Bharat Biotech's Covaxin likely to get clearance from DCGI today
New Delhi, Jun 22: Bharat Biotech's Covaxin is likely to get clearance from Drugs Controller General of India (DCGI) today, news agency ANI reported quoting Sources. Earlier, the agency had also reported that Hyderabad-based company submitted data from the Phase III clinical trials of its COVID vaccine to the drug regulator.
According to data from Phase III trials conducted on 25,800 participants across India, Bharat Biotech's Covaxin is 77.8 per cent effective in protecting against COVID-19.
Phase III data approval will likely also help Bharat Biotech secure an EUL (emergency use listing) from the World Health Organization.
This is the first made-in-India vaccine developed by Bharat Biotech in collaboration with the Indian Council of Medical Research and National Institute of Virology.
The meeting comes ahead of Bharat Biotech's 'pre-submission' meet with the WHO for the approval of the COVID vaccine.
Bharat Biotech's Covaxin is one of the three vaccines which are currently being used in India.