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Moderna mRNA flu vaccine to get FDA panel review
Outside experts will review safety and effectiveness data for the mRNA shot, which could become the first seasonal flu vaccine of its kind in the United States.
- The Food and Drug Administration announced on Thursday that an advisory committee will meet June 18 to review Cambridge-based Moderna's MFLUSIVA flu vaccine, according to a Federal Register notice.
- Researchers reported earlier this month that Moderna's vaccine outperformed conventional flu shots in a late-stage international trial involving more than 40,000 adults aged 50 and older.
- Although the FDA initially rejected Moderna's application in February over comparison group concerns, it reversed course after the company submitted an amended application for agency review.
- This hearing follows the ouster of former FDA commissioner Marty Makary last week, whose tenure faced criticism for lack of transparency and infrequent advisory committee use.
- Acting commissioner Kyle Diamantas now leads the agency toward an August 5 decision deadline, as the vaccine faces scrutiny regarding mRNA technology from Health Secretary Robert F. Kennedy Jr.
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Moderna mRNA flu vaccine to get FDA panel review
Moderna’s experimental mRNA flu shot will be reviewed by a Food and Drug Administration (FDA) advisory panel next month, a move that suggests a more stable approach to drug reviews after the firing of former agency head Marty Makary. The panel will meet June 18 to discuss and make recommendations on the safety and effectiveness of Moderna’s MFLUSIVA flu vaccine, according to a Federal Register notice published…
·Washington, United States
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FDA Plans Rare Advisory Hearing to Debate Moderna’s Flu Shot
Moderna Inc.’s experimental flu shot made with mRNA technology will be reviewed by a Food and Drug Administration advisory panel next month, a sign that the agency may be increasing transparency into its decision-making after several controversies.
·New York, United States
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Coverage Details
Total News Sources9
Leaning Left2Leaning Right1Center6Last UpdatedBias Distribution67% Center
Bias Distribution
- 67% of the sources are Center
67% Center
L 22%
C 67%
11%
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