IN ADULTS ≥65, MODERNA mRNA QIV DEMONSTRATED HIGHER ANTIBODY RESPONSE RATES VS FLUZONE® HIGH-DOSE1*
Moderna mRNA QIV immunogenicity data1
Moderna mRNA QIV delivered a superior immune response vs high-dose flu vaccine in adults 65 and older*
All prespecified success criteria for the co-primary immunogenicity endpoints were sequentially tested and met.
- For noninferiority, the lower bound of the 95% Cl for the GMT ratio exceeded 0.667 and the lower bound of the 95% Cl for the seroconversion rate difference exceeded -10% for each strain
- The lower bounds of the 97.5% CIs also exceeded the more stringent prespecified success criteria of >1.0 for the GMT ratio and >0% for the seroconversion rate difference for each strain
GMT ratio of Moderna mRNA QIV vs Fluzone® High-Dose (95% CI)
Strain | Moderna mRNA QIV (n=1425) over Fluzone® High-Dose (n=1409) |
|---|---|
A/H1N1 | 1.34 (1.25, 1.43) |
A/H3N2 | 1.21 (1.13, 1.30) |
B/Victoria | 1.25 (1.19, 1.32) |
% SCR differences between Moderna mRNA QIV and Fluzone® High-Dose (95% CI)
Strain | Moderna mRNA QIV (n=1425) minus Fluzone® High-Dose (n=1409) |
|---|---|
A/H1N1 | 13.42 (9.79, 17.01) |
A/H3N2 | 8.59 (4.91, 12.24) |
B/Victoria | 9.67 (6.50, 12.83) |
The clinical experience with Moderna mRNA QIV is relevant to mFLUSIVA because both vaccines are manufactured using the same process, and mFLUSIVA and Moderna mRNA QIV differ only in the addition of the mRNA encoding the B/Yamagata antigen.
*Moderna mRNA QIV demonstrated superior HAI antibody responses vs Fluzone® High-Dose.
In a head-to-head clinical trial, Moderna mRNA QIV delivered a higher immune response vs Fluzone® High-Dose in patients aged ≥651
Moderna mRNA QIV was studied in a head-to-head clinical trial vs Fluzone® High-Dose1
High-dose study: A phase 3, randomized, double-blind, active-controlled study in patients aged ≥65 to evaluate the immunogenicity and safety of Moderna mRNA QIV (n=1502) vs Fluzone® High-Dose (n=1489). The co-primary endpoints were hemagglutination inhibition geometric mean titer and the seroconversion rates at Day 29.
Moderna mRNA QIV | Fluzone® High-Dose | |
|---|---|---|
≥65 years of age | 1502 received | 1489 received |
GMT = geometric mean titer;
HAI = hemagglutination inhibition;
QIV = quadrivalent influenza vaccine;
SCR = seroconversion rate.
GMT = geometric mean titer; HAI = hemagglutination inhibition; QIV = quadrivalent influenza vaccine; SCR = seroconversion rate.
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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.
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.