FDA Approves FluMist for Use in 2- to 5-Year-Olds

However, vaccine can increase risk of wheezing, hospitalizations in children under age 2

WEDNESDAY, Sept. 19 (HealthDay News) -- The U.S. Food and Drug Administration has approved the FluMist intranasal influenza vaccine for children ages 2 to 5. The vaccine should not be given to any patient with asthma or children under 5 with wheezing as it may increase the risk of wheeze.

FluMist increased the risk of wheeze and hospitalization in children under age 2 in clinical trials, so it should not be used in this age group. The vaccine, which is made by MedImmune Vaccines, Inc. of Gaithersburg, Md., has already been approved for healthy children and adults aged 5 to 49.

The side effects can include nasal congestion, runny nose and slight fever.

"The goal of preventing influenza is now more attainable with the availability of FluMist for younger children," said Jesse L. Goodman, M.D., director of the FDA's Center for Biologics Evaluation and Research, in a statement. "This approval also offers parents and health professionals a needle-free option for squeamish toddlers, who may be reluctant to get a traditional influenza shot."

Flu vaccines are recommended for all children aged 6 to 59 months because, like older adults, they are at greater risk of flu complications.

Two other vaccines are approved for use in children. Fluzone can be used in children over 6 months of age and Fluvirin can be used in children age 4 or older.

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