FluMist Use in Children Under Two Under Scrutiny After TGA Alert
09 Jun 2026
The Therapeutic Goods Administration (TGA) has reminded healthcare workers that FluMist is only approved for people aged 24 months to under 18 years. The warning follows more than 100 reports in May where the vaccine was mistakenly given to infants younger than two.
FluMist is a needle-free flu vaccine given as a nasal spray and has recently been included in state-funded programs in New South Wales, Queensland, South Australia and Western Australia. However, the age groups covered vary between states.
According to the TGA’s Database of Adverse Event Notifications, 161 reports linked to FluMist were recorded in May. Of these, 116 involved children aged one year or younger. Most cases were linked to vaccination errors, including giving the vaccine to the wrong age group or using the wrong product. Some reports also noted confusion with product labels or incorrect scheduling.
The TGA confirmed that none of the reports were classified as serious, but stressed the importance of checking a child’s age before giving the vaccine and following official product information.
Early research cited by the regulator has shown higher hospitalisation rates in infants aged 6–11 months and wheezing in those aged 6–23 months after vaccination, which is why it is not approved for children under two.
RACGP respiratory medicine chair Dr Kerry Hancock said the warning is an important reminder as the vaccine becomes more widely used. She noted that injectable flu vaccines remain available for children under two, while FluMist is better suited for older children who may be anxious about needles.
She also suggested that wider funding and inclusion in the National Immunisation Program could improve access for eligible age groups.
A small number of additional errors were also reported in older adults, including people over 45 receiving the vaccine by mistake.
FluMist is not currently part of the National Immunisation Program but is available privately in some states.
FluMist Use in Children Under Two Under Scrutiny After TGA Alert
Source: Therapeutic Goods Administration (TGA) alert and newsGP (RACGP news)