Open Letter from UK doctors: Safety and Ethical Concerns Surrounding COVID-19
Vaccination in Children
We wish to notify you
of our grave concerns regarding all proposals to administer COVID-19 vaccines
to children. Recently leaked Government
documents suggested that a COVID-19 vaccine rollout in children over 12 years
old is already planned for September 2021, and the possibility of children as
young as 5 years old being vaccinated in the summer in a worst-case scenario.[1]
We have been deeply disturbed to hear several Government and SAGE
representatives calling in the media for the COVID -19 vaccine rollout to be
“turning to children as fast as we can”.[2] Teaching materials circulated to London schools
contain emotionally loaded questions and inaccuracies[3]. In addition, there has been disturbing
language used by teaching union leaders, implying that coercion of children to
accept the COVID-19 vaccines through peer pressure in schools was to be
encouraged, despite the fact that coercion to accept a medical treatment is
against UK and International Laws and Declarations.[4]
Rhetoric such as this is irresponsible and unethical, and encourages the public
to demand the vaccination of minors with a product still at the research stage and
about which no medium- or long-term effects are known, against a disease which
presents no material risk to them. A
summary of our reasons is given below and a more
detailed fully referenced explanation is available.[5]
Risks
and benefits in medical treatments
Vaccines, like any other medical treatment, come
with varied risks and benefits. Therefore, we must consider
each product, individually, on its merits, and specifically for which patients
or sections of the population is the risk/benefit ratio acceptable. For COVID-19 vaccines
the potential benefits are clear for the elderly and vulnerable. however, for
children, the balance of benefit and risk would be quite different. We are
raising these concerns as part of an informed debate, which is a vital part of
the proper, scientific process. We must ensure that there is no repeat of any
past tragedies which have occurred especially when vaccines are rushed to
market. For example, the swine flu vaccine, Pandemrix, rolled out following the
pandemic of 2010, resulted in over one thousand cases of narcolepsy, a
devastating brain injury, in children and teenagers, before being withdrawn.[6] Dengvaxia, a new vaccine against Dengue, was also
rolled out to children ahead of the full trial outcomes, and 19 children died
of possible antibody-dependent enhancement (ADE) before the vaccine was withdrawn.[7] We must not risk a repeat of this with the COVID-19
vaccines, which would not only impact on the children and families affected,
but would also have a hugely damaging effect on vaccination uptake in general.
No medical intervention should be introduced on a
‘one size fits all’ basis, but instead should be fully assessed for suitability
according to the characteristics of the age cohort and of the individuals
concerned, weighing up the risk versus benefit profile for each cohort and the
individuals within a group. This
approach was outlined last October, by the head of the Government Vaccine Task
Force, Kate Bingham, who said “We just need to vaccinate everyone at risk….There’s going to be no vaccination of people under 18.
It’s an adult-only vaccine, for people over 50, focusing on health workers and
care home workers and the vulnerable.”[8]
Children do not need
vaccination for their own protection
Healthy children are
at almost no risk from COVID-19, with risk of
death as low as 1 in 2.5 million[9].
No previously healthy child under the
age of 15 died during the pandemic in the UK and admissions to hospital or
intensive care are exceedingly rare[10]
with most children having no or very mild symptoms. Although Long-Covid has been cited as a reason
for vaccinating children, there is little hard data. It appears less common and
much shorter-lived than in adults and none of the vaccine trials have studied
this outcome[11] [12]. The inflammatory condition, PIMS, was listed as
a potential adverse effect in the Oxford AstraZeneca children’s trial[13]. Naturally acquired immunity will give broader and better lasting
immunity than vaccination[14].
Indeed, many children will already be immune[15].
Individual children at very high risk can already
receive vaccination on compassionate grounds[16].
Children do not need
vaccination to support herd immunity
Already, two thirds of the adult population have received at least one dose of a COVID-19 vaccine[17]. Models that assume vaccination of children is required to reach herd immunity have failed to account for the proportion who had immunity prior to March 2020 and those who have acquired it naturally[18]. Recent modelling suggested that the UK had achieved the required herd immunity threshold on 12 April 2021[19].
Children do not
transmit SARS-CoV-2 as readily as adults, moreover adults living or working
with young children are at lower risk of severe COVID-19[20]. Schools have not been shown to be the focus
on spread to the community, teachers have a lower risk of COVID -19 than other
working age adults [21].
