The Indian drug regulator’s subject expert committee (SEC) has approved Bharat Biotech’s locally-made Covid-19 vaccine, Covaxin, for emergency use in the country, the union health ministry said on Saturday evening.
This is the second vaccine to be cleared for India after the Oxford-AstraZeneca vaccine got the go-ahead on Friday evening.
Confirming the accelerated approval, the health ministry said that the SEC has granted permission to Covaxin for restricted emergency use "in public interest as an abundant precaution, in clinical trial mode, especially in the context of infection by mutant strains".
The committee constituted by Central Drug Standard Control Organisation had on Friday maintained that the data provided by Bharat Biotech for its coronavirus vaccine was not sufficient for grant of emergency use approval and had asked for more information, but granted its approval on Saturday..
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