India’s 1st COVID-19 Vaccine Candidate ‘Covaxin’ Gets Nod For Human Clinical Trials

The country’s ‘first’ indigenous COVID-19 vaccine COVAXIN, developed by city-based Bharat Biotech in collaboration with ICMR and NIV, has got the nod for human clinical trials from the Drug Controller General of India, the company said on Monday.

The Phase I and Phase II clinical trials of the vaccine for SARS-CoV-2, approved after pre-clinical studies demonstrated safety and immune response, would start across the country next month.

The collaboration with Indian Council of Medical Research (ICMR) and the National Institute of Virology (NIV) was instrumental in the development of the vaccine, the company
said in a release.

The indigenous and inactivated vaccine has been developed at Bharat Biotechs BSL-3 (Bio-Safety Level 3) high containment facility located in the Genome Valley here, a release said.

The Drug Controller General of India CDSCO (The Central Drugs Standard Control Organisation), Ministry of Health & Family Welfare granted permission to initiate Phase I & II Human clinical trials after the company submitted results generated from pre-clinical studies, demonstrating safety and immune response. Human clinical trials are scheduled to start across India in July 2020, the release said.

Chairman and Managing Director of the company Dr. Krishna Ella said: We are proud to announce COVAXIN, Indias first indigenous vaccine against COVID-19. 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. Our R&D and Manufacturing teams worked tirelessly to deploy our proprietary technologies towards this platform,” he said.

Expedited through the 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 released added.

Besides Bharat Biotech, at least five other Indian companies are working on a vaccine for the deadly coronavirus while similar efforts are underway in different countries.

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Arushi Sana is the Co Founder of NYK Daily. She was a Forensic Data Analyst previously employed with EY (Ernst & Young). She aims to develop a global community of knowledge and journalism par excellence through this News Platform. Arushi holds a degree in Computer Science Engineering. She is also a Mentor for women suffering from Mental Health, and helps them in becoming published authors. Helping and educating people always came naturally to Arushi. She is a writer, political researcher, a social worker and a singer with a flair for languages. Travel and nature are the biggest spiritual getaways for her. She believes Yoga and communication can make the world a better place, and is optimistic of a bright yet mysterious future!

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