India’s First Indigenous Vaccine (COVAXIN) for COVID-19 Approved to Move to Clinical Trials In July

Jul 1, 2020 | COVID-19, Genome Valley, India, Investor Watch, News, Vaccine

India’s First Indigenous Vaccine (COVAXIN) for COVID-19 Approved to Move to Clinical Trials In July

Bharat Biotech, a Hyderabad-based venture, has successfully developed India’s first vaccine candidate for COVID-19 in collaboration with the Indian Council of Medical Research (ICMR) and the National Institute of Virology (NIV). Called COVAXIN, the national drug regulator—The Drug Controller General of India or CDSCO, of the Ministry of Health & Family Welfare granted permission to initiate Phase 1/2 human clinical trials recently as the company submitted the positive results from its preclinical research studies evidencing safety and immune response. Clinical trials will commence in India in July 2020.

The Investigational Vaccine Born in India

This SARS-CoV-2 strain was isolated in NIV, Pune and in collaboration moved to Hyderabad where Bharat Biotech conducted studies. The “made in India” inactivated vaccine was developed and produced in Bharat Biotech’s Bio-Safety Level 3 (BSL-3) High Containment facility located in Genome Valley.

Dr. Krishna Ella, the Chairman and Managing Director of Bharat Biotech, declared, “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.”

India’s Government Steps in to Help

The Indian government expedited approvals through national protocols helping the company accelerate its goals in completing the comprehensive pre-clinical research. The results have been quite promising in regards to both safety and effective immune responses.

The Company

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. 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® combating Polio, Rotavirus and Typhoid infections respectively. Bharat Biotech has successfully partnered with NIV-ICMR having developed JENVAC® , a licensed Japanese Encephalitis vaccine. The recent acquisition of the Rabies vaccine facility, Chiron Behring, Ankleshwar has positioned Bharat Biotech as the largest Rabies vaccine manufacturer in the world.