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Influenza A H1N1 Intranasal Vaccine

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Influenza A H1N1 Intranasal Vaccine

Influenza A H1N1 Intranasal Vaccine

Influenza A H1N1 Intranasal Vaccine Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Influenza A (H1N1) 2009 Monovalent Vaccine Live, Intranasal is an immunization used for the active immunization of individuals 2-49 years of age against influenza disease caused by pandemic (H1N1) 2009 virus. Common side effects include wheezing and hypersensitivity reactions.

Clinical studies are ongoing with Influenza A (H1N1) 2009 Monovalent Vaccine Live, Intranasal to determine the optimal number of doses. Influenza A vaccine may interact with aspirin, antiviral medications, or other vaccines. Tell your doctor all medications and supplements you use and all vaccines you recently received. During pregnancy, Influenza A Vaccine should be used only if prescribed. It is unknown if this drug passes into breast milk. Consult your doctor before breastfeeding.

Our Influenza A (H1N1) 2009 Monovalent Vaccine Live, Intranasal Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Influenza A H1N1 Intranasal Vaccine FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

MedImmune's Influenza A (H1N1) 2009 Monovalent Vaccine Live, Intranasal and seasonal trivalent Influenza Vaccine Live, Intranasal (FluMist) are manufactured by the same process.

The data in this section were obtained from clinical trials and post-marketing experience with FluMist.

Influenza A (H1N1) 2009 Monovalent Vaccine Live, Intranasal is not approved for use in children < 24 months of age. In a clinical trial with FluMist, among children 6-23 months of age, wheezing requiring bronchodilator therapy or with significant respiratory symptoms occurred in 5.9% of FluMist recipients compared to 3.8% of active control (injectable influenza vaccine made by Sanofi Pasteur Inc.) recipients (Relative Risk 1.5, 95% CI: 1.2, 2.1). Wheezing was not increased in children ≥ 24 months of age.

Hypersensitivity, including anaphylactic reaction, has been reported during postmarketing experience with FluMist.

[See WARNINGS AND PRECAUTIONS.]

Adverse Reactions in Clinical Trials

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

A total of 9537 children and adolescents 1-17 years of age and 3041 adults 18-64 years of age received FluMist in randomized, placebo-controlled Studies D153-P501, AV006, D153-P526, AV019 and AV009 described below. In addition, 4179 children 6-59 months of age received FluMist in Study MI-CP111, a randomized, active-controlled trial. Among pediatric FluMist recipients 6 months-17 years of age, 50% were female; in the study of adults, 55% were female. In MI-CP111, AV006, D153-P526, AV019 and AV009, subjects were White (71%), Hispanic (11%), Asian (7%), Black (6%), and Other (5%), while in D153-P501, 99% of subjects were Asian.

Adverse Reactions in Children and Adolescents

In a placebo-controlled safety study (AV019) conducted in a large Health Maintenance Organization (HMO) in children 1-17 years of age (n = 9689), an increase in asthma events, captured by review of diagnostic codes, was observed in children < 5 years of age (Relative Risk 3.53, 90% CI: 1.1, 15.7). This observation was prospectively evaluated in Study MI-CP111.

In MI-CP111, an active-controlled study, increases in wheezing and hospitalization (for any cause) were observed in children < 24 months of age, as shown in Table 1.

Table 1: Percentages of Children with Hospitalizations and Wheezing from MI-CP111

Adverse Reaction Age Group FluMist Active Controla
Hospitalizationsb 6-23 months (n = 3967) 4.2 % 3.2 %
24-59 months (n= 4385) 2.1 % 2.5 %
Wheezingc 6-23 months (n = 3967) 5.9 % 3.8 %
24-59 months (n = 4385) 2.1 % 2.5 %
a Injectable influenza vaccine made by Sanofi Pasteur Inc.
b From randomization through 180 days post last vaccination.
c Wheezing requiring bronchodilator therapy or with significant respiratory symptoms evaluated from randomization through 42 days post last vaccination.

Most hospitalizations observed were gastrointestinal and respiratory tract infections and occurred more than 6 weeks post vaccination. In post hoc analysis, rates of hospitalization in children 6-11 months of age (n = 1376) were 6.1% in FluMist recipients and 2.6% in active control recipients.

