The approval of COVAXIN for emergency use is a giant leap for innovation and novel product development in India, Krishna Ella, Chairman and Managing Director of Bharat Biotech, said.

Expressing delight on the DCGI-Central Standards Control Organization grant of permission for emergency use of its Covid-19 vaccine, the CMD of vaccine maker said, "It is a proud moment for the nation and a great milestone in India's scientific capability. While this vaccine addresses an unmet medical need during this pandemic, our goal is to provide global access to populations that need it the most. COVAXIN has generated excellent safety data with robust immune responses to multiple viral proteins that persist."

"The development of COVAXIN was based on a public-private partnership between ICMR, NIV and Bharat Biotech. We thank Director-General ICMR Balram Bhargava for his leadership in this project," he said.

The Subject Expert Committee of Central Drugs Standards Control Organization made the recommendations for the Drugs Controller General of India's final decision.

COVAXIN Phase III clinical trials

This vaccine is a highly purified and inactivated two dose SARS-CoV2 vaccine, manufactured in a Vero cell manufacturing platform with a safety track record of over 300 million doses. The Phase III human clinical trials of COVAXIN began in mid-November targeted to cover 26,000 volunteers across India, This is India's first and only Phase III efficacy study for a COVID-19 vaccine, and the largest phase III efficacy trial ever conducted for any vaccine in India. It has been evaluated in approximately 1000 subjects in Phase I and Phase II clinical trials, promising safety and immunogenicity results.

Developed in collaboration with the Indian Council of Medical Research (ICMR)-National Institute of Virology (NIV), COVAXIN is indigenous, inactivated vaccine developed and manufactured in Bharat Biotech's BSL-3 (Bio-Safety Level 3) bio-containment facility, one of its kind in the world.

The evaluation of COVAXIN has resulted in several unique product characteristics, including long term persistence of immune responses to multiple viral proteins instead of only the spike protein. It demonstrated broad-spectrum neutralizing capability with heterologous SARS-CoV2 strains, thus potentially reducing or eliminating escape mutants. It critical characteristic is the demonstrated safety profile, which is significantly lower than several other vaccines with published data.  

Thus far, the product development and clinical trial data have generated five publications, 4 of which have been accepted and published soon. The publication of phase II trial data is undergoing the peer review process. As a part of our regulatory guidelines, all data has been submitted to the DCGI and CDSCO.

Bharat Biotech has 140 global patents and a product portfolio of more than 16 vaccines, four bio-therapeutics, registrations in more than 116 countries and WHO Pre-qualifications.

The company has delivered over 4 billion doses of vaccines worldwide and continues to lead innovation. It has developed vaccines for influenza H1N1, Rotavirus, Japanese Encephalitis, Rabies, Chikungunya, Zika and the world's first tetanus-toxoid conjugated vaccine for Typhoid.

 

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