Pfizer breached ABPI Code over Prevenar 13 leavepiece implying a “new indication” in HIV (AUTH/2483/2/12)

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Key facts

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Case number	AUTH/2483/2/12
Complainant	Consultant in sexual health and HIV medicine
Company	Pfizer
Medicine	Prevenar 13 (pneumococcal polysaccharide conjugate vaccine (13-valent, adsorbed))
Material	One-page leavepiece printed both sides (ref VAC291)
Main issue	Implied “new indication” for HIV; omission of key SPC caution in main copy; misleading impression about licensed indication
Complaint received	28 February 2012
Case completed	17 April 2012
Applicable Code year	2011
Breach clauses	3.2, 7.2, 9.1
No breach clauses	4.1
Sanctions	Undertaking received; leavepiece withdrawn; additional sanctions not stated
Appeal	No appeal

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

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A consultant in sexual health and HIV medicine complained about a Pfizer leavepiece for Prevenar 13 (ref VAC291).
The leavepiece headline read “HIV and invasive pneumococcal disease” with “New Indication”, while the actual adult indication shown was for adults aged 50 years and older.
The reverse side continued the HIV theme, discussing increased risk in adults with HIV and vaccine efficacy in that population, and repeated “Prevenar 13 New Indication” (for adults 50+).
The complainant alleged the piece implied a new indication for use in HIV infection, despite SPC warnings that safety and immunogenicity data were not available for HIV/immunocompromised groups and vaccination should be considered individually.
The SPC caution was not referenced in the main body of the leavepiece (only within the prescribing information section).
Pfizer acknowledged the material could be misinterpreted and withdrew the leavepiece and briefed the sales team.

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Breach found: Clause 3.2.
Breach found: Clause 7.2.
Breach found: Clause 9.1.
No breach: Clause 4.1 (legibility of prescribing information not unacceptable in the original piece).
No appeal.

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