India’s 1st COVID-19 Vaccine -COVAXIN, gets DCGI approval for Phase I & II Human Clinical Trials

India’s 1st COVID-19 Vaccine -COVAXIN, developed by Bharat Biotech gets DCGI approval for Phase I & II Human Clinical Trials

Hyderabad I Bharat Biotech has successfully developed COVAXIN™, India’s 1stvaccine candidate for COVID-19, in collaboration with the Indian Council of Medical Research (ICMR) -National Institute of Virology (NIV). The SARS-CoV-2 strain was isolated in NIV, Pune and transferred to Bharat Biotech. The indigenous, inactivated vaccine developed and manufactured in Bharat Biotech’s BSL-3 (Bio-Safety Level 3) High Containment facility located in Genome Valley, Hyderabad, India. The Drug Controller General of India-CDSCO, Ministry of Health & Family Welfare 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. Announcing the vaccine development milestone, Dr. Krishna Ella, Chairman and Managing Director said: “We are proud to announce COVAXIN™, India’s 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.”

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.

Speaking about Bharat Biotech’s prowess, Suchitra Ella, Joint Managing Director said, “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.”

Bharat Biotech’s track record in developing vero cell culture platform technologies has been proven in several vaccines for Polio, Rabies, Rotavirus, Japanese Encephalitis, Chikungunya and Zika.About Bharat Biotech Bharat Biotech has established an excellent track record of innovation with more than 140 global patents, a wide product portfolio of more than 16 vaccines, 4 bio-therapeutics, registrations in more than 116 countries and WHO Pre-qualifications. Located in Genome Valley, the hub for the global biotech industry, the company has built a world-class vaccine & bio-therapeutics, research & product development, Bio-Safety Level 3 manufacturing, and vaccine supply and distribution.

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Having delivered more than 4 billion doses of vaccines worldwide , Bharat Biotech continues to lead innovation and has developed vaccines for H1N1, Rotavirus, Japanese Encephalitis, Rabies, Chikungunya, Zika and the world’s first conjugated vaccine for Typhoid. The company is proficient in conducting extensive multi centre clinical trials, having completed more than 75 trials in over 300,000 subjects globally. Our commitment to global social innovation programs and public-private partnerships resulted in the introduction of path-breaking WHO pre-qualified vaccines BIOPOLIO®ROTAVAC®and Typbar TCV®combatting Polio, Rotavirus and Typhoid infections respectively. Bharat Biotech has successfully partnered with NIV-ICMR having developed JENVAC®, a licensed Japanese Encephalitis vaccine.

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The recent acquisition of the Rabies vaccine facility, Chiron Behring, Ankleshwar has positioned Bharat Biotech as the largest Rabies vaccine manufacturer in the world.