India’s first and only phase III trial of a COVID-19 vaccine has crossed 13,000 subjects – the half-way mark – and proceeding successfully across multiple sites in India, Bharat Biotech, the maker of the inoculant, Covaxin, announced today. The trials in the first and second phases had led to promising results.
A statement from Bharat Biotech said today The phase III human clinical trials, which have started in mid-November, target 26,000 volunteers across India. Covexin was evaluated in approximately 1,000 subjects in the first two phases, with the results receiving acceptance in international peer-reviewed scientific journals.
“This is an unique vaccine trial ever to take place in India, and we are overwhelmed with the steady rise in participation. We sincerely thank all the 13,000 volunteers across the country for their support in enabling us to bring out a safe and effective Indian vaccine for COVID-19,” Suchitra Ella, Joint Managing Director of Bharat Biotech, said in the statement. A study at New Delhi’s All India Institute of Medical Sciences, for instance, had signed up only around 200 participants, compared with a goal of 1,500-2,000, NDTV had reported.