6 ADVERSE REACTIONS
FLUAD (Influenza Vaccine, Adjuvanted) Suspension for Intramuscular Injection 201-201 Formula Initial U.S. Approval: 2015
BRIEF SUMMARY: See package insert for full prescribing information.
1 INDICATIONS AND USAGE
FLUAD is an inactivated influenza vaccine indicated for active immunization against influenza disease caused by influenza virus subtypes A and type B contained in the vaccine. FLUAD is approved for use in persons 65 years of age and older. Approval is based on the immune response elicited by FLUAD. Data demonstrating a decrease in influenza disease after vaccination with FLUAD are not available. [see Clinical Studies (14)]
4 CONTRAINDICATIONS
Do not administer FLUAD to anyone with a history of severe allergic reaction (e.g. anaphylaxis) to any component of the vaccine, including egg protein [see Description (11)], or to a previous influenza vaccine.
5 WARNINGS AND PRECAUTIONS
5.1 Guillain-Barré Syndrome If Guillain-Barré syndrome (GBS) has occurred within 6 weeks of receipt of prior influenza vaccine, the decision to give FLUAD should be based on careful consideration of the potential benefits and risks. The 1976 swine influenza vaccine was associated with an elevated risk of GBS. Evidence for a causal relationship of GBS with other influenza vaccines is inconclusive; if an excess risk exists, it is probably slightly more than 1 additional case per 1 million persons vaccinated. [see References (1)]
5.2 Preventing and Managing Allergic Reactions Appropriate medical treatment and supervision must be available to manage possible anaphylactic reactions following administration of the vaccine.
5.3 Latex The tip caps of the prefilled syringes contain natural rubber latex which may cause allergic reactions in latex sensitive individuals. [see Description (11)]
5.4 Altered Immunocompetence The immune response to FLUAD in immunocompromised persons, including individuals receiving immunosuppressive therapy, may be lower than in immunocompetent individuals. [see Concurrent Use With Immunosuppressive Therapies (7.2)]
5.5 Syncope Syncope (fainting) may occur in association with administration of injectable vaccines including FLUAD. Ensure procedures are in place to avoid injury from falling associated with syncope.
5.6 Limitations of Vaccine Effectiveness Vaccination with FLUAD may not protect all vaccine recipients against influenza disease.
6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, the adverse reaction rates observed in the clinical trials of a vaccine cannot be directly compared to rates in the clinical trials of another vaccine and may not reflect rates observed in clinical practice.
Solicited adverse reactions were assessed in a multicenter, observer-blind, randomized controlled study (Study 1) conducted in the United States, Colombia, Panama and the Philippines. The safety analysis set included 3545 FLUAD recipients and 3537 AGRIFLU (Influenza Vaccine) recipients. The enrolled subject population in Study 1 was 65 to 97 years of age (mean 72 years) and 64% were female. Within each treatment group, 53% were Asian, 28% were Caucasian, 18% were Hispanic, 1% were Black, and fewer than 1% each were Native American/ Alaskan, Pacific Islander/Hawaiian, or Other.
Solicited local (injection site) and systemic adverse reactions were collected from subjects in Study 1 who completed a symptom diary card for seven days following vaccination. The reported frequencies of solicited local and systemic adverse events from Study 1 are presented in Table 1.
Table 1. Percentages of Subjects ≥ 65 Years of Age With Solicited Local and Systemic Adverse Reactions in Days 1-7 After Administration of FLUAD or AGRIFLU (a U.S. Licensed Comparator) NCT01162122
Study 1 FLUAD (Na Local
Injection site Pain
Tenderness
Any 25.0 12.2 Moderateb
Severec
3.9 0.3
Erythema
25 to ≤ 50 mm 51 to ≤ 100 mm > 100 mm Any
Induration
25 to ≤ 50 mm 51 to ≤ 100 mm > 100 mm Any
Swelling
25 to ≤ 50 mm 51 to ≤ 100 mm > 100 mm
3.0 0.1 1.2 1.1 0.2 0.0 1.3 1.0 0.3 0.0 1.2 1.0 0.2
1.9 0.2
Any 21.1 11.2 Moderate Severe Any
1.0 0.2 0.5 0.5
<0.1 0.0 0.5 0.5 0.0 0.0 0.4 0.4
<0.1
<0.1 0.0
=3418-3496) Percentage
(Na AGRIFLU
=3420-3488) Percentage
Page 1 |
Page 2 |
Page 3 |
Page 4 |
Page 5 |
Page 6 |
Page 7 |
Page 8 |
Page 9 |
Page 10 |
Page 11 |
Page 12 |
Page 13 |
Page 14 |
Page 15 |
Page 16 |
Page 17 |
Page 18 |
Page 19 |
Page 20 |
Page 21 |
Page 22 |
Page 23 |
Page 24 |
Page 25 |
Page 26 |
Page 27 |
Page 28 |
Page 29 |
Page 30 |
Page 31 |
Page 32 |
Page 33 |
Page 34 |
Page 35 |
Page 36 |
Page 37 |
Page 38 |
Page 39 |
Page 40 |
Page 41 |
Page 42 |
Page 43 |
Page 44 |
Page 45 |
Page 46 |
Page 47 |
Page 48 |
Page 49 |
Page 50 |
Page 51 |
Page 52 |
Page 53 |
Page 54 |
Page 55 |
Page 56 |
Page 57 |
Page 58 |
Page 59 |
Page 60
