Moderna has been called out by the Prescription Medicines Code of Practice Authority (PMCPA) after a National Health Service (NHS) paediatrician offered children £1,500 ($2,000) via WhatsApp to take part in a clinical trial.
The complaint was filed in the UK on behalf of the Children’s Covid Vaccines Advisory Council, described as a group of health professionals and academics who have concerns over the use of Covid-19 vaccines in healthy children. The PMCPA said in their complaint that a paediatrician, who worked at an unnamed NHS hospital in the UK, posted the message in hopes of soliciting participants.
During the meeting of the research ethics committee, a member said: “This amount seems much higher than what would be considered a reasonable reimbursement and therefore would contravene clinical trial regulations. The Medicines for Human Use (Clinical Trials) Regulations (2004) explicitly prohibit the giving of incentives or financial inducements to children…or their parents.”
Moderna responded to the allegations, saying it found out about the existence of the WhatsApp message in January 2024. The vaccine manufacturer said that it provided approved, appropriate materials for use during the trial; however, the paediatrician in question did not use the approved materials.
The PMCPA panel reviewing the complaint said the £1,500 figure came from the company’s draft “Parent Information Sheet and Informed Consent Form”. Moderna confirmed that no participants were paid the incorrect amounts mentioned in the referenced paediatrician’s message and participants only received compensation for expenses such as travel costs.
The panel responded to this claim, saying: “Moderna’s failure to clearly communicate the ‘draft’ status of the document, which led to the offer of an inappropriate financial incentive, indicated that high standards had not been maintained.”
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By GlobalDataModerna was found to have breached two clauses as a result of the paediatrician’s message. Clause 5.1, failing to maintain high standards; and clause 2, bringing discredit upon, and reducing confidence in, the pharmaceutical industry.
Under the EU Clinical Trials Regulation, financial incentives are not allowed for participants under 16 to prevent undue influence and ensure that trial involvement is based on informed consent rather than monetary gain. Although minors may be reimbursed for expenses, this cannot be framed as an incentive.
The Phase III NextCOVE trial (NCT05815498) enrolled adults and children aged 12 and older in several locations around the UK, US, and Canada. Moderna reported positive topline data from the trial in March 2024, which was evaluating the company’s next-generation Covid-19 vaccine candidate mRNA-1283. The trial met its primary endpoints, with mRNA-1283 eliciting a higher immune response against the SARS-CoV-2 virus, including the Omicron BA.4/BA.5 and original strains, when compared to mRNA-1273.222.
