Please see Important Saftey Information at the bottom of this page
Information for Healthcare Professionals

Efficacy of FluMist® in Children Aged 24 to 59 Months.

FluMist demonstrated significant reductions in influenza versus the flu shot in a large head-to-head influenza vaccine trial in children1; 2:*†

Comparative Efficacy in Children Aged 24 to 59 Months During 2004-2005 Influenza Season‡

FluMist vs. Flu Shot - Overall Efficacy Against Influenza Illness

  • Matched strains: 52.5% reduction in flu cases vs the flu shot
    (1.4% vs 2.9%)2
  • Mismatched strains: 54.2% reduction in flu cases vs the flu shot
    (3.2% vs 7.1%)2
  • Overall efficacy: 54.4% reduction in flu cases vs the flu shot
    (4.5% vs 9.8%)2
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  • * Full study published in The New England Journal of Medicine – February, 2007.
  • † Study Design: Randomized, double-blind, double-dummy comparison of the relative efficacy of FluMist and TIV intramuscular injection that included children 24 months to 59 months of age, with a 42-day and a 6-month follow-up for safety through the end of the influenza surveillance period for the 2004-2005 influenza season (N=4,166). Vaccine-naïve children in both groups received 2 doses. Comparative efficacy vs culture-confirmed modified CDC influenza-like illness due to matched and mismatched strains [ATP population]. Injectable influenza vaccine made by Sanofi Pasteur, Inc.
  • ‡ Data is representative of the indicated population; full study population is represented in the Prescribing Information.
  • § The attack rates for FluMist vs the flu shot for all strains circulating during the 2004-2005 flu season were as follows: A/New Caledonia (H1N1) (0.0% vs 1.0%), A/Wyoming (H3N2) (0% vs 0%), A/California-like (H3N2) (1.2% vs 4.9%), matched B/Yamagata lineage (1.4% vs 1.9%, NS), and mismatched B/Yamagata lineage and B/Victoria (2.1% vs 2.3%, NS), respectively.

FluMist achieved these significant reductions against matched and mismatched influenza strains:

Comparative Efficacy in Children Aged 24 to 59 Months During 2004-2005 Influenza SeasonII

FluMist vs. Flu Shot - Matched and Mismatched Efficacy Against Influenza Illness

Hide Footnotes
  • II Data is representative of the indicated population; full study population is represented in the Prescribing Information.
  • ** The attack rates for FluMist vs the flu shot for all matched strains circulating during the 2004-2005 flu season were as follows: A/New Caledonia (H1N1) (0.0% vs 1.0%), A/Wyoming (H3N2) (0% vs 0%), and matched B/Yamagata lineage (1.4% vs 1.9%, NS), respectively.
  • †† The attack rates for FluMist vs the flu shot for all mismatched strains circulating during the 2004-2005 flu season were as follows: A/California-like (H3N2) (1.2% vs 4.9%), and mismatched B/Yamagata lineage and B/Victoria (2.1% vs 2.3%, NS), respectively.

Next: Effectiveness of FluMist in Adults

Important Safety Information

FluMist® is a 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.