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Coronavirus: US drug regulator rejects emergency use approval for Bharat Biotech’s Covaxin


The United States Food and Drug Administration has rejected Bharat Biotech’s proposal for an emergency use authorisation of its Covid vaccine, Mint reported on Friday. Ocugen, Bharat Biotech’s partner in the US, on Thursday said the company will now seek a full approval of Covaxin.

The US biopharmaceutical company said it will pursue submission of a biologics licence application for its coronavirus vaccine candidate.

“Although we were close to finalizing our EUA application for submission, we received a recommendation from the FDA to pursue a BLA path,” said Shankar Musunuri, the chief executive officer and co-founder of Ocugen. “While this will extend our timelines, we are committed to bringing Covaxin to the US. This differentiated vaccine is a critical tool to include in our national arsenal given its potential to address the SARS-CoV-2 variants, including the delta variant, and given the unknowns about what will be needed to protect US population in the long term.”

Currently, many countries do not recognise Covaxin. As countries open their borders for non-essential travel to fully vaccinated individuals, a “vaccine passport” is fast becoming a travel requirement.

The development comes at a time when Bharat Biotech is facing criticism for not sharing its phase-3 trial data nearly six months after its vaccine was granted…

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