Human clinical trials of Bharat Biotech’s vaccine for coronavirus disease (Covid-19) will start from July, the Hyderabad-based biotechnology giant has said.
Bharat Biotech had claimed on Monday to have successfully developed India’s first Covid-19 vaccine, Covaxin, and said it has the permission from the Drug Controller General of India (DCGI) to start human clinical trials.
A release from the company said the vaccine was developed in collaboration with the Indian Council of Medical Research (ICMR) and National Institute of Virology (NIV).
“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,” it said.
It said the drug controller under the Union health ministry granted permission to initiate Phase I and II of 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.
Dr Krishna Ella, Bharat Biotech’s chairperson and managing director, said while announcing the vaccine development milestone that the company was proud to announce Covaxin.
“The collaboration with ICMR and NIV was instrumental in the development of this vaccine. The proactive support and guidance from the Central Drugs Standard Control Organisation (CDSCO) has enabled approvals to this project. Our research and development and manufacturing teams worked tirelessly to deploy our proprietary technologies towards this platform,” Ella said.
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, Ella said.
Suchitra Ella, the company’s joint managing director, said Bharat Biotech’s ongoing research and expertise in forecasting epidemics had enabled it to successfully manufacture a vaccine for the H1N1 pandemic.
“We are committed to advancing vaccine development as a matter of national importance to demonstrate India’s strength in handling future pandemics,” she said.