NEW DELHI: The Committee of Experts on Matter of the Central Organization for the Control of Medicines Standards on Friday has maintained that the data provided by Bharat Biotech for its coronavirus vaccine ‘Covaxin’ is not sufficient for the granting of emergency use approval and has asked for more information, top sources said.
Earlier on Friday, the expert committee, which is tasked with examining covid-19 vaccine proposals, recommended an emergency license for ‘Covishield’ manufactured by the Serum Institute of India. It became the first vaccine to secure 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’.
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.
Pfizer was the first to apply for expedited approval on December 4, followed by Serum Insstitute and Bharat Biotech on December 6 and 7, respectively.
The meeting occurs one day before the vaccine trial is scheduled to begin in all states and Union Territories equip the administration in the management of vaccine supply, storage and logistics, including cold chain management.
The central government plans to vaccinate almost 30 million people in the first phase of the campaign. It will be offered to 1 crore of healthcare workers, along with 2 crore of essential and frontline workers and 27 crore of elderly, mostly over 50 with comorbidities.
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