AUTH/3842/10/23: Fluenz Tetra ‘Post-Administration Information’ leaflet – alleged missing SmPC safety points (No breach)

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Key facts

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Case number	AUTH/3842/10/23
Company	AstraZeneca UK Limited
Complainant	Anonymous, contactable health professional
Product/material	Fluenz Tetra “Post Administration Information” booklet (HCP-facing; part of a suite of administration materials on an HCP-gated promotional website)
Main allegation	Two SmPC statements (immunocompromised contact transmission caution; salicylate avoidance for 4 weeks) missing from the main body of the post-administration booklet, posing patient safety risk
Applicable Code	2021 ABPI Code of Practice
Clauses considered	Clauses 6.1, 5.1, 2
Panel decision	No breach of Clause 6.1 (x2), Clause 5.1, Clause 2
Appeal	No appeal
Complaint received	30 October 2023
Case completed	16 December 2024

Reviewed by Dr Anzal Qurbain (FFPM) — ABPI Final Signatory

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An anonymous, contactable health professional complained about AstraZeneca’s “Post Administration Information” booklet for Fluenz Tetra (live attenuated nasal influenza vaccine), available on an HCP-gated promotional website in Great Britain.
The complainant alleged two SmPC statements (re: avoiding close contact with severely immunocompromised individuals for 1–2 weeks post-vaccination; and avoiding salicylates for 4 weeks post-vaccination unless medically indicated) were missing from the main body of the post-administration booklet (pages 2–3), creating a patient safety risk.
AstraZeneca argued both points are primarily pre-administration considerations and were included in its “Pre-administration Information” booklet; and also appeared in the prescribing information (PI) included on page 4 of the post-administration booklet.
The Panel reviewed the suite of four administration booklets (storage, pre-, during, post-administration) hosted together, plus a video resource.

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No breach of Clause 6.1 (x2) (information accurate, up to date and not misleading) regarding both alleged omissions.
No breach of Clause 5.1 (high standards).
No breach of Clause 2 (discredit to the industry).
No appeal.

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