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Risks of Hospitalization and Wheezing in Children Younger than 24 Months of Age: In clinical trials, risks of hospitalization and wheezing were increased in children younger than 2 years of age who received FluMist Trivalent [see Clinical Trials Experience under Adverse Reactions].
Asthma, Recurrent Wheezing, and Active Wheezing: Children younger than 5 years of age with recurrent wheezing and persons of any age with asthma may be at increased risk of wheezing following administration of FluMist Trivalent. FluMist Trivalent has not been studied in persons with severe asthma or active wheezing.
Guillain-Barré Syndrome: If Guillain-Barré syndrome (GBS) has occurred within 6 weeks of any prior influenza vaccination, the decision to give FluMist Trivalent should be based on careful consideration of the potential benefits and potential risks.
The 1976 swine influenza vaccine (inactivated) was associated with an elevated risk of GBS. Evidence for causal relation of GBS with other influenza vaccines is inconclusive; if an excess risk exists, based on data for inactivated influenza vaccines, it is probably slightly more than 1 additional case per 1 million persons vaccinated.
Altered Immunocompetence: The effectiveness of FluMist Trivalent has not been studied in immunocompromised persons. Data on safety and shedding of vaccine virus after administration of FluMist Trivalent in immunocompromised persons are limited to 173 persons with HIV infection and 10 mild to moderately immunocompromised children and adolescents with cancer [see Pharmacology: Pharmacodynamics under Actions].
Medical Conditions Predisposing to Influenza Complications: The safety of FluMist Trivalent in individuals with underlying medical conditions that may predispose them to complications following wild-type influenza infection has not been established.
Management of Acute Allergic Reactions: Appropriate medical treatment must be immediately available to manage potential anaphylactic reactions following administration of FluMist Trivalent [see Severe Allergic Reactions under Contraindications].
Limitations of Vaccine Effectiveness: FluMist Trivalent may not protect all individuals receiving the vaccine.
Use in Children: FluMist Trivalent is not approved for use in children younger than 24 months of age because use of FluMist Trivalent in children 6 through 23 months has been associated with increased risks of hospitalization and wheezing in clinical trials [see Risks of Hospitalization and Wheezing in Children Younger than 24 Months of Age as previously mentioned; Clinical Trials Experience under Adverse Reactions].
The effectiveness of FluMist Trivalent in children 6 years through 17 years of age is supported by demonstration of efficacy in younger children 6 through 71 months of age and effectiveness in adults 18 through 49 years of age [see Pharmacology: Pharmacodynamics: Clinical Studies under Actions].
Use in the Elderly: FluMist Trivalent is not approved for use in persons 65 years of age and older because in a clinical study (AV009), effectiveness of FluMist Trivalent to prevent febrile illness was not demonstrated in adults 50 through 64 years of age [see Pharmacology: Pharmacodynamics: Clinical Studies: Effectiveness Study of FluMist Trivalent in Adults under Actions]. In this study, solicited events among individuals 50 through 64 years of age were similar in type and frequency to those reported in younger adults. In a clinical study of FluMist Trivalent in persons 65 years of age and older, subjects with underlying high-risk medical conditions (N = 200) were studied for safety. Compared to controls, FluMist Trivalent recipients had a higher rate of sore throat.
