Who May Be A Candidate?

FluMist® is a vaccine indicated for active immunization of individuals 2-49 years of age against influenza disease caused by influenza virus subtypes A and type B contained in the vaccine.

Most individuals 2-49 years of age — more than 80% — are candidates for FluMist®. Fewer than 20% of individuals may have exclusionary conditions.1-6

Please see complete Prescribing Information for a complete list of contraindications, warnings, precautions, and adverse events.

*Twenty percent is derived from disease prevalence rates in the medical literature.

Contraindications

Hypersensitivity

elegibility checklist

FluMist is contraindicated in individuals with a history of hypersensitivity, especially anaphylactic reactions to eggs, egg proteins, gentamicin, gelatin, or arginine or with life-threatening reactions to previous influenza vaccinations.

Concomitant Pediatric and Adolescent
Aspirin Therapy and Reye's Syndrome

FluMist is contraindicated in children and adolescents (2 through 17 years of age) receiving aspirin therapy or aspirin-containing therapy, because of the association of Reye's syndrome with aspirin and wild-type influenza infection. Children or adolescents should not be given aspirin until four weeks after vaccination with FluMist.

Warnings and Precautions

Risks in Children <24 Months of Age

Do not administer 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.

Asthma/Recurrent Wheezing

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 benefits outweigh the potential risks.

Do not administer 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 FluMist should be based on careful consideration of the potential benefits and potential risks.

Altered Immunocompetence

Data supporting the safety and effectiveness of FluMist administration in immunocompromised individuals are limited to 174 individuals with HIV infection and 10 mild to moderately immunocompromised children and adolescents with cancer.

Medical Conditions Predisposing to Influenza Complications

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. FluMist should not be administered unless the potential benefit outweighs the potential risk.

Management of Acute Allergic Reactions

Appropriate medical treatment supervision must be available to manage possible anaphylactic reactions following administration of the vaccine.

Limitations of Influenza Vaccine Effectiveness

FluMist may not protect all individuals receiving the vaccine.

View Eligibility Checklist PDF arrow

Important Safety Information

FluMist® (Influenza Vaccine Live, Intranasal) is a vaccine indicated for active immunization of individuals 2-49 years of age against influenza disease caused by influenza virus subtypes A and type B contained in the vaccine.

FluMist is contraindicated in individuals with history of hypersensitivity to eggs, egg proteins, gentamicin, gelatin or arginine or with life-threatening reactions to previous influenza vaccinations, and in children and adolescents receiving concomitant aspirin or aspirin-containing therapy.

Do not administer FluMist to children <24 months of age due to an increased risk of hospitalization and wheezing that was observed in clinical trials. FluMist should not be administered to any individual with asthma and to children <5 years of age with recurrent wheezing unless the potential benefit outweighs the potential risk. Do not administer FluMist to individuals with severe asthma or active wheezing.

If Guillain-Barré syndrome has occurred with prior influenza vaccination, the decision to give FluMist should be based on careful consideration of the potential benefits and risks. Data supporting the safety and effectiveness of FluMist administration in immunocompromised individuals are limited. FluMist should not be administered to individuals with underlying medical conditions predisposing them to wild-type influenza infection complications unless the potential benefit outweighs the potential risk. FluMist should be given to a pregnant woman only if clearly needed.

Most common adverse reactions (occurring at ≥10% in individuals receiving FluMist and at least 5% greater than in placebo) are runny nose or nasal congestion in recipients of all ages, fever >100°F in children 2-6 years of age, and sore throat in adults.

FluMist may not protect all individuals receiving the vaccine. FluMist is for intranasal administration only.

Please see accompanying complete Prescribing Information, including Patient Information [PDF PDF].

References
  1. Centers for Disease Control and Prevention. Prevention and control of influenza with vaccines: recommendations of the Advisory Committee on lmmunization Practices (ACIP), 2010. MMWR. 2010 Aug 6;59(RR-8):1-62.
  2. Vezina RM, Lesko SM, Corwin MJ, Gottlieb DJ. Association of early infant exposures to wheezing and asthma by age five. Paediatr Perinat EpidemioI, 2001, 15(4):A34-A35.
  3. Yawn BP, Wollan P, Scanlon P, Kurland M. Are we ready for universal school-based asthma screening? An outcomes evaluation. Arch Pediatr Adolesc Med. 2002;156.1256-1262.
  4. U.S Census-lntercensal estimates of the United States resident population by age and sex. http://www.census.gov/popest/archives/EST901NTERCENSAL/US-EST901NT-07/US-EST901NT-07.csv. Accessed April 12, 2010.
  5. Savage JH, Matsui EC, Skripak JM, Wood RA. The natural history of egg allergy. J Allergy Clln Immunol. 2007:120:1413-1417.
  6. Centers for Disease Control and Prevention. Estimates of influenza vaccination target population sizes in 2006 and recent vaccine uptake levels. http://www.cdc.gov/flu/professionals/vaccination/pdf/targetpopchart.pdf. Accessed April 12, 2010