Safety and Tolerability

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.1

CDC/AICP* Says... LAIV [FluMist] transmission from a recently vaccinated person causing clinically important illness in an immunocompromised contact has not been reported to date.7

Vaccine Safety & Tolerability in Adults EXPAND HIDE

Summary of Solicited Adverse Events in Healthy Adults Aged 18-49 Years1*

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 and sore throat in adults.

Events FluMist*
(n=2,458)
%		 Placebo
(n=1,290)
%
Runny nose 44 27
Headache 40 38
Sore throat 28 17
Tiredness/weakness 26 22
Muscle aches 17 15
Cough 14 11
Chills 9 6

* Reported within 7 days of either vaccine or placebo administration.

All solicited events were transient.

Vaccine Safety & Tolerability in Children EXPAND HIDE

Safety in Children

FluMist had a safety profile generally comparable to the flu shot and placebo in over 7,000 children 2-6 years of age studied. The most common adverse reactions are runny nose or nasal congestion and fever >100°F in children 2-6 years of age.1

Placebo Studies Active-Controlled
Study
2-6 Years of Age* 2-5 Years of Age†‡
Events 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 vaccine 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 separate trial of children 9-17 years old, and in another trial comparing the refrigerated and frozen formulation in children and adults 5-49 years old, solicited events and other adverse reactions were generally consistent with observations from previous trials.

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: MedImmune, LLC.