InvestorQ : Is it true that the US FDA has rejected the Bharat Biotech Vaccine for COVID usage in the US?
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Is it true that the US FDA has rejected the Bharat Biotech Vaccine for COVID usage in the US?

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Arti Chavan answered.
6 months ago
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That is correct because the US FDA has rejected the grant of emergency use authorisation or EUA to Bharat Biotech’s Covaxin. While Bharat Biotech’s Covaxin had secured EUA approval from 14 countries, the FDA raised doubts over its safety and efficacy. In fact, the FDA has asked their US partner, Ocugen, to pursue the Biologics License Applications or BLA route for Covaxin, which implies full approval rather than just emergency usage approval.

However, Bharat Biotech has contended that the US decision was more of a policy decision not to grant EUA since the pandemic was relatively under better control now. Hence the US FDA has been now insisting on standard full approvals only. This is hardly surprising since no vaccine manufactured or developed from India has ever received EUA or full licensure from USFDA. Indian government has assured that this will not impact the use of Covaxin in India.

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