Bharat Biotech Labels Previously Submitted Phase 3 Trial Data As "Incorrect"

According to previous reports, the WHO will consider Bharat Biotech's application for evaluation of its shot, Covaxin, on June 23.



ANI reported Bharat Biotech as saying, "News reports about Bharat Biotech submitting phase 3 data to WHO are inaccurate and lack any evidence." Covaxin, a vaccine developed by Bharat Biotech, is one of three vaccines now in use in India. The Serum Institute of India (SII) in Pune is producing Covishield, an Oxford University-AstraZeneca injection, while Russia's Sputnik V gained emergency use authorization (EUA) in April.


The Drugs Controller General of India (DCGI) awarded EUA to both Covaxin and Covishield in January for the statewide immunization effort that began on the 16th of that month.


According to Bharat Biotech, an interim review of the studies indicated Covaxin to be 78 percent effective against symptomatic sickness and 100 percent effective against serious illness.


The US Food and Drug Administration (USFDA) has rejected Bharat Biotech's application for a EUA for Covaxin in the United States, citing "the absence of data on clinical trials." Following the FDA's ruling, Bharat Biotech's US partner, Ocugen Inc, announced that the shot would now be approved for full use.


Bharat Biotech had initially told a news source that Covaxin's Phase-3 trial findings would be publicly disclosed in July and that the business would then file for full authorization of the Covid-19 vaccines in India.

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