Bharat Biotech’s Covid vaccine gets DCGI nod for clinical trials

Indian vaccine manufacturer Bharat Biotech has announced obtaining the approvals of the Drug Controller General of India to initiate phase-I and II human clinical trials for the vaccine candidate for Covid-19 it developed in collaboration with the National Institute of Virology, part of the Indian Council of Medical Research.
The SARS-CoV-2 strain was isolated in NIV and transferred to Bharat Biotech, which has developed the indigenous, inactivated vaccine at its biosafety level-3 (BSL-3) high containment facility located in Genome Valley in Hyderabad outskirts.

The DCGI granted permission to Bharat Biotech to initiate human clinical trials after the Hyderabad headquartered vaccine maker submitted results generated from preclinical studies, demonstrating safety and immune response. Human clinical trials are scheduled to start across India in July, said the company in a late evening statement.

Announcing the development milestone for the first indigenous vaccine candidate Covaxin, Bharat Biotech chairman Dr Krishna Ella said, “The collaboration with ICMR and NIV was instrumental in the development of this vaccine.”

Stating that the proactive support and guidance from the Central Drugs Standard Control Organisation has enabled approvals to the project, Krishna Ella said, “Our R&D and manufacturing teams worked tirelessly to deploy our proprietary technologies towards this platform.”

Bharat Biotech said it accelerated objective in completing the comprehensive pre-clinical trials, which were expedited through national regulatory protocols. The company claimed that the results from these studies were promising and showed extensive safety and effective immune responses.

“Our ongoing research and expertise in forecasting epidemics has enabled us to successfully manufacture a vaccine for the H1N1 pandemic,” said joint managing director Suchitra Ella, adding that the company created the only BSL-3 containment facilities for manufacturing and testing in India.

The Hyderabad headquartered vaccine producer had developed several vaccines for Polio, Rabies, Rotavirus, Japanese Encephalitis, Chikungunya, and Zika, using the Vero cell culture platform technologies.