mFLUSIVA PROVIDES SEASONAL PROTECTION FOR FLU1
In adults aged ≥50,
mFLUSIVA achieved 26.6% higher rVE than Fluarix®1,2
Study 1 primary endpoint:
mFLUSIVA was superior in preventing flu as measured by rVE (relative vaccine efficacy)*
All 3 prespecified success criteria for the primary efficacy endpoint were sequentially tested and met.
- For noninferiority, the lower bound of the 2-sided 95% CI for mFLUSIVA's rVE vs the licensed standard-dose comparator exceeded -10%
- The lower bound of the 95% Cl also exceeded the more stringent prespecified success criteria of >0% and >9.1%
26.6% rVE
(95% CI; 16.7, 35.4); P<0.001
mFLUSIVA | Fluarix® | |
|---|---|---|
Participants with influenza-like illness | 2.0% (411/20,179) | 2.8% (557/20,124) |
*Relative vaccine efficacy (rVE) shows how well one vaccine prevents illness compared with another. Participants had RT-PCR-confirmed protocol-defined ILI regardless of influenza strain.
mFLUSIVA was studied in a head-to-head clinical trial vs Fluarix®1
Standard-dose study: A phase 3, randomized, double-blind, active-controlled clinical study in patients aged ≥50 to evaluate the efficacy and safety of mFLUSIVA (n=20,350) vs Fluarix® (n=20,353). The primary efficacy endpoint was RT-PCR–confirmed protocol-defined ILI† caused by any influenza A or B strains beginning at least 14 days post-vaccination through the end of the influenza season.
†Protocol-defined ILI included at least 1 systemic symptom (temperature >37.2°C [>99.0°F], chills, feverish, tiredness, headaches, or myalgia) and at least 1 respiratory symptom (sore throat, cough, sputum production, wheezing, or difficulty breathing).
mFLUSIVA | Fluarix® | |
|---|---|---|
≥50 years of age | 20,350 received | 20,353 received |
ILI = influenza-like illness; RT-PCR = reverse transcriptase-polymerase chain reaction.
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Indication and Important Safety Information
INDICATION
mFLUSIVA (Influenza Vaccine, mRNA) is a vaccine indicated for active immunization for the prevention of influenza disease caused by influenza virus subtypes A and type B represented in the vaccine. mFLUSIVA is approved for use in persons 50 years of age and older.
The indication for persons 65 years of age and older is approved under accelerated approval based on immune responses. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.
IMPORTANT SAFETY INFORMATION
Contraindications
Do not administer mFLUSIVA to individuals with a history of a severe allergic reaction (e.g., anaphylaxis) to mFLUSIVA or any of its components.
Warnings and Precautions
- Management of Acute Allergic Reactions: Appropriate medical treatment must be immediately available to manage potential anaphylactic reactions following administration of mFLUSIVA.
- Guillain-Barré Syndrome (GBS): If GBS occurred within 6 weeks of a previous influenza vaccination, carefully consider the risks and benefits before administering mFLUSIVA.
- Syncope (fainting): May occur in association with administration of injectable vaccines. Procedures should be in place to avoid injury from fainting.
- Altered Immunocompetence: Immunocompromised persons, including individuals receiving immunosuppressive therapy, may have a diminished immune response to mFLUSIVA.
- Limitations of Vaccine Effectiveness: mFLUSIVA may not protect all vaccine recipients.
Adverse Reactions
The most commonly reported adverse reactions (≥10%) in participants 50 through 64 years of age were injection site pain, fatigue, headache, myalgia, arthralgia, chills, and axillary swelling or tenderness. The same adverse reactions were most commonly reported (≥10%) in participants 65 years of age and older.
Reporting Adverse Events and Vaccine Administration Errors
The vaccination provider is responsible for mandatory reporting of certain adverse events to the Vaccine Adverse Event Reporting System (VAERS) online at https://vaers.hhs.gov or by calling 1-800-822-7967.
Please click for mFLUSIVA Full Prescribing Information.
References
- mFLUSIVA Prescribing Information. ModernaTX, Inc.
- Leroux-Roels I, Huang G, Ferguson M, et al; Fluent Trial Investigators. Efficacy and safety of an mRNA seasonal influenza vaccine in adults. N Engl J Med. 2026;394(18):1803-1813. doi:10.1056/NEJMoa2516491
Colorado & Connecticut prescribers and pharmacists may view WAC information at modernadirect.com/wac-disclosure
mFLUSIVA is a trademark of Moderna. All other trademarks are the property of their respective owners.