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the FDA Blocked Moderna's New Flu Shot

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· 18h · on MSN

Why the FDA blocked Moderna’s new flu shot

The head of the agency’s vaccine division, Vinay Prasad, has overruled pushback from career staffers.

· 7h

FDA Declines to Review Moderna’s mRNA Flu Vaccine Application

· 2h · on MSN

FDA rejects Moderna’s mRNA flu vaccine application - for reasons with no basis in the law

· 1d

Moderna says US refusing to review mRNA-based flu shot

Vaccine manufacturer Moderna said Tuesday the US Food and Drug Administration was refusing to review an application for its first mRNA-based flu shot.

· 1d

FDA declines to review Moderna's mRNA flu shot

· 1d

F.D.A. Refuses to Review Moderna Flu Vaccine

· 1d

FDA refuses to review Moderna's influenza vaccine application

In its refusal-to-file letter, the FDA said ‌Moderna's choice to compare mRNA-1010 to an already licensed standard-dose seasonal influenza was the sole reason for the refusal to initiate a review of ...

· 1d

FDA refuses to review Moderna’s application for mRNA flu vaccine, company says

· 1d

FDA Refuses to Consider Approving Use of Moderna’s New Flu Vaccine

STAT

FDA’s rejection of Moderna threatens to stifle broader vaccine industry

Experts say the FDA "moved the goalposts" on Moderna, creating "a destructive precedent that will undermine the future of vaccine development" in the U.S.

Moderna’s work developing seasonal vaccines is ‘risky’ under current FDA, analyst says

The biotech announced Tuesday evening that in a rare move, the Food and Drug Administration won’t review its application for a mRNA-based flu vaccine over concerns about the choice of vaccine tested against the experimental vaccine in Phase 3 clinical trials. Moderna described the FDA as “inconsistent” in its communications.