US FDA refuses EUA nod for Bharat Biotech's COVAXIN: The implications of the decision
The United States has decided not to grant Hyderabad based Bharat Biotech's Covid-19 vaccine, Covaxin, an emergency use authorization (EUA). Even before the company's American partner, Ocugen, submitted an EUA application for the vaccine, the decision was communicated to them. The FDA also stated that it may have to further prioritise among the requests for Covid-19 vaccines. The vaccine will still be reviewed by the US FDA as part of the standard approval process, which may take some time. Meanwhile, Bharat Biotech has applied for an Emergency Use Licence from the World Health Organization, which it expects to receive between July and September of this year.
EUA applications for various Covid-19 vaccines have been validated within months of submitting the necessary data.