Drug controller approves Phase 1, 2 trials of India’s first COVID-19 vaccine candidate

Aditi Tandon
Tribune News Service
New Delhi, June 30

India’s first COVID-19 Vaccine—COVAXIN, developed by Bharat Biotech in collaboration with the Indian Council of Medical Research, on Tuesday received the approval for phase one and two human clinical trials from the Drug Controller General of India.

Bharat Biotech has developed COVAXIN in association with ICMR’s National Institute of Virology (NIV) Pune.

The SARS-CoV-2 strain was isolated at NIV, Pune and transferred to Bharat Biotech.

The indigenous, inactivated vaccine developed and manufactured in Bharat Biotech’s Bio-Safety Level-3 High Containment facility located in Genome Valley, Hyderabad.

The Drug Controller General of India granted permission to initiate Phase I & II Human clinical trials after the company submitted results generated from preclinical studies, demonstrating safety and immune response.

Human clinical trials in India are scheduled to start by July 2020.

Announcing the vaccine development milestone, Dr Krishna Ella, Chairman and Managing Director said: “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.”

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.