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‘Incorrect’: Bharat Biotech dismisses reports it submitted phase 3 trial data to WHO
Earlier, there were reports WHO will review on June 23 Bharat Biotech’s application seeking review for its shot, Covaxin.
Hyderabad-based Bharat Biotech, which has developed India’s only home-made shot against the coronavirus disease (Covid-19), on Thursday denied reports it has submitted phase 3 trial data of the vaccine to the World Health Organization (WHO) for its approval, news agency ANI reported.
Also Read: Bharat Biotech to hold Covaxin pre-submission meeting with WHO next Wednesday
“News reports on Bharat Biotech submitting phase 3 data to WHO is incorrect and lacks any evidence,” ANI quoted the vaccine manufacturer as saying. Bharat Biotech’s vaccine, Covaxin, is among three shots currently being used in India. Pune-based Serum Institute of India (SII) is manufacturing Oxford University-AstraZeneca’s shot locally as Covishield, while Russia’s Sputnik V received emergency use authorisation (EUA) in April.
Both Covaxin and Covishield were granted EUA by the Drugs Controller General of India (DCGI) in January for the nationwide vaccination drive which began on the 16th of that month.
Earlier, there were reports that Bharat Biotech submitted Covaxin’s phase 3 trial data to WHO on Wednesday, with the global health body set to review its application for approval on June 23. The firm, however, has been facing questions over its phase 3 trial data; it first said it will make the results of the trial public in June, only to announce later that it will, in fact, do so in July.
Also Read: Covaxin phase 3 trial results to be out in July, says Bharat Biotech
An interim analysis of the trials found Covaxin found it to be 78% effective against symptomatic disease, and 100% against serious illness, according to Bharat Biotech.
Recently, the United States Food and Drug Administration (USFDA) turned down Bharat Biotech’s application seeking EUA for Covaxin in the US, citing “the lack of data on clinical trials.” Following the FDA’s decision, Bharat Biotech’s partner in the US, Ocugen Inc, announced they would now seek a full-use approval for the shot.
