Leading vaccine maker Bharat Biotech on Monday announced that it has successfully developed Covaxin, India's first vaccine candidate for COVID-19, in collaboration with the Indian Council of Medical Research (ICMR) and National Institute of Virology (NIV) and will begin its human trials next month.
Drugs Controller General of India (DCGI) Dr VG Somani’s office confirmed to TNM that the approval for human trials had been given for the vaccine in question.
The SARS-CoV-2 strain was isolated in NIV, Pune and transferred to Bharat Biotech. The indigenous, inactivated vaccine was developed and manufactured in Bharat Biotech's BSL-3 (Bio-Safety Level 3) High Containment facility located in Genome Valley, Hyderabad, the company said in a statement.
The Drug Controller General of India - Central Drugs Standard Control Organisation (CDSCO), Ministry of Health & Family Welfare granted permission to initiate Phase I and II human clinical trials after the company submitted results generated from preclinical studies, demonstrating safety and immune response.
Human clinical trials are scheduled to start across India in July 2020.
"We are proud to announce Covaxin, India's first indigenous vaccine against COVID-19. The collaboration with the ICMR and the NIV was instrumental in the development of this vaccine. The proactive support and guidance from the CDSCO has enabled approvals to this project. Our R&D and Manufacturing teams worked tirelessly to deploy our proprietary technologies towards this platform," said Dr. Krishna Ella, Chairman and Managing Director, Bharat Biotech.
Expedited through national regulatory protocols, the company accelerated its objective in completing the comprehensive pre-clinical studies. Results from these studies have been promising and show extensive safety and effective immune responses.
Bharat Biotech is also in the process of developing CoroFlu – a nasal vaccine for COVID-19 – in collaboration with virologists at University of Wisconsin–Madison and vaccine company FluGen. A Bharat Biotech press release from April says, “Refinement of the CoroFlu vaccine concept and testing in laboratory animal models at UW–Madison is expected to take three to six months. Bharat Biotech in Hyderabad, India will then begin production scale-up for safety and efficacy testing in humans. CoroFlu could be in human clinical trials by the fall of 2020.”
(With IANS inputs)