FDA Approves FluMist For Children Ages 2 to 5

MedImmune has cleared a significant hurdle to revive its long-troubled nasal flu vaccine, announcing yesterday that the Food and Drug Administration had approved FluMist for children 2 to 5 years old.

It spent $100 million on a study that showed FluMist was 55 percent more successful than flu shots at protecting children from influenza. The results were used to support MedImmune's expanded approval application, though the FDA is not allowing use of FluMist for children under 2, who had more side effects.

Steve - Here is verbatim what the prescribing information states:

Safety.
FluMist is a live attenuated influenza virus 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>100°F in children 2-6 years of age, and sore throat in adults. FluMist may not protect all individuals receiving the vaccine.

Steve's Comment: all research and safety studies were paid for by the vaccine manufacturer.

Ingredients.
In addition to the flu viruses, each 0.2 mL dose also contains 0.188 mg/dose monosodium glutamate, 2.00 mg/dose hydrolyzed porcine gelatin, 2.42 mg/dose arginine, 13.68 mg/dose sucrose, 2.26 mg/dose dibasic potassium
phosphate, 0.96 mg/dose monosodium phosphate, and <0.015 style="font-style: italic;">Steve's Comment: contains two types of Monosodium Glutamate, sugar, and an antibiotic.

Mechanism of Action.
Immune mechanisms conferring protection against influenza following receipt of FluMist vaccine are not fully understood. Likewise, naturally acquired immunity to wild-type influenza has not been completely elucidated. Serum antibodies, mucosal antibodies and influenza-specific T cells may play a role in prevention and recovery from infection. Influenza illness and its complications follow infection with influenza viruses. Global surveillance of influenza identifies yearly antigenic variants. For example, since 1977, antigenic variants of influenza A (H1N1 and H3N2) viruses and influenza B viruses have been in global circulation. Antibody against one influenza virus type or subtype confers limited or no protection against another. Furthermore, antibody to one antigenic variant of influenza virus might not protect against a new antigenic variant of the same type or subtype. Frequent development of antigenic variants through antigenic drift is the virologic basis for seasonal epidemics and the reason for the usual change of one or more new strains in each year’s influenza vaccine. Therefore, influenza vaccines are standardized to contain the strains (i.e., typically two type A and one type B), representing the influenza viruses likely to be circulating in the United States in the upcoming winter. Annual revaccination with the current vaccine is recommended because immunity declines during the year after vaccination, and because circulating strains of influenza virus change from year to year.

Steve's Translation: every year, we guess what we think will be the most virulent strains.

FluMist recipients should avoid close contact (e.g., within the same household) with anyone with a weakened immune system for at least 21 days after receiving the vaccine.

Steve's Comment: did they consider close contact with immune compromised children in a school or day care setting? They tell you 21 days because it is a live virus...it could give someone else the flu!

Here is the link to FluMist Prescribing Info:
http://www.flumist.com/pdf/FluMist-prescribing-information.pdf