Dr June Raine, CEO MHRA
Professor Lim Wei Shen, Chairman JCVI COVID-19 vaccines sub-committee
Professor Chris Whitty, Chief Medical Officer
Dr Jenny Harries, CEO, UKHSA
Hon.Sajid Javid, MP, Secretary of State for Health & Social Care
30th June 2022
Dear Dr Raine,
Re: Covid-19 vaccines for 6 months to 4 years age group
We are writing to you urgently concerning the announcement that the FDA has granted an Emergency Use Authorisation for both Pfizer and Moderna Covid-19 vaccines in preschool children.
We would urge you to consider very carefully the move to vaccinate ever younger and younger children against SARS-CoV-2, despite the gradual but significant reducing virulence of successive variants, the increasing evidence of rapidly waning vaccine efficacy, the increasing concerns over long-term vaccine harms, and the knowledge that the vast majority of this young age group have already been exposed to SARS-CoV-2 repeatedly and have demonstrably effective immunity. Thus, the balance of benefit and risk which supported the rollout of mRNA vaccines to the elderly and vulnerable in 2021, is totally inappropriate for small children in 2022.
(...)
We summarize below the overwhelming arguments against this vaccination.
A. Extremely low risk from COVID-19 to young children
In the whole of 2020 and 2021, not a single child aged 1-9 died where COVID-19 was the sole diagnosis on the death certificate, according to ONS data.
A detailed study in England from March 1st 2020 to March 1st 2021 found only six children under 18 years died with no co-morbidities. There were no deaths aged 1-4 years.
Children clear the virus more easily than adults.
Children mount effective, robust, and sustained immune responses.
Since the arrival of the Omicron variant, infections have been generally much milder. That is also true for unvaccinated under-5s.
By June 2022 it is now estimated that 89% of 1-4-year-olds had already had SARS-CoV-2 infection.
Recent data from Israel show excellent long-lasting immunity following infection in children, especially in 5-11s.
B. Poor vaccine efficacy
In adults, it has become apparent that vaccine efficacy wanes steadily over time, necessitating boosters at regular intervals. Specifically, vaccine efficacy has waned more rapidly against the latest Omicron variants.
In children, vaccine efficacy has waned more rapidly in 5-11s than in 12-17s, possibly related to the lower dose used in the pediatric formulation. One study from New York showed efficacy against Omicron falling to only 12% by 4-5 weeks and to negative values by 5-6 weeks post second dose.
In the Pfizer 0-4s trial, the efficacy after two doses fell to negative values, necessitating a change to the trial protocol. After a third dose there was a suggestion of efficacy from 7-30 days but there is no data beyond 30 days to see how quickly this will wane.
C. Potential harms of COVID-19 vaccines for children
There has been great concern about myocarditis in adolescents and young adults, especially in males after the second dose, estimated at one per 2,600 in active post-marketing surveillance in Hong Kong. The emerging evidence of persistent cardiac abnormalities in adolescents with post-mRNA vaccine myopericarditis, as demonstrated by cardiac MRI at 3-8 months follow up, suggests this is far from ‘mild and short-lived’. The potential for longer term effects requires further study and calls for the strictest application of the precautionary principle in respect of the youngest and most vulnerable children.
Although post-vaccination myocarditis appears to be less common in 5-11-year-olds than older children, it is, nonetheless, increased over baseline.
In the Pfizer study, 50% of vaccinated children had systemic adverse events, including irritability and fever. Diagnosis of myocarditis is much more difficult in younger children. No troponin levels or ECG studies were documented. Even a vaccinated child in the trial, hospitalized with fever, calf pain and a raised CPK, had no report of D-dimers, anti-platelet antibodies or troponin levels.
In Pfizer’s 5-11s post-authorization conditions, it is required to conduct studies looking for myocarditis and is not due to report results until 2027.
Of equal concern are, as yet unknown, negative effects on the immune system. In the 0-4s trial, only seven children were described as having “severe” COVID-19 – six vaccinated and one given placebo. Similarly, for the 12 children with recurrent episodes of infection, 10 were vaccinated against only two who received placebo. These are all tiny figures and much too small to rule out any adverse impact such as antibody dependent enhancement (ADE) and other impacts on the immune system.
Also unanswered is the question of Original Antigenic Sin. It is of note that in a large Israeli study, those infected after vaccination had poorer cover than those vaccinated after infection. In the Moderna trial, N-antibodies were seen in only 40% of those infected after vaccination, compared with 93% of those infected after placebo.
