India's drug regulator committee on Friday said that it has asked Hyerderbad-based vaccine manufacturer Bharat Biotech to submit efficacy data of the ongoing phase 3 trials of its Covid-19 vaccine candidate 'Covaxin.' Post the necessary modifications, Bharat Biotech is also asked to submit revised clinical trial protocol for review of the committee. Covaxin is one of the two Covid-19 vaccines approved for emergency use in India, though efficacy data from its late-stage trial is yet to be published. In an earlier report, Bharat Biotech expects results from an ongoing trial involving 25,800 participants in India only by March, though the country's drug regulator has called the vaccine safe and effective amid criticism from some doctors and health experts. Meanwhile, Bharat Biotech today confirmed that the company has signed an agreement with Brazil for the supply of 20 million doses of Covaxin vaccine.

Source: Mint February 26, 2021 14:56 UTC