Short-term safety
concerns
As of 6th
May, the MHRA[22] has
received a total of 215,939 adverse events, including 1102 deaths in
association with SARS-CoV-2 vaccines.
Reports of strokes due to cerebral venous thromboses were initially in
low numbers but as awareness increased, many more reports led to the conclusion
that AstraZeneca vaccine should not be used for adults under 40 years of age
and this unpredicted finding has also led to the suspension of the Oxford
AstraZeneca children’s trial.
Similar events have
been noted with Pfizer & Moderna vaccines on the US adverse reporting
system (VAERS)[23] and it
is likely that this is a class effect related to production of spike protein. New
UK guidelines on managing Vaccine-Induced Thrombotic Thrombocytopenia (VITT)[24]
include all COVID-19
vaccines in their advice. The possibility of further unexpected safety issues cannot be ruled
out. In Israel, where the vaccines have
been widely rolled out to young people and teenagers, the Pfizer vaccine has
been linked to several cases of myocarditis in young men[25]
and concerns have been raised about reports of altered menstrual cycles and
abnormal bleeding in young women following the vaccine.[26]
Most concerning with
regard to possible vaccination of children, is that there have now been a number
of deaths associated with vaccination reported to the VAERS system in
the US, despite the vaccines
only being given to children within trials and a very recent rollout to 16-17 year olds[27].
Long-term safety
concerns
All Phase 3 COVID-19
vaccine trials are ongoing and not due to conclude until late 2022/early 2023. The
vaccines are, therefore, currently experimental with only limited short-term
and no long-term adult safety data available. In addition, many are using a completely new
mRNA vaccine technology, which has never previously been approved for use in
humans[28].
The mRNA is effectively a pro-drug and it not known how much spike protein any
individual will produce. Potential late-onset effects can take months or years
to become apparent. The limited children’s trials undertaken to date are
totally underpowered to rule out uncommon but severe side effects.
Children have a
lifetime ahead of them, and their immunological and neurological systems are
still in development, making them potentially more vulnerable to adverse
effects than adults. A
number of specific concerns have been raised already, including autoimmune
disease and possible effects on placentation and fertility.[29] A recently published paper raised the
possibility that mRNA COVID-19 vaccines could trigger prion-based,
neurodegenerative disease[30].
All potential risks, known and unknown, must be balanced against risks of
COVID-19 itself, so a very different benefit/risk balance will apply to
children than to adults.
Conclusion
There is important
wisdom in the Hippocratic Oath which states, “First do no harm”. All medical interventions carry a risk of
harm, so we have a duty to act with caution and proportionality. This
is particularly the case when considering mass intervention in a healthy
population, in which situation there must be firm evidence of benefits far
greater than harms. The current, available
evidence clearly shows that the risk versus benefit calculation does NOT
support administering rushed and experimental COVID -19 vaccines to children, who have virtually no risk from COVID -19, yet face known and unknown risks from the vaccines. The
Declaration of the Rights of the Child states that, “the child, by reason of
his physical and mental immaturity, needs special safeguards and care,
including appropriate legal protection”.[31] As adults we have a duty of care
to protect children from unnecessary and foreseeable harm.
We conclude that it is
irresponsible, unethical and indeed, unnecessary, to
include children under 18 years in the national COVID-19 vaccine rollout. Clinical trials in children also pose huge ethical
dilemmas, in light of the lack of potential benefit to
trial participants and the unknown risks. The end of the current Phase 3 trials
should be awaited as well as several years of safety data in adults, to rule
out, or quantify, all potential adverse effects.
We call upon our
governments and the regulators not to repeat mistakes from history, and to
reject the calls to vaccinate children against COVID-19. Extreme
caution has been exercised over many aspects of the pandemic, but surely now is
the most important time to exercise true caution – we must not be the generation of adults
that, through unnecessary haste and fear, risks the health of children.
