The US Food and Drug Administration (FDA) has rejected the proposal for emergency use authorization (EUA) of Bharat Biotech’s Covaxin. Ocugen, which has done a deal with Bharat Biotech to supply Covaxin to the United States said that they will now be seeking full approval of the coronavirus vaccine.

“Although we were close to finalizing our EUA application for submission, FDA recommended us 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.

Ocugen had submitted data from the Covaxin trial in March this year, because of which the US FDA rejected the emergency authorization. The health regulator in its revised guideline which issued earlier this month said that it won’t grant emergency authorization to new applications. Still, Ocugen said that the company will be eligible to submit its EUA in June.

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“Since we have been in discussions with the FDA since last year, we do not believe that the FDA’s revised guidance raises any concerns about our ability to submit the EUA for Covaxin, which is expected to be submitted to the FDA in June. We believe that the FDA’s new guidance confirms that Ocugen meets all criteria for submission of EUA,” the company’s statement from 26 May read.