India’s first COVID-19 vaccine ‘COVAXIN’ gets DCGI approval for clinical trials

COVAXIN, India's first vaccine candidate against the new coronavirus, developed by vaccine maker Bharat Biotech, gets DCGI approval for Phase I and II clinical trials.

COVAXIN, India’s first candidate vaccine against the new coronavirus, developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR) – National Institute of Virology (NIV), received approval from the Drug Controller General of India (DCGI) to perform phase I and 2 trials in humans. According to the vaccine manufacturer, human clinical trials of the experimental COVID-19 are slated to begin nationwide in July 2020.

The SARS-CoV-2 strain was isolated from NIV, Pune and transferred to Bharat Biotech. The inactivated indigenous vaccine will be developed and manufactured by Bharat Biotech’s BSL-3 (Bio-Safety Level 3) High Containment facility located in Genome Valley, Hyderabad, India, the firm said in a statement Monday.

The Drug Controller General of India – CDSCO, Ministry of Health and Family Welfare, granted permission to start Phase I and II trials in humans after the company presented the results generated from preclinical studies, demonstrating safety and response. immune.

“We are proud to announce COVAXIN, India’s first indigenous vaccine against COVID-19. Collaboration with ICMR and NIV was instrumental in the development of this vaccine. Proactive support and guidance from CDSCO have led to the approval of this project. Our R&D and manufacturing teams worked tirelessly to implement our proprietary technologies on this platform, ”said Dr. Krishna Ella, President and CEO of Bharat Biotech, announcing the milestone of vaccine development.

The company accelerated its goal by completing comprehensive preclinical studies. The results of these studies have been promising, showing extensive safety and effective immune responses.

“Our research and experience in forecasting epidemics has enabled us to successfully manufacture a vaccine against the H1N1 pandemic. Continuing our focus on creating the only BSL-3 containment facilities for manufacturing and testing in India, Bharat Biotech is committed to advancing vaccine development as a matter of national importance to demonstrate India’s strength in handling future pandemics, “said Ms. Suchitra Ella (Joint Managing Director).

Bharat Biotech’s track record in developing Vero cell culture platform technologies has been demonstrated in several vaccines against polio, rabies, rotavirus, Japanese Encephalitis, Chikungunya and Zika.

According to the Ministry of Health, the total number of coronavirus cases in India reached 5.48,318 as of Monday night. Worldwide, the new coronavirus has claimed at least 501,847 lives and infected up to 10,161,240 people.

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