Table 2 shows an analysis of pooled solicited events, occurring in at least 1% of FluMist recipients and at a higher rate compared to placebo, post Dose 1 for Study D153-P501 and AV006 and solicited events post Dose 1 for Study MI-CP111. Solicited events were those about which parents/guardians were specifically queried after vaccination with FluMist. In these studies, solicited events were documented for 10 days post vaccination. Solicited events post Dose 2 for FluMist were similar to those post Dose 1 and were generally observed at a lower frequency.

Table 2: Summary of Solicited Events Observed within 10 Days after Dose 1 for Vaccinea and either Placebo or Active Control Recipients; Children 2-6 Years of Age

  D153-P501 & AV006   MI-CP111
FluMist
N=876-1759c
Placebo
N=424-1034c
FluMist
N=2170c
Active Controlb
N=2165c
Event % % % %
Runny Nose/Nasal Congestion 58 50 51 42
Decreased Appetite 21 17 13 12
Irritability 21 19 12 11
DecreasedActivity(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
a Frozen formulation used in AV006; Refrigerated formulation used in D153-P501 and MI-CP111.
b Injectable influenza vaccine made by Sanofi Pasteur Inc.
c Number of evaluable subjects (those who returned diary cards) for each event. Range reflects differences in data collection between the 2 pooled studies.

In clinical studies D153-P501 and AV006, other adverse reactions in children occurring in at least 1% of FluMist recipients and at a higher rate compared to placebo were: abdominal pain (2% FluMist vs. 0% placebo) and otitis media (3% FluMist vs. 1% placebo).

An additional adverse reaction identified in the active-controlled trial, MI-CP111, occurring in at least 1% of FluMist recipients and at a higher rate compared to active control was sneezing (2% FluMist vs. 1% active control).

In a separate trial (MI-CP112) that compared the refrigerated and frozen formulations of FluMist in children and adults 5-49 years of age, the solicited events and other adverse events were consistent with observations from previous trials. Fever of > 103°F was observed in 1 to 2% of children 5-8 years of age.

In a separate placebo-controlled trial (D153-P526) using the refrigerated formulation in a subset of older children and adolescents 9-17 years of age who received one dose of FluMist, the solicited events and other adverse events were generally consistent with observations from previous trials. Abdominal pain was reported in 12% of FluMist recipients compared to 4% of placebo recipients and decreased activity was reported in 6% of FluMist recipients compared to 0% of placebo recipients.

Adverse Reactions in Adults

In adults 18-49 years of age in Study AV009, summary of solicited adverse events occurring in at least 1% of FluMist recipients and at a higher rate compared to placebo include runny nose (44% FluMist vs. 27% placebo), headache (40% FluMist vs. 38% placebo), sore throat (28% FluMist vs. 17% placebo), tiredness/weakness (26% FluMist vs. 22% placebo), muscle aches (17% FluMist vs. 15% placebo), cough (14% FluMist vs. 11% placebo), and chills (9% FluMist vs. 6% placebo).

In addition to the solicited events, other adverse reactions from Study AV009 occurring in at least 1% of FluMist recipients and at a higher rate compared to placebo were: nasal congestion (9% FluMist vs. 2% placebo) and sinusitis (4% FluMist vs. 2% placebo).

Postmarketing Experience

The following adverse reactions have been identified during postapproval use of FluMist. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to vaccine exposure.

Congenital, familial and genetic disorder: Exacerbation of symptoms of mitochondrial encephalomyopathy (Leigh syndrome).

Gastrointestinal disorders: Nausea, vomiting, diarrhea

Immune system disorders: Hypersensitivity reactions (including anaphylactic reaction, facial edema and urticaria)

Nervous system disorders: Guillain-Barré syndrome, Bell's Palsy

Respiratory, thoracic and mediastinal disorders: Epistaxis

Skin and subcutaneous tissue disorders: Rash

Read the entire FDA prescribing information for Influenza A H1N1 Intranasal Vaccine (Influenza A H1N1 Monovalent Intranasal Vaccine Live) »

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