US FDA Rejects Emergency Use Authorisation For Bharat Biotech’s Covaxin

The US Food and Drug Administration (FDA) has rejected Bharat Biotech’s proposal for an emergency use authorization (EUA) of its coronavirus vaccine. Ocugen, a biopharmaceutical company, which has inked a deal with Bharat Biotech for the supply of Covaxin to the US  said that they will now be seeking a full approval of the coronavirus vaccine. It stated that the decision was based on a recommendation from the US FDA, which also sought more information and data for full approval.

“Although we were close to finalizing our EUA application for submission, we received a recommendation from the FDA to pursue a biologics license application (BLA) path. While this will extend our timelines, we are committed to bringing Covaxin to the US,” Dr Shankar Musunuri, Ocugen CEO, said in a statement. 

Notably, Ocugen had submitted partial data from the Covaxin trial in March this year, following which the USFDA rejected the emergency authorization. Earlier last month, the health regulator in its revised guideline for covid vaccine approval that said it won’t  grant emergency authorization to new applications. But despite that Ocugen said that the company will be eligible to submit its EUA in June. 

“Since we have been in discussions with the FDA since late last year, we do not believe that the FDA’s recently revised guidance regarding EUAs raises any concerns about our ability to submit the EUA for Covaxin as planned, which is currently in process and which we expect to submit to the FDA in June. We believe that the FDA’s new guidance confirms that Ocugen continues to meet all criteria for submission of an EUA,” the company’s statement from 26 May read.

Meanwhile, the results of third phase trials of India’s first indigenously developed Covid-19 vaccine Covaxin are expected to be released next month. Covaxin manufacturer Bharat Biotech said its service provider, IQVIA, has started final statistical analysis.

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