FDA OKs FluMist for Kids Aged 2-5

Sept. 19, 2007 -- The FDA today approved FluMist, the nasal spray flu vaccine, for children aged 2 to 5.

FluMist was previously only approved for healthy people aged 5 through 49.

"This approval offers parents and health professionals a needle-free option for squeamish toddlers, who may be reluctant to get a traditional influenza shot," says Jesse Goodman, MD, in an FDA news release.

Goodman directs the FDA's Center for Biologics Evaluation and Research.

Flu season is right around the corner. The best time to get vaccinated is October or November, but you can still get vaccinated in December or later, according to the CDC.

About FluMist

FluMist contains a weakened form of live flu virus, which prepares the body to defend itself against those viruses during flu season.

Flu shots, which are also available for kids, contain killed flu virus. Flu shots or FluMist don't cause the flu.

Flu vaccines are redesigned each year to target the flu viruses that experts expect to be most common during the upcoming flu season. So last year's flu vaccine won't help you this year.

The FDA approved FluMist's younger age limit for children based on three studies that included about 6,400 children aged 6 months to nearly 5 years.

Two studies compared FluMist to a placebo spray containing no flu vaccine. FluMist trumped the placebo at preventing the flu.

In the third study, children got FluMist or a flu shot. Both vaccines were effective at preventing flu but didn't totally prevent flu.

Commonly observed adverse events from the vaccine were generally mild and most often included runny nose and/or nasal congestion, as well as a slight fever in children aged 2 to 6.

Flu Vaccination for Children

The CDC recommends yearly flu vaccinations for all children aged 6 to 59 months (nearly 5 years old).

Until today, there have been only two vaccines licensed in the U.S. for children under the age of 5. One influenza vaccine, Fluzone, is indicated for people over 6 months of age, while another vaccine, Fluvirin, is available for use in children aged 4 and older.

Children under the age of 2 should not receive FluMist because there was an increased risk of hospitalization and wheezing for this age group during the clinical trials.

FluMist shouldn't be given to anyone with asthma or to kids younger than 5 with recurrent wheezing because of the potential for increases in wheezing after receiving the vaccine.

People who are allergic to any of FluMist's components, including eggs or egg products, shouldn't receive the vaccine.

FluMist is made by MedImmune Vaccines Inc. Fluvirin is made by Novartis Vaccines and Diagnostics Ltd. Fluzone is made by Sanofi Pasteur Inc.