COVAXIN, India’s first vaccine candidate against the novel coronavirus, developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR) and the National Institute of Virology (NIV), has received approval from the Drug Controller General of India (DCGI) to conduct Phase I and 2 human trials. According to the vaccine maker, human clinical trials of the experimental COVID-19 are scheduled to start across the country in July.
The Drug Controller General of India has approved the company’s application to conduct a Phase I and II clinical trial of Covaxin, which was developed along with the Indian Council of Medical Research’s National Institute of Virology, the company said in a statement on Monday.
“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 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, announcing the vaccine development milestone.
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.
“Our ongoing research and expertise in forecasting epidemics has enabled us to successfully manufacture a vaccine for the H1N1 pandemic. Continuing our focus on creating the only BSL-3 containment facilities for manufacturing and testing in India, Bharat Biotech is committed to advancing vaccine development as a matter of national importance to demonstrate India’s strength in handling the future pandemics,” said Mrs Suchitra Ella, Joint Managing Director.
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.
Human clinical trials are scheduled to start across the country in July for the vaccine, which was developed and manufactured in Bharat Biotech’s facility at Genome Valley in Hyderabad, India.
India, which lags only the United States, Brazil and Russia in total cases, reported close to 20,000 new infections on Monday, data from the country’s federal Ministry of Health.
Health Ministry report said, India’s total coronavirus cases reached 5,48,318 as of Monday evening. Worldwide, the novel coronavirus has now claimed at least 501,847 lives and infected as many as 10,161,240 people.