This is where it all began
We urge you to read the entire chain of communications below. It is, quite frankly, a terrifying account of a total lack of adequate regulatory procedures in the UK in clinical trials involving children. Medical ethics have well and truly left the building.
16th February 2021 (email sent 23:03)
To: Professor Andrew Pollard, Chairman, JCVI, lead investigator Oxford Vaccines Trial
CC:
- Dr June Raine, Chief Executive, MHRA
- Anne Longfield, Children’s Commissioner
- Professor Russell Viner, President, RCPCH
- Professor Archard, Chairman, Nuffield Council on Bioethics
- Sir Nicholas Bratzer, Chairman, British Institute of Human Rights
Dear Prof Pollard,
As a retired paediatrician, I was shocked to see the Oxford Vaccine Group advertising on Twitter for children aged 6-17 to join the latest Sars-CoV-2 vaccine trial[1]. In the two days it has taken me coposing this letter, I now see from tonight’s BBC news that the trial has already begun.
We know that the risk to children of becoming seriously unwell with Covid-19 is extremely low and of death, even lower[2], so it is hard to see any clinical reason why this vaccine should be rolled out routinely to children. The Joint Committee on Vaccination and Immunisation[3] advises that only those children at very high risk of exposure and serious outcomes, such as older children with severe neuro-disabilities that require residential care, should be offered vaccination. The immunisation ‘Green Book’ states that clinicians should discuss the risks and benefits of vaccination with a person with parental responsibility, who should be told about the paucity of safety data for the vaccine in children aged under 16 years[4].
Of necessity, the vaccines being rolled out have only limited short-term safety data and as yet no long-term safety data. That may be acceptable in an emergency and for those at significant risk from Covid-19, hence the temporary approval[5]. The use of a vaccine that has not yet completed Phase 3 safety trials is, however, clearly inappropriate for children who are at such low risk from Covid-19, and for whom so many more years lie ahead and whose immune and neurological systems are still developing. In addition, DNA viral vector vaccines are a new technology which has only been used in a very limited way previously (Ebola vaccines) and without significant long-term safety data for children to provide reassurance. Thus, the proposed trial appears to be extremely premature. Indeed with only 300 children planned to recruit, it cannot answer questions about safety, only presumably about immune response to various doses as outlined.
I was therefore even more concerned when I opened the link to the website[6] and looked at the information being offered to potential recruits. It has a series of FAQs including,
“What are the advantages of taking part?” “Knowledge gained from this study will help us develop a vaccine against the newly emerging coronavirus disease COVID-19.” But surely the vaccine has already been developed.
It then goes on to ask, “What are the disadvantages of taking part?” and answers with a list of the immediate side effects reported in the adult trials. But nowhere does it even mention that there is as yet NO long term safety data in adults or children.
It is hard to see how such a trial complies with the Nuremberg Code[7] or indeed that of the UK guidance on research in children[8].
Surely the precautionary principle must be applied, and this and similar studies should not proceed, at least until the long-term adult safety studies are fully published, anticipated in January 2023.
I would be very grateful for a copy of the trial protocol and the research ethics committee approval as a matter of urgency.
Yours
Dr Rosamond Jones, MD, FRCPCH (retired paediatrician)
[1] Oxford Vaccine Group on Twitter: “We have a new COVID-19 study open for recruitment. If your child is aged 6-17 years and in good health they may be eligible to participate. Click on the link to find out more. https://twitter.com/OxfordVacGroup/status/1360515657910136833
[4] Greenbook chapter 14a_v6 (publishing.service.gov.uk)
[5] Information for UK recipients on COVID 19 Vaccine AstraZeneca – GOV.UK (www.gov.uk)
[7] The Nuremberg Code (cirp.org)
[8] https://www.nuffieldbioethics.org/publications/children-and-clinical-research
Reply received within 13 minutes, 16th February 2021, 23:16
Dear Ros,
Thank you for your email. I certainly agree with you that we are yet to establish the safety and immunogenicity of the vaccine in children and for this reason the parents and children/young people are fully informed before taking part in the trial about what is and isn’t known about the vaccine. The trial has been approved by the MHRA, the ethics committee and the Health Research Authority and parallels similar trials being run by other developers as part of the paediatric investigational plan that is agreed with regulators.
The policy on use of vaccines for children is yet to be determined and any decision will be developed independently with scientific advice from JCVI. (note that I do not chair or participate in the jcvi covid19 committee).
AJP
Andrew J Pollard FRCPCH PhD FMedSci
Professor of Paediatric Infection and Immunity
Response sent at 23:24
Dear Andrew,
Many thanks for your prompt reply. I still have to say, I find it totally terrifying and watching a 13-year old on tonight’s news receiving the 1st dose with her mother ‘so proud of her’, did nothing to reassure me. Have you really spelt out the possibility of serious long-term adverse outcomes of which we yet know nothing? I would be very grateful if you could send me the trial protocol and ethics approval. Quite different for me aged 70 and with therefore a significant risk from covid and only a few years to go if there is a problem.
Medicine is littered with late unexpected disasters. When our vaccine minister declares it is ‘safe’ in pregnancy, thalidomide springs to my mind.
I am hugely supportive of all your efforts to get us to where we are in such a short space of time, so not trying to create waves, but felt obliged to speak out.
Best wishes
Ros (retired Wexham Park Hospital)
Reply received from Professor Adam Finn, also member of JCVI on 11th March 2021
Hi
Public info on COV006 including PISs is at: https://covid19vaccinetrial.co.uk/cov006-oxford
All governance approvals are in place as for all active trials
BW
Adam Finn
Professor of Paediatrics, University of Bristol
co-incidentally, the same day of receipt of Professor Finn’s bland response, the serious side effects of the AstraZeneca covid injection was already playing out across Europe. In the UK, our regulators continued to say, “SAFE AND EFFECTIVE”.
March 11th 2021 News item in British Medical Journal Covid-19: European countries suspend use of Oxford-AstraZeneca vaccine after reports of blood clots
