The Journal. The Flu Shot Drama at the FDA
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Feb 18, 2026 
Liz Essley Whyte, a Wall Street Journal health-policy reporter, unpacks the FDA’s flip-flopping over Moderna’s mRNA flu-shot filing. She walks through the surprise initial rejection, debates over trial standards and randomized controlled trials, internal leadership clashes, and how talks with the White House changed course.
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mRNA Offers Faster Flu Response
- mRNA vaccines let makers change targets faster than traditional vaccines, which suits the shifting flu virus.
- That quicker turnaround could be crucial in a flu pandemic or for better seasonal matches.
Higher Trial Bar Raises Development Costs
- The FDA historically accepted immune-response studies rather than full randomized trials for tweaked vaccines.
- New leadership demanded randomized controlled trials, raising costs and time for makers like Moderna.
Unusual Scientific Rejection At Screening
- FDA refused to review Moderna's submission citing inadequate clinical trial design and inappropriate comparator.
- Such substantive scientific rejections at the docket stage are unusual for the agency.