Bharat Biotech has announced successful recruitment of 23,000 volunteers 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, 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.
COVAXIN is a highly purified and inactivated 2 dose SARS-CoV2 vaccine.