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The Innovative, New Flu Vaccine From Moderna Is Here
The first and only mRNA flu vaccine—manufactured without eggs1,2
mFLUSIVA is a vaccine indicated for active immunization for the prevention of influenza caused by influenza disease 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.
What makes mFLUSIVA unique?
mFLUSIVA is the first and only mRNA flu vaccine. mFLUSIVA does not contain any preservatives, adjuvants, or human- or animal-derived materials. Eggs are not used in the manufacturing process.
How was mFLUSIVA studied in clinical trials?
Study 1
- Study 1 was a Phase 3, randomized, double-blind, active-control trial conducted during a single influenza season (2024-2025) in participants 50 years of age and older. Participants were randomized to receive mFLUSIVA, containing A/Wisconsin/67/2022 (H1N1), A/Massachusetts/18/2022 (H3N2), and B/Austria/1359417/2021 (Victoria lineage), or a US-licensed standard dose (SD) inactivated influenza vaccine comparator (Fluarix® Quadrivalent marketed outside the U.S. under other trade names or Fluarix®, both manufactured by GlaxoSmithKline Biologicals). Randomization was stratified by age (50 through 64 years of age or 65 years of age and older) and by influenza vaccination status in the previous influenza season
- The per-protocol analysis set for efficacy assessments included 20,179 participants who received mFLUSIVA and 20,124 participants who received an SD comparator influenza vaccine. The study excluded immunocompromised individuals or those on immunosuppressive medications
- The primary efficacy endpoint was real-time RT-PCR-confirmed protocol-defined ILI* caused by any influenza A or B strains beginning at least 14 days postvaccination through the end of the influenza season
Study 2†
- Study 2 was a randomized, double-blind, active-controlled study conducted in the United States to evaluate the immunogenicity and safety of Moderna mRNA quadrivalent influenza vaccine in adults 65 years of age and older during the 2023-2024 influenza season. The per-protocol immunogenicity set for the primary analysis included 1,425 participants who received Moderna mRNA quadrivalent influenza vaccine and 1,409 participants who received a high-dose (HD) inactivated influenza vaccine comparator (Fluzone® High-Dose Quadrivalent, U.S.-licensed, manufactured by Sanofi Pasteur Inc.). Randomization was stratified by influenza vaccination status in the previous influenza season
- The co-primary endpoints were HAI, GMT, and the seroconversion rates at Day 29
How did mFLUSIVA perform in clinical trials?
In participants ≥50 years, mFLUSIVA demonstrated a 26.6% (95% CI: 16.7, 35.4) increase in relative vaccine efficacy (rVE) vs Fluarix® against influenza-like illness or against the flu.
mFLUSIVA met all prespecified criteria for noninferiority and superiority vs Fluarix®.
- The 3 prespecified success criteria (sequentially tested) for the primary efficacy endpoint were met. The lower limit of the 2-sided 95% CI of the relative vaccine efficacy (rVE) of mFLUSIVA relative to the licensed SD comparator vaccine for noninferiority was >-10%; the lower limits for the more stringent prespecified success criteria were >0% and >9.1%
What is the safety profile of mFLUSIVA?
Across both studies, while higher rates of solicited adverse reactions were noted, they were typically mild to moderate in severity.
- In adults 50 through 64 years of age who received mFLUSIVA, the most commonly reported (≥10%) adverse reactions were injection site pain (68.7%), fatigue (48.1%), headache (41.9%), myalgia (40.6%), arthralgia (31.5%), chills (27.5%), and axillary (underarm) swelling or tenderness (20.3%)
- In adults 65 years of age and older who received mFLUSIVA, the most commonly reported (≥10%) adverse reactions were injection site pain (62.9%), fatigue (42.1%), headache (33.7%), myalgia (30.2%), arthralgia (24.1%), chills (18.1%), and axillary (underarm) swelling or tenderness (14.2%)
*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).
†The clinical experience with Moderna mRNA quadrivalent influenza vaccine is relevant to mFLUSIVA. The Moderna mRNA quadrivalent influenza vaccine (containing 50 micrograms [mcg] of total RNA, with equal amounts [12.5 mcg] of each of the 4 RNAs encoding the hemagglutinin [HA] glycoproteins of A/Wisconsin/67/2022 pdm09-like virus [H1N1], A/Darwin/6/2021-like virus [H3N2], B/Austria/1359417/2021-like virus [B/Victoria], and B/Phuket/3073/2013-like virus [B/Yamagata]) is manufactured using the same process as mFLUSIVA and differs only in the addition of the RNA encoding the B/Yamagata antigen.
GMT = geometric mean titer; HAI = hemagglutination inhibition; HD = high-dose; ILI = influenza-like illness; RT-PCR = reverse transcriptase–polymerase chain reaction; SD = standard-dose.
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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.
- Centers for Disease Control and Prevention. ACIP recommendations summary. Updated June 10, 2026. Accessed August 7, 2026. https://www.cdc.gov/flu/hcp/vax-summary/acip-recommendations.html
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.