Influenza A (H1N1) 2009 Monovalent Vaccine Live, Intranasal

• 21 pages
• September 15, 2009

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use Influenza A (H1N1) 2009 Monovalent Vaccine Live, Intranasal safely and effectively. See full prescribing information for Influenza A (H1N1) 2009 Monovalent Vaccine Live, Intranasal

Influenza A (H1N1) 2009 Monovalent Vaccine Live, Intranasal Manufactured by MedImmune, LLC Intranasal Spray Initial U.S. Approval: 2003

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5 WARNINGS AND PRECAUTIONS

MedImmune’s Influenza A (H1N1) 2009 Monovalent Vaccine Live, Intranasal and seasonal trivalent Influenza Vaccine Live, Intranasal (FluMist) are manufactured by the same process. Information in this section is based on studies conducted with FluMist.

5.1 Risks in Children <24 Months of Age

Do not administer Influenza A (H1N1) 2009 Monovalent Vaccine Live, Intranasal or FluMist to children <24 months of age. In clinical trials, an increased risk of wheezing post-vaccination was observed in FluMist recipients <24 months of age. An increase in hospitalizations was observed in children <24 months of age after vaccination with FluMist. [See Adverse Reactions (6.1).]

5.2 Asthma/Recurrent Wheezing

Influenza A (H1N1) 2009 Monovalent Vaccine Live, Intranasal or FluMist should not be administered to any individuals with asthma or children < 5 years of age with recurrent wheezing because of the potential for increased risk of wheezing post vaccination unless the potential benefit outweighs the potential risk.
Do not administer Influenza A (H1N1) 2009 Monovalent Vaccine Live, Intranasal or FluMist to individuals with severe asthma or active wheezing because these individuals have not been studied in clinical trials.

5.3 Guillain-Barré Syndrome

If Guillain-Barré syndrome has occurred within 6 weeks of any prior influenza vaccination, the decision to give Influenza A (H1N1) 2009 Monovalent Vaccine Live, Intranasal or FluMist should be based on careful consideration of the potential benefits and potential risks [see also Adverse Reactions (6.2)].

5.4 Altered Immunocompetence

Administration of Influenza A (H1N1) 2009 Monovalent Vaccine Live, Intranasal, or FluMist live virus vaccine, to immunocompromised persons should be based on careful consideration of potential benefits and risks. Although FluMist was studied in 57 asymptomatic or mildly symptomatic adults with HIV infection [see Clinical Studies (14.3)], data supporting the safety and effectiveness of FluMist administration in immunocompromised individuals are limited.

5.5 Medical Conditions Predisposing to Influenza Complications

The safety of Influenza A (H1N1) 2009 Monovalent Vaccine Live, Intranasal or FluMist in individuals with underlying medical conditions that may predispose them to complications following wild-type influenza infection has not been established. Influenza A (H1N1) 2009 Monovalent Vaccine Live, Intranasal should not be administered unless the potential benefit outweighs the potential risk.

5.6 Management of Acute Allergic Reactions

Appropriate medical treatment and supervision must be available to manage possible anaphylactic reactions following administration of the vaccine [see Contraindications (4.1)].

5.7 Limitations of Vaccine Effectiveness

Influenza A (H1N1) 2009 Monovalent Vaccine Live, Intranasal may not protect all individuals receiving the vaccine.

6 ADVERSE REACTIONS

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 post-marketing experience with FluMist. [See Warnings and Precautions (5.1) and Adverse Reactions (6.1, 6.2).]

6.1 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.

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.

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).

6.2 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

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