Efficacy

FluMist® starts working where flu typically starts — in the nose — to help stimulate a natural immune response.1,2

Since influenza strains change year to year, past clinical trial results are not indicative of future results.

Scroll down to see full Important Safety Information.

Efficacy in Adults EXPAND HIDE

Adult Effectiveness Study: Reductions in Influenza-like Illness (ILI) vs. Placebo1,5

In healthy adults ≤49 years of age, FluMist was substantially effective in reducing cases of influenza-like illness (ILI).

Adult Flu Vaccine Effectiveness Study
HIDE Footnotes

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 through 49 years of age during the 7-week, site-specific outbreak period during the 1997-1998 influenza season. Results based on illness signs and symptoms; enrollees not tested specifically for influenza.

Flu vaccine effectiveness was not demonstrated in a subgroup of adults 50 years to 64 years of age.

Challenge Study: Efficacy in Preventing Influenza vs. Placebo6

FluMist® (Influenza Vaccine Live, Intranasal) Efficacy vs. Placebo
HIDE Footnotes

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 during the 1995-1996 influenza season.

Efficacy in Children EXPAND HIDE

Overall Efficacy in Children Aged 24 to 59 Months During 2004-2005 Influenza Season (FluMist vs. Flu Shot)1-3*

In a large, head-to-head influenza vaccine trial in children published in the New England Journal of Medicine, FluMist demonstrated a 54% reduction in influenza cases versus the flu shot.1-3†

Overall efficacy against influenza illness graph

In the same study:

  • Children receiving the flu shot were 2 times more likely to get the flu than those who received FluMist.1-3
  • FluMist demonstrated similar results against mismatched strains.1-3

HIDE Footnotes & Study Design

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-naive 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].

† 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.

§ Injectable influenza vaccine made by Sanofi Pasteur, Inc.

Matched & Mismatched Efficacy in Children Aged 24 to 59 Months During 2004-2005 Influenza Season (FluMist vs. Flu Shot)1-3 II

FluMist achieved these significant reductions against matched and mismatched influenza strains:1-3

Matched and mismatched efficacy against influenza disease graph
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.

Important Safety Information

FluMist® (Influenza Vaccine Live, Intranasal) 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, the decision to give FluMist should be based on careful consideration of the potential benefits and risks. Data supporting the safety and effectiveness of FluMist administration in immunocompromised individuals are limited. 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.

Please see accompanying complete Prescribing Information, including Patient Information [PDF PDF].

References
  1. FluMist [package insert]. Gaithersburg, MD: Medlmmune, LLC.
  2. Centers for Disease Control and Prevention. Key Facts about Influenza (Flu) & Flu Vaccine. http://www.cdc.gov/flu/keyfacts.htm. Accessed April 1, 2011.
  3. Belshe RB, Edwards KM, Vesikari T, et al. Live attenuated versus inactivated influenza vaccine in infants and young children. N Engl J Med. 2007;356:685-696.
  4. Belshe RB, Ambrose CS, Yi T. Safety and efficacy of live attenuated influenza vaccine in children 2-7 years of age. Vaccine. 2008;26 (suppl 4):D10-D16.
  5. Nichol KL, Mendelman PM, Mallon KP, et al. Effectiveness of live, attenuated intranasal influenza virus vaccine in healthy, working adults: a randomized controlled trial. JAMA. 1999;281:137-144.
  6. Treanor JJ, Kotloff K, Betts RF, et al. Evaluation of trivalent, live, cold-adapted (CAIV-T) and inactivated (TIV) influenza vaccines in prevention of virus infection and illness following challenge of adults with wild-type influenza A (H1N1), A (H3N2), B viruses. Vaccine. 1999;18:899-906.