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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.
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.