India’s first Covid-19 vaccine cleared for human clinical trials by regulator
The vaccine has been developed by a Hyderabad-based company in collaboration with the Indian Council of Medical Research (ICMR)
India’s ‘first’ indigenous COVID-19 vaccine COVAXIN, developed by Hyderabad-based Bharat Biotech has received approval for human clinical trials from the Drug Controller General of India (DCGI), a report in india.com quoted the company as saying on Monday.
The vaccine has been developed in collaboration with the Indian Council of Medical Research (ICMR) and the National Institute of Virology (NIV).
Phase I and Phase II clinical trials of the vaccine for SARS-CoV-2 would start across the country next month, the report said.
Bharat Biotech is one of at least five Indian companies working on a vaccine for the deadly coronavirus.
According to the report, the Drug Controller General of India CDSCO (The Central Drugs Standard Control Organisation), Ministry of Health & Family Welfare granted permission to initiate Phase I & II Human clinical trials after the company submitted results generated from pre-clinical studies, demonstrating safety and immune response.
India.com quoted Chairman and Managing Director of the company Dr. Krishna Ella as saying that the proactive support and guidance from CDSCO had enabled approvals to this project. The company’s R&D and manufacturing teams worked tirelessly to deploy proprietary technologies towards this platform, he said.
The indigenous and inactivated vaccine has been developed at Bharat Biotechs BSL-3 (Bio-Safety Level 3) high containment facility located in the Genome Valley here, the report said.