FDA Approves AstraZeneca's Flumist for Toddlers
U.S. health officials said Wednesday they approved the Flumist nasal spray influenza vaccine for children between ages 2 and 5.
Flumist is made by MedImmune, which was recently acquired by AstraZeneca.
Previously, the vaccine was approved only for healthy children age 5 and older and adults up to age 49. The approval "offers parents and health professionals a needle-free option for squeamish toddlers, who may be reluctant to get a traditional influenza shot," said Dr. Jesse Goodman, head of FDA's Center for Biologics Evaluation and Research.
Children under 2 should not receive Flumist because there was an increased risk of hospitalization and wheezing in that age group during MedImmune's clinical trials, the FDA said.
Flumist also should not be given to anyone with asthma or to children under 5 with recurrent wheezing, the agency said.
Side effects from Flumist were generally mild and most often included runny nose, nasal congestion or a slight fever in children 2 to 6 years old, the FDA said.