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Influenza A H1N1 Intranasal Vaccine

"There are two types of flu vaccine: the flu shot and the nasal spray vaccine. Both types of vaccine are being made against 2009 H1N1 swine flu. The nasal spray flu vaccine (sometimes called LAIV for Live Attenuated Influenza Vaccine) is a v"...

Influenza A H1N1 Intranasal Vaccine

Warnings
Precautions

WARNINGS

Included as part of the PRECAUTIONS section.

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.

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.]

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.

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].

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], data supporting the safety and effectiveness of FluMist administration in immunocompromised individuals are limited.

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.

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].

Limitations of Vaccine Effectiveness

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

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment of Fertility

Neither Influenza A (H1N1) 2009 Monovalent Vaccine Live, Intranasal nor FluMist have been evaluated for carcinogenic or mutagenic potential or potential to impair fertility.

Use In Specific Populations

MedImmune's Influenza A (H1N1) 2009 Monovalent Vaccine Live, Intranasal and seasonal trivalent Influenza Vaccine Live, Intranasal (FluMist) are manufactured by the same process. Available information for FluMist is provided in this section.

Pregnancy

Pregnancy Category C

Animal reproduction studies have not been conducted with Influenza A (H1N1) 2009 Monovalent Vaccine Live, Intranasal or FluMist. It is not known whether Influenza A (H1N1) 2009 Monovalent Vaccine Live, Intranasal or FluMist can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Influenza A (H1N1) 2009 Monovalent Vaccine Live, Intranasal or FluMist should be given to a pregnant woman only if clearly needed.

The effect of FluMist on embryo-fetal and pre-weaning development was evaluated in a developmental toxicity study using pregnant rats receiving the frozen formulation. Groups of animals were administered FluMist either once (during the period of organogenesis on gestation day 6) or twice (prior to gestation and during the period of organogenesis on gestation day 6), 250 microliter/rat/occasion (approximately 110-140 human dose equivalents), by intranasal instillation. No adverse effects on pregnancy, parturition, lactation, embryo-fetal or pre-weaning development were observed. There were no FluMist related fetal malformations or other evidence of teratogenesis noted in this study.

Nursing Mothers

It is not known whether Influenza A (H1N1) 2009 Monovalent Vaccine Live, Intranasal or FluMist is excreted in human milk. Therefore, as some viruses are excreted in human milk and additionally, because of the possibility of shedding of vaccine virus and the close proximity of a nursing infant and mother, caution should be exercised if Influenza A (H1N1) 2009 Monovalent Vaccine Live, Intranasal or FluMist is administered to nursing mothers.

Pediatric Use

Safety and effectiveness of FluMist has been demonstrated for children 2 years of age and older with reduction in culture-confirmed influenza rates compared to active control (injectable influenza vaccine made by Sanofi Pasteur Inc.) and placebo [see Clinical Studies]. Influenza A (H1N1) 2009 Monovalent Vaccine Live, Intranasal is not approved for use in children < 24 months of age. FluMist use in children < 24 months has been associated with increased risk of hospitalization and wheezing in clinical trials [see WARNINGS AND PRECAUTIONS and ADVERSE REACTIONS].

Geriatric Use

Influenza A (H1N1) 2009 Monovalent Vaccine Live, Intranasal is not approved for use in individuals ≥ 65 years of age. Subjects with underlying high-risk medical conditions (n=200) were studied for safety. Compared to controls, FluMist recipients had a higher rate of sore throat.

Use in Individuals 50-64 Years of Age

Influenza A (H1N1) 2009 Monovalent Vaccine Live, Intranasal is not approved for use in individuals 50-64 years of age. In Study AV009, effectiveness of FluMist was not demonstrated in individuals 50-64 years of age (n=641). Solicited adverse events were similar in type and frequency to those reported in younger adults.

Last reviewed on RxList: 11/5/2009
This monograph has been modified to include the generic and brand name in many instances.

Warnings
Precautions
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