News agency ANI has reported, Bharat Biotech has submitted data from phase 3 trials of the vaccine to the Drugs Controller General of India (DCGI). A senior government official says that “We’ve received the data from phase 3 trials,”
The report also suggests that the Subject Expert Committee (SEC) is likely to meet on Tuesday to review the phase 3 data. Covaxin is among three vaccines being used in the nationwide drive against Covid-19. It was approved by the DCGI in January, along with the Oxford University-AstraZeneca shot which is being manufactured locally by the Pune-based Serum Institute of India (SII) as Covishield. A third vaccine, Russia’s Sputnik V, was granted emergency use authorisation (EUA) in April.
Last week, Bharat Biotech supposed rumours it had submitted phase 3 data to the World Health Organization’s (WHO) for the global health body’s approval, calling such reports “incorrect and lacking any evidence.” Reports claimed WHO would review Bharat Biotech’s application on June 23.
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