To all members of the FDA 29.04.22
29th March 2022
To all members of the FDA vaccines committee
Dear Colleagues,
Re: Pfizer Covid-19 mRNA vaccine EUA application for children aged 6 months to 4 years, returning to FDA in April
We are a group of health professionals and scientists from the UK and we are writing to urge you to please reject the Pfizer application for Emergency Use Authorisation of the mRNA Covid-19 vaccines in children aged 6 months to 4 years. Although we are not American citizens, we take the liberty of approaching you in the awareness that your decision will have repercussion for children in our country, in Europe and across the world.
In the following, we invite you to consider the available evidence in evaluating the risk-benefit balance for this age group.
We all know from anecdotal evidence in everyday life and from the hard evidence of a vast body of published literature that, thankfully, healthy children and teenagers are resilient to the SARS-Cov2 virus. Their innate and adaptive immune systems have proven to be able to fight the virus brilliantly, demonstrating an excellent infection recovery rate close to 100% and extremely low risk of death in the absence of comorbidities. This has been observed consistently throughout the pandemic worldwide, as seen in the large studies in the UK, Germany and USA.
A recent study published in the Lancet summarizes with clarity the mortality data collected across the world during the pre-vaccine era, confirming the J-shaped pattern of the Covid-19 infection fatality rate (IFR) versus age: with values vanishingly small for children and adolescents (the lowest death rate occurring at age 7 years), it shows unequivocally that Covid-19 poses virtually zero risk to healthy children.
Furthermore, the vast majority of children has already been exposed to the virus; certainly, this is the case for the UK. Their naturally acquired immunity has proven to be superior to that of adults, in terms of longer-lasting functional antibodies, better cellular response (T-cells) and enhanced recognition of variants. Real world data, therefore, do not provide any evidence of an “emergency” for this age group.
We also would like to invite you to reflect on the results of the Pfizer clinical trial in children aged 6 months to four years, which have demonstrated a failed vaccine immunogenicity after both second and third doses. Coupled with the real word data demonstrating a negative effectiveness of the mRNA Covid-19 vaccine in the next age group (5 to 11 years) after the emergence of the Omicron variant, it becomes practically impossible to find a rational justification for recommending this type of vaccination to children.
While there appears to be no benefit to be gained, the risks the Covid-19 vaccines pose to children are extremely alarming.
The observation of declining protection against infections, hospitalisations and deaths among the fully vaccinated raises the serious concern of a possible disruption of both innate and adaptive immune responses following repeated doses, temporally close to each other, which every time trigger the same humoral response to a now obsolete spike protein. 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.
The VAERS database, despite its passive surveillance nature and resulting under-reporting, presents an alarming safety profile for the Covid-19 vaccines in all age groups, in terms of both number and severity of the adverse reactions. The most serious and common injury thus far is that of myocarditis, which poses a grave risk for young children, particularly males, as its incidence has been observed to increase with decreasing age and with the second mRNA vaccine dose. Perhaps the most accurate estimate of myocarditis incidence in adolescents (age 12 to 17 years) comes from Hong Kong, where an active monitoring program has been in place since the vaccine rollout. The alarming finding of an incidence rate as high as 1 in 2,563 in males after the second dose has prompted the authorities to implement a single dose policy in this age group. Extremely concerning also is 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. The potential for longer term effects requires further study and calls for prudence.
The information from the CDC at the conclusion of 2021 was concerning: during just 4 weeks, 4,249 adverse events were reported for children aged 5-11 with 100 listed as serious, 15 had increased troponin (12 confirmed to be myocarditis), 12 had seizures and 2 died. Since then, the number of reports of children deaths in the VAERS database has sadly increased, while a particularly disturbing case has been removed without a reason being provided:
https://openvaers.com/covid-data/child-reports/1975356
https://openvaers.com/covid-data/child-reports/2109625
https://openvaers.com/covid-data/child-reports/2152560
https://www.icandecide.org/ican_press/report-of-toddlers-death-disappears-from-vaers-and-cdc-has-no-records-as-to-why/
https://openvaers.com/covid-data/child-summaries
We imagine you are aware that the FDA authorization of the Covid-19 vaccine in children aged 6 months to 4 years, would likely result in the CDC adding it to the childhood schedule. It is painfully clear that this would serve the aim of Pfizer to obtain an indefinite liability protection, which would lead to vaccine mandates and widespread iatrogenic injury. It is likely that this regime will be exported to the UK and Europe.