There is evidence of vaccine-induced disruption of both innate and adaptive immune responses. The possibility of developing an impaired immune function would be disastrous for children, who have the most competent innate immunity, which by now has been effectively trained by the circulating virus.
Totally unknown is whether there will be any adverse effect on T-cell function leading to an increase in cancers.
Also, in terms of reproductive function, limited animal bio-distribution studies showed lipid nanoparticles concentrate in ovaries and testes. Adult sperm donors have showed a reduction in sperm counts particularly of motile sperm, falling by three months post-vaccination and remaining depressed at four to five months.
Even for adults, concerns are rising that serious adverse events are in excess of hospitalizations from COVID-19.
D. Informed consent
For 5-11s, the JCVI, in recommending a “non-urgent offer” of vaccination, specifically noted the importance of fully informed consent with no coercion.
With the low uptake in this age group, the presence of ‘therapy dogs’, advertisements including superhero images and information about child vaccination protecting friends and family all clearly run contrary to the concept of consent, fully informed and freely given.
The complete omission of information explaining to the public the different and novel technology used in COVID-19 vaccines compared to standard vaccines, and the failure to inform of the lack of any long-term safety data, borders on misinformation.
(...)
Professor Angus Dalgleish, MD, FRCP, FRACP, FRCPath, FMed Sci, Principal, Institute for
Cancer Vaccines & Immunotherapy (ICVI)
Prof Anthony Fryer, PhD, FRCPath, Professor of Clinical Biochemistry, Keele University
Professor David Livermore, BSc, PhD, Retired Professor of Medical Microbiology, UEA
Professor John Fairclough FRCS FFSEM retired Honorary Consultant Surgeon
Lord Moonie, MBChB, MRCPsych, MFCM, MSc, House of Lords, former parliamentary under-
secretary of state 2001-2003, former consultant in Public Health Medicine
Dr Abby Astle, MA(Cantab), MBBChir, GP Principal, GP Trainer, GP Examiner
Dr Michael D Bell, MBChB, MRCGP, retired General Practitioner
Dr Alan Black, MBBS, MSc, DipPharmMed, Retired Pharmaceutical Physician
Dr David Bramble, MBChB, MRCPsych, MD, Consultant Psychiatrist
Dr Emma Brierly, MBBS, MRCGP, General Practitioner
Dr David Cartland, MBChB, BMedSci, General practitioner
Dr Peter Chan, BM, MRCS, MRCGP, NLP, General Practitioner, Functional medicine
practitioner
Michael Cockayne, MSc, PGDip, SCPHNOH, BA, RN, Occupational Health Practitioner
Julie Coffey, MBChB, General Practitioner
John Collis, RN, Specialist Nurse Practitioner, retired
Mr Ian F Comaish, MA, BM BCh, FRCOphth, FRANZCO, Consultant Ophthalmologist
James Cook, NHS Registered Nurse, Bachelor of Nursing (Hons), Master of Public Health
Dr Clare Craig, BMBCh, FRCPath, Pathologist
Dr David Critchley, BSc, PhD in Pharmacology, 32 years’ experience in Pharmaceutical R&D
Dr Jonathan Engler, MBChB, LlB (hons), DipPharmMed
Dr Elizabeth Evans, MA(Cantab), MBBS, DRCOG, Retired Doctor
Dr John Flack, BPharm, PhD, retired Director of Safety Evaluation at Beecham Pharmaceuticals and retired Senior Vice-president for Drug Discovery SmithKline Beecham
Dr Simon Fox, BSc, BMBCh, FRCP, Consultant in Infectious Diseases and Internal Medicine
Dr Ali Haggett, Mental health community work, 3rd sector, former lecturer in the history of
medicine
David Halpin, MB BS FRCS, Orthopaedic and trauma surgeon (retired)
Dr Renée Hoenderkampf, General Practitioner
Dr Andrew Isaac, MB BCh, Physician, retired
Dr Steve James, Consultant Intensive Care
Dr Keith Johnson, BA, DPhil (Oxon), IP Consultant for Diagnostic Testing
Dr Rosamond Jones, MBBS, MD, FRCPCH, retired consultant paediatrician
Dr Tanya Klymenko, PhD, FHEA, FIBMS, Senior Lecturer in Biomedical Sciences
Dr Charles Lane, MA, DPhil, Molecular Biologist
Dr Branko Latinkic, BSc, PhD, Molecular Biologist
Dr Felicity Lillingstone, IMD DHS PhD ANP, Doctor, Urgent Care, Research Fellow
Dr Theresa Lawrie, MBBCh, PhD, Director, Evidence-Based Medicine Consultancy Ltd, Bath
Katherine MacGilchrist, BSc (Hons), MSc, CEO/Systematic Review Director, Epidemica Ltd.
