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mRNA Flu Vaccine Meets Primary End Point Among Older Adults
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Key Takeaways
- The 2024-2025 influenza season was severe, with high illness rates, hospitalizations, and fatalities, emphasizing the need for better vaccines.
- Moderna's mRNA-1010 vaccine showed 26.6% overall efficacy and 27.4% efficacy in older adults, with robust strain-specific results.
Moderna's mRNA-1010 flu vaccine shows promising efficacy, especially for older adults, addressing the urgent need for better influenza prevention.
The 2024-2025 influenza season was extraordinarily severe. As of the week ending February 8, 2025, outpatient respiratory illness rates remained above baseline for 11 consecutive weeks. Pediatric fatalities reached at least 68 by that date.1 CDC estimates project 47 million illnesses, 610,000 hospitalizations, and 26,000 deaths for the 2024-2025 season. In high-impact regions like California, flu hospitalizations exceeded capacity, with over 70% of respiratory specimens testing positive. This health burden underscores the critical need for more effective vaccines.2
With flu season reaching record highs, Modernas mRNA-1010 has shown stronger protection, especially in older adults. | Image Credit: Prostock-studio | stock.adobe.com
mRNA‑1010: A New Standard in Flu Vaccine Efficacy
Moderna’s P304 phase 3 trial evaluated their quadrivalent mRNA vaccine, mRNA-1010, among 40,805 adults aged 50 years and older. The study met its primary end point, demonstrating an overall relative vaccine efficacy (rVE) of 26.6% compared to a licensed standard-dose vaccine. Strain-specific efficacy was equally encouraging: 29.6% rVE against A/H1N1, 22.2% against A/H3N2, and 29.1% against B/Victoria. Significantly, older adults aged 65 years or older saw a 27.4% rVE—a group particularly vulnerable to influenza complications.3
Stéphane Bancel, MBA, CEO of Moderna, emphasized the finding, stating “The severity of this past flu season underscores the need for more effective vaccines.”4
Earlier studies comparing mRNA‑1010 to standard and high-dose egg-based vaccines in adults 18 years and older found that it evoked robust humoral responses with acceptable tolerability. Solicited adverse reactions—primarily injection site pain, fatigue, headache, and myalgia—were mostly mild (grade 1-2), and no vaccine-related serious adverse events were reported.5
Central to Enhanced Flu Protection
With flu activity still high, pharmacists can explain how vaccines like mRNA-1010 improve protection—highlighting high rVE rates and encouraging vaccination. Managing cold-chain requirements, reconstitution processes, and billing for new mRNA vaccines falls squarely within pharmacists’ domain. Pharmacists should also record and report any adverse effects via the Vaccine Adverse Event Reporting System and share immunogenicity data with clinical partners. Given low vaccination uptake, especially among high-risk populations, proactive pharmacist-led immunization campaigns are critical to reducing flu burden.1-5
Conclusion
The 2024-2025 influenza season’s heightened severity demands improved preventive tools. Moderna’s mRNA-1010 shows superior efficacy—26.6% overall and 27.4% in older adults—along with a favorable safety profile. Pharmacists, through patient engagement, logistics management, and surveillance, are uniquely positioned to maximize the impact of these next-generation vaccines and safeguard public health.
REFERENCES
1. Centers for Disease Control and Prevention. Weekly US Influenza Surveillance Report, week 06 ending February 8, 2025. CDC FluView. 2025. https://www.cdc.gov/fluview/surveillance/2025-week-06.html
2. Centers for Disease Control and Prevention. Estimated influenza disease burden, 2024–2025 season. CDC. Accessed 2025. https://www.cdc.gov/flu-burden/php/data-vis/2024-2025.html
3. Moderna, Inc. Moderna announces positive Phase 3 results for seasonal influenza vaccine. News release. June 30, 2025. https://news.modernatx.com/news/news-details/2025/Moderna-Announces-Positive-Phase-3-Results-for-Seasonal-Influenza-Vaccine/default.aspx
4. Medicines/Health section. Moderna’s experimental flu vaccine more effective than approved shot in study. Reuters. June 30, 2025. https://www.reuters.com/business/healthcare-pharmaceuticals/modernas-influenza-vaccine-superior-licensed-shot-study-2025-06-30/
5. Soens M, Ananworanich J, Hicks B, et al. A phase 3 randomized safety and immunogenicity trial of mRNA‑1010 seasonal influenza vaccine in adults. Vaccine. 2025;50:126847. doi:10.1016/j.vaccine.2025.126847
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