PV Bulletin

TGA Safety Alert: FluMist Indicated Age Range Errors

Reports of FluMist being administered in error to children under 2 years of age; product indicated for ≥24 months.

Primary source: https://www.tga.gov.au/news/safety-updates/be-alert-flumist-indicated-age-range

PV Impact Brief

Urgency: HighConfidence: high

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).

Action needed

Confirm child is 24 months or older before administering FluMist; review Product Information; verify patient age against indication.

Relevant for
Regulatory Intelligence LeadSignal Management Lead
Processes impacted
Signal ManagementLabeling
Owner

Regulatory Intelligence Lead

Review cadence

single-event

Regulatory action details

Action type
Safety Alert
Publication date
2026-06-05
Safety issue
Reports have been identified of FluMist being administered in error to children under 2 years of age. FluMist is indicated only for those aged 24 months to less than 18 years.

Affected products

  • FluMist (Influenza Vaccine Live, Intranasal)
    MedImmune, LLC

PV internal implications

Confirm child is 24 months or older before administration. Review Product Information including indication and contraindications.

View regulator source

Evidence and confidence

Confidence: highSource updated: Jun 5, 2026

Full briefing

Practical implication

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.

View original source

Published from the Firecrawl agent regulatory extraction pipeline.

#Safety Signals#Safety Update#Therapeutic Goods Administration (TGA)#other#firecrawl-agent#regulatory-extraction

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