Second Open Letter to all members of the FDA vaccines committee

Further call to halt Covid-19 vaccine programme for children

Dear Colleagues,

Re: Pfizer Covid-19 mRNA vaccine EUA application for children aged 6 months to 4 years; and

Moderna Covid-19 mRNA vaccine EUA application for children aged 6 months to 17 years

We are a group of health professionals and scientists from the UK, who submitted a letter to the FDA meeting in March regarding our concerns over the potential authorisation of Pfizer vaccine for children aged 6 months to 4 years and our letter is reattached today in readiness for your June meeting.  No new evidence has come to light since our March letter, which gives any credibility to the necessity, safety or even efficacy of this vaccine for infants. 

We know that children in this age group have excellent innate immunity and also cross-reactivity from previous human coronavirus infections.  Moreover, numerous disclosures from Pfizer, compelled to be released by a court order, give grounds for increased concerns over safety for older children and adults.  You already have all these papers in your possession, so we will not enumerate them here. The latest VAERS data on deaths and injuries in children aged 5-17 is summarised here and alone gives sufficient reason not to roll this vaccine out to ever younger age-groups.  

Regarding the Moderna vaccine, it is also very surprising to see this authorisation being proposed, given that the adverse effects of Moderna would appear to be even higher than for Pfizer, possibly because of the higher dosage, which may be associated with a slightly longer duration of action. Indeed, several countries halted Moderna for young adults because of this.  Also, Moderna’s own animal studies have shown that previously vaccinated macaque monkeys showed a reduced response to a new omicron vaccine, compared to a booster with  the original vaccine, confirming concerns raised over immune imprinting. 

Of note, the latest UK government update on the Moderna vaccine includes the following statements:

 The safety and efficacy of Spikevax in children and adolescents less than 6 years of age have not yet been established. No data are available.”

“There is an increased risk for myocarditis and pericarditis following vaccination with Spikevax…. Available data suggest that the course of myocarditis and pericarditis following vaccination is not different from myocarditis or pericarditis in general.”

“The duration of protection afforded by the vaccine is unknown as it is still being determined by ongoing clinical trials.”

“The licensing authority has deferred the obligation to submit the results of studies with the Spikevax in one or more subsets of the paediatric population in prevention of COVID-19.”

“Carcinogenicity studies were not performed.”

You have the power to stop this. Please follow your conscience and your professional duty to do no harm. Please reject both Pfizer and Moderna’s EUA applications for children.

