India’s first COVID-19 vaccine gets approval for human trials
Popular vaccine manufacturer Bharat Biotech on Monday announced that India’s first vaccine candidate against the novel coronavirus- COVAXIN- will now be used for conduction of human clinical trials after getting approval from the Drug Controller General of India (DCGI).
COVAXIN has been developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR) and the National Institute of Virology (NIV).
A strain of novel coronavirus (SARS-CoV-2) was isolated at NIV and transferred to Bharat Biotech following which the development of vaccine started.
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 was granted permission to conduct human clinical trials after it had submitted results generated from preclinical studies, demonstrating safety and immune response.
The human clinical trials are scheduled to start across India in July, 2020, the company said in a release.
Results are expected to be out by October 2020, following which larger clinical trials will be conducted.
“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,” said Krishna Ella, Chairman and Managing Director, Bharat Biotech.
Bharat Biotech has accelerated its objective in completing 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.
“Bharat Biotech is committed to advancing vaccine development as a matter of national importance to demonstrate India’s strength in handling future pandemics,” said Suchitra Ella, joint managing director, Bharat Biotech.