The U.S. Food and Drug Administration (FDA) has approved Moderna's mRNA-based flu vaccine, mFLUSIVA, for adults aged 50 and older, marking the first approval of an mRNA flu shot in the United States.
Key Takeaways
The FDA has approved Moderna's mRNA-based flu vaccine, mFLUSIVA, for adults aged 50 and older. The vaccine is expected to be available for the 2026-27 flu season.
- FDA approves first mRNA flu shot from Moderna
- Vaccine shown 27% more effective than standard flu shots in trials
- Health Secretary Robert F. Kennedy Jr., a vaccine skeptic, has opposed mRNA technology
- Moderna to conduct additional study for adults aged 65 and older
Source Claims Check
High Consensus| Claim | Status | Reason | |
|---|---|---|---|
| Vaccine Name | Broad Agreement | mFLUSIVA | |
| Target Age Group | Broad Agreement | 50 and older | |
| Vaccine Effectiveness | Broad Agreement | 27% more effective than standard flu shots | |
| Availability | Broad Agreement | in a few weeks for the 2026-27 flu season |
The vaccine is expected to be available in time for the 2026-27 respiratory virus season. Moderna's research involving more than 40,000 people found that mFLUSIVA is safe and appears to produce stronger protection than traditional flu vaccines. The company reported that the vaccine was about 27% more effective than standard flu shots.
The approval comes despite significant pushback from Health Secretary Robert F. Kennedy Jr., a vocal vaccine skeptic who has worked to thwart vaccinations and canceled 22 federal mRNA vaccine development projects worth $500 million last year, according to UPI. The FDA initially refused to review Moderna's application but reversed course after discussions with the company.
The Advisory Committee on Immunization Practices of the Centers for Disease Control and Prevention usually meets after the FDA approves a new vaccine. However, Kennedy replaced all committee members with vaccine skeptics, and a federal judge ruled in March that he did not follow federal legal procedures when doing so. The committee hasn't met since.
Moderna's CEO Stéphane Bancel stated that the approval reflects the ongoing potential of their mRNA platform to help address important public health challenges. Many public health officials believe the mRNA flu vaccine has advantages, such as being updated and produced more quickly than standard vaccines, which could be crucial in responding to new flu strains.
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