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the FDA Blocked Moderna's New Flu Shot

FDA refuses to review Moderna's mRNA flu shot

The Food and Drug Administration rejected Moderna’s application for its mRNA-based flu vaccine, the drugmaker said Tuesday.

· 11h · on MSN

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

· 1d · on MSN

Why the FDA blocked Moderna’s new flu shot

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U.S. Health Officials Defend Rejection of Moderna’s Flu Vaccine

The Food and Drug Administration on Wednesday backtracked on its refusal to review Moderna’s mRNA flu vaccine, while making an unusual public defense of its decisions on drug approvals.

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Moderna shares fall as FDA declines to review new flu vaccine

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FDA Refuses to Review Moderna's mRNA Flu Shot

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

The agency told Moderna that its application didn’t contain an “adequate and well-controlled” trial because the control arm didn’t reflect the “best-available standard of care in the United States at ...

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

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FDA refuses to review Moderna’s mRNA flu vaccine application

Fierce Biotech

UPDATE: After Moderna's rebuke, HHS stands behind FDA decision to spurn mRNA flu filing

"The FDA rejected Moderna's application for filing because the company refused to follow very clear FDA guidance from 2024 to test its product in a clinical trial against a [Centers for Disease Control and Prevention (CDC)] recommended flu vaccine to compare safety and efficacy," Makary said in the statement.

BioSpace

FDA’s Prasad Weathers Personal Controversy, Internal Strife Amid Moderna Imbroglio

Vinay Prasad, the FDA's Center for Biologics Evaluation and Research head, is accused of interpersonal impropriety as pushback builds against his decision to reject Moderna’s influenza vaccine candidate.

BioPharma Dive

FDA refuses to review Moderna’s mRNA flu vaccine

Moderna claimed that the decision, issued by top vaccine regulator Vinay Prasad, was “inconsistent” with prior FDA communications and went against the regulator’s established guidance for flu shots.