Strategic Legal Affairs
Dr Philip Cruz
UK Medical Director
Moderna Biotech UK Ltd
Darius Hughes, Moderna Biotech UK
Sue Harrison, Chair, Berkshire B REC
Dame Rachel de Souza, Children’s Commissioner for England
Dr Peter Sidebotham, Child Safeguarding Practice Review Panel
4 August 2023
Dear Dr Cruz,
NextCOVE Study (CTA Ref 51307/0015/001-0001)
UsForThem is a grassroots organisation of parents and grandparents speaking up for the rights and interests of children. We campaigned effectively and prominently throughout the pandemic for children’s welfare and wellbeing to be given appropriate prominence and ethical consideration in policy decisions affecting them. We continue to campaign on those topics and to pursue accountability for poor decision-making which has impacted negatively on children.
In that regard, I write with reference to the above clinical trial involving children, approved by the MHRA and the Health Research Authority in May 2023 with IRAS ID 1007516, although it appears not yet to be searchable on the HRA’s database. We understand that this is a Phase 3 clinical trial of an investigational bivalent COVID-19 vaccine for adults and children aged 12 years and over which you believe may protect against sickness from the Covid virus.
We wish to raise with you our serious concerns about the ethical basis of this trial, and in particular to highlight apparent violations of both ethical and child safeguarding principles and consequently UK law in connection with the scope and promotion to date of that trial. This is notwithstanding a favourable opinion apparently having been given by the Berkshire B Research Ethics Committee in May 2023. In the first instance responsibility for remedying those serious violations rests with you and the senior executive team at Moderna.
By copy to this letter we are bringing our concerns to the attention of the Children’s Commissioner for England, and the Child Safeguarding Practice Review Panel. We shall also be highlighting our concerns to parliamentarians, not least because we believe the example of your trial raises serious broader child safeguarding issues about which lessons may need to be learned.
We hope that in the meantime you will be able to respond promptly, candidly and transparently to our questions and concerns. both to clear up any misunderstandings and to demonstrate Moderna’s commitment to acting ethically and within the law.
This letter will be published shortly. You may therefore receive similar enquiries from concerned parents, grandparents and other members of the public.
The purpose of Moderna’s trial
We understand that the purpose of Moderna’s international trial is to compare two types of mRNA Covid vaccines for use as boosters for adults and children aged 12 and over.
At present, the only children in the UK for whom a Covid vaccine is available are those aged 6 months to 4 years in a high risk category; the offer of a vaccine to all other children has been withdrawn. For the autumn/winter booster program this year it is anticipated that only high risk cohorts will be offered a booster, and indeed healthy young adults are not now recommended to have boosters.
This approach of course reflects an appreciation of the low risk of illness to which healthy young adults and children are exposed from the virus. In January 2023 the JCVI published a paper which explains the number of people needed to vaccinate with a booster to prevent a single COVID-19 hospitalisation. For the age group 16 to 19 years (the youngest group for which figures are provided), that number is 76,000. To prevent a single serious covid-19 hospitalisation in this age group, that number rises to 193,500.
It is not therefore apparent how receiving a Covid booster vaccine at this point could be justified on the basis that it provides any meaningful clinical benefit to an individual child aged 12 to 17 years recruited into your trial. Indeed, a recruitment brochure apparently produced for the trial to explain the proposition to prospective child participants and their parents does not mention any potential direct health benefit from participating in the trial; instead it explains Moderna’s aim “to learn more about how [the vaccine] works in the body”.
Transparency of risk, and informed consent
As regards transparency of risk from participating in the Moderna trial, and thus the possibility of informed consent, 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 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. 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.
Finally, the brochure notes that “Compensation may be provided for your time”. We have been led to understand 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.
UK ethical and legal requirements
Paragraphs 9 and 10 of Part 4 of Schedule 1 to The Medicines for Human Use (Clinical Trials) Regulations 2004, echoing the Declaration of Helsinki which sets ethical principles for medical research involving human subjects, 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, and that there should be a direct benefit to the participant obtained by participating in the trial:
“9. The clinical trial relates directly to a clinical condition from which the minor suffers or is of such a nature that it can only be carried out on minors.
- Some direct benefit for the group of patients involved in the clinical trial is to be obtained from that trial.”
Paragraph 16 of that same Part 4 mandates expressly that “The interests of the patient always prevail over those of science and society”. In other words, any trial involving children must prioritise the wellbeing of children ahead of any scientific exploration or broader potential societal benefit.
Finally, paragraph 8 is unequivocally clear that no financial incentives or inducements can lawfully be offered to a child or their family except provision for compensation for injury or loss suffered as a result of participation. This too echos the Declaration of Helsinki and the UNICEF-sponsored Ethical Research Involving Children guidance.
We understand that the Research Ethics Committee will have been obliged to take the Declaration of Helsinki into consideration when considering Moderna’s ethics application.
Our questions and safeguarding concerns
In light of this, it appears that insofar as it involves recruiting children and investigating the results of injecting them with Covid booster vaccines, including one which is still in development and therefore experimental, Moderna’s trial fails to comply with international ethical standards and also fails to meet UK legal requirements for trials involving children.
This 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.
We hope that Moderna will wish to help put to rest these concerns by sharing transparently its ethical rationale for recruiting children into this trial, a rationale which must have been articulated in plain understandable terms to the Berkshire B Research Ethics Committee.
- Can you therefore please confirm the basis on which Moderna considers that its trial meets the strict ethical and UK legal requirements identified above, which are in place to safeguard the wellbeing of children?
- Will you also agree please to publish or otherwise share a copy of the submission or submissions made to the Berkshire B REC under Moderna’s sponsorship articulating the ethical basis for this trial, including in particular the ethical basis for recruiting children and compatibility with the Declaration of Helsinki? Should there be personal or commercially sensitive information in that paperwork which does not have a bearing on the ethical justification, please feel free to redact that information; if the submission cross-refers to other documents which contain confidential or other sensitive or restricted information, again please share that referenced information with necessary redactions or otherwise in a manner which does not compromise its confidentiality.
- If you are not willing to publish or share a copy of those submission materials (redacted if necessary), please can you provide a clear and granular explanation for why you are not willing to be transparent about Moderna’s ethical justification for this trial.
- And finally, can you please confirm categorically whether this trial is currently recruiting, or will be recruiting, any further candidates aged between 12 and 17 in the UK? And whether whether any children in that age group in the UK are currently or will soon be participating actively in the trial?
The issues we have raised in this letter are serious and pressing. We hope that you can therefore acknowledge receipt of this letter promptly and commit to providing a substantive response in short order.
On the basis that our questions request information all of which should be relatively at your fingertips given the commercial significance of this trial for Moderna, a period of no more than 10 working days seems reasonable.