FluMist is not indicated in children < 24 months of age. In a clinical trial, 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 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 post-marketing.

[See Warnings and PRECAUTIONS and ADVERSE REACTIONS]

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

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

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 ages 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.

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

Aspirin Therapy

Do not administer FluMist to children or adolescents who are receiving aspirin therapy or aspirin-containing therapy [see CONTRAINDICATIONS].

Antiviral Agents Against Influenza A and/or B

The concurrent use of FluMist with antiviral agents that are active against influenza A and/or B viruses has not been evaluated. However, based upon the potential for antiviral agents to reduce the effectiveness of FluMist, do not administer FluMist until 48 hours after the cessation of antiviral therapy and antiviral agents should not be administered until two weeks after administration of FluMist unless medically indicated. If antiviral agents and FluMist are administered concomitantly, revaccination should be considered when appropriate.

Concomitant Inactivated Vaccines

The safety and immunogenicity of FluMist when administered concurrently with inactivated vaccines have not been determined. Studies of FluMist excluded subjects who received any inactivated or subunit vaccine within two weeks of enrollment. Therefore, healthcare providers should consider the risks and benefits of concurrent administration of FluMist with inactivated vaccines.

Concomitant Live Vaccines

Concurrent administration of FluMist with the measles, mumps and rubella vaccine and the varicella vaccine was studied in 1245 children 12-15 months of age. Adverse events were similar to those seen in other clinical trials with FluMist [see ADVERSE REACTIONS]. No evidence of interference with immune responses to measles, mumps, rubella, varicella and FluMist vaccines was observed. The safety and immunogenicity in children > 15 months of age have not been studied.

Intranasal Products

There are no data regarding co-administration of FluMist with other intranasal preparations.

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