Bharat Biotech’s ‘COVAXIN’ gets approval for phase 3 trials in India


Covaxin, the Covid-19 vaccine being developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR), has received approval for conducting final phase trials. The Drugs Controller General of India (DCGI) permitted the Hyderabad-based firm to initiate Phase 3 trials.

The Phase 3 trials for Covaxin are likely to start next month. Applying for approval on October 2, Bharat Biotech told DCGI that the study will involve 28,500 volunteers from ten states. The subjects will be given two doses of the experimental vaccine within a gap of 28 days.

Meanwhile, IAVI, a non-profit scientific research organization and Serum Institute of India announced an agreement with Merck to develop SARS-CoV-2 neutralizing monoclonal antibodies (mAbs) co-invented by IAVI and Scripps Research as innovative interventions to address the Covid-19 pandemic.