Dr June Raine, CEO, MHRA,
cc: Professor Lim, Chairman, JCVI
Sajid Javid MP, Secretary of State for Health & Social Care
Commission on Human Medicines
Paediatric Medicines Expert Advisory Group
14th November 2021
Dear Dr Raine,
Re safety of COVID-19 vaccines in children
We are a group of doctors and scientists who wrote to you on 17th May, then again on 6th June and most recently to the JCVI on 19th August regarding our major concerns over the safety and indeed the necessity for COVID-19 vaccines for children. Our specific questions remain unanswered, despite increasing evidence of vaccine adverse events in this age group both abroad and in the UK. Your promise made Nov 20th 2020, “There is absolutely no chance that we will compromise on standards of safety or effectiveness” seems to have been abandoned.
Our combined clinical and scientific experience leaves us deeply concerned about safety for teenagers receiving the vaccines at the present time and in particular, the lack of timely analysis and publication of adverse events occurring in 12-17-year-olds. Following the FDA and CDC authorisation of the Pfizer vaccine for 5-11-year-olds, we are also concerned that emergency use authorisation will be granted here before the outcomes in 12-17s have been fully assessed, and despite an open acknowledgement from Pfizer that ‘the number of participants in the current clinical development program is too small to detect any potential risks of myocarditis associated with vaccination. Long-term safety of COVID-19 vaccine in participants 5 to <12 years of age will be studied in 5 post-authorization safety studies, including a 5-year follow-up study to evaluate long term sequelae of post-vaccination myocarditis/pericarditis’.
We have the following urgent questions.
- Given the demonstrated excess in deaths in young men aged 15-19 since May 2021, can you provide a breakdown by vaccination status, providing interval in days between vaccination if any and death?
- Given an estimated 76% of school children have already been infected with Sars-CoV-2, plus the clear superiority of natural over vaccine-induced immunity, how can these children benefit?
- Given the poor N-antibody response when natural infection follows vaccination, can you be sure that non-immune children won’t be forced into a programme of recurrent booster shots as seen in adults?
- Have you seen any data which can predict the quantity of spike protein produced by individuals following a specified dose of mRNA and have you any biodistribution data for humans?
- What follow-up data have you seen from the American group reporting late gadolinium enhancement on cardiac MRI scans?
- What other potential long term side effects have been considered?
- What is the NNTV (number needed to vaccinate) to prevent one death or hospital admission?
- Given that children are not seriously impacted by COVID-19, and there has never been an emergency situation regarding children’s health relating to SARS-CoV-2 infection, how have you defined ‘Emergency’ for the purposes of these authorisations? What ethical considerations have been considered?
- Dr Rosamond Jones, MD, FRCPCH, retired consultant paediatrician
- Professor Keith Willison, PhD, Professor of Chemical Biology, Imperial, London
- Professor David Livermore, BSc, PhD, Professor of Medical Microbiology, University of East Anglia
- Professor Anthony J Brookes, Department of Genetics & Genome Biology, University of Leicester
- Professor Richard Ennos, MA, PhD. Honorary Professorial Fellow, University of Edinburgh
- Professor Angus Dalgleish, MD, FRCP, FRACP, FRCPath, FMed Sci, Professor of Oncology, St George Hospital, London
- 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 John Flack, BPharm, PhD. Retired Director of Safety Evaluation, Beecham Pharmaceuticals 1980-1989 and Senior Vice-president for Drug Discovery 1990-92 SmithKline Beecham
- Dr Alan Mordue, MBChB, FFPH. Retired Consultant in Public Health Medicine & Epidemiology
- Dr Roland Salmon, MB BS, MRCGP, FFPH, Former Director, Communicable Disease Surveillance Centre Wales
- Dr Gerry Quinn, PhD. Postdoctoral researcher in microbiology and immunology
- Dr Geoffrey Maidment, MD, FRCP, retired consultant physician
- Mr Malcolm Loudon, MBChB, MD, FRCSEd, FRCS(Gen Surg), MIHM,VR, Consultant Surgeon
- Dr Branko Latinkic, BSc, PhD, Reader in Biosciences
- Dr Helen Westwood MBChB MRCGP DCH DRCOG, General Practitioner
- Katherine MacGilchrist, BSc (Hons), MSc, CEO/Systematic Review Director, Epidemica Ltd.
- Mr James Royle, MBChB, FRCS, MMedEd, Colorectal surgeon
- Dr Livia Tossici-Bolt, PhD, NHS Clinical Scientist
- Dr Elizabeth Evans MA(Cantab), MBBS, DRCOG, Retired Doctor
- Dr Mark A Bell, MBChB, MRCP(UK), FRCEM, Consultant in Emergency Medicine
- Mr Ian F Comaish, MA, BM BCh, FRCOphth, FRANZCO, Consultant ophthalmologist
- Dr Scott Mitchell, MBChB, MRCS, Associate Specialist in Emergency Medicine
- Dr Andrew Isaac, MB BCh, Physician, retired
- Dr Theresa Lawrie, MBBCh, PhD, Director, Evidence-Based Medicine Consultancy Ltd, Bath
- Dr Emma Brierly, MRCGP, General Practitioner
- Dr Rohaan Seth, Bsc (hons), MBChB (hons), MRCGP, Retired General Practitioner
- Dr Franziska Meuschel, MD, ND, PhD, LFHom, BSEM, Nutritional, Environmental and Integrated Medicine
- Dr Kulvinder Singh Manik MBChB, MRCGP, MA(Cantab), LLM, Gray’s Inn
- Dr Peter Chan, BM, MRCS, MRCGP, NLP, General Practitioner, Functional medicine practitioner
- Dr Marco Chiesa, MD, FRCPsych, Consultant Psychiatrist & Visiting Professor, UCL
- Dr Alan Black, MBBS, MSc, DipPharmMed, retired pharmaceutical physician
- Dr Noel Thomas, MA, MBChB, DCH, DObsRCOG, DTM&H, MFHom, retired doctor
- Dr Michael D Bell, MBChB, MRCGP, retired General Practitioner
- Dr Sarah Myhill, MBBS, Dip NM, Retired GP, Independent Naturopathic Physician
- Margaret Moss, MA (Cantab), CBiol, MRSB, Director, The Nutrition and Allergy Clinic, Cheshire
- Dr David Morris, MBChB, MRCP(UK), General Practitioner
- Dr Greta Mushet, MBChB, MRCPsych, retired Consultant Psychiatrist in Psychotherapy
- Dr Jenny Goodman, MA, MB ChB, Ecological Medicine
- Dr Charles Forsyth, MBBS, BSEM, Independent Medical Practitioner
- Dr Fiona Martindale, MbChB, MRCGP, GP in out of hours
- Dr Christina Peers, MBBS, DRCOG, DFSRH, FFSRH, Menopause Specialist
- Dr Chris Newton, PhD, Biochemist working in immuno-metabolism
- Dr Stefanie Williams, Dermatologist
- Dr David Bramble, MBChB, MRCPsych, MD, Consultant Psychiatrist
- Dr Damien Downing, MBBS, MRSB, private physician
- Mr Anthony Hinton, MBChB, FRCS, Consultant ENT surgeon, London
- Dr Julie Maxwell, MBBCh, MRCPCH, Associate Specialist Community Paediatrician
- Dr Tanya Klymenko, PhD, FHEA, FIBMS, Senior lecturer in Biomedical Sciences
- and others …..