Covaxin Shows 77.8% Efficacy in Phase 3 Trials: Reports
The SEC will now send Covaxin’s Phase-3 trial data to the Drugs Controller General of India (DCGI) for review.
The results of phase three clinical trials of Bharat Biotech’s Covaxin vaccine show 77.8 percent efficacy, say media reports, citing sources.
The Subject Expert Committee (SEC) has reviewed the pharmaceutical company’s data, but no approval has been given yet. The panel met on Tuesday, 22 June, to carry out the review.
The SEC will now send the data to the Drugs Controller General of India (DCGI) for review.
Meanwhile, media reports have quoted unnamed sources as saying that DCGI is also likely to give its clearance on Tuesday.
Earlier on Tuesday, Bharat Biotech had told ANI, “It is critical to understand that Phase-3 data will first be submitted to the CDSCO (the Central Drugs Standard Control Organisation)...followed by peer-reviewed journals with a timeline of approximately three months for publication.”
Bharat Biotech's Plans for EUL
The pharma company is also expected to hold a “pre-submission” meeting on Wednesday, with the World Health Organization (WHO) for international emergency use listing (EUL) of Covaxin.
The EUL, from the WHO, will allow Bharat Biotech to export its vaccine and ease international travel for Indian citizens who have been inoculated with it; since it is yet to be recognised 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 (FDA) on 11 June.
The FDA’s refusal to grant emergency use authorisation to the Indian drugmaker’s vaccine has also been attributed to the lack of data made available on the clinical trials for the vaccine.
In a recent study conducted by the National Institute of Virology-Indian Council of Medical Research (ICMR) and Bharat Biotech, it was found that Covaxin provides protection against the Delta (B.1.617.2) and the Beta (B.1.351) variants of COVID-19. However, it also uncovered that the vaccine produces lesser antibodies against the two variants as compared to the original strain.
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