New Delhi: Bharat Biotech’s Covaxin is 77.8 per cent effective in protecting against COVID-19, shows the results of Phase III trial data approved by the DCGI’s Subject Expert Committee, according to the reports. Covaxin has shown 77.8% efficacy in the Phase 3 trials conducted across India, the reports add.Also Read - COVID Symptoms? Follow These Measures Immediately For Quick Recovery And Help Others From Getting Infected
The Subject Expert Committee (SEC) has reviewed Bharat Biotech’s data, but no approval has been given yet. The expert panel met on Tuesday afternoon to review the Covaxin trial results. Covaxin is one of the three vaccines which are currently being used in India. The phase III data of its vaccine has been questioned various times and this is what makes the data that ascertains the efficacy of the vaccine crucial. Also Read - India's Daily COVID Tally Crosses 13k Mark, Health Minister Mandaviya to Chair Crucial Meeting on Rising Cases
Reports further add that the SEC will now send the data to the Drugs Controller General of India (DCGI) for review. On Tuesday, Bharat Biotech made a presentation in which the data was presented to the panel, showing 77.8% efficacy of Covaxin. Also Read - Mood Swings, Rashes and Stomach Ache: Long Covid Symptoms in Infected Kids Can Last For 2 Months. Deets Here
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 approval by the DCGI of Covaxin’s phase-III data will help Bharat Biotech secure an EUL (emergency use listing) from the World Health Organization (WHO). It is important to note that 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.