The company has Phase 1 and phase 2 data ready and would submit the interim data from large scale efficacy trials to the DCGI for review.
After Pfizer and Serum Institute of India, Hyderabad-based Bharat Biotech
has applied for an emergency use authorisation for its investigational vaccine candidate, Covaxin, to the Indian regulator. The firm is conducting its Phase 3 trial, involving 26,000 participants.
This is one of the largest efficacy trials held in the country. The firm has Phase 1 and Phase 2 data ready and will submit the interim data from the large-scale efficacy trials to the Drug Controller General of India.
Officials from the Central Drugs Standard Control Organization and the Indian Council of Medical Research have been in touch with the firm.