TGA Warns Against FluMist Administration in Children Under 2 Following Over 100 Adverse Event Reports
核心洞察
The TGA has issued a safety alert after identifying 161 adverse event reports for FluMist in May 2026, with 116 involving children under two years of age.
Early clinical trial data showed increased rates of hospitalisation in infants aged 6–11 months and wheezing in children aged 6–23 months following vaccination.
None of the reported adverse events were classified as serious, but the TGA urges health professionals to confirm a child is 24 months or older before administering the nasal vaccine.
The Therapeutic Goods Administration (搜索) (TGA) has issued an urgent safety alert warning healthcare professionals not to administer the FluMist nasal influenza (搜索) vaccine to children under two years of age, following a surge in adverse event notifications involving off-label use in infants.
A search of the TGA's Database of Adverse Event Notifications (DAEN) in May 2026 identified 161 adverse event reports linked to the trade name "FluMist." Of these, 116 reports—more than 70%—involved administration errors in children aged one year or younger. The reports included 89 instances of "product administered to patient of inappropriate age," 38 cases of "wrong product administered," four "vaccination error" reports, three describing an "inappropriate schedule of product information," and one citing "product label confusion."
The regulator noted that none of the reports was classified as serious, but the volume of errors has prompted immediate concern. The data does not specify which health professionals delivered the vaccinations or whether any further adverse effects occurred.
Clinical Trial Evidence Behind the Age Restriction
The TGA's warning referenced early clinical trial data that underpins the age restriction for FluMist. According to the regulator, these trials indicated increased rates of hospitalisation in children aged 6–11 months and wheezing in children aged 6–23 months following vaccination. FluMist is formally indicated for the prevention of influenza (搜索) in children and adolescents aged 24 months to less than 18 years.
State-Funded Programs and Uptake
FluMist, a needle-free vaccine delivered via nasal spray, was introduced this year as part of state-government-funded programs in New South Wales, Queensland, South Australia, and Western Australia. The ages covered by these state-funded programs vary widely. The vaccine is not currently listed under the National Immunisation Program (NIP) but is available privately in jurisdictions where no subsidies have been put in place.
Dr Kerry Hancock, Chair of RACGP Specific Interests Respiratory Medicine, described the TGA warning as a timely reminder for a vaccine likely to see widespread use this year. "It's only TGA-approved for [the 2–17] age group and we need to ensure that's the age group that gets it, that it's not inappropriately administered to children less than two years of age," she said.
Addressing Vaccination Errors and Parental Pressure
Dr Hancock acknowledged that some vaccinators may encounter pressure from parents seeking the needle-free option for younger children but emphasised that injectable influenza (搜索) vaccinations remain widely available for children under two. She noted that the nasal-spray vaccine is particularly valuable for older children. "To me, it's the older children who are a bit more frightened of needles," she said. "To be able to offer that age group, especially the primary school and high school age groups, a nasal vaccine is just phenomenal."
A further search of the DAEN on 9 June also identified five reports of older patients being administered the vaccine in error, all of whom were aged 45 or older.
Recommendations for Health Professionals
The TGA has outlined clear steps for health professionals to minimise the risk of incorrect administration: confirm the child is 24 months or older before administering FluMist, and carefully review the Product Information available on the TGA website, including the indication, dose, method of administration, and contraindications.
Dr Hancock expressed support for broader access to the vaccine, calling for its inclusion on the NIP for children aged 2–4 and urging state governments to consider funding older age groups where they do not already. "If we've got that evidence, why don't we put that into action?" she said.