FluMist® (Influenza Vaccine Live, Intranasal) is a vaccine indicated for active immunization of persons 2-49 years of age for the prevention of influenza disease caused by influenza A subtype viruses and the type B virus contained in the vaccine. FluMist is for intranasal administration only.
FluMist is contraindicated in persons who have had a severe allergic reaction to any vaccine component including egg protein, gentamicin, gelatin, and arginine, or after a previous dose of any influenza vaccine, and in children and adolescents receiving concomitant aspirin or aspirin-containing therapy.
In clinical trials, the risks of hospitalization and wheezing were increased in children <2 years of age who received FluMist. Children <5 years of age with recurrent wheezing and persons of any age with asthma may be at increased risk of wheezing following FluMist administration. FluMist has not been studied in persons with severe asthma or active wheezing.
If Guillain-Barré syndrome has occurred within 6 weeks of any prior influenza vaccination, the decision to give FluMist should be based on careful consideration of the potential benefits and risks. The effectiveness of FluMist has not been studied in immunocompromised persons. The safety of FluMist in individuals with underlying medical conditions predisposing them to wild-type influenza infection complications has not been established. FluMist may not protect all individuals receiving the vaccine.
The most common solicited adverse reactions (occurring at ≥10% in FluMist recipients and at least 5% greater than in placebo recipients) were runny nose or nasal congestion in recipients of all persons 2-49 years, fever >100℉ in children 2-6 years, and sore throat in adults 18-49 years.
Please see accompanying complete Prescribing Information for FluMist, including Patient Information.
*CDC/ACIP = Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices