Effectiveness of FluMist in Adults
In healthy adults 18 to 49 years of age, FluMist demonstrated substantial effectiveness in reducing cases of influenza 1,2:
Reduction of ILI vs placebo in a multicenter, randomized, double-blind, placebo-controlled trial in 3,637 adults (FluMist n=2,411, placebo n=1,226) 18 years to 49 years of age during the 7-week, site-specific outbreak period.
Prevention of laboratory-documented influenza vs placebo in a multicenter, randomized, double-blind, placebo-controlled trial in 60 healthy adults (FluMist n=29, placebo n=31) 18 years to 41 years of age who were challenged with wild-type virus.
Effectiveness was not demonstrated in a subgroup of adults 50 years to 64 years of age.
FluMist also demonstrated significant reductions in influenza versus the flu shot in a large head-to-head influenza vaccine trial in children 1,3*.
Next: Safety & Tolerability in Children
* Full study published in The New England Journal of Medicine – February, 2007.
Important Safety Information
FluMist is a live attenuated influenza virus vaccine indicated for active immunization of individuals
2 - 49 years of age against influenza disease caused by influenza virus subtypes A and type B contained in the vaccine.
FluMist is contraindicated in individuals with history of hypersensitivity to eggs, egg proteins, gentamicin, gelatin or arginine
or with life-threatening reactions to previous influenza vaccinations, and in children and adolescents receiving concomitant aspirin or aspirin-containing therapy.
Do not administer FluMist to children <24 months of age due to an increased risk of hospitalization and wheezing that was observed in clinical trials. FluMist should
not be administered to any individual with asthma and to children <5 years of age with recurrent wheezing unless the potential benefit outweighs the potential risk.
Do not administer FluMist to individuals with severe asthma or active wheezing.
If Guillain-Barré syndrome has occurred with prior influenza vaccination or if an individual is immunocompromised, the decision to give FluMist should be based on careful consideration of the potential benefits and risks. FluMist should not be administered to individuals with underlying medical conditions predisposing them to wild-type influenza infection complications unless the potential benefit outweighs the potential risk. FluMist should be given to a pregnant woman only if clearly needed.
Most common adverse reactions (occurring at ≥10% in individuals receiving FluMist and at least 5% greater than in placebo) are runny nose or nasal congestion in recipients of all ages, fever >100°F in children 2-6 years of age, and sore throat in adults.
FluMist may not protect all individuals receiving the vaccine. FluMist is for intranasal administration only.
See the complete Prescribing Information for more information.
