Reproduced with permission from Therapeutic Goods Administration (TGA) Medicines Safety Update 5 June 2026.

 

Summary

The TGA have identified reports of FluMist being administered in error to children under 2 years of age.

FluMist is a new influenza vaccine delivered via nasal spray and is indicated for the prevention of influenza in children and adolescents aged 24 months to less than 18 years.

Early clinical trial data indicated increased rates of hospitalisation in children aged 6–11 months and wheezing in children aged 6–23 months following vaccination.

A search of the TGA’s Database of Adverse Event Notifications in May 2026, identified 161 adverse event reports for the trade name ‘FluMist’. Most of these reports (116) involved administration errors in children under 2 years of age, including:*

  • 89 ‘product administered to patient of inappropriate age’
  • 38 ‘wrong product administered’
  • 4 ‘vaccination error’
  • 3 ‘inappropriate schedule of product information’
  • 1 ‘product label confusion’
 

What health professionals should do

To minimise the risk of incorrect administration of FluMist, health professionals should:

  • Confirm the child is 24 months or older before administering FluMist.
  • Carefully review the Product Information, available on the TGA website, including the indication, dose, method of administration and contraindications.

See the full article on the TGA website.


* More than one term can be reported per adverse event report. None of these reports was classified as serious.