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FDA Rejects Moderna's Flu Vaccine Over Trial Design Flaws

2/13/2026

45 6 Full Breakdown

Summary

Story summary

The U.S. Food and Drug Administration declined to review Moderna's mRNA-1010 due to inadequate trial design.
The vaccine remains under review in other countries.
The agency faulted using a standard-dose flu vaccine as a comparator, saying it does not reflect best care for older adults under Health Secretary Robert F. Kennedy Jr.
The decision was signed by Vinay Prasad.
Moderna says the refusal contradicts prior guidance and requests a meeting.

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Story summary

The U.S. Food and Drug Administration declined to review Moderna's mRNA-1010 due to inadequate trial design.
The vaccine remains under review in other countries.
The agency faulted using a standard-dose flu vaccine as a comparator, saying it does not reflect best care for older adults under Health Secretary Robert F. Kennedy Jr.
The decision was signed by Vinay Prasad.
Moderna says the refusal contradicts prior guidance and requests a meeting.