mFLUSIVA COMES IN A READY‑TO‑USE, PRE‑FILLED SYRINGE1
Storage1
Store refrigerated between 2°C to 8°C (36°F to 46°F). Do not freeze. Do not use after the expiration date shown on the label. Syringes should not be returned to refrigerated conditions after being stored at room temperature
Store refrigerated between 2°C to 8°C (36°F to 46°F). Do not freeze. Do not use after the expiration date shown on the label. Syringes should not be returned to refrigerated conditions after being stored at room temperature
mFLUSIVA may be stored between 8°C to 25°C (46°F to 77°F) for up to 12 hours after removal from refrigerated conditions. Discard the pre-filled syringe if not used within this time
mFLUSIVA may be stored between 8°C to 25°C (46°F to 77°F) for up to 12 hours after removal from refrigerated conditions. Discard the pre-filled syringe if not used within this time
Minimize exposure to room light. Avoid exposure to direct sunlight and ultraviolet light
Minimize exposure to room light. Avoid exposure to direct sunlight and ultraviolet light
mFLUSIVA is administered as a single 0.38 mL intramuscular injection1
Preparation for Administration
- Verify that the label on the pre-filled syringe states 2026-2027 formula
- Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit
- mFLUSIVA is a white to off-white suspension that may contain visible white or translucent product-related particulates. Do not administer if the vaccine is discolored or contains other particulate matter
- Do not shake
- With tip cap upright, remove tip cap by twisting counterclockwise until tip cap releases. Remove tip cap in a slow, steady motion. Avoid pulling tip cap while twisting
- Attach the needle by twisting it in a clockwise direction until the needle fits securely on the pre-filled syringe
- Discard after single use
Stay on top of the latest advancements
Sign up for resources and the latest news.
By submitting your information, you agree to Moderna’s Terms and Conditions. You also acknowledge that your information will be processed in accordance with Moderna’s Privacy Statement. This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.
We’re here to help!
Please contact us if you have any questions about ordering and product availability or to arrange an appointment with our field staff.
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.
Reference
- mFLUSIVA Prescribing Information. ModernaTX, Inc.
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.