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Safety & Tolerability

FLUMIST Safety and Tolerability

FLUMIST Safety and Tolerability

Study in eligible children 2 to 17 years of age1

In clinical studies, FluMist was well-tolerated and had a safety profile comparable to placebo.1

Most common adverse reactions in children and adults

The most common solicited adverse reactions (occurring ≥10% in vaccine recipients and at least 5% greater than in placebo) reported were runny nose or nasal congestion in persons 2-49 years, fever >100°F in children 2-6 years, and sore throat in adults 18-49 years.

Summary of Solicited Adverse Reactions Observed Within 10 Days after Dose 1 for FluMist and Either Placebo or Active Control Recipients in Children 2 through 6 Years of Age
FluMist*
N = 876-1759		 Placebo‡
N = 424-1034		 FluMist†
N = 2170		 Active Control§
N = 2165
Event % % % %
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°F Oral 16 11 13 11
> 100 - ≤ 101°F Oral 9 6 6 4
> 101 - ≤ 102°F Oral 4 3 4 3

* NCT00192244; see www.clinicaltrials.gov
† NCT00128167; see www.clinicaltrials.gov
‡ Study D153-P501 used saline placebo; Study AV006 used AF-SPG placebo.
§ Inactivated Influenza Virus Vaccine manufactured by Sanofi Pasteur Inc., administered intramuscularly.
¶ Number of evaluable subjects (those who returned diary cards) for each reaction. Range reflects differences in data collection between the 2 pooled studies.

Study in eligible individuals 18 to 49 years of age1

A clinical trial subset of children 9-17 years of age who received a single dose of FluMist demonstrated solicited and unsolicited adverse reactions consistent with previous trials. Patients receiving FluMist reported abdominal pain at higher rates than placebo recipients (12% vs. 4%). More FluMist recipients reported decreased activity compared to placebo recipients (6% vs 0%).

Unsolicited adverse reactions occurring in at least 1% of FluMist recipients and at a higher rate (≥1% rate difference after rounding) were abdominal pain (2% FluMist vs 0% placebo), otitis media (3% FluMist vs 1% placebo), and sneezing (2% FluMist vs 1% active control).

Summary of solicited adverse reactions in eligible adults 18 to 49 years of age1
Event FluMist Placebo
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%

In Study AV009, unsolicited adverse reactions occurring in at least 1% of FluMist recipients and at a higher rate (≥1% rate difference after rounding) compared to placebo were nasal congestion (9% FluMist vs 2% placebo) and sinusitis (4% FluMist vs 2% placebo).

IMPORTANT SAFETY INFORMATION

  • Do not administer FLUMIST to persons who have had a severe allergic reaction (e.g., anaphylaxis) to any component of the vaccine, including egg protein, or after a previous dose of any influenza vaccine, or to children and adolescents through 17 years of age who are receiving aspirin or aspirin-containing therapy
  • In clinical trials, the risks of hospitalization and wheezing were increased in children younger than 2 years of age who received FLUMIST
  • Children younger than 5 years of age with recurrent wheezing and persons of any age with asthma may be at increased risk of wheezing following the administration of FLUMIST. FLUMIST has not been studied in persons with severe asthma or active wheezing
  • If Guillain-Barré syndrome has occurred within 6 weeks of any prior influenza vaccination, the decision to give FLUMIST should be based on careful consideration of the potential benefits and risks
  • The effectiveness of FLUMIST has not been studied in immunocompromised persons
  • The safety of FLUMIST in individuals with underlying medical conditions that may predispose them to complications following wild-type influenza infection has not been established
  • Appropriate medical treatment must be immediately available to manage potential anaphylactic reactions following administration of FLUMIST
  • FLUMIST may not protect all individuals receiving the vaccine
  • The most common solicited adverse reactions (≥10% in vaccine recipients and at least 5% greater than in placebo) reported after FLUMIST were runny nose or nasal congestion (ages 2-49 years), fever >100 °F (children ages 2-6 years), and sore throat (adult ages 18-49 years)

FLUMIST is a vaccine indicated for active immunization of persons 2 through 49 years of age for the prevention of influenza disease caused by influenza virus subtypes A and type B contained in the vaccine. FLUMIST is for intranasal administration only.

Please see full Prescribing Information for FLUMIST, including Patient Information.

You may report side effects related to AstraZeneca products.