Covaxin Phase 3 Trials Data Submitted To DCGI; Expert Panel Likely To Meet Today
New Delhi: The Hyderabad-based COVID vaccine manufacturing company Bharat Biotech submitted data from the Phase III clinical trials of Covaxin to Drugs Controller General of India (DCGI).
“The required data has been submitted, and the meeting of the expert panel is likely to take place today,” said an official in the government aware of the development, on condition of anonymity.
The drug regulator’s SEC (subject expert committee) is expected to meet around noon to discuss the results. The data has not yet been fully published in a recognised, peer-reviewed journal.
Bharat Biotech also has a pre-submission meeting scheduled with representatives of WHO (World Health Organisation) on Wednesday, June 23, for emergency use listing (EUL) of Covaxin, their vaccine against Coronavirus disease (Covid-19).
Covaxin, India’s first make-in-India vaccine, has shown an efficacy of 78% in the final interim Phase 3 analysis, according to reports.