You have the power to stop this. Please follow your conscience and your professional duty to do no harm. Please reject Pfizer’s EUA application for children of 6 months to 4 years old.
Sincerely,
Dr Livia Tossici-Bolt, PhD, Clinical Scientist
Dr Rosamond Jones, MD, FRCPCH, retired consultant paediatrician, chairman CCVAC
Mr Ian F Comaish, MA, BM BCh, FRCOphth, FRANZCO, Consultant ophthalmologist
Katherine MacGilchrist, BSc (Hons), MSc, CEO/Systematic Review Director, Epidemica Ltd.
Dr David Cartland, MBChB, BMedSci, General practitioner
Dr Elizabeth Evans, MA(Cantab), MBBS, DRCOG, Retired Doctor
Dr Angharad Powell, MBChB, BSc (hons), DFRSH, DCP (Ireland), DRCOG, DipOccMed, MRCGP, General Practitioner
Mr James Royle, MBChB, FRCS, MMedEd, Colorectal surgeon
Dr Helen Westwood MBChB MRCGP DCH DRCOG, General Practitioner
Dr Geoffrey Maidment, MBBS, MD, FRCP, Consultant physician, retired
Dr Noel Thomas, MA, MBChB, DObsRCOG, DTM&H, MFHom, Retired Doctor
Dr Gerry Quinn, PhD, Microbiologist
Dr David Critchley, BSc, PhD, 32 years in pharmaceutical R&D as a clinical research scientist
Dr Emma Brierly, MBBS, 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
Professor Anthony J Brookes, Professor of Genomics & Health Data Science, University of Leicester
Dr Jayne LM Donegan, MBBS, DRCOG, DCH, DFFP, MRCGP, General Practitioner
Mr Anthony Hinton, MBChB, FRCS, Consultant ENT surgeon, London
Dr Keith Johnson, BA, D.Phil (Oxon), IP Consultant for Diagnostic Testing
Dr Michael D Bell, MBChB, MRCGP, retired General Practitioner
Dr Tanya Klymenko, PhD, FHEA, FIBMS, Senior Lecturer in Biomedical Sciences
Dr Elyse Baril-Guerard, MD, CCFP, MRCGP, General Practitioner
Dr Pauline Jones MB BS retired general practitioner
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 Jon Rogers, MB ChB (Bristol), Retired General Practitioner
Rev Dr William J U Philip MB ChB, MRCP, BD, Senior Minister The Tron Church, Glasgow, formerly physician specialising in cardiology
Dr John Flack, BPharm, PhD. Retired Director of Safety Evaluation at Beecham Pharmaceuticals and retired Senior Vice-president for Drug Discovery SmithKline Beecham
Dr Alan Mordue, MBChB, FFPH (ret). Retired Consultant in Public Health Medicine & Epidemiology
Julie Annakin, RN, Immunisation Specialist Nurse
Dr Christina Peers, MBBS, DRCOG, DFSRH, FFSRH, Menopause Specialist
Dr Carmen Wheatley, DPhil, Orthomolecular Oncology
Mr Angus Robertson, BSc, MB ChB, FRCSEd (Tr & Orth), Consultant Orthopaedic Surgeon
Dr Jenny Goodman, MA, MBChB, Ecological Medicine
Dr Kulvinder S. Manik MBChB, MRCGP, MA(Cantab), LLM, Gray’s Inn
David Halpin, MB BS FRCS, Orthopaedic and trauma surgeon (retired)
Dr Charles Lane, Molecular Biologist
Dr Stephen Ting, MB CHB, MRCP, PhD, Consultant Physician
Dr Sarah Myhill, MBBS, retired GP and Naturopathic Physician
Dr Felicity Lillingstone, IMD DHS PhD ANP, Doctor, Urgent Care, Research Fellow
Dr Peter Chan, BM, MRCS, MRCGP, NLP, General Practitioner, Functional Medicine Practitioner, GP Trainer
Mr Lasantha Wijesinghe, FRCS, Consultant vascular surgeon
…. and other members of the Children’s Covid Vaccine Advisory Council
