Bharat Biotech develops India's first vaccine candidate, Covaxin, for COVID-19: Human trials to start soon

Bharat Biotech is all set to initiate Phase I and II human clinical trials for Covacin, India's first indigenous vaccine for COVID-19.

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Written By: Jahnavi Sarma | Updated : June 30, 2020 9:20 AM IST

Scientists across the world have been working tirelessly since the beginning of the pandemic to develop a vaccine for the COVID-19 virus. There have been many hits and misses along the way. Many scientists also made outlandish claims. But now there seems to be light at the end of the tunnel. Many vaccines are almost in the final stages of development and human trials are going on in many parts of the world. There are hopeful contenders from different regions of the world and all of them are hopeful of developing an effective vaccine for COVID-19.

Scientists have also looked at existing drugs to fight the pandemic, but nothing has emerged conclusively from this yet. Though some experts say that a vaccine may be in the market by as soon as the end of the year, the World Health Organisation has said that this is within a year to 18 months. As of now, everybody is keeping their fingers crossed that there may be some good news on the vaccine front soon. But now trials are about to start for Covacin, India's first indigenous vaccine.

This is an indigenous, inactivated vaccine

Leading vaccine maker Bharat Biotech on Monday announced that it has successfully developed Covaxin, India's first vaccine candidate for COVID-19, in collaboration with the Indian Council of Medical Research (ICMR) and National Institute of Virology (NIV). The SARS-CoV-2 strain was isolated in 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 said in a statement.

Phase 1 and 2 human trials to start soon

The Drug Controller General of India - Central Drugs Standard Control Organisation (CDSCO), Ministry of Health & Family Welfare granted permission to initiate Phase I and II human clinical trials after the company submitted results generated from preclinical studies, demonstrating safety and immune response. Human clinical trials are scheduled to start across India next month.

"We are proud to announce Covaxin, India's first indigenous vaccine against COVID. The collaboration with the ICMR and the NIV was instrumental in the development of this vaccine. The proactive support and guidance from the CDSCO has enabled approvals to this project. Our R&D and Manufacturing teams worked tirelessly to deploy our proprietary technologies towards this platform," said Dr. Krishna Ella, Chairman and Managing Director, Bharat Biotech.

Pre-clinical studies completed in record time

Expedited through national regulatory protocols, the company accelerated its objective in completing the comprehensive pre-clinical studies. Results from these studies have been promising and show extensive safety and effective immune responses.

(With inputs from IANS)

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