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,[i]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[ii] presented to the FDA has huge gaps in the evidence provided:
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.[iii]
We summarise below the overwhelming arguments against this vaccination.
A. Extremely low risk from Covid-19 to young children
B. Poor vaccine efficacy
C. Potential harms of Covid-19 vaccines for children
D. Informed consent
E. Effect on public confidence
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)
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
Dr Ruth Wilde, MB BCh, MRCEM, AFMCP, Integrative & Functional Medicine Doctor
and others …..
[i] NHS vaccinations and when to have them. https://www.nhs.uk/conditions/vaccinations/nhs-vaccinations-and-when-to-have-them/
[ii] EUA amendment request for Pfizer-BioNTech COVID-19 Vaccine for use in children 6 months through 4 years of age. Submitted to the FDA 15/06/2022. https://www.fda.gov/media/159195/download
[iii] Denmark admits – in retrospect we didn’t get much out of vaccinating the children. Report from a press conference 27-06-2022. https://europe-cities.com/2022/06/27/denmark-admits-in-retrospect-we-did-not-get-much-out-of-vaccinating-the-children/
[iv] COVID-19 Deaths and Autopsies Feb 2020 to Dec 2021, Table 1: Number of Deaths Where COVID-19 Was the Only Cause Mentioned on the Death Certificate, 1 February 2020 to 31 December 2021, by Sex and Age Group, England and Wales, Jan. 17, 2022, Office for National Statistics. https://www.ons.gov.uk/aboutus/transparencyandgovernance/freedomofinformationfoi/covid19deathsandautopsiesfeb2020todec2021
[v] Smith C, Odd D, Harwood R et al. Deaths in Children and Young People in England following SARS-CoV-2 infection during the first pandemic year: a national study using linked mandatory child death reporting data. Nature Medicine 28 (2022): 185–192,https://www.nature.com/articles/s41591-021-01578-1.pdf
[vi] Kevin J. Selva, Carolien E. van de Sandt, Melissa M. Lemke, et al., Systems Serology Detects Functionally Distinct Coronavirus Antibody Features in Children and Elderly, Nature Communications 12, no. 2037 (2021), https://doi.org/10.1038/s41467-021-22236-7.
[vii] Alexander C. Dowell, Megan S. Butler, Elizabeth Jinks, et al., “Children Develop Robust and Sustained Cross-Reactive Spike-Specific Immune Responses to SARS-CoV-2 Infection,” Nat Immunol 23 (2022): 40–49, https://doi.org/10.1038/s41590-021-01089-8
[viii] Wang L, Berger NA, Kaelber DC, Davis PB, Volkow ND, Xu R. COVID infection severity in children under 5 years old before and after Omicron emergence in the US. Preprint. https://www.medrxiv.org/content/10.1101/2022.01.12.22269179v1.full.pdf
[ix] MRC Biostatistics Unit. Report on Nowcasting and Forecasting – 23rd June 2022. https://www.mrc-bsu.cam.ac.uk/now-casting/nowcasting-and-forecasting-23rd-June-2022/
[x] Patalon T & Maccabi KS. Naturally-acquired Immunity Dynamics against SARS-CoV-2 in Children and Adolescents. Preprint21/06/2022. https://www.medrxiv.org/content/10.1101/2022.06.20.22276650v1
[xi] Dorabawila V, Hoefer D, Bauer UE et al. Effectiveness of the BNT162b2 vaccine among children 5-11 and 12-17 years in New York after the Emergence of the Omicron Variant. Preprint 28/02/2022. https://www.medrxiv.org/content/10.1101/2022.02.25.22271454v1.full-text
[xii] Chua GT, KWan MYW, Chui CSL et al. Epidemiology of Acute Myocarditis/Pericarditis in Hong Kong Adolescents Following Comirnaty Vaccination. N Engl J Med 2022; 386: 394-396. https://www.ncbi.nlm.nih.gov/labs/pmc/articles/PMC8767823/
[xiii] Schauer J, Buddhe S, Gulhabe A et al. Persistent Cardiac Magnetic Resonance Imaging Findings in a Cohort of Adolescents with Post-Coronavirus Disease 2019 mRNA Vaccine Myopericarditis. J Pediatr 2022; 245: 233-7. https://doi.org/10.1016/j.jpeds.2022.03.032
