Contingency Planning

FDA Approves Nasal Influenza Vaccine for Use in Younger Children

October 2, 2007

The U.S. Food and Drug Administration has approved expanding the population for use of the nasal influenza vaccine FluMist to include children between the ages of two and five.

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 five years of age and older and to adults up to age 49.

"The goal of preventing influenza is now more attainable with the availability of FluMist for younger children," says Jesse L. Goodman, MD, director, 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."

The U.S. Centers for Disease Control and Prevention recommends that all children age six months to 59 months receive a vaccination to protect against influenza. Studies have shown that children younger than five 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 U.S. population.

However, there have been only two vaccines licensed in the United States for children under the age of 5. One influenza vaccine, Fluzone, is indicated for people over six months of age, while another vaccine, Fluvirin, is available for use in children age four and older.

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 disease 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. 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.

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 two to six years of age.

FluMist should not be administered to anyone with asthma or to children under the age of five 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.

- DHHS