India’s 1st COVID-19 vaccine gets human trial approval
India’s first COVID-19 vaccine got the approval for human trials from the country’s drug regulator, as number of coronavirus-related cases and deaths continues upward, a drug company announced, Anadolu Agency reports.
The vaccine, named COVAXIN, has been developed by Bharat Biotech compnay, in collaboration with the Indian Council of Medical Research and the National Institute of Virology (NIV).
The indigenous, inactivated vaccine was developed from a SARS-CoV-2 strain, which was isolated by the NIV and transferred to the company’s BSL-3 High Containment facility located at Hyderabad city in southern India, Bharat Biotech said in a statement.
“Our ongoing research and expertise in forecasting epidemics has enabled us to successfully manufacture a vaccine for the H1N1 pandemic,” said Suchitra Ella, joint managing director of the company.
The permission to initiate Phase I & II Human clinical trials came 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.