WHILE HIGHER RATES OF SOLICITED ADVERSE REACTIONS WERE NOTED, THEY WERE TYPICALLY MILD TO MODERATE IN SEVERITY1
mFLUSIVA has a well-characterized safety profile demonstrated in more than 20,000 adults aged ≥501
- Fatigue, headache, and myalgia were the most frequently observed solicited systemic adverse reactions for both groups
- Pain and axillary swelling or tenderness were the most frequently observed solicited local adverse reactions for both groups
Solicited local adverse reactions1
Standard-dose study (adults aged ≥50) with solicited local adverse reactions (Any Grade and Grade 3) within 7 days of vaccination*
50 through 64 years of age | 65 years of age and older | |||
|---|---|---|---|---|
Local Adverse Reactions | mFLUSIVA
n=1510 n (%) | SD Comparator
n=1502 n (%) | mFLUSIVA
n=1505 n (%) | SD
Comparator
n=1495 n (%) |
Injection site pain, Any Grade† | 1038 (68.7) | 517 (34.4) | 947 (62.9) | 377 (25.2) |
Injection site pain, Grade 3† | 17 (1.1) | 1 (<0.1) | 10 (0.7) | 0 |
Axillary (underarm) swelling or tenderness, Any Grade† | 306 (20.3) | 104 (6.9) | 214 (14.2) | 80 (5.4) |
Axillary (underarm) swelling or tenderness, Grade 3† | 4 (0.3) | 1 (<0.1) | 6 (0.4) | 0 |
Swelling (hardness), Any Grade‡ | 96 (6.4) | 18 (1.2) | 76 (5.0) | 27 (1.8) |
Swelling (hardness), Grade 3‡ | 4 (0.3) | 2 (0.1) | 5 (0.3) | 2 (0.1) |
Erythema (redness), Any Grade‡ | 66 (4.4) | 19 (1.3) | 51 (3.4) | 19 (1.3) |
Erythema (redness), Grade 3‡ | 4 (0.3) | 1 (<0.1) | 6 (0.4) | 1 (<0.1) |
High-dose study (adults aged ≥65) with solicited local adverse reactions (Any Grade and Grade 3) within 7 days of vaccination*
Local Adverse Reactions | Moderna mRNA QIV n=1502n (%) | HD Comparator n=1488-1489 n (%) |
|---|---|---|
Injection site pain, Any Grade† | 971 (64.6) | 546 (36.7) |
Injection site pain, Grade 3† | 23 (1.5) | 6 (0.4) |
Axillary (underarm) swelling or
tenderness, Any Grade† | 252 (16.8) | 128 (8.6) |
Axillary (underarm) swelling or
tenderness, Grade 3† | 8 (0.5) | 6 (0.4) |
Swelling (hardness), Any Grade‡ | 67 (4.5) | 25 (1.7) |
Swelling (hardness), Grade 3‡ | 6 (0.4) | 2 (0.1) |
Erythema (redness), Any Grade‡ | 42 (2.8) | 20 (1.3) |
Erythema (redness), Grade 3‡ | 6 (0.4) | 3 (0.2) |
Most adverse reactions were mild or moderate with a median duration of 2 days.
There were no Grade 4 solicited local adverse reactions reported in these studies.
* 7 days included day of vaccination and the subsequent 6 days. Events were collected in the electronic diary (e-diary).
† Pain and axillary (underarm) swelling or tenderness grading scale: no interference with activity (Grade 1); some interference with activity (Grade 2); prevents daily activity (Grade 3).
‡ Swelling (hardness) and erythema (redness) grading scale: 25 to 50 mm/2.5 to 5 cm (Grade 1); 51 to 100 mm/5.1 to 10 cm (Grade 2); >100 mm/>10 cm (Grade 3).
HD = high-dose; SD = standard-dose.
