Nasal Influenza Vaccine Approved for Younger Children
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On September 19, 2007, FDA approved the nasal influenza vaccine FluMist for use in children between the ages of 2 and 5. Approval for the vaccine, which contains a weakened form of the live virus and is sprayed in the nose, was previously limited to healthy children 5 years of age and older and to adults up to age 49. FluMist is manufactured by MedImmune Vaccines, Inc., Gaithersburg , Md.
"The goal of preventing influenza is now more attainable with the availability of FluMist for younger children," says Jesse L. Goodman, M.D., director of FDA's Center for Biologics Evaluation and Research. "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."
Until now, there were only two influenza vaccines licensed in the U.S. for children under age 5. Fluzone, manufactured by sanofi pasteur Inc., Swiftwater , Pa. , is indicated for people over 6 months of age. Fluvirin, made by Novartis Vaccines and Diagnostics Ltd, Liverpool, England, is available for children age 4 and older.
Safety and Effectiveness
Approximately 6,400 infants and children age 6 months to 59 months received FluMist in three studies to support the vaccine's safety and effectiveness. Two studies compared FluMist to placebo (no vaccine), both of which demonstrated the vaccine's effectiveness in preventing influenza illness.
A third study compared FluMist to an inactivated or "killed" seasonal influenza vaccine shot. The results showed that there were 53 cases of influenza among 3,900 children who received FluMist compared to 93 cases among the same number of children who received an inactivated or “killed” seasonal influenza vaccine shot.
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 2 to 6 years of age.
Who Should NOT Receive FluMist?
- 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 should not be administered to anyone with asthma or to children under the age of 5 years with recurrent wheezing because of the potential for increased wheezing after receiving the vaccine.
- People who are allergic to any of FluMist's components, including eggs or egg products, should also not receive the vaccine.
The U.S. Centers for Disease Control and Prevention recommends that all children age 6 months to 59 months receive a vaccination to protect against influenza.
Studies have shown that children younger than 5 years had rates of influenza-associated hospitalizations similar to those among individuals age 50 through 64 years, emphasizing the need for improved influenza prevention efforts for this younger population.
This article appears on FDA's Consumer Update page, which features the latest on all FDA-regulated products.
Date Posted: September 26, 2007