Hyderabad-based Bharat Biotech has submitted phase-III clinical trial data for its vaccine Covaxin to the Drugs Controller General of India (DCGI over the weekend, government sources told ANI.
Covaxin is one of the three vaccines India is using in its inoculation program, which gathered speed on Monday as record 86 lakh doses were administered.
The Bharat Biotech vaccine is awaiting WHO's Emergency Use Listing (EUL) after the global health regulator accepted its expression of interest for the same, and a pre-submission meeting has been scheduled for June 23.
Phase-III trial data will further provide details of the efficacy of the vaccine and are required for the EUL. Covaxin was developed in association with the Indian Council of Medical Research (ICMR).
The drugmaker had claimed in March that Covaxin has 81 per cent interim efficacy in preventing coronavirus in those who have not been infected, after the second dose.
Published 22 June 2021, 03:14 IST