Signatories
Dr Rosamond Jones, MD,
FRCPCH, retired consultant paediatrician
Lord Moonie, MBChB, MRCPsych,
MFCM, MSc, House of Lords, former parliamentary
undersecretary
of state 2001-2003, former consultant in
Public Health Medicine
Prof Anthony Fryer, PhD, FRCPath, Professor of Clinical Biochemistry, Keele University
Professor Karol Sikora, MA, MBBChir, PhD, FRCR, FRCP, FFPM, Dean of Medicine, Buckingham
University, Professor of Oncology
Professor Angus Dalgleish, MD, FRCP, FRACP, FRCPath, FMed Sci, Professor of
Oncology, St Georges
Hospital, London
Professor Richard Ennos,
MA, PhD. Honorary Professorial Fellow, University of Edinburgh
Professor Anthony J
Brookes, Department of Genetics &
Genome Biology, University of Leicester
Professor Keith Willison, PhD, Professor of Chemical Biology, Imperial,
London
Dr John A Lee, MBBS,
PhD, FRCPath, retired Consultant
Histopathologist, former Clinical Professor
of
Pathology at Hull York Medical School
Professor John A Fairclough, BM
BS, BMed Sci, FRCS, FFSEM(UK), Professor Emeritus, Honorary
Consultant Orthopaedic Surgeon
Dr Alan Mordue, MBChB, FFPH (ret). Retired Consultant in Public
Health Medicine & Epidemiology
Dr Elizabeth Evans, MA, MBBS, DRCOG,
retired doctor
Mr Malcolm Loudon, MB ChB, MD, FRCSEd,
FRCS (Gen Surg). MIHM, VR. Consultant Surgeon
Dr Gerry Quinn, PhD,
Microbiologist
Dr C Geoffrey
Maidment, MD, FRCP, retired consultant physician
Dr K Singh, MBChB, MRCGP, general practitioner
Dr Pauline Jones MB
BS retired general practitioner
Dr Holly
Young, BSc, MBChB, MRCP, Consultant physician, Croydon University Hospital
Dr David Critchley, BSc, PhD, 32
years in pharmaceutical R&D as a clinical research scientist
Dr Padma Kanthan, MBBS, General practitioner
Dr Thomas Carnwath, MBBCh,MA,
FRCPsych, FRCGP, consultant psychiatrist
Dr M, BSc(Hons) Medical Microbiology & Immunobiology, MBBCh BAO, MSc in Clinical
Gerontology, MRCP(UK), FRCEM, FRCP(Edinburgh). NHS Emergency Medicine & geriatrics
Dr Helen Westwood MBChB MRCGP DCH
DRCOG, general practitioner
Dr M A Bell, MBChB, MRCP(UK), FRCEM,
Consultant in Emergency Medicine, UK
Mr Ian F Comaish,
MA, BM BCh, FRCOphth,
FRANZCO, Consultant ophthalmologist
Dr Jayne LM
Donegan MBBS, DRCOG, DCH, DFFP, MRCGP, general practitioner
Dr Dayal
Mukherjee, MBBS MSc
Dr Clare Craig, BM,BCh, FRCPath,
Pathologist
Mr C P Chilton, MBBS,
FRCS, Consultant urologist emeritus
Dr Theresa Lawrie,
MBBCh, PhD, Director, Evidence-Based Medicine Consultancy Ltd, Bath
Dr Jason Lester, MRCP, FRCR, Consultant Clinical Oncologist, Rutherford
Cancer Centre, Newport
Dr Scott McLachan, FAIDH, MCSE, MCT, DSysEng,
LLM, MPhil., Postdoctoral researcher, Risk &
Information management Group
Michael
Cockayne, MSc, PGDip, SCPHNOH, BA, RN, Occupational health practitioner
Dr John Flack, BPharm, PhD. Retired
Director of Safety Evaluation at Beecham Pharmaceuticals
1980-1989 and Senior Vice-president for Drug
Discovery 1990-92 SmithKline Beecham
Dr Stephanie Williams,
Dermatologist
Dr Greta Mushet, retired Consultant
Psychiatrist in Psychotherapy. MBChB, MRCPsych
Dr JE, MBChB, BSc, NHS hospital junior
doctor
Mr Anthony Hinton, MBChB, FRCS,
Consultant ENT surgeon, London
Dr Elizabeth Corcoran, MBBS, MRCPsych, Psychiatrist
Dr Alan Black, MB BS, MSc, DipPharmMed, retired pharmaceutical physician
Dr Christina Peers, MBBS,DRCOG,DFSRH,FFSRH, Menopause Specialist
Dr Marco Chiesa, MD, FRCPsych, Consultant Psychiatrist & Visiting Professor,
