COVID-19: US FDA Denies Approval for Emergency Use of Bharat Biotech’s Covaxin


New Delhi: The US Food and Drug Administration (FDA) has rejected the emergency use authorization (EUA) of Covaxin, a COVID vaccine developed by Hyderabad-based Bharat Biotech.

The FDA has asked for additional data, informed Ocugen, the US partner of the Indian vaccine maker.

The FDA recommended Ocugen to “pursue a Biologics Licence Application (BLA) submission instead of a EUA application” and “requested additional information and data”, according to reports.

Earlier, Ocugen and Bharat Biotech had announced that they have entered into an amendment to their co-development, supply, and commercialization agreement to expand Ocugen’s exclusive territory to commercialise Covaxin to now also include Canada.

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