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Moderna's mRNA Flu Vaccine mFlusiva Approved by FDA for Adults 50 and Older
Key points
- FDA approved Moderna's mFlusiva (mRNA-1010) flu vaccine.
- Approved for adults aged 50 and older.
- First mRNA-based flu vaccine to receive FDA approval.
- Effective against four common influenza strains.
- Approval followed a Phase 3 clinical trial with 40,805 adults.
FDA Approval for mFlusiva
The U.S. Food and Drug Administration (FDA) has approved Moderna's mRNA seasonal flu vaccine, mFlusiva (mRNA-1010). This approval makes mFlusiva available for adults aged 50 and over, marking a significant development in vaccine technology.
The vaccine is designed to be effective against the four most common strains of influenza, which the World Health Organization (WHO) reported in 2017 cause up to five million severe flu cases and up to 650,000 respiratory deaths annually.
First mRNA Flu Vaccine
This approval represents the first time an mRNA-based flu shot has received FDA clearance. The technology, previously utilized in COVID-19 vaccines, is now expanding its application to seasonal influenza prevention.
The approval follows an initial refusal by the FDA to review the vaccine, but later proceeded with a unanimous recommendation from FDA advisors in June.
Clinical Trials and Efficacy
Moderna's mFlusiva underwent human testing trials since 2021. A Phase 3 clinical trial enrolled 40,805 adults across 11 countries to evaluate its safety and efficacy compared to an approved non-mRNA vaccine.
The trial's findings led to approval for individuals aged 50 to 64, and accelerated approval for those 65 and older. Researchers concluded that mRNA-1010 was superior in efficacy to existing seasonal flu shots and demonstrated a good safety record.
Impact on Public Health
The introduction of mFlusiva provides a new option for influenza prevention, particularly for older populations who are often more vulnerable to severe flu outcomes. This approval could influence future vaccine development and the broader application of mRNA technology in public health.
✨ This summary was generated by AI from the outlets' reporting listed below. It is not independently verified and may contain errors — check the original sources. How BrevFeed works →
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How outlets covered it
The FDA has approved Moderna's mRNA-1010 (mFLUSIVA) flu vaccine for adults aged 50 and older, marking the first mRNA-based flu shot to receive such approval. This approval follows a unanimous recommendation from FDA advisors based on superior efficacy and a good safety record in trials, and it introduces a new technology platform to seasonal flu vaccination.
The US Food and Drug Administration (FDA) has approved Moderna's mRNA seasonal flu vaccine, mFlusiva (mRNA-1010), for adults aged 50 and over. This approval marks a significant step in expanding mRNA technology beyond COVID-19 vaccines and offers a new option for influenza prevention in older populations.