NEW DELHI: Bharat Biotech International Ltd has started the massive phase 3 of clinical trials of its covid-19 vaccine ‘Covaxin’. The company plans to enrol 26,000 participants in total, making it the first phase 3 efficacy study for a covid-19 vaccine and the largest efficacy trial ever conducted in India. As part of the trial, 26,000 participants will be enrolled at 25 trial sites across the country over the coming months. Of the 25 sites, eight have received approval from their respective ethics committees for the clinical trial, according to data on the government’s clinical trial registry. As per clinical trial norms, each trial site has its own ethics committee which monitors whether the trial conducted at the centre is meeting ethics and the study protocol.

Source: Mint November 16, 2020 12:00 UTC