The Drug Controller General of India (DCGI) on June 29 granted permission to Bharat Biotech to initiate Phase I and II human clinical trials of its novel coronavirus, or COVID-19 vaccine.
The permission to conduct human trials was granted after the company submitted results generated from pre-clinical studies, demonstrating safety and immune response.
"Results from these studies have been promising and show extensive safety and effective immune responses," the management said.
Human clinical trials are scheduled to start across India in July.
Bharat Biotech is developing a COVID-19 vaccine in collaboration with the Indian Council of Medical Research (ICMR) and National Institute of Virology (NIV), Pune.
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.
“The collaboration with ICMR and NIV was instrumental in the development of this vaccine. The proactive support and guidance from CDSCO has enabled approvals to this project. Our R&D and manufacturing teams worked tirelessly to deploy our proprietary technologies towards this platform,” said Krishna Ella, Chairman and Managing Director of Bharat Biotech.
The vaccine was expedited through national regulatory protocols.
Bharat Biotech said it has proven track record in developing vero cell culture platform technologies in several vaccines for polio, rabies, rotavirus, Japanese encephalitis, chikungunya and zika.
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