A grassroots organisation consisting of parents and grandparents has today written to Moderna Biotech to express their serious concerns regarding the legal and ethical basis for their recruitment of children to trial a new Covid vaccine product.

The Trial

The trial namely NextCOVE Study (CTA Ref 51307/0015/001-0001)  is a phase 3 clinical trial involving children of an investigational bivalent COVID-19 vaccine for adults and children aged 12 years and over.

It involves recruiting children aged 12 to  17 years old and approved by the MHRA and the Health Research Authority in May 2023 to investigate the results following injecting them with an experimental Covid booster vaccine.

The group, UsforThem argues that the boosters in Moderna’s trial, one of which is still in the developmental stage, do not comply with international ethical standards and also fail to meet UK legal requirements for trials involving children.

Safeguarding Concerns

The UsForThem group state that the recruitment for this trial therefore “raises very serious child safeguarding concerns, both in relation to this specific trial in the UK and more broadly in relation to the processes at Moderna and the Research Ethics Committee which signed off on this trial.”

They have highlighted violations of both ethical and child safeguarding principles and have addressed them in a letter to Dr Philip Cruz, UK Medical Director of Moderna Biotech UK with copies also sent to the ethics committee.

(source)

No Benefit to Children

First of all, there is no benefit at all to the children. The purpose of Moderna’s international trial is said to be to compare two types of mRNA Covid vaccines for use as boosters for adults and children aged 12 and over.

Yet, it is even deemed unnecessary by the usual drug pushers who have said that the only children in the UK for whom a Covid vaccine is available are children in a “high-risk category” and aged between 6 months to 4 years. ^Source 

Thankfully, the offer of a vaccine to all other children has been withdrawn and it has now been anticipated that for the autumn/winter booster program this year, only “high-risk” cohorts will be offered a booster, due to boosters not being recommended for healthy young adults. A paper from the Joint Committee on Vaccination and Immunisation  (JCVI) adds weight to that argument.

Therefore, there is no justification at all for any child to receive a Covid booster on the basis that it would provide any meaningful clinical benefit to an individual child aged 12 to 17 years old.

Harm to Children

We are all aware of the potential risks of the mRNA jabs, and even the trial brochure acknowledges that “… 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”.

It mentions possible side effects including fever, headache, aches and pains typically lasting between 2 and 3 days, but makes no mention of myocarditis, the effects of which can include permanent scarring to the heart muscle with increased risk for sudden death; this is despite the 12 to 17-year-old age group being among those believed to be most affected by that serious condition, according to data presented by the US CDC to the FDA. ^Source 

“Indeed it appears the FDA has been concerned enough about that risk to have commissioned a study of children in the US with myocarditis after Covid vaccination,” the group said.

UK ethical and legal requirements

Clearly, this should be seen to violate the Medicines for Human Use (Clinical Trials) Regulations 2004, which echo the Declaration of Helsinki which sets ethical principles for medical research involving human subjects.

The regulations make perfectly clear that it is a legal condition for any trial involving minor participants that the trial relate to a clinical condition affecting or likely to affect the participant, according to UsForThem.

In accordance with these regulations, there should also be a direct benefit to the participant obtained by participating in the trial (Source).

Paragraphs 9 and 10 of Part 4 of Schedule 1 states:

Paragraph 16 of that same Part 4 mandates expressly that:

This means that any trial involving children must prioritise the well-being of children ahead of any scientific exploration or broader potential societal benefit. Clearly, this trial does not.

Unlawful Compensation

Finally, the Moderna recruitment brochure offers the children compensation, stating that “Compensation may be provided for your time.”

According to UsForThem, they believe that at least one of the UK medical centres involved in Moderna’s trial has offered to pay a lump sum of £1,500 to each child at the completion of the trial.

Again, even this is going against the UK legal and Ethical guidelines, which explicitly state in paragraph 8 that no financial incentives or inducements can lawfully be offered to a child or their family except the provision for compensation for injury or loss suffered as a result of participation.

Response Requested

UsForThem, among other questions, is asking for confirmation from Moderna that they can confirm the basis on which they consider that the trial meets the strict ethical and UK legal requirements (identified above) which are in place to safeguard the wellbeing of children.

They request that Moderna “respond promptly, candidly, and transparently to the questions and concerns in order that they clear up any misunderstandings and to demonstrate their commitment to acting ethically and within the law and have asked that the response be given within ten days.”

We hope that they get their response, but it would appear that Moderna will pay no regard as they have to the regulations and guidelines in place to protect the children. The same goes too for those on the ethics committee who seem to have failed to do the job they are enrolled to do! Thankfully we have good people taking this role upon themselves and calling them out. All the best of luck to them.

The Letter can be read here