No emergency approval for Covaxin, expert panel seeks more data from Bharat Biotech
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No approval for Indian COVID vaccine, expert panel seeks more data from Bharat Biotech
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NEW DELHI: Subject Expert Committee (SEC) of the national drug regulator is likely to hold a meeting with Bharat Biotech on Saturday to consider its Covid-19 vaccine applicant, Covaxin.
The committee constituted by Central Drug Standard Control Organisation on Friday had maintained that the data provided by Bharat Biotech for its coronavirus vaccine is not sufficient for grant of emergency use approval and had asked for more information.
The committee had convened a meeting to take a call on the emergency use authorisation sought by the Serum Institute, Bharat Biotech and America s Pfizer for their coronavirus vaccines candidates.
The expert committee, which is tasked with vetting covid-19 vaccine proposals, recommended emergency licensure for the Serum Institute of India-manufactured Covishield . It becomes the first vaccine to secure a recommendation for emergency use in India.