Dr Geoffrey Maidment, MBBS, MD, FRCP, Consultant physician, retired
Ahmad K Malik FRCS (Tr & Orth) Dip Med Sport, Consultant Trauma & Orthopaedic Surgeon
Dr Kulvinder Singh Manik, MBBS, General Practitioner
Dr Fiona Martindale, MBChB, MRCGP, General Practitioner
Dr S McBride, BSc(Hons) Medical Microbiology & Immunobiology, MBBCh BAO, MSc in Clinical
Gerontology, MRCP(UK), FRCEM, FRCP(Edinburgh). NHS Emergency Medicine & geriatrics
Mr Ian McDermott, MBBS, MS, FRCS(Tr&Orth), FFSEM(UK), Consultant Orthopaedic Surgeon
Dr Franziska Meuschel, MD, ND, PhD, LFHom, BSEM, Nutritional, Environmental and Integrated Medicine
Dr Scott Mitchell, MBChB, MRCS, Emergency Medicine Physician
Dr Alan Mordue, MBChB, FFPH. Retired Consultant in Public Health Medicine & Epidemiology
Dr David Morris, MBChB, MRCP(UK), General Practitioner
Margaret Moss, MA (Cantab), CBiol, MRSB, Director, The Nutrition and Allergy Clinic, Cheshire
Dr Alice Murkies, MD FRACGP MBBS, General Practitioner
Dr Greta Mushet, MBChB, MRCPsych, retired Consultant Psychiatrist in Psychotherapy
Dr Sarah Myhill, MBBS, retired GP and Naturopathic Physician
Dr Rachel Nicholl, PhD, Medical researcher
Sue Parker Hall, certified transactional analyst (CTA, psychotherapy); MSc (Counselling &
Supervision) MBACP (senior accredited practitioner); EMDR practitioner, Psychotherapist
Dr Christina Peers, MBBS, DRCOG, DFSRH, FFSRH, Menopause specialist
Rev Dr William J U Philip MB ChB, MRCP, BD, Senior Minister The Tron Church, Glasgow,
formerly physician specialising in cardiology
Dr Angharad Powell, MBChB, BSc (hons), DFRSH, DCP (Ireland), DRCOG, DipOccMed,
MRCGP, General Practitioner
Dr Gerry Quinn, PhD. Postdoctoral researcher in microbiology and immunology
Dr Johanna Reilly, MBBS, General Practitioner
Jessica Righart, MSc, MIBMS, Senior Critical Care Scientist
Mr Angus Robertson, BSc, MB ChB, FRCSEd (Tr & Orth), Consultant Orthopaedic Surgeon
Dr Jessica Robinson, BSc(Hons), MBBS, MRCPsych, MFHom, Psychiatrist and Integrative
Medicine Doctor
Dr Jon Rogers, MB ChB (Bristol), Retired General Practitioner
Mr James Royle, MBChB, FRCS, MMedEd, Colorectal surgeon
Dr Roland Salmon, MB BS, MRCGP, FFPH, Former Director, Communicable Disease
Surveillance Centre Wales
Sorrel Scott, Grad Dip Phys, Specialist Physiotherapist in Neurology, 30 years in NHS
Dr Rohaan Seth, BSc (hons), MBChB (hons), MRCGP, Retired General Practitioner
Dr Gary Sidley, retired NHS Consultant Clinical Psychologist
Dr Annabel Smart, MBBS, retired General Practitioner
Natalie Stephenson, BSc (Hons) Paediatric Audiologist
Dr Zenobia Storah, MA (Oxon), Dip Psych, DClinPsy, Senior Clinical Psychologist (Child and
Adolescent)
Dr Julian Tompkinson, MBChB MRCGP, General Practitioner GP trainer PCME
Dr Noel Thomas, MA, MBChB, DCH, DObsRCOG, DTM&H, MFHom, retired doctor
Dr Stephen Ting, MB CHB, MRCP, PhD, Consultant Physician
Dr Livia Tossici-Bolt, PhD, Clinical Scientist
Dr Carmen Wheatley, DPhil, Orthomolecular Oncology
Dr Helen Westwood MBChB MRCGP DCH DRCOG, General Practitioner
Mr Lasantha Wijesinghe, FRCS, Consultant Vascular Surgeon
Dr Damian Wilde, PhD (Chartered) Specialist Clinical Psychologist
https://childrensunion.org/6-month-to-4-years-covid-vaccines/
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