[xiv] Su JR. COVID-19 vaccine safety updates: Primary series in children and adolescents ages 5–11 and 12–15 years, and booster doses in adolescents ages 16–24 years. ACIP meeting 05-01-2022. https://www.cdc.gov/vaccines/acip/meetings/downloads/slides-2022-01-05/02-COVID-Su-508.pdf
[xv] Cincinnati Children’s Hospital, Health Library. Myocarditis in Children. Myocarditis in Children | Symptoms, Causes, Treatment & Prognosis (cincinnatichildrens.org)
[xvi] Yahi N, Chahinian H, Fantini J. Infection-enhancing anti-SARS-CoV-2 antibodies recognize both the original Wuhan/D614G strain and Delta variants. A potential risk for mass vaccination?. J Infect. 2021;83(5):607-635. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8351274/
[xvii] Brown EL, Essigmann HT. Original Antigenic Sin: the Downside of Immunological Memory and Implications for COVID-19. mSphere 2021; 6(2): e00056-21. ttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC8546681/
[xviii] Goldberg Y, Mandel M, Bar-On YM et al. Protection and waning of natural and hybrid COVID-19 immunity. N Engl J Med 2022; 386: 2201-12. https://www.nejm.org/doi/pdf/10.1056/NEJMoa2118946?articleTools=true
[xix] Follmann D, Janes HE, Buhule OD et al. Anti-nucleocapsid antibodies following SARS-CoV-2 infection in the blinded phase of the mRNA-1273 Covid-19 vaccine efficacy clinical trial. Preprint 19-04-2022. https://www.medrxiv.org/content/10.1101/2022.04.18.22271936v1.full
[xx] Föhse FK, Geckin B, Overheul GJ et al. The BNT162b2 mRNA vaccine against SARS-CoV-2 reprograms both adaptive and 2 innate immune responses. Preprint 06-05-2021. https://doi.org/10.1101/2021.05.03.21256520
[xxii] Singh N, Bharara Singh A. S2 subunit of SARS-nCoV-2 interacts with tumor suppressor protein p53 and BRCA: an in silico study. Transl Oncol. 2020;13(10):100814. https://www.ncbi.nlm.nih.gov/labs/pmc/articles/PMC7324311/
[xxiii] Pfizer-bio-distribution-confidential-document-translated-to-english.pdf. https://www.naturalnews.com/files/Pfizer-bio-distribution-confidential-document-translated-to-english.pdf
[xxiv] Gat I,Kedem A, Dviri M et al. Covid-19 Vaccination BNT162b2 Temporarily Impairs Semen Concentration and Total Motile Count among Semen Donors. Andrology 2022;1–7. https://onlinelibrary.wiley.com/doi/epdf/10.1111/andr.13209
[xxv] Fraiman J, Erviti J, Jones M, Greenland S, Whelan P, Kaplan RM, Doshi P. Serious Adverse Events of Special Interest Following mRNA Vaccination in Randomized Trials. Preprint 23-06-2022. https://ssrn.com/abstract=4125239
[xxvi] JCVI statement on vaccination of children aged 5 to 11 years old. 16-02-2022. https://www.gov.uk/government/publications/jcvi-update-on-advice-for-covid-19-vaccination-of-children-aged-5-to-11/jcvi-statement-on-vaccination-of-children-aged-5-to-11-years-old
[xxvii] Therapy dogs comfort children during Covid jabs. BBC News. 27-02-2022. https://www.bbc.co.uk/news/uk-england-wiltshire-60529628
[xxviii] Evans E. “Calling All Superhero Kids”: The Unethical Targeting of Young Children by the NHS with COVID-19 Vaccine Adverts. The Daily Sceptic 19-06-2022. https://dailysceptic.org/archive/calling-all-superhero-kids-the-unethical-targeting-of-young-children-by-the-nhs-with-covid-19-vaccine-adverts/
[xxix] NHS South East London Clinical Commissioning Group. FAQs – Vaccinating 5 to 11 year olds. https://selondonccg.nhs.uk/what-we-do/covid-19/covid-19-vaccine/faqs/faqs-vaccinating-5-to-11-year-olds/
[xxx] What is in the vaccine and how does it work? | NHS. 30-04-2021. https://www.youtube.com/watch?v=zgtWpwkS9u4&list=PLnhASgDToTktp2HIjdyeo2fsI6Agcn1ul&index=6
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