Covaxin, a giant leap for innovation in India, says Bharat Biotech CMD

Our Bureau Hyderabad | Updated on January 03, 2021

CKrishna Ella, CMD

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, has said.

Expressing delight on the DCGI-Central Standards Control Organisation grant of permission for emergency use of his company’s Covid-19 vaccine, he 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 ICMR Director-General Balram Bhargava for his leadership in this project,” he said.

The Subject Expert Committee of Central Drugs Standards Control Organisation made the recommendations for the final decision of the Drugs Controller-General of India.

This vaccine is 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 1,000 subjects in Phase I and Phase II clinical trials, with 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.

Bharat Biotech has 140 global patents and a product portfolio of more than 16 vaccines, 4 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.

Published on January 03, 2021

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