Solicited systemic adverse reactions1
Standard-dose study (adults aged ≥50) with solicited systemic adverse reactions (Any Grade and Grade 3) within 7 days of vaccination§
50 through 64 years of age | 65 years of age and older | |||
|---|---|---|---|---|
Systemic Adverse Reactions | mFLUSIVA n=1510ǁ n (%) | SD Comparator n=1502ǁ n (%) | mFLUSIVA n=1505ǁ n (%) | SD Comparator n=1495ǁ n (%) |
Fatigue, Any Grade¶ | 727 (48.1) | 309 (20.6) | 633 (42.1) | 300 (20.1) |
Fatigue, Grade 3¶ | 59 (3.9) | 9 (0.6) | 38 (2.5) | 4 (0.3) |
Headache, Any Grade¶ | 633 (41.9) | 302 (20.1) | 507 (33.7) | 236 (15.8) |
Headache, Grade 3¶ | 33 (2.2) | 6 (0.4) | 26 (1.7) | 4 (0.3) |
Myalgia, Any Grade¶ | 613 (40.6) | 196 (13.0) | 454 (30.2) | 152 (10.2) |
Myalgia, Grade 3¶ | 44 (2.9) | 4 (0.3) | 32 (2.1) | 3 (0.2) |
Arthralgia, Any Grade¶ | 476 (31.5) | 167 (11.1) | 363 (24.1) | 150 (10.0) |
Arthralgia, Grade 3¶ | 34 (2.3) | 3 (0.2) | 23 (1.5) | 3 (0.2) |
Chills, Any Grade¶ | 415 (27.5) | 71 (4.7) | 273 (18.1) | 58 (3.9) |
Chills, Grade 3¶ | 42 (2.8) | 3 (0.2) | 20 (1.3) | 1 (<0.1) |
Nausea/vomiting, Any Grade# | 147 (9.7) | 61 (4.1) | 112 (7.4) | 41 (2.7) |
Nausea/vomiting, Grade 3# | 3 (0.2) | 1 (<0.1) | 2 (0.1) | 1 (<0.1) |
Fever, Any Grade** | 90 (6.0) | 13 (0.9) | 84 (5.6) | 13 (0.9) |
Fever, Grade 3** | 11 (0.7) | 2 (0.1) | 6 (0.4) | 1 (<0.1) |
High-dose study (adults aged ≥65) with solicited systemic adverse reactions (Any Grade and ≥Grade 3) within 7 days of vaccination§
Systemic Adverse Reactions | Moderna mRNA QIV n=1502 n (%) | HD Comparatorn=1487-1488
n (%) |
|---|---|---|
Fatigue, Any Grade†† | 669 (44.5) | 293 (19.7) |
Fatigue, Grade 3†† | 52 (3.5) | 12 (0.8) |
Myalgia, Any Grade†† | 626 (41.7) | 239 (16.1) |
Myalgia, Grade 3†† | 48 (3.2) | 11 (0.7) |
Headache, Any Grade†† | 592 (39.4) | 258 (17.3) |
Headache, Grade 3†† | 35 (2.3) | 10 (0.7) |
Arthralgia, Any Grade†† | 529 (35.2) | 210 (14.1) |
Arthralgia, Grade 3†† | 35 (2.3) | 11 (0.7) |
Chills, Any Grade‡‡ | 443 (29.5) | 115 (7.7) |
Chills, Grade 3‡‡ | 18 (1.2) | 5 (0.3) |
Nausea/vomiting, Any Grade# | 192 (12.8) | 63 (4.2) |
Nausea/vomiting, Grade 3# | 4 (0.3) | 3 (0.2) |
Fever, Any Grade§§ | 127 (8.5) | 21 (1.4) |
Fever, Grade 3§§ | 9 (0.6) | 1 (<0.1) |
Fever, Grade 4§§ | 2 (0.1) | 0 |
§ 7 days included day of vaccination and the subsequent 6 days. Events were collected in the electronic diary (e-diary).
ǁ Except for fever, which had n=1505 (mFLUSIVA 50 through 64 years), n=1501 (SD comparator 50 through 64 years), n=1496 (mFLUSIVA ≥65 years), n=1491 (SD comparator ≥65 years).
¶ Fatigue, headache, myalgia, arthralgia, and chills grading scale: no interference with activity (Grade 1); some interference with activity (Grade 2); prevents daily activity (Grade 3).
# Nausea/vomiting grading scale: no interference with activity or 1-2 episodes/24 hours (Grade 1); some interference with activity or >2 episodes/24 hours (Grade 2); prevents daily activity or requires outpatient intravenous hydration (Grade 3).
**Fever grading scale: ≥38.0°C to ≤38.4°C/≥100.4°F to ≤101.1°F (Grade 1); ≥38.5°C to ≤38.9°C/≥101.2°F to ≤102.0°F (Grade 2); ≥39.0°C to ≤40.0°C/≥102.1°F to ≤104.0°F (Grade 3).
†† Fatigue, myalgia, headache, and arthralgia grading scale: no interference with activity (Grade 1); some interference with activity (Grade 2); prevents daily activity (Grade 3).
‡‡ Chills grading scale: no interference with activity (Grade 1); some interference with activity not requiring medical intervention (Grade 2); prevents daily activity and requires medical intervention (Grade 3).
§§ Fever grading scale: ≥38.0°C to ≤38.4°C/≥100.4°F to ≤101.1°F (Grade 1); ≥38.5°C to ≤38.9°C/≥101.2°F to ≤102.0°F (Grade 2); ≥39.0°C to ≤40.0°C/≥102.1°F to ≤104.0°F (Grade 3); ≥40.1°C or ≥104.1°F (Grade 4).
Serious adverse events were infrequent and similar to those in comparator groups1
mFLUSIVA | Fluarix® | |
|---|---|---|
Standard-dose study | 2.2% (455/20,350) | 1.9% (392/20,353) |
Moderna mRNA QIV | Fluzone® High-Dose | |
|---|---|---|
High-dose study | 2.7% (41/1502) | 2.6% (38/1489) |
QIV = quadrivalent influenza vaccine.
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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.