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.
Here are the few things to know about the COVAXIN:
COVAXIN is an 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 Indian Council of Medical Research (ICMR) and Bharat Biotech had partnered to develop a fully indigenous vaccine for COVID-19.
The scientists used the virus strain isolated at ICMR's National Institute of Virology (NIV), Pune to develop COVAXIN.
COVAXIN human clinical trials are scheduled to begin in next month July 2020 across the country.
However, at present no information is available as to when the vaccine will be available in the market for human use.
"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 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."
(With inputs from ANI)
