First COVID-19 vaccine in India developed by Bharat Biotech gets DCGI approval for human trials

Credit: pixabay.com

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 2020.

The SARS-CoV-2 strain was isolated in NIV, Pune and transferred to Bharat Biotech. The indigenous, inactivated vaccine has been developed and manufactured at Bharat Biotech’s BSL-3 (Bio-Safety Level 3) High Containment facility located in Genome Valley, Hyderabad, India, the firm said in a release on Monday.

The Drug Controller General of India - CDSCO, Ministry of Health & Family Welfare, granted permission to initiate Phase I and II human trials after the company submitted results generated from preclinical studies, demonstrating safety and immune response.

Chairman and Managing Director of the company Dr. Krishna Ella said: We are proud to announce COVAXIN, Indias first indigenous vaccine against COVID-19. The collaboration with ICMR and NIV was instrumental in the development of this vaccine.

 Source: timesnownews, indiatvnews

Current Issue

NEWSLETTER