AstraZeneca press releases on COVID-19 vaccine: unqualified “safe” claims and relative risk without absolute risk context

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Key facts

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Case	AUTH/3518/5/21
Parties	Member of the public v AstraZeneca
Material	Two press releases (30 December 2020; 18 March 2021)
Main issues	Unqualified use of “safe”; efficacy presented as RRR without sufficient absolute risk context
Applicable Code year	2019
Breach clauses	7.2, 7.9, 9.1
No breach clauses	2, 26.2
Sanctions	Undertaking received; additional sanctions not stated
Complaint received	27 May 2021
Case completed	7 July 2022
Appeal	Appeal by the complainant (Clause 2 and Clause 26.2 points unsuccessful)

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

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A member of the public complained about two AstraZeneca press releases hosted on AstraZeneca UK Limited’s website (dated 30 December 2020 and 18 March 2021).
The complainant alleged the vaccine was described as “safe” (unqualified) and that efficacy was presented using relative risk reduction (RRR) without absolute risk reduction (ARR).
AstraZeneca argued both releases were intended for a financial/investor audience (Regulatory News Release / Corporate Business Release) and therefore could rely on the Clause 26.2 supplementary information for financial information (meaning Clause 7 would not apply).
The Panel considered the releases did not identify their business importance or clearly limit the intended audience to investors, and could reach the general public via broader media outlets.
The Panel found the unqualified (and in one release repeated) use of “safe” made the releases not balanced and therefore Clause 7 applied.
For the 30 December 2020 release, the Panel found that presenting vaccine efficacy as 70.4% (RRR) without sufficient absolute risk context could mislead some readers (including members of the public) into assuming it was an absolute rate.
On appeal, the complainant challenged the “no breach” findings for Clauses 2 and 26.2; the Appeal Board ultimately upheld no breach for both.

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Breach of Clause 7.9 in relation to each press release (unqualified use of the word “safe”).
Breach of Clause 7.2 (RRR presented without sufficient absolute risk context) in relation to the 30 December 2020 press release.
No breach of Clause 26.2 (on a narrow technical point about whether the vaccine was classified as a prescription only medicine at the relevant time; upheld on appeal).
Breach of Clause 9.1 (failure to maintain high standards).
No breach of Clause 2 (not considered to warrant particular censure; upheld on appeal).

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