Hyderabad-based biotechnology company Bharat Biotech, that manufactures Covaxin, has submitted phase-III clinical trial data of its vaccine to the Drugs Controller General of India (DCGI) over the weekend, sources said on Tuesday. Covaxin’s Phase 3 trial data which has shown 77.8% efficacy was approved by the Subject Expert Committee (SEC) under DCGI,
“Bharat Biotech submitted Phase 3 clinical trials data of Covaxin to Drugs Controller General of India (DCGI) over the weekend,” government sources were quoted as saying by ANI.
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 said.
The update comes after a recent study conducted by the National Institute of Virology-Indian Council of Medical Research (ICMR) and Bharat Biotech revealed that Covaxin provides protection against the Delta (B.1.617.2) and the Beta (B.1.351) variants of Covid-19.
The DCGI’s approval of Covaxin’s phase-III 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.
According to reports, Bharat Biotech is expected to hold a ‘pre-submission’ meeting with WHO authorities on Wednesday.