Sincerely,

  • Professor Anthony J Brookes, Professor of Genomics and Health Data Science, University of Leicester
  • Professor Angus Dalgleish, MD, FRCP, FRACP, FRCPath, FMed Sci, Principal, Institute for cancer vaccines and Immunotherapy (ICVI)
  • Professor Richard Ennos, MA, PhD. Honorary Professorial Fellow, University of Edinburgh
  • Professor John Fairclough, FRCS FFSEM, retired Honorary Consultant Surgeon 
  • Professor Keith Willison, PhD, Professor of Chemical Biology, Imperial College, London
  • Lord Moonie, MBChB, MRCPsych, MFCM, MSc, House of Lords, former parliamentary under-secretary of state 2001-2003, former consultant in Public Health Medicine
  • Dr Livia Tossici-Bolt, PhD, Clinical Scientist
  • Dr Rosamond Jones, MBBS, MD, FRCPCH, retired consultant paediatrician, chairman CCVAC
  • Dr Theresa Lawrie, MBBCh, PhD, Director, Evidence-Based Medicine Consultancy Ltd, Bath
  • Katherine MacGilchrist, BSc (Hons), MSc, CEO/Systematic Review Director, Epidemica Ltd.
  • Julie Annakin, RN, Immunisation Specialist Nurse
  • Dr Elyse Baril-Guerard, MD, CCFP, MRCGP, General Practitioner
  • Dr David Bell, MBBS, PhD, FRCP(UK), Public Health Physician
  • Dr Mark A Bell, MBChB, MRCP(UK), FRCEM, Consultant in Emergency Medicine
  • Dr Michael D Bell, MBChB, MRCGP, retired General Practitioner
  • Dr Alan Black, MBBS, MSc, DipPharmMed, retired pharmaceutical physician
  • Dr Emma Brierly, MBBS, MRCGP, General Practitioner
  • Kim Bull, Foundation Degree in Paramedic Science, Paramedic
  • Dr Elizabeth Burton, MB ChB, Retired 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
  • 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 (MPH)
  • Dr Zac Cox, BDS, LCPH, Dentist
  • Dr David Critchley, BSc, PhD, 32 years in pharmaceutical R&D as a clinical research scientist
  • Dr Sue de Lacy, MBBS MRCGP AFMCP UK, Integrative Medicine Doctor
  • Dr Jayne LM Donegan, MBBS, DRCOG, DCH, DFFP, MRCGP, General Practitioner
  • Dr Damien Downing, MBBS, MRSB, private physician
  • Dr Elizabeth Evans, MA(Cantab), MBBS, DRCOG, Retired Doctor
  • Dr Christopher Exley, PhD, FRSB, Bioinorganic Chemist
  • Dr John Flack, BPharm, PhD, retired Director of Safety Evaluation at Beecham Pharmaceuticals and retired Senior Vice-president for Drug Discovery SmithKline Beecham
  • Dr Jenny Goodman, MA, MBChB, Ecological Medicine
  • David Halpin, MB BS FRCS, Orthopaedic and trauma surgeon (retired)  
  • Sue Parker Hall, certified transactional analyst (CTA, psychotherapy); MSc (Counselling & Supervision) MBACP (senior accredited practitioner); EMDR practitioner, Psychotherapist
  • Dr Catherine Hatton, MBChB, General Practitioner
  • Dr Ali Haggett, Mental health community work, 3rd sector, former lecturer in the history of medicine
  • Mr Anthony Hinton, MBChB, FRCS, Consultant ENT surgeon, London
  • Dr Renee Hoenderkamp, General Practitioner
  • Dr Keith Johnson, BA, DPhil (Oxon), IP Consultant for Diagnostic Testing
  • Dr Pauline Jones, MBBS, retired general practitioner 
  • Dr Gemma Kemp, MBBS, FRCPath, Consultant Forensic Pathologist
  • Dr Tanya Klymenko, PhD, FHEA, FIBMS, Senior Lecturer in Biomedical Sciences
  • Dr Charles Lane, DPhil, Molecular Biologist
  • Dr Geoffrey Maidment, MBBS, MD, FRCP, Consultant physician, retired
  • Dr Kulvinder S Manik, MBChB, MA(Cantab), LLM, Gray’s Inn
  • Dr Fiona Martindale, MBChB, MRCGP, GP out-of-hours
  • 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 Affiliations, IDF, BSEM, Nutritional, Environmental and Integrated Medicine
  • 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 Greta Mushet, MBChB, MRCPsych, retired Consultant Psychiatrist in Psychotherapy
  • Dr Sarah Myhill, MBBS, retired GP and Naturopathic Physician
  • Dr Chris Newton, PhD, Biochemist working in immuno-metabolism
  • Dr Rachel Nicholl, PhD, Medical researcher
  • 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, Microbiologist 
  • 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 Rohaan Seth, BSc (hons), MBChB (hons), MRCGP, Retired General Practitioner
  • Dr Noel Thomas, MA, MBChB, DObsRCOG, DTM&H, MFHom, Retired Doctor
  • Dr Stephen Ting, MB CHB, MRCP, PhD, Consultant Physician
  • Dr Helen Westwood MBChB MRCGP DCH DRCOG, General Practitioner
  • Dr Carmen Wheatley, DPhil, Orthomolecular Oncology
  • Mr Lasantha Wijesinghe, FRCS, Consultant Vascular Surgeon
  • Dr Ruth Wilde, MB BCh, MRCEM, AFMCP, Integrative & Functional Medicine Doctor

  …. and other members of the Children’s Covid Vaccine Advisory Council

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