FDA approves Moderna's mRNA flu vaccine after initial pushback
Summary
The U.S. Food and Drug Administration (FDA) has approved Moderna's new seasonal flu vaccine called mFLUSIVA, which uses mRNA technology. The vaccine is approved for adults 50 years and older and is the first flu shot using this technology to get FDA approval.Key Facts
- The FDA approved Moderna's mRNA flu vaccine, mFLUSIVA, for adults 50 and older.
- This is the first influenza vaccine using mRNA technology to be approved by the FDA.
- mRNA technology is a method that uses genetic instructions to teach the body to fight infections.
- Moderna’s vaccine showed better effectiveness in a trial of 40,000 adults compared to one standard flu vaccine.
- The FDA initially rejected Moderna’s application due to concerns about the trial's comparison group.
- After Moderna updated its application and agreed to more studies, the FDA reversed its decision and approved the vaccine.
- The vaccine is expected to be available in the 2026-27 flu season.
- There was some disagreement within the U.S. Department of Health about mRNA vaccine projects before the approval.
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