Further call to halt covid-19 vaccine roll-out in children
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 also strongly challenge the addition of Covid-19 vaccination into the routine child immunisation programme, despite no demonstrated clinical need, known and unknown risks (see below) and the fact that these vaccines still have only conditional marketing authorisation.
It is noteworthy that the Pfizer documentation presented to the FDA has huge gaps in the evidence provided:
- The protocol was changed mid-trial. The original 2-dose schedule exhibited poor immunogenicity with efficacy far below the required standard. A third dose was added by which time many of the original placebo recipients had been vaccinated.
- There was no statistically significant difference between the placebo and vaccinated groups in either the 6–23-month age group or the 2-4-year-olds even after the third dose. Astonishingly the results were based on just three participants in the younger age group (1 vaccinated and 2 placebo) and just seven participants in the older 2–4-year-olds (2 vaccinated and 5 placebo). Indeed, for the younger age the confidence intervals ranged from minus 367% to plus 99%. The manufacturer stated that the numbers were too low to draw any confident conclusions. Moreover, these limited numbers come only from children infected more than 7 days after the third dose.
- Over the whole time period from the first dose onwards (see page 39 Tables 19 & 20), there were a total of 225 infected children in the vaccinated arm and 150 in the placebo arm, giving a calculated vaccine efficacy of only 25% (14% for the 6-23 months, and 33% for 2-4s).
- The additional immunogenicity studies against Omicron, requested by the FDA, only involved a total of 66 children tested one month after the third dose (see page 35).
It is incomprehensible that the FDA considered that this represents sufficient evidence on which to base a decision to vaccinate healthy children. When it comes to safety, the data is even thinner: only 1057 children, some already unblinded, were followed for just 2 months. It is noteworthy that Sweden and Norway are not recommending the vaccine for 5-11s and Holland is not recommending it for children who have already had Covid-19. The director of the Danish Health and Medicines Authority stated recently that with what is now known, the decision to vaccinate children was a mistake.
We summarise 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 1st March 2020 to 1st March 2021 found only 6 children under 18 years died with no comorbidities. 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 shows 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 paediatric 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,1 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 1/2600 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 shot-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, none-the-less, 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, hospitalised with fever, calf pain and a raised CPK, had no report of D-dimers, antiplatelet antibodies or troponin levels.
- In Pfizer’s 5-11s post-authorisation conditions, they are required to conduct studies looking for myocarditis and are 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 7 children were described as having ‘severe’ Covid-19 – 6 vaccinated and 1 given placebo. Similarly, for the 12 children with recurrent episodes of infection, 10 were vaccinated against only 2 who received placebo. These are all tiny figures and much too small to rule out any adverse impact such as antibody dependant 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 to 93% of those infected after placebo.
- There is evidence of vaccine-induced disruption of both innate and adaptiveimmune 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 biodistribution 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 3 months post-vaccination and remaining depressed at 4-5 months.
- Even for adults, concerns are rising that serious adverse events are in excess of hospitalisations 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.
E. Effect on public confidence
- Vaccines against much more serious diseases, such as polio and measles, need to be prioritised. Pushing an unnecessary and novel, gene-based vaccine onto young children risks seriously undermining parental confidence in the whole immunisation programme.
- The poor quality of the data presented by Pfizer risks bringing the pharmaceutical industry into disrepute and the regulators if this product is authorised.
In summary, young healthy children are at minimal risk from Covid-19, especially since the arrival of the Omicron variant. Most have been repeatedly exposed to SARS-CoV-2 virus, yet have remained well, or have had short, mild illness. As detailed above, the vaccines are of brief efficacy, have known short- to medium-term risks and unknown long-term safety. Data for clinically useful efficacy in small children are scant or absent. In older children, for whom they are already licensed, they have been promoted via ethically dubious schemes to the potential detriment of other, and vital, parts of the childhood vaccination programme.
For a tiny minority of children for whom the potential for benefit clearly and unequivocally outweighed the potential for harm, vaccination could have been facilitated by restrictive licences. Whether following the precautionary principle or the instruction to First Do No Harm, such vaccines have no place in a routine childhood immunisation programme.
- Professor Angus Dalgleish, MD, FRCP, FRACP, FRCPath, FMed Sci, Principal, Institute for Cancer Vaccines & Immunotherapy (ICVI)
- Professor Anthony J Brookes, Professor of Genomics and Health Data Science, University of Leicester
- 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
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- 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
- Dr 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 Theresa Lawrie, MBBCh, PhD, Director, Evidence-Based Medicine Consultancy Ltd, Bath
- Dr Felicity Lillingstone, IMD DHS PhD ANP, Doctor, Urgent Care, Research Fellow
- 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 Noel Thomas, MA, MBChB, DCH, DObsRCOG, DTM&H, MFHom, retired doctor
- Dr Stephen Ting, MB CHB, MRCP, PhD, Consultant Physician
- Dr Julian Tompkinson, MBChB MRCGP, General Practitioner GP trainer PCME
- Dr Livia Tossici-Bolt, PhD, Clinical Scientist
- Dr Helen Westwood MBChB MRCGP DCH DRCOG, General Practitioner
- Dr Carmen Wheatley, DPhil, Orthomolecular Oncology
- Mr Lasantha Wijesinghe, FRCS, Consultant Vascular Surgeon
- Dr Damian Wilde, PhD, (Chartered) Specialist Clinical Psychologist
- Dr Ruth Wilde, MB BCh, MRCEM, AFMCP, Integrative & Functional Medicine Doctor
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