Clinical trials of Bharat Biotech’s COVAXIN cross 13,000 volunteers

The company also announced that it is co developing the covid vaccine for the US market

Hyderabad: Bharat Biotech also announced successful recruitment of 13,000 volunteers, and continued progress towards achieving the goal of 26,000 participants for the Phase-3 clinical trial of COVAXIN across multiple sites in India, the company said in a statement.

The vaccine began human trial in mid-November. It has evaluated approximately 1000 subjects in Phase I and Phase II clinical trials, with promising results, the statement said.

COVAXIN is a highly purified and inactivated SARS-CoV2 vaccine. It is manufactured in a Vero cell and has a safety track record of more than 300 million doses.

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The COVID-19 vaccine by Bharat Biotech is developed in collaboration with the Indian Council of Medical Research (ICMR) and National Institute of Virology (NIV). It is developed and manufactured in Bharat Biotech’s BSL-3 (Bio-Safety Level 3) bio-containment facility.

“This is an unprecedented vaccine trial ever to take place in India, and we are overwhelmed with a steady rise in participation. We sincerely thank all the 13000 volunteers across the country for their support in enabling us to bring out a safe and efficacious Indian vaccine for COVID-19. This pro-vaccine public health volunteerism is a morale booster for us to achieve our milestone target of 26,000 soon,” said Ms Suchitra Ella, the Joint Managing Director of Bharat Biotech.

Bharat Biotech to co-develop Covid-19 vaccine for US market

Meanwhile, Bharat Biotech and Ocugen, Inc, a leading biopharmaceutical company on Tuesday announced that the companies have signed a binding letter of intent (LOI) to co-develop Bharat Biotech’s COVID-19 vaccine candidate, COVAXIN, for the United States market.

As per the LOI, Ocugen will have US rights to the vaccine candidate and, in collaboration with Bharat Biotech, will be responsible for clinical development, registration, and commercialization for the US market. The companies have begun collaborating and will finalize details of the definitive agreement in the next few weeks.

“We are delighted to collaborate with Bharat Biotech to potentially bring COVAXIN to the US market. In the face of the coronavirus pandemic, it is incumbent upon all of us to find solutions that have the potential to save lives and restore normalcy to our day-to-day activities,” said Dr. Shankar Musunuri, Chairman, CEO, and Co-Founder of Ocugen. 

“The development and clinical evaluation of COVAXIN marks a significant milestone for vaccinology in India. COVAXIN has garnered interest from several countries worldwide for supplies and introduction and we are excited to collaborate with Ocugen to bring it to the US market,” said Dr. Krishna Ella, Chairman & Managing Director of Bharat Biotech.

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