TGA Urges Caution Following FluMist Administration Errors in Young Children

The Therapeutic Goods Administration (TGA) is reminding healthcare professionals to carefully check age eligibility before administering FluMist, following reports that the nasal spray influenza vaccine has been given to children younger than its approved age range.

FluMist is a live attenuated influenza vaccine delivered as a nasal spray and is approved for use in children and adolescents aged 24 months to less than 18 years.

A review of adverse event reports submitted to the TGA identified 161 reports involving FluMist up to May 2026. Of these, 116 related to administration errors in children under two years of age. The most commonly reported issues included administering the vaccine to children who were too young, giving the wrong vaccine product, and other vaccination-related errors.

Importantly, none of the reported cases were classified as serious.

The TGA has advised healthcare professionals to confirm that children are at least 24 months of age before administering FluMist and to carefully review the Product Information, including approved indications, dosing instructions, administration methods and contraindications.

Early clinical trial data found increased rates of hospitalisation in infants aged 6–11 months and increased wheezing in children aged 6–23 months following vaccination, which is why FluMist is not approved for use in children under two years of age.

FluMist offers an alternative to injectable influenza vaccines and has demonstrated similar effectiveness in children. While it is not currently funded under the National Immunisation Program, several Australian states and territories have introduced funded programs for eligible children, with private prescriptions available elsewhere.

The TGA encourages all immunisation providers to remain vigilant and ensure vaccines are administered according to approved age indications to minimise the risk of administration errors.

Read the full safety update on the Therapeutic Goods Administration website.