ROCKVILLE, Md. -- The FDA has expanded the indications for FluMist, a nasal influenza vaccine, to include children ages two to five.
ROCKVILLE, Md., Sept. 20 -- The FDA has expanded the indications for FluMist, a nasal influenza vaccine, to include children ages two to five.
The aerosolized vaccine, which contains a weakened form of the live virus, had already been approved for use in patients ages five to 49.
The FDA did not extend approval of the drug for children under the age of two because clinical trials showed an increased risk of hospitalization and wheezing for children in that age group.
But extension of the indications to pre-schoolers offers "a needle-free option for squeamish toddlers, who may be reluctant to get a traditional influenza shot," said Jesse L. Goodman, M.D., M.P.H., director of the FDA's Center for Biologics Evaluation and Research.
FluMist now joins two other flu vaccines approved for pre-school children. Fluzone is approved for those six months and older and Fluvirin is approved for children four and older.
Approximately 6,400 infants and children ages six months to 59 months received FluMist in three studies to support the vaccine's safety and effectiveness.
Two studies compared FluMist to placebo, both of which demonstrated effectiveness in preventing influenza illness.
A third study compared FluMist to an inactivated seasonal influenza vaccine delivered via injection. In that trial, there were 53 cases of influenza disease among 3,900 children who received FluMist compared with 93 cases in the control group.
Commonly observed adverse events from the vaccine were generally mild and most often included runny nose and nasal congestion, as well as a slight fever in children ages two to six.
FluMist should not be administered to anyone with asthma or to children under the age of five who have 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 CDC recommends that all children ages six months to 59 months receive a vaccination to protect against influenza. Studies have shown that children younger than five had rates of influenza-associated hospitalizations similar to those among individuals ages 50 through 64, emphasizing the need for improved influenza prevention efforts for this younger population.