其 他 安 全 警 示
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| Australia: Be alert to FluMist indicated age range (English only) |
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The Therapeutic Goods Administration (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.
TGA searched their 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’
* More than one term can be reported per adverse event report.
None of these reports was classified as serious.
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.
Background
FluMist is a live attenuated influenza vaccine administered as an intranasal vaccine, with one spray given into each nostril. It may be given at the same time as live or non-live vaccines and has shown similar efficacy to injectable influenza vaccines in children.
Please refer to the following website in TGA for details:
http://www.tga.gov.au/news/safety-updates/be-alert-flumist-indicated-age-range
In Hong Kong, FluMist Quadrivalent Influenza Intranasal Vaccine (HK-65690) and FluMist Trivalent Influenza Intranasal Vaccine (HK-68239) are pharmaceutical products registered by AstraZeneca Hong Kong Limited. Both products are prescription-only medicine. So far, the Department of Health (DH) has received 3 cases of adverse drug reaction report with regards to FluMist and these cases were not related to administration to children under 2 years of age. The current product inserts of the 2 local registered FluMist vaccines are indicated for use in persons 2 through 49 years of age. The DH will remain vigilant on safety update of the vaccine issued by other overseas drug regulatory authorities.
Ends/Saturday, Jun 6, 2026
Issued at HKT 12:00
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