Setback to Bharat Biotech: CDSCO panel rejects to approve Covaxin, seeks more data
New Delhi: The Subject Expert Committee of the Central Drug Standard Control Organisation on Friday has held that the data provided by Bharat Biotech for its coronavirus vaccine 'Covaxin' is not sufficient for grant of emergency use approval and has asked for more information, top sources said.
Earlier on Friday, the expert committee, which is tasked with vetting covid-19 vaccine proposals, recommended emergency licensure for the Serum Institute of India-manufactured 'Covishield'. It become the first vaccine to secure recommendation for emergency use in India.
The Pune-based Serum Institute has partnered with Oxford-AstraZeneca for conducting clinical trials and manufacturing 'Covishield' while Bharat Biotech has collaborated with the Indian Council of Medical Research (ICMR) for 'Covaxin'.
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.
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