr Krishna Ella, Chairman and Managing Director, Bharat Biotech, said, “We are proud to announce Covaxin, India’s first indigenous vaccine against Covid-19. The collaboration with ICMR and NIV was instrumental in the development of this vaccine. The proactive support and guidance from CDSCO have enabled approvals for this project.”
According to a media release by the company, the company accelerated its objective in completing the comprehensive pre-clinical studies by expediting the national regulatory protocols.
Results from these studies have been promising and show extensive safety and effective immune responses, it said.
Suchitra Ella, Joint Managing Director, Bharat Biotech said, “Bharat Biotech is committed to advancing vaccine development as a matter of national importance to demonstrate India’s strength in handling future pandemics.”
What is an inactivated vaccine?
The process involves growing the virus on a large scale and killing/inactivating the virus with a chemical. Once the vaccine is injected into a human, it has no potential to infect or replicate, since it is a killed virus. It helps the immune system mount an antibody response towards virus.
