DCGI gives nod to Bharat Biotech to conduct phase I & II Human clinical trials to develop indigenous vaccine for COVID-19
Jun 30, 2020
New Delhi [India], June 30 : The Drug Controller General of India (DCGI) has granted permission to Bharat Biotech International Limited (BBIL) to conduct Phase I and II Human clinical trials to develop an indigenous vaccine for COVID-19 -- in the name COVAXIN.
For this, Indian Council of Medical Research (ICMR) and BBIL had partnered to develop a fully indigenous vaccine for COVID-19 using the virus strain isolated at ICMR's National Institute of Virology (NIV), Pune.
"The Central Drug Standard Control Organization (CDSCO)--the office of DCGI has 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 are scheduled to start across India in July 2020," stated the spokesperson of Bharat Biotech.
The indigenous, inactivated vaccine developed and manufactured in Bharat Biotech's BSL-3 (Bio-Safety Level 3) high containment facility located in Genome Valley in Hyderabad.
"The strain was successfully transferred from NIV to Bharat Biotech International Ltd. (BBIL). Work on vaccine development has been initiated between the two partners. ICMR-NIV are providing continuous support to BBIL for vaccine development. ICMR and BBIL will seek fast-track approvals to expedite vaccine development, subsequent animal studies and clinical evaluation of the candidate vaccine," said ICMR official.
Announcing the vaccine development milestone, Dr Krishna Ella, Chairman and Managing Director, Bharat Biotech, 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."
