Moderna Offered Children £1,500 to Enroll in COVID Booster Shot Trial
- by Rishma Parpia
- Published
- Bioethics
The Prescription Medicines Code of Practice Authority (PMCPA), an organization responsible for overseeing the marketing practices of pharmaceutical companies in the United Kingdom, criticized Moderna, Inc. for sending an unauthorized WhatsApp message that proposed a payment of £1,500 (about $2,000) to children for participating in a clinical trial for its COVID-19 booster shot.1
Complaint Filed Against Moderna for Ethics Violation
A complaint on behalf of Children’s COVID Vaccines Advisory Council (CCVAC), a group of health professionals and academics, who have concerns over the use of COVID shots in healthy children, was filed with PMCPA. Moderna Biotech U.K. Ltd. was cited for offering £1,500 to children 12 to 18 years old to enroll in a COVID shot clinical trial in 2023. The trial, named NextCOVE, recruited participants aged 12 and older from several centers across the U.K., United States and Canada.2
The complaint stated:
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.3
The complaint explained that a clinical trial recruitment center, overseen by Moderna, used social media to recruit children for a clinical trial by offering unapproved financial incentives. The complaint stated that the action by Moderna violates the Medicines for Human Use (Clinical Trials) Regulations (2004) and goes against the guidance outlined in Integrated Research Application System’s Q A46. The complaint also cited Moderna for failing to adhere to the recommendations in the “PMCPA Social
Media Guidance 2023”.4The complaint also stated that a pediatrician employed at a hospital in the U.K. was responsible for sharing information on WhatsApp advertising that researchers were looking for participants aged 12 to 18 to receive Moderna’s COVID booster shot. In the message, the doctor mentioned an incentive for participants, stating, “What’s in it for them? £1500 upon completing the study.”5
Ruling Cites Moderna for Failing to Maintain High Standards
In response to the complaint, Moderna denied breaching the marketing code. The company stated that trial sites were provided with a local information pack from its contract research organization, which included preliminary documents submitted for ethics and regulatory review. After these documents received full approval, the contract research organization sent out updated final versions. Moderna indicated that the pediatrician who sent the message from a personal phone likely used the outdated figure from the earlier files.6
After reviewing the evidence, the PMCPA stated:
Moderna had been let down because the approved recruitment materials were not utilized,” but questioned whether the company had made it clear enough to trial sites that substantial changes could be made to the documents in the local information pack. The panel commented that the process outlined by Moderna was “confusing.”7
The PMCPA panel found that the complainant did not provide enough evidence to show that Moderna broke any codes so they decided there was no breach of any of the clauses, but they agreed with the complainant that Moderna did not maintain high standards. The panel made statement:
The panel considered that Moderna’s failure to ensure only approved recruitment materials were used had led to a WhatsApp message being sent by a third party that contained an unapproved and inappropriately high financial incentive to encourage the recruitment of children. On balance, the Panel considered that this brought discredit upon and reduced confidence in the pharmaceutical industry.8
If you would like to receive an e-mail notice of the most recent articles published in The Vaccine Reaction each week, click here.
Click here to view References:
No comments:
Post a Comment