AstraZeneca voluntary admission: unsubstantiated ‘no transmission’ claim for Fluenz Tetra (AUTH/3157/2/19)

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Key facts

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Case number	AUTH/3157/2/19
Company	AstraZeneca
Product	Fluenz Tetra (live attenuated influenza vaccine (LAIV))
Material type	Health professional website (training modules) and HCP Q&A booklet
Main issue	Claim about absence of laboratory-confirmed LAIV transmission/illness could not be substantiated; misleading impression
Applicable Code year	2016
Clauses breached	7.2, 7.4, 9.1
Complaint received	12 February 2019
Case completed	08 May 2019
Appeal	No appeal
Sanctions applied	Undertaking received
Corrective actions described	Statement/pages removed (12 December 2018); Q&A booklet recalled (13 December 2018); individuals retrained

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

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AstraZeneca voluntarily admitted a claim on the Fluenz Tetra (LAIV) health professional website (fluenztetra.co.uk) could not be substantiated by the reference cited.
The same statement also appeared in a Q&A booklet aimed at health professionals.
The statement was used in response to transmission-risk questions and included: “Approximately 125.6 million doses… have been distributed worldwide… and there have been no laboratory-confirmed reports of LAIV virus transmission or illness associated with LAIV virus transmission”.
AstraZeneca identified the issue after a member of the public queried transmission data (6 December 2018). The site required visitors to declare they were a health professional; members of the public were not granted access to modules.
AstraZeneca concluded the impression created by the statement could not be supported by the cited references; it also acknowledged that while numbers were very small, there had been cases of secondary transmission.
Corrective actions described by AstraZeneca: removed the statement and associated pages (12 December 2018), recalled the Q&A booklet (13 December 2018), and retrained individuals involved.

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The Panel ruled the claim was misleading and could not be substantiated.
Breaches were ruled for Clauses 7.2, 7.4 and 9.1 (as acknowledged by AstraZeneca).
No appeal.

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