Open Letter to MHRA: 23-08-2021

Dr June Raine, CEO, MHRA 10 South Collonade, Canary Wharf, LONDON E14 4PU 23rd August 2021 Dear Dr Raine, Re safety of COVID-19 vaccines in children Thank you for your letter of 20th August in reply to our letter of 6th June. We had requested this information as a matter of urgency so are dismayed that even now, after a 10-week delay, you have provided no data to support the statements made. Our questions were very specific and I will re-iterate them below. Your statement that the benefit / risk balance for 12-15s is ‘similar’ to that for 16-24s, is particularly puzzling, given the death rate increases progressively with increasing age yet it appears that the correlation with age is in the reverse direction for adverse events, particularly myocarditis. From ONS data between 1st April 2020 and 31st July 2021 ie including 2 winter peaks of infections, there were precisely 4 deaths in the 0-9s, 9 deaths for 10-14s, 22 deaths in 15-19s and 55 deaths in 20-24s. Thus, the potential benefit for the younger age groups cannot be the same even when compared with young adults. Conversely data from the CDC and from Israel confirm that myocarditis risk is highest in the youngest age groups. We must therefore ask again for the data you have used to be made public as a matter of urgency. These questions from our 6th June letter have not been answered. What calculations of the risk of myocarditis have you included? Why have you not published the data delineated by age band so that young adults can make properly informed choices? How have deaths in 12-17 year-olds from VAER been factored into your deliberations? Have you seen any data which can predict the quantity of spike protein produced by individuals following a specified dose of mRNA? What potential long term side effects have been considered? What NNT have you used in your calculations? 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 this authorisation? Yours sincerely, Dr Rosamond Jones, MD, FRCPCH, retired consultant paediatrician Prof Anthony Fryer, PhD, FRCPath, Professor of Clinical Biochemistry, Keele University Professor Anthony J Brookes, Department of Genetics & Genome Biology, University of Leicester Professor David Livermore, BSc, PhD, Professor of Medical Microbiology, University of East Anglia Professor John A Fairclough, BM BS, BMed Sci, FRCS, FFSEM(UK), Professor Emeritus, Honorary Consultant Orthopaedic 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 Karen Horridge, MB ChB(Hons), MSc, MRCP, FRCPCH, Consultant Paediatrician (Disability) Dr Alan Mordue, MBChB, FFPH (ret). Retired Consultant in Public Health Medicine & Epidemiology Mr Malcolm Loudon, MB ChB, MD, FRCSEd, FRCS (Gen Surg). MIHM, VR. Consultant Surgeon Dr David Critchley, BSc, PhD, 32 years in pharmaceutical R&D as a clinical research scientist. Mr Anthony Hinton, MBChB, FRCS, Consultant ENT surgeon, London Dr John Flack, BPharm, PhD. Retired Director of Safety Evaluation at Beecham Pharmaceuticals 1980-1989 and Senior Vice-president for Drug Discovery 1990-92 SmithKline Beecham Michael Cockayne, MSc, PGDip, SCPHNOH, BA, RN, Occupational health practitioner Dr C Geoffrey Maidment, MD, FRCP, retired consultant physician Dr Christina Peers, MBBS, DRCOG, DFSRH, FFSRH, Menopause Specialist Mr T James Royle MBChB, FRCS(Ed), MMedEd, Colorectal surgeon Noel Thomas, MA, MB ChB, DCH, DObsRCOG, DTM&H, MFHom, retired doctor Dr Scott McLachan, FAIDH, MCSE, MCT, DSysEng, LLM, MPhil(Sc), Risk & Information Management Group Dr Holly Young, BSc, MBChB, MRCP, Consultant physician, Croydon University Hospital Dr David Critchley, BSc, PhD, 32 years in pharmaceutical R&D as a clinical research scientist. Dr Alan Black, MB BS MSc DipPharmMed, retired pharmaceutical physician Dr K Singh, MBChB, MRCGP, general practitioner Mr Ian F Comaish, MA, BM BCh, FRCOphth, FRANZCO, Consultant ophthalmologist Dr David Bramble, MBChB, MRCPsych, MD. Consultant Psychiatrist Dr Theresa Lawrie, MBBCh, PhD, Director, Evidence-Based Medicine Consultancy Ltd, Bath Dr Fiona Martindale, MbChB, MRCGP, GP, Out of hours Dr Gerry Quinn, PhD, Postdoctoral Researcher, Microbiology and Immunology Dr Elizabeth Evans, MA, MBBS, DRCOG, Retired doctor Dr Greta Mushet, retired Consultant Psychiatrist in Psychotherapy. MBChB, MRCPsych …….and 30 others
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