The PCMPA has slammed Moderna over an unapproved WhatsApp message that offered children in the U.K. 1,500 pounds sterling ($2,000) to participate in a clinical trial of its COVID-19 booster vaccine.

U.K. self-regulatory body the PMCPA received a complaint about a message sent by a pediatrician. In the message, the pediatrician, who worked at a hospital in the U.K., provided an overview of a study that was then enrolling children aged 12 to 18 years to receive Moderna’s COVID-19 vaccine as a booster. The message included the line “What’s in it for them? £1500 on completion of the study.”

As the complainant noted, Moderna proposed offering 1,505 pounds to participants in its submission to the research ethics committee (REC). However, the REC said the amount “seems much higher than what would be considered a reasonable reimbursement,” leading Moderna to reduce the sum to a substantially lower 185 pounds.

Moderna said trial sites received a local information pack from its contract research organization that contained documents that had been sent for ethics and regulatory review. Once the documents received full approval, the CRO sent updated final versions of the texts. Moderna said the pediatrician, who sent the message from their personal phone, appeared to have taken the figure from the old files.

The case rested on whether Moderna was accountable for the message. Moderna denied it breached the marketing code. The denial reflected the biotech’s belief it followed the rules and the “decision by a pediatrician to send an unapproved WhatsApp message with incorrect information does not constitute Moderna failing to maintain high standards.” Moderna made its case in its response to the PMCPA.

“The practice of distributing materials that have not yet been approved by the EC or MHRA in the form of a local information pack aligns with [Health Research Authority] guidelines,” the biotech said. “This procedure is not merely a sponsor or CRO-driven process but follows advice and guidance from the HRA.”

After assessing the evidence, the PMCPA said “Moderna had been let down as the approved recruitment materials had not been used” but queried whether the company had made it “sufficiently clear” to trial sites that “substantive changes” could be made to documents in the local information pack. The panel said the process described by Moderna was “confusing.”

The panel ruled the complainant failed to show Moderna was noncompliant with applicable codes, laws and regulations, resulting in it concluding there was no breach of one of the clauses. But the panel sided with the complainant on the question of whether the biotech failed to maintain high standards.

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