A doctors group is questioning the ethics of a partnership between Moderna and NHS centres around England in a clinical trial of a new mRNA COVID-19 vaccine for children and adults over 12.
Doctors from HART, an organisation that was set up to share concerns about policy relating to COVID-19, have expressed concerns about the trial as they believe COVID-19 vaccine boosters are unlikely benefit to children. Furthermore, they have also questioned payment incentives.
In June, NextCOVE, a Phase 3 clinical trial conducted by Moderna, commenced. This was to study a new investigational vaccine as a booster dose in children and adults to “learn more about how it works in the body.”
Participants were chosen at random to receive either the investigational booster dose of mRNA-1283.222 or mRNA-1273.222.
“You or your child, along with approximately 10,748 other individuals, will be helping researchers learn more about Moderna’s latest investigational vaccine that may help protect people from getting sick if they come into contact with the virus,” wrote Moderna.
“You or your child’s participation could contribute to a potential solution to the evolving COVID-19 pandemic, which has affected the entire world,” it added.
The trial lasts around 13 months and includes up to six trial site visits and three safety phone calls. Participants have the right to drop out of the trial at any time and for any reason.
The NextCOVE Study was approved by the Medicines and Healthcare Products Regulatory Agency (MRHA) in March.
Cover Expenses
HART has raised concerns regarding payments during the trials. According to the NHS, some clinical trials offer payment, while some do not, while others just cover travel expenses.
HART saw a WhatsApp message that appears to show a paediatrician at the Royal London Hospital Children’s Clinical Research Facility at Barts Health NHS Trust offering £1,500 on completion of the study.
The Epoch Times has not been able to confirm who the message is from nor verify its authenticity.
A spokeswoman for Barts Health NHS Trust told The Epoch Times by email that “the wording of the message is misleading.”
In a statement, she added: “We offered to cover expenses and time for taking part to those participating in the NextCOVE trial, which is paid for by the study sponsor and is common in studies involving healthy volunteers. This trial, like all those run at our trust, has been fully approved by an independent research ethics board and has gone through regulatory checks.”
Moderna is the study sponsor.
The Epoch Times has seen emails from the chief executive of another NHS trust participating in the trial, who HART subsequently contacted with their concerns.
The executive said that no 12- to 15-year-olds are offered financial incentives for being in the trial.
He said that “adolescent participants’ parents are allowed to be reimbursed for travel expenses up to £50 only.”
He added that he supplies leaflets outlining the risks and benefits of taking part in the study, and both have paragraphs dedicated to the risk of myocarditis.
Declaration of Helsinki
Dr. Ros Jones, a retired consultant paediatrician who is part of HART, showed The Epoch Times Moderna’s recruitment brochure (pdf), which she believes indicates that the trial is not compliant with the Declaration of Helsinki.
This, she said, is because there is no likely benefit to the children themselves, who since June 30 are no longer eligible for any boosters or primary COVID-19 vaccines in the UK.
“It’s hard to see how anybody actually thinks that children might benefit from this, and yet they think they can put them in a trial,” Dr. Jones told The Epoch Times.
The Declaration of Helsinki, adopted in 1964, states that “All medical research involving human subjects must be preceded by careful assessment of predictable risks and burdens to the individuals and groups involved in the research in comparison with foreseeable benefits to them and to other individuals or groups affected by the condition under investigation.”
The leaflet, which is available on the NHS Rotherham Doncaster and South Humber site, says that the “trial vaccine is investigational and has not yet been approved for use in adults or children. This means we are still researching the product and we do not know if it is effective and safe to use. We do not know if it will prevent SARS-CoV-2 infection or reduce the severity of COVID-19 illness.”
There is no mention of vaccine-related myocarditis in the leaflet.
HART sent a letter to 35 participating centres and has so far received 10 replies, two saying that they are not taking part in the trial, and seven pointing out that they have not and are not planning to recruit any under-18s.
The Epoch Times has seen another email from the director of a major commercial research unit who said he shared HART’s concern about “the quality of the information leaflet.”
While not involved in the Moderna mRNA vaccine trial, he said his highly experienced company has “never done a trial in children” nor intends to do so.
‘Everybody’s Had COVID’
Dr. Jones said that, “We’re now in a position where variants are very mild, everybody’s had COVID and we’ve stopped recommending boosters to the general population of healthy adults, let alone children.”
She noted that in August the UK government said that people under the age of 65 will no longer be offered COVID-19 vaccines unless they are otherwise eligible.
A spokesman for the Health Research Authority (HRA) told The Epoch Times by email, “The Medicines for Human Use (Clinical Trials) Regulations 2004 prohibit incentives or financial inducements for children to participate in clinical trials of investigational medicinal products (CTIMPs).”
The HRA is an arm’s length body of the Department of Health and Social Care in England that exists to “provide a unified national system for the governance of health research.”
Within that are 80 NHS research ethics committees across the UK that “exist to safeguard the rights, safety, dignity, and well-being of research participants.”
“Research Ethics Committees (RECs) review applications for research carried out in the NHS and clinical trials of medicines, and they consider whether the research is ethical, fair, legal, and safe. This includes considering any proposed reimbursement for participants,” said the spokesman.
“In this instance the REC requested that financial arrangements were limited to reimbursement of travel and related expenses to parents or carers of participating children,” he added.
Moderna did not respond to The Epoch Times’ request for comment.
