Moderna is facing criticism after a National Health Service (NHS) pediatrician in the UK allegedly offered children £1,500 ($2,000) via WhatsApp to participate in the company's Phase III NextCOVE trial (NCT05815498) for its next-generation COVID-19 vaccine candidate, mRNA-1283. The incident has raised concerns about potentially inappropriate incentives in clinical trials involving minors.
The complaint was filed by the Children’s Covid Vaccines Advisory Council, a group of health professionals and academics expressing reservations about COVID-19 vaccines in healthy children. The PMCPA (Prescription Medicines Code of Practice Authority) reviewed the complaint, which stated that the pediatrician, working at an unnamed NHS hospital, posted the message to solicit participants for the trial.
Regulatory Concerns
During a research ethics committee meeting, a member highlighted that the offered amount exceeded reasonable reimbursement and contravened clinical trial regulations. The Medicines for Human Use (Clinical Trials) Regulations (2004) explicitly prohibit financial inducements to children or their parents in clinical trials.
Moderna's Response
Moderna acknowledged the WhatsApp message in January 2024 and stated that while they provided approved materials for the trial, the pediatrician did not use them. The PMCPA panel indicated that the £1,500 figure originated from Moderna’s draft "Parent Information Sheet and Informed Consent Form." Moderna clarified that no participants received the incorrect amount, and compensation was limited to expenses like travel costs.
However, the PMCPA panel responded by stating, "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."
Breach of Conduct
As a result of the pediatrician’s message, Moderna was found to have breached Clause 5.1 (failing to maintain high standards) and Clause 2 (bringing discredit upon, and reducing confidence in, the pharmaceutical industry).
Implications of Financial Incentives
EU Clinical Trials Regulation prohibits financial incentives for participants under 16 to prevent undue influence and ensure informed consent. While reimbursement for expenses is allowed, it cannot be framed as an incentive.
About the NextCOVE Trial
The Phase III NextCOVE trial enrolled adults and children aged 12 and older across the UK, US, and Canada. In March 2024, Moderna reported positive topline data, indicating that mRNA-1283 elicited a higher immune response against SARS-CoV-2, including the Omicron BA.4/BA.5 and original strains, compared to mRNA-1273.222.
