FluMist® (Influenza Virus Vaccine Live, Intranasal) is the first and only nasal spray flu vaccine approved in the U.S. to help prevent influenza and is indicated for the active immunization of eligible individuals two to 49 years of age against influenza disease caused by influenza virus subtypes A and type B contained in the vaccine. FluMist is different from the flu shot in that it uses live, attenuated – or weakened – viruses within the vaccine to help stimulate an immune response that is designed to closely resemble the body’s natural response to an influenza infection. FluMist is needle- and preservative-free.
In a pivotal study that included more than 4,000 children between the ages of two and five years of age during the 2004-2005 influenza season, there was a 54 percent reduction in cases of flu in children who received FluMist compared with those who received the traditional flu shot (4.5 percent vs. 9.8 percent, respectively). In the study, FluMist demonstrated a reduction in influenza rates compared to the inactivated vaccine against strains that were both matched and mismatched to the vaccine.
Influenza, commonly referred to as “the flu,” is a contagious disease caused by the influenza virus. The flu, much like the common cold, is airborne and can be easily transmitted from person to person. When a person infected with the flu virus sneezes, coughs, or even speaks, microscopic droplets that contain the virus are expelled into the air, which, if inhaled, can infect others. The flu can also be transmitted by touching contaminated surfaces and then touching the eyes, nose or mouth. Once the virus enters the respiratory system, it invades the lining of the throat, nasal passages and sometimes the lungs, and can cause an infection. The virus then infects healthy cells, rapidly reproducing thousands of copies, which can, in turn, infect other cells throughout the respiratory tract. Each year, up to 60 million Americans get the flu. Resulting complications cause more than 200,000 hospitalizations and about 36,000 deaths in the U.S. each year.
Important Safety Information
FluMist is a live attenuated influenza virus vaccine indicated for active immunization of individuals two to 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 less than two years 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 less than five 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-Barre 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 in 10 percent or more of individuals receiving FluMist and at a rate at least five percent higher than in those receiving placebo) are runny nose or nasal congestion in recipients of all ages, fever more than 100 degrees Fahrenheit in children two to six 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 complete Prescribing Information for FluMist,
call 1-877-FLUMIST (1-877-358-6478) or visit FluMist.com for additional information.
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