NEW DELHI: The Subject Matter Expert Committee (SEC) of the national drug regulator is likely to hold a meeting with Bharat Biotech on Saturday to consider your Covid-19 vaccine applicant, Covaxin.
The committee constituted by the Central Organization for the Control of Medicines Standards on Friday had held that the data provided by Bharat Biotech for its coronavirus vaccine is not sufficient to grant approval for emergency use and had asked for more information.
The committee had called a meeting to take a call about the emergency use authorization requested by the Serum Institute, Bharat Biotech and America’s Pfizer for their coronavirus vaccine candidates.
The expert committee, which is tasked with examining covid-19 vaccine proposals, recommended an emergency license for the Serum Institute of India-made ‘Covishield‘. It becomes the first vaccine to get a recommendation for emergency use in India.
The Pune-based Serum Institute has partnered with Oxford-AstraZeneca to conduct clinical trials and manufacture ‘Covishield’, while Bharat Biotech has collaborated with the Indian Council for Medical Research (ICMR) for ‘Covaxin’.
Pfizer was the first to apply for expedited approval on December 4, followed by the Serum Institute and Bharat Biotech on December 6 and 7, respectively.
(With inputs from agencies)
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