Information for Healthcare Professionals

References

  1. Prescribing Information for FluMist® (Influenza Virus Vaccine Live, Intranasal). MedImmune, LLC, Gaithersburg, MD.
  2. Data on file, MedImmune, LLC, Gaithersburg, MD.
  3. Centers for Disease Control and Prevention. Prevention and control of seasonal influenza with vaccines: Recommendations of the Advisory Committee on Immunization Practices (ACIP), 2009 <http://www.cdc.gov/mmwr/preview/mmwrhtml/rr58e0724a1.htm>. MMWR. 2009;58(Early Release):1-52.
  4. Tam JS, Capeding MR, Lum LC, et al. Efficacy and Safety of a Live Attenuated, Cold-Adapted Influenza Vaccine, Trivalent (CAIV-T) Against Culture-Confirmed Influenza in Young Children in Asia. Pediatr Infect Dis J. 2007; 26: 619-628.
  5. Treanor JJ, Kotloff K, Betts RF, et al. Evaluation of trivalent, live, cold-adapted (CAIV-T) and inactivated (TIV) influenza vaccines in prevention of virus infection and illness following challenge of adults with wild-type influenza A (H1N1), A (H3N2), and B viruses. Vaccine. 1999;18:899-906.
  6. Nichol KL, Mendelman PM, Mallon KP, et al. Effectiveness of Live, Attenuated Intranasal Influenza Virus Vaccine in Healthy, Working Adults: A Randomized Controlled Trial. JAMA. 1999; 282: 137-144.
  7. Centers for Disease Control and Prevention. Recommended Immunization Schedules for Persons Aged 0-18 Years − United States, 2008. MMWR. 2007;56(51&52):Q1-Q4. Available at: http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5701a8.htm. Accessed July 8, 2009.
  8. Epidemiology and Prevention of Vaccine-Preventable Diseases, 11th Edition, (The Pink Book) published by the National Immunization Program, Centers for Disease Control and Prevention. Chapter 10: Influenza. Available at http://www.cdc.gov/vaccines/pubs/pinkbook/downloads/flu-508.pdf. Accessed July 8, 2009.
  9. American Academy of Pediatrics. Recommendations for Prevention and Control of Influenza Immunization in Children, 2009-2010. Available at: http://aapredbook.aappublications.org/news/FluPolicy2009-10.pdf. Accessed August 11, 2009.
  10. Centers for Disease Control and Prevention: Advisory Committee Recommends Influenza Vaccination for Children 6 months through 18 years of age. Available at http://www.cdc.gov/media/pressrel/2008/r080227.htm. Accessed July 8, 2009.

Important Safety Information

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.

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 or if an individual is immunocompromised, the decision to give FluMist should be based on careful consideration of the potential benefits and risks. 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.