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India's first COVID-19 vaccine candidate COVAXIN gets approval for human trials

E Kumar Sharma     June 29, 2020

Hyderabad-based vaccine major Bharat Biotech announced on Monday that its vaccine candidate for COVID-19, COVAXIN has been granted permission for advancing to human trials. The company claims it is "India's first vaccine candidate for COVID-19, developed in collaboration with the Indian Council of Medical Research (ICMR) - National Institute of Virology (NIV)".

A note issued by the company says, "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, India."

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It says, the Drug Controller General of India under Central Drugs Standard Control Organisation of Ministry of Health and Family Welfare has "granted permission to initiate Phase I & 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 in July 2020."

There are no details on how long the next steps are likely to take and when the vaccine is likely to be launched in the market. Those within the industry say the company seems to have achieved vaccine stabilisation and completion of animal studies in record time considering that it was only on May 9, 2020 that the ICMR announced collaboration with Bharat Biotech "to develop a fully indigenous vaccine for COVID-19 using the virus strain isolated at ICMR's National Institute of Virology (NIV), Pune".

The next step would be to complete phase I of human trials and based on that the drug regulator will indicate the number of people on whom the vaccine would have to tried in phase II. The whole process of phase I and II should take another three to four months and the vaccine could be out in around four to five months, if all goes well.

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"The collaboration with ICMR and NIV was instrumental in the development of this vaccine. Our R&D and manufacturing teams worked tirelessly to deploy our proprietary technologies towards this platform," the note by Bharat Biotech quotes Dr Krishna Ella, Chairman and Managing Director of the company, as saying.

"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," the note further says.

Suchitra Ella, Joint Managing Director at Bharat Biotech, adds: "Our ongoing research and expertise in forecasting epidemics has enabled us to successfully manufacture a vaccine for 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."

However, this is not the only Indian company working on a COVID-19 vaccine. Others in the race include Serum Institute and Biological E.

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