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US' FDA delays use of India's Covaxin, asks to file for 'full approval'
short by Ankush Verma / on Friday, 11 June, 2021
US' Food and Drug Administration (FDA) has delayed the use of Bharat Biotech's Covaxin COVID-19 vaccine. "Although we were close to finalising our Emergency Use Authorisation application for submission, we received a recommendation from the FDA to pursue a BLA path," Bharat Biotech's US partner, Ocugen, said. BLA is a "full approval" mechanism by the FDA for drugs and vaccines.