COVAXIN- India’s First Indigenous Vaccine Approved for Human Trials

Image courtesy: Bharat Biotech

By Sahana Shankar, Ph.D. Candidate

India is one of the world leaders in generic drug manufacturing. In the current pandemic situation, there are no less than 20 vaccines against COVID-19 being developed across the public and private sectors in India.

On June 29, Bharat Biotech announced that its COVID-19 vaccine candidate COVAXIN has been approved for clinical trials (Phases I and II) in humans after “promising” results from preclinical data. “The SARS-CoV-2 strain was isolated in the National Institute of Virology (NIV), Pune, and transferred to Bharat Biotech. The indigenous inactivated vaccine was developed and manufactured in Bharat Biotech’s BSL-3 (Bio-Safety Level 3) High Containment facility located in Genome Valley, Hyderabad,” the company added.

The vaccine has been put through “comprehensive preclinical studies” to ensure that it can mount an effective immune response without compromising safety. Based on these studies, COVAXIN has been expedited through the regulatory procedures and approved by the Drug Controller General of India (DCGI), who heads the Central Drugs Standard Control Organisation (CDSCO), a government department which controls drug licenses and sets standards for drug manufacturing.

Dr. Krishna Ella, Chairman and Managing Director of Bharat Biotech, said, “The collaboration with the Indian Council of Medical Research (ICMR) and NIV was instrumental in the development of this vaccine. The proactive support and guidance from CDSCO have enabled approvals to this project. We worked tirelessly to deploy our proprietary technologies towards this platform.”

In May 2020, Bharat Biotech partnered with Thomas Jefferson University in Philadelphia to develop a vaccine based on deactivated rabies vaccine designed by Dr. Mathias Schnell’s lab, which works on infectious diseases. Under the license agreement, Bharat Biotech has the rights to develop and market Jefferson’s vaccine, if approved, in more than 80 countries.

Bharat Biotech has significant experience with vaccine development. It manufactured the H1N1 vaccine during the swine flu outbreak and has over 140 global patents and 16 vaccines in its portfolio. Their most significant vaccine is arguably the rotavirus vaccine Rotavac, a next-generation vaccine against viral gastroenteritis that was approved by the WHO after laboratory tests from Oxford University rendered it safe and effective. Mrs. Suchitra Ella, Joint Managing Director said, “Bharat Biotech is committed to advancing vaccine development as a matter of national importance to demonstrate India’s strength in handling future pandemics.”

COVAXIN clinical trials are scheduled to begin in July. However, the company did not share details on the duration of the trials, manufacturing, or likely availability in the market. With the number of cases in India rising exponentially, all eyes will be on COVAXIN and future vaccine candidates.

Related Article: India’s First Homemade COVID-19 PCR Kit Commercially Approved by Government

References

1. https://www.bharatbiotech.com/images/press/Indias-1st-COVID-19-Vaccine-COVAXIN-Developed-by-Bharat-Biotech-gets-DCGI-approval-for-Phase-I-and-II-Human-Clinical-Trials.pdf
2. https://www.thehindubusinessline.com/companies/bharat-biotech-thomas-jefferson-university-ink-deal-to-develop-covid-19-vaccine-candidate/article31631406.ece#

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Author

Sahana Shankar