Covaxin phase III clinical trials show 77.8% efficacy
The phase III clinical trials of Bharat Biotech’s Covaxin showed 77.8 per cent efficacy, said media reports on Tuesday citing sources.
By Newsmeter Network Published on 22 Jun 2021 12:30 PM GMT
Hyderabad: The phase III clinical trials of Bharat Biotech's Covaxin showed 77.8 per cent efficacy, said media reports on Tuesday citing sources.
The trial was conducted on 25,800 subjects.
The efficacy rate was revealed on Tuesday after Hyderabad-based Bharat Biotech, the manufacturer of the COVID-19 vaccine Covaxin, submitted the phase III clinical trial data of its vaccine to the Drugs Controller General of India (DCGI) over the weekend.
The data is yet to be published in an internationally-recognized and 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 III 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 told ANI earlier on Tuesday.
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 Subject Expert Committee (SEC) has reviewed the pharmaceutical company's data but no approval has been given yet. The SEC will now send the data to the Drugs Controller General of India (DCGI) for review.
The DCGI's approval of Covaxin's phase III data will help Bharat Biotech secure an emergency use listing (EUL) from the World Health Organization (WHO). This will allow Bharat Biotech to export its vaccine and also ease international travel for Indian citizens who have been inoculated with Covaxin since it is yet to be recognized as a valid COVID-19 vaccine by foreign governments.
The vaccine manufacturer was denied emergency use of its vaccines by the US Food and Drugs Administration on 11 June. The FDA's refusal to grant emergency use authorization to the Indian drugmaker's vaccine has also been attributed to the lack of data made available on clinical trials.
