TGA issued a safety update alerting health professionals to FluMist administration errors in children under 2 years and reinforcing the indicated age range (≥24 months to <18 years).
Off-label use in younger children carries risks of hospitalisation and wheezing; errors are widespread (116 of 161 reports).
Confirm child is 24 months or older before administering FluMist; review Product Information; verify patient age against indication.
Regulatory Intelligence Lead
single-event
Confirm child is 24 months or older before administration. Review Product Information including indication and contraindications.
Confirm child is 24 months or older before administering FluMist; review Product Information; verify patient age against indication.
TGA reports 116 administration errors of FluMist in children under 2 years, based on 161 adverse event reports from May 2026 database search. Early clinical data showed increased hospitalisation (6-11 months) and wheezing (6-23 months). Health professionals must confirm age ≥24 months before administration.
What changed: TGA issued a safety update alerting health professionals to FluMist administration errors in children under 2 years and reinforcing the indicated age range (≥24 months to <18 years).
Why it matters: Off-label use in younger children carries risks of hospitalisation and wheezing; errors are widespread (116 of 161 reports).
Practical implication: Confirm child is 24 months or older before administering FluMist; review Product Information; verify patient age against indication.
Published from the Firecrawl agent regulatory extraction pipeline.
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