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

Safety & Tolerability Data in Children

Summary of Solicited Events in Children1

Placebo Studies Active-Controlled Study
Event 2 Years to 6 Years of Age* 2 Years to 5 Years of Age†‡
FluMist®
(n=876-1,764)
% 		Placebo
(n=424-1,036)
% 		FluMist
(n=2,170)
% 		Flu shot
(n=2,165)
%
Runny nose/nasal congestion 58 50 51 42
Decreased appetite 21 17 13 12
Irritability 21 19 12 11
Decreased activity (lethargy) 14 11 7 6
Sore throat 11 9 5 6
Headache 9 7 3 3
Muscle aches 6 3 2 2
Chills 4 3 2 2
Fever
100°-101°F Oral 9 6 6 4
101°-102°F Oral 4 3 4 3
  • * Solicited events occurring in at least 1% of FluMist recipients and at a higher rate compared to placebo observed within 10 days after dose 1 for vaccine and placebo recipients.
  • † A randomized, double-blind, double-dummy comparison of FluMist intranasal mist and TIV intramuscular injection that included children 24 months to 59 months of age in the 2004-2005 influenza season (N=4,335).
  • ‡ Solicited events observed within 10 days after dose 1 in children 24 months to 59 months of age.

Additional adverse reactions observed in the above trials that occurred in at least 1% of FluMist recipients, and at a higher rate compared to placebo, were abdominal pain, otitis media, diarrhea, and sneezing.

In a trial of children 9 years to 17 years of age, and in a trial comparing the refrigerated and frozen formulation in children and adults 5 years to 49 years of age, solicited events and other adverse reactions were generally consistent with observations from previous trials.

Next: Safety & Tolerability Data 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.