Moderna: unapproved WhatsApp trial recruitment message offered £1,500 to children (AUTH/3886/3/24)

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Key facts

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Field	Details
Case number	AUTH/3886/3/24
Complainant	Children’s Covid Vaccines Advisory Council (CCVAC) (complaint on behalf of)
Company	Moderna Biotech UK Ltd
Product / activity	NextCOVE COVID booster vaccine clinical trial recruitment
Channel	WhatsApp message (social media/messaging)
Key allegation	Recruitment of children using an unapproved financial incentive (£1,500 on completion)
Applicable Code year	2021
Complaint received	2 March 2024
Case completed	6 August 2024
Appeal	No appeal
Breach findings	Clause 5.1; Clause 2
No breach findings	Clause 3.4
Sanctions	Undertaking received; Advertisement

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

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A complaint (on behalf of Children’s Covid Vaccines Advisory Council) alleged an inappropriate financial inducement was used to recruit children into Moderna’s NextCOVE COVID booster vaccine clinical trial.
A paediatrician at a contracted NHS trust trial site sent a WhatsApp message (from a personal phone) recruiting “children aged 12–18 years” and stating: “What’s in it for them? £1500 on completion of the study.”
The £1,500 figure appeared to come from an early version of the Parent Information Sheet/Informed Consent Form (PIS-ICF) that was later changed following ethics committee feedback; Moderna said the approved approach limited compensation to reimbursement of expenses and removed the amount from the PIS-ICF.
Moderna said it was unaware of the WhatsApp message until January 2024; it met with the site and initiated a Quality Event to investigate the inappropriate use of non-ethics-committee-approved documentation.
The Panel considered the sponsor’s process for distributing documents in “Local Information Packs” (pre-approval) confusing and prone to version-control errors, and noted the documents did not clearly indicate they were drafts subject to substantive change.
The Panel applied third-party responsibility (Clause 1.24) and held Moderna responsible under the Code for the message sent by an employee of a contracted third party (the NHS trust).

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Breach of Clause 5.1 (Failing to maintain high standards).
Breach of Clause 2 (Bringing discredit upon, and reducing confidence in, the pharmaceutical industry).
No breach of Clause 3.4 (Requirement that companies must comply with all applicable codes, laws and regulations to which they are subject).

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