Bharat Biotech recruits 13,000 subjects for Covaxin Phase-3 trials
Trials that began during mid-November are targeted to be done in 26,000 volunteers across multiple sites in India
Hyderabad: Bharat Biotech has recruited 13,000 volunteers, and continues progress towards achieving the goal of 26,000 participants for Phase-3 clinical trial of Covaxin across multiple sites in India.
The Phase-3 human clinical trials of Covaxin began mid-November, targeted to be done in 26,000 volunteers across India, is India’s first and only Phase III efficacy study for a Covid-19 vaccine, and the largest Phase-3 efficacy trial ever conducted for any vaccine in India.
The company said Covaxin has been evaluated in approximately 1,000 subjects in Phase I and Phase II clinical trials, with promising safety and immunogenicity results, with acceptance in international peer reviewed scientific journals.
Speaking on the occasion, Suchitra Ella, joint managing director, Bharat Biotech said, “This is an unprecedented vaccine trial ever to take place in India, and we are overwhelmed with the steady rise in participation.”
Covaxin is a highly purified and inactivated 2 dose SARS-CoV2 vaccine, manufactured in a Vero cell manufacturing platform with a safety track record of more than 300 million doses.
The vaccine by Bharat Biotech is developed in collaboration with the Indian Council of Medical Research (ICMR) – National Institute of Virology (NIV). This indigenous, inactivated vaccine is developed and manufactured in the company’s BSL-3 (Bio-Safety Level 3) bio-containment facility.
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