Bharat Biotech has announced successful recruitment of 13,000 volunteers, and continued progress towards achieving the goal of 26,000 participants for Phase-3 clinical trial of COVAXIN™ across multiple sites in India.
The Phase III human clinical trials of COVAXIN™ began mid-November, targeted to be done in 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. COVAXIN™ has been evaluated in approximately 1000 subjects in Phase I and Phase II clinical trials, with promising safety and immunogenicity results, with acceptance in international peer reviewed scientific journals.
COVAXIN™, India’s indigenous COVID-19 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 Bharat Biotech’s BSL-3 (Bio-Safety Level 3) bio-containment facility, one of its kind in the world.
COVAXIN™ is a highly purified and inactivated 2 dose SARS-CoV2 vaccine, manufactured in a Vero cell manufacturing platform with an excellent safety track record of more than 300 million doses.
Speaking on the occasion, Ms. Suchitra Ella, Joint Managing Director of 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. 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 – Thank you volunteers Thank you India.”