The UK’s pharma marketing watchdog, the Prescription Medicines Code of Practice Authority, is taking issue with the way Moderna allegedly sought to increase participation in a Covid-19 vaccine trial for children via WhatsApp messages touting £1,500 ($2,000) payments to participate.
The complaint was filed on behalf of the Children’s Covid Vaccines Advisory Council, a group of health professionals and academics who say they have concerns with the use of Covid-19 vaccines in healthy children. The council alleges Moderna permitted the recruitment of children into a clinical trial “using a social media posting and a financial inducement which had demonstrably not received the required approval from a research ethics committee.”
Moderna disputed the allegations and said that one pediatrician used their personal phone to send a WhatsApp message inviting recipients to join the trial, known as NextCOVE, and suggested a payment of £1,500.
In November 2023, an ethics committee helping oversee the trial flagged that the application manager reviewing the trial “stated this [£1,500] amount seemed much higher than what would be considered a reasonable reimbursement and therefore would contravene clinical trial regulations,” according to minutes of the meeting shared by the UK group.
European clinical trial regulations prohibit any incentives or financial inducements to children under 16 years, or their parents or legal representatives, to participate in clinical trials of investigational medicinal products.
Moderna said in its response to the PMCPA that it only became aware of this WhatsApp message in January, and that the message was not endorsed or approved by the pediatrician’s employer, an unnamed NHS trust.
“It is not a method of advertising or standard recruitment procedure for any clinical trial conducted within the Trust, nor was it approved by Moderna,” the company said. It didn’t respond to Endpoints News‘ request for further comment.
But the panel at PMCPA reviewing the complaint said that Moderna admitted that the £1,500 figure came from an early draft of the company’s “Parent Information Sheet and Informed Consent Form” — although ultimately, participants only received compensation for expenses like travel costs.
“Moderna can confirm that no participants were paid the incorrect amounts mentioned in the referenced paediatrician’s message,” the company told the UK group.
The PMCPA’s panel said in its ruling that it’s concerned about the use of a recruitment message that wasn’t appropriately reviewed and offered an inappropriate financial incentive.
“The panel considered that its observations on the approval and distribution process for the ‘Parent Information Sheet and Informed Consent Form’ and 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,” the ruling says.