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].

*CDC/ACIP = Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices

References
  1. FluMist [package insert]. Gaithersburg, MD: Medlmmune, LLC.
  2. Centers for Disease Control and Prevention. Key Facts about Influenza (Flu) & Flu Vaccine. http://www.cdc.gov/flu/keyfacts.htm. Accessed April 1, 2011.
  3. 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.
  4. 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.
  5. 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.
  6. 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.
  7. Savage JH, Matsui EC, Skripak JM, Wood RA. The natural history of egg allergy. J Allergy Clln Immunol. 2007:120:1413-1417.
  8. 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