Moderna: unapproved clinical trial recruitment tweets/articles, unclear sponsorship and misleading statements (AUTH/3815/8/23)

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Key facts

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Case	AUTH/3815/8/23
Company	Moderna
Complaint about	Tweets, online articles and participant information sheets/informed consent forms for a Moderna-sponsored clinical trial
Trial	NextCOVE phase 3 clinical trial evaluating Moderna’s COVID-19 vaccine (investigational vaccine mRNA-1283.222 as booster vs mRNA-1273.222) in adults and children aged 12 years and over
Channel	Twitter/X and NHS Trust website; local news website also referenced
Applicable Code year	2021
Complaint received	30 August 2023
Case completed	13 January 2025
Appeal	Appeal by the complainant; several rulings overturned
Breach clauses (final)	Clause 2; Clause 5.1 (x2); Clause 5.5 (x2); Clause 6.1 (x3)
No breach clauses (final)	Clause 5.1 (x4); Clause 5.5; Clause 6.1 (x5); Clause 6.2; and for PIS/ICF (out of scope): Clause 2, Clause 5.1, Clause 6.4
Sanctions	Undertaking received; Advertisement

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

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A complaint was made about four tweets and two online articles used to recruit participants (including ages 12+) to the Moderna-sponsored phase 3 NextCOVE COVID-19 vaccine trial.
The tweets/articles had not been through the required approval process (they were not the REC-approved materials Moderna said it had provided to the site).
Key items considered within scope included:
- Tweet B (from the patient recruitment centre) and its reply, featuring images including a school-age child holding a teddy bear and certificate, and wording inviting those “over the age of 12” to get in touch.
- Tweet D (from the NHS Trust) stating “If you’re aged 12–60+ you can join too” and linking to an NHS Trust website article encouraging participation.
- Linked NHS Trust website article (“COVID booster study recruits first participants”) containing statements the Panel considered misleading/unbalanced about efficacy and safety (eg “make a big difference” and “minimal risks”).
Separate allegations about participant information sheets/informed consent forms using the word “safe” were ruled out of scope of the Code.
The complainant appealed seven Panel rulings; the Appeal Board overturned some findings (notably Clause 2 and additional Clause 5.1/5.5 breaches).

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Breach of Clause 2 (Appeal Board overturned Panel’s no breach): Bringing discredit upon, and reducing confidence in, the pharmaceutical industry.
Breach of Clause 5.1 (x2) (one overturned at appeal): Failing to maintain high standards.
Breach of Clause 5.5 (x2) (one overturned at appeal): Failing to be sufficiently clear as to the company’s role and involvement.
Breach of Clause 6.1 (x3): Making a misleading claim.
No Breach of Clause 6.2: Requirement that claims/information/comparisons must be capable of substantiation.
Out of scope documents (participant information sheet/informed consent forms):
- No Breach of Clause 2
- No Breach of Clause 5.1
- No Breach of Clause 6.4

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