Pfizer press release on COVID-19 vaccine efficacy ruled misleading for omitting absolute risk context (AUTH/3519/5/21)

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Key facts

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Case	AUTH/3519/5/21
Complainant	Member of the public
Company	Pfizer Limited (press release issued by Pfizer Limited and BioNTech)
Material	Press release
Date of material	2 December 2020
Issue	Presentation of vaccine efficacy using relative risk reduction without sufficient absolute-risk context/explanation for a public audience
Applicable Code year	2019
Breach clauses	Clause 7.2; Clause 9.1
No breach clauses	Clause 2; Clause 26.2
Sanctions	Undertaking received; Additional sanctions: Not stated
Complaint received	27 May 2021
Case completed	19 February 2022
Appeal	No appeal

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

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A member of the public complained about a Pfizer/BioNTech press release dated 2 December 2020 discussing COVID-19 vaccine efficacy.
The complainant alleged the release presented relative risk reduction (RRR) only, without absolute risk reduction (ARR), contrary to Code requirements, and was not factual/balanced for a public audience.
The complainant cited commentary (including a Lancet article) arguing that ARR was much smaller (the complainant believed ~0.84% for the Pfizer study).
Pfizer argued ARR was difficult to calculate meaningfully in a fast-changing pandemic across multiple countries and could itself mislead; it said the press release included the absolute number of events (170 cases) to provide context and aligned with regulator/public health reporting.
The PMCPA Panel considered that, without explanation and additional absolute context (eg cases and subjects in each arm), some readers—especially the public—could assume the efficacy percentage was an absolute rate.

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Breach of Clause 7.2 (misleading information/insufficiently complete presentation; relative risk referenced without adequate absolute-risk context).
Breach of Clause 9.1 (high standards not maintained, consequent on the above).
No breach of Clause 26.2 on a narrow technical point: at the time of the press release the vaccine had temporary authorisation and was not legally classified as a prescription only medicine, and Clause 26.2 applies to prescription only medicines.
No breach of Clause 2; the Panel noted the unique pandemic circumstances and did not consider the case warranted the particular censure of Clause 2.
No appeal.

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