Moderna: ECCMID “product theatre” presentation ruled promotional and inconsistent with Spikevax SPC (AUTH/3746/2/23)

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Key facts

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Case	AUTH/3746/2/23
Company	Moderna
Product	Spikevax
Setting	European Congress of Clinical Microbiology and Infectious Diseases (ECCMID), Lisbon, Portugal
Date of event	24 April 2022 (10:30–10:50)
Complainant	Named, contactable complainant (described themself as a member of the public)
Applicable Code year	2021
Complaint received	27 February 2023
Case completed	9 August 2024
Appeal	No appeal
Breach clauses	Clause 2; Clause 5.1; Clause 11.2
No breach clauses	Clause 11.1; Clause 15.6
Sanctions	Undertaking received; Additional sanctions: Advertisement

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

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What happened

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A named complainant (member of the public) alleged that a Moderna session at ECCMID (Lisbon, 24 April 2022) was effectively a “Product Theatre” promoting Spikevax and included off-label booster-dose comparisons.
The session title suggested a broad, balanced technology discussion (“Clinical Perspectives on mRNA Vaccine Technology: Demonstrating Potential Through Pandemic Response”), but the Panel found the content was overwhelmingly about Spikevax.
The presentation comprised 23 slides; 15 were solely about Spikevax and included Spikevax prescribing information; three included comparisons with other vaccines.
The complainant provided an audio recording; the Panel noted verbal claims such as “excellent efficacy”, “staggeringly high efficacy in the elderly” and “the side effects are far less serious than COVID itself”.
Booster data were presented using a 100 microgram Spikevax dose in a clinical study, while the GB/EU SPC at the time described a 50 microgram booster dose for adults.
The speaker also stated the booster “can be used in teenagers”, which the Panel considered misleading because the SPC stated boosters were for individuals 18 years of age and older.
Moderna argued the event was international, led by its US parent, approved to Portuguese requirements, and intended as scientific discussion; it also noted it joined ABPI/accepted PMCPA jurisdiction in January 2023 (after the April 2022 event).
The Panel considered the matter within scope because Moderna Biotech UK Limited contracted with a UK health professional speaker and the audience included UK health professionals (UK HCPs were, on the balance of probabilities, invited via congress materials).

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Outcome

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Breach of Clause 2 Bringing discredit upon, and reducing confidence in, the pharmaceutical industry.
Breach of Clause 5.1 Failing to maintain high standards.
Breach of Clause 11.2 Promoting a medicine in a manner that was inconsistent with its SPC.
No Breach of Clause 11.1 Requirement that a medicine must not be promoted prior to the grant of its marketing authorisation.
No Breach of Clause 15.6 Requirement that promotional materials and activities must not be disguised.
No appeal.

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Clauses

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Clause 2 Bringing discredit upon, and reducing confidence in, the pharmaceutical industry
Clause 5.1 Failing to maintain high standards
Clause 11.2 Promoting a medicine in a manner that was inconsistent with its SPC
Clause 11.1 Requirement that a medicine must not be promoted prior to the grant of its marketing authorisation
Clause 15.6 Requirement that promotional materials and activities must not be disguised

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Moderna: ECCMID “product theatre” presentation ruled promotional and inconsistent with Spikevax SPC (AUTH/3746/2/23)

Key facts

What happened

Outcome

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