India’s first COVID-19 vaccine gets approval for clinical trials
Bharat Biotech’s COVAXIN, India’s first vaccine candidate for COVID-19, gets DCGI nod for Phase I and II clinical trials in July 2020.
In welcome news for the coronavirus-battered world, Hyderabad-based Bharat Biotech has developed COVAXIN, India’s first vaccine candidate for COVID-19, in collaboration with the Indian Council of Medical Research (ICMR) - National Institute of Virology (NIV).
The SARS-CoV-2 strain was isolated at NIV, Pune, and transferred to Bharat Biotech. The indigenous, inactivated vaccine has been developed and manufactured in Bharat Biotech’s BSL-3 high containment facility in Genome Valley, Hyderabad.
Bharat Biotech's COVAXIN can be India's first vaccine for coronavirus after completion of human trials.
The Drug Controller General of India - CDSCO, Ministry of Health & Family Welfare, has granted permission to initiate Phase I and II human trials after Bharat Biotech submitted results generated from pre-clinical studies, demonstrating safety and immune response.
Human clinical trials are scheduled to start across India in July 2020.
Dr Krishna Ella, Chairman and Managing Director of Bharat Biotech, said, “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. We worked tirelessly to deploy our proprietary technologies towards this platform.”
Expedited through national regulatory protocols , the company accelerated its objective to complete comprehensive pre-clinical studies. Results from these studies have been promising and show extensive safety and effective immune responses.
Suchitra Ella, Joint Managing Director, Bharat Biotech, said, “Our ongoing research and expertise in forecasting epidemics enabled us to successfully manufacture a vaccine for the H1N1 pandemic. We are continuing our focus on creating the only BSL-3 containment facilities for manufacturing and testing in India.”
In the past, Bharat Biotech has developed vero cell culture platform technologies, which have been helpful in several vaccines for polio, rabies, rotavirus, Japanese encephalitis, chikungunya, and Zika.
Other Indian firms working on COVID-19 vaccines include Zydus Cadila, Serum Institute of India, and Panacea Biotec.
Meanwhile, India’s coronavirus burden continues to rise. With over 18,000 cases reported on Monday, the number of COVID-19 cases rose to 5,67,423. The Ministry of Home Affairs has releases Unlock 2.0 guidelines, which will be in force till 31 July.
(Edited by Teja Lele Desai)
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