The Phase III human clinical trials of Covaxin, which began in mid-November last year, require 26,000 volunteers across India, Bharat Biotech said in a statement. 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 around 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, it added.
The company has developed the vaccine in collaboration with the Indian Council of Medical Research (ICMR) - National Institute of Virology (NIV).