Hyderabad-based biotechnology company Bharat Biotech’s Covaxin has shown 77.8% efficacy in phase 3 trials. The company’s phase 3 trial efficacy data has been approved by the Centre’s Subject Expert Committee (SEC), government sources told CNN-News18 on Tuesday. Covaxin is also likely to get clearance from the Drugs Controller General of India (DCGI) today.
Bharat Biotech had submitted phase-III clinical trial data of its vaccine to DCGI over the weekend.
The data is yet to be published in an internationally recognised, peer-reviewed journal. Bharat Biotech had earlier said the data will be published after it is submitted to the national regulator and will be released within approximately three months.
“It is critical to understand that Phase 3 data will first be submitted to CDSCO (the Central Drugs Standard Control Organisation)… followed by peer-reviewed journals with a timeline of approximately three months for publication,” Bharat Biotech had said earlier this month.
The SEC, a group of independent experts that advises the national drug regulator, met to review the ‘made in India’ Covaxin’s phase three data on Tuesday.
The DCGI in January had granted permission for emergency use of Covaxin based on its phase 1 and 2 clinical trials that comprised about 680 participants.
Bharat Biotech is set to hold its pre-submission meeting with the World Health Organization (WHO) on Wednesday (June 23) for the listing of Covaxin. The approval by WHO will make it easier for made-in-India vaccine recipients to travel abroad.
The DCGI’s approval of Covaxin’s phase 3 data will help Bharat Biotech secure an EUL (emergency use listing) from the World Health Organization (WHO). The vaccine is yet to be recognised by foreign governments and had suffered setbacks after Bharat Biotech was denied emergency use of its vaccines by the US Food and Drugs Administration on 11 June.
The EUL from WHO will allow Bharat Biotech to export its vaccine and also ease international travel for Indian citizens who have received Covaxin doses.
Read all the Latest News, Breaking News and Coronavirus News here.
Comments
0 comment