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.

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.

Related updates for your role

publicFDA · USA · Updated Sep 4, 2026

FDA Grants Accelerated Approval to Etcamah for Advanced Breast Cancer

Urgency: High

Regulatory teams must prepare for updating labeling to include details on the new indication and required diagnostic methods, along with planning for the confirmatory studies mandated by the FDA.

Signal ManagementLabelingRegulatory Intelligence Lead
SOP Impact2 SOPs
ConfidenceHigh
Relevant for: Regulatory Intelligence Lead
verifiedRegulatory action: Regulators
Read impact briefarrow_forward
publicMHRA · UK · Updated Sep 4, 2026

Change to the definition of regulated activity with children from 1 September 2026

Urgency: High

Organizations must re-evaluate roles related to children's activities and prepare to request Enhanced DBS checks including access to the Children’s Barred List check starting from 1 September 2026.

Country ComplianceRegulatory Intelligence Lead
SOP Impact1 SOPs
ConfidenceHigh
Relevant for: Regulatory Intelligence Lead
verifiedRegulatory action: Regulators
Read impact briefarrow_forward
publicUK Health Security Agency · UK · Updated Sep 7, 2026

Low Flu Vaccination Rates Among Primary School Children

Urgency: High

Parents are reminded to complete and return flu vaccination consent forms promptly as vaccination sessions in schools are set to start this week, aiming for completion by late November.

Signal ManagementPV Quality Lead
SOP Impact1 SOPs
ConfidenceHigh
Relevant for: PV Quality Lead, Medical Safety Lead
verifiedRegulatory action: Regulators
Read impact briefarrow_forward
publicANSM (France) · France · Updated Sep 7, 2026Translated From French

Recall of Gore Viabahn Endoprosthesis with Bioactive Heparin Coating

Urgency: High

Health establishments receiving affected devices must be notified, and protocols established to ensure compliance with the recall.

Signal ManagementQPPV
SOP Impact1 SOPs
ConfidenceHigh
Relevant for: QPPV, Medical Safety Lead
verifiedRegulatory action: Regulators
Read impact briefarrow_forward