UCL
Elizabeth Burton, MB
ChB, retired general practitioner
Noel Thomas, MA, MB ChB, DCH, DObsRCOG,
DTM&H, MFHom, retired doctor
Malcolm Sadler, MBBS,
FRCGP, retired general practitioner with 37 years in Medical Practice
Dr Ian Bridges, MBBS, Retired general practitioner
Mr T James Royle MBChB, FRCS(Ed), MMedEd,
Colorectal surgeon
Dr Fiona Martindale, MbChB, MRCGP, GP in out of hours
Dr Karen Horridge, MB ChB(Hons), MSc, MRCP, FRCPCH, Consultant Paediatrician (Disability)
Mr Christian Duncan, Consultant Plastic Surgeon, MB BCh, BAO, MPhil, FRCSI, FRCS (Plast)
Dr David Bramble, MBChB, MRCPsych, MD. Consultant Psychiatrist
Dr Jessica Robinson,
BSc(Hons),
MBBS,
MRCPsych,
MFHom,
Psychiatrist
& Integrative Medicine Doctor
Katherine MacGilchrist, BSc (Hons) Pharmacology, MSc Epidemiology, CEO,
Systematic Review
Director, Epidemica
Ltd
David Halpin MB BS, FRCS, Orthopaedic
and trauma surgeon (retired)
Jemma Dale, BSc
(Hons), Biomedical Scientist
Dr Helen Macklin, MBBS,
DRCOG, MRCGP, general practitioner
Dr Mark Atkinson, MBBS, BSc
(Hons), FRSPH. Retired Medical Doctor
Dr Anne Renfrew, MB ChB, MRCOG, MRCGP, DCH, Retired
general practitioner
Dr S Allam, MB ChB, FRCA, Consultant
Anaesthetist, UK
Dr David Morris, MBChB, MRCP(UK), General
Practitioner
Dr. Peter Chan, BM, MRCS, MRCGP, General Practitioner, Functional medicine practitioner
Dr
Sam White, MBChB, MRCGP, General Practitioner, Functional medicine practitioner
Dr Sarah Myhill
MBBS, Dip NM, Retired GP, Independent
Naturopathic Physician
[1] https://www.dailymail.co.uk/news/article-9502227/Coronavirus-UK-Children-young-12-Covid-vaccines-September.html
[2] https://www.dailymail.co.uk/news/article-9285157/Sage-member-calls-children-Covid-jab-fast-avoid-risk-resurgence.html
[4] https://www.telegraph.co.uk/news/2021/05/02/schools-back-mass-vaccinations-children-headteachers-say-peer/
[5] https://www.hartgroup.org/wp-content/uploads/2021/05/Covid-19_Vaccine_in_Children_FULL_document.pdf
[7] https://www.sciencemag.org/news/2019/04/dengue-vaccine-fiasco-leads-criminal-charges-researcher-philippines
[9] https://gh.bmj.com/content/bmjgh/5/9/e003094.full.pdf
[11] Illness duration and
symptom profile in a large cohort of symptomatic UK school-aged children tested
for SARS-CoV-2
[13] https://www.hartgroup.org/wp-content/uploads/2021/05/COV006_Participant-Information-Sheet-16-17-years_V2.0_09Feb2021.pdf
[16] https://www.gov.uk/government/publications/priority-groups-for-coronavirus-covid-19-vaccination-advice-from-the-jcvi-30-december-2020/joint-committee-on-vaccination-and-immunisation-advice-on-priority-groups-for-covid-19-vaccination-30-december-2020
[18] https://www.bmj.com/content/370/bmj.m3563?fbclid=IwAR2v7qLBSWYOv4LdJB6ziwvzPa-CvrvoaB1uzLQNRTMeCDkHHDo0a6Tsrto
[20] Sharing a household with children and risk of COVID-19: a study of
over 300,000 adults living in healthcare worker households in Scotland
[24] Guidance produced from the Expert Haematology Panel (EHP) focussed on
Covid-19 Vaccine induced Thrombosis and Thrombocytopenia
[25] https://www.timesofisrael.com/israel-said-probing-link-between-pfizer-shot-and-heart-problem-in-men-under-30/
[26] https://www.haaretz.com/israel-news/.premium-women-say-covid-vaccines-affect-their-periods-so-why-don-t-doctors-care-1.9754865
[28] https://www.immunology.org/coronavirus/connect-coronavirus-public-engagement-resources/types-vaccines-for-covid-19