COMPLETELY ignoring the urgent request sent to them earlier this week by the Children’s Covid Vaccine Advisory Council (CCVAC) not to authorise Covid vaccines for infants down to the age of six months, (a principle that applies to all the brands of vaccine) the Medicines and Healthcare products Regulatory Agency (MHRA) yesterday did just that. They authorised the Pfizer/BioNTech Covid-19 vaccine for use in babies and infants aged six months to four years. It is an astonishingly defiant move even by MHRA standards, one which flies in the face of all the evidence – or lack of it when it comes to safety.
In her zeal to help the mRNA technology industry, it appears that MHRA chief Dr June Raine has thrown any residual precautionary principle to the winds – and quite literally the baby out with the bath water. The MHRA decision, remarkably, comes at a time when increasing numbers of doctors and scientists are daring to express reservations about the Covid vaccine project as a whole and, in particular, to join in arguing emphatically against this vaccine for children.
Here is the CCVAC letter, once against setting out why children’s health must not be risked for a novel vaccine for which children, in particular, have no need. Attracting more signatures than ever, it was sent earlier this week by Dr Ros Jones and CCVAC. Please note who has been cc’d. If they disregard this, they are culpable too.
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Dame June Raine, CEO, Medicines and Healthcare products Regulatory Authority
Cc: Professor Lim Wei Shen, Joint Committee on Vaccination and Immunisation; Professor Sir Munir Pirmohamed, Chair, Commission on Human Medicines; Rt Hon Stephen Barclay, Secretary of State, Department of Health and Social Care
4th December 2022
Dear Dame June,
Re: Conditional Marketing Authorisation for Covid-19 vaccines for 6 months-5 years
We understand that Moderna has applied for an extension of its CMA down to infancy, following agreement by the European Medicines Agency.
We are writing to strongly recommend against such an action and also against the possibility of introducing Covid-19 vaccines into the routine children’s immunisation programme, for the following reasons, many of which have already been shared with the FDA:
Firstly, as for other paediatric age-groups, the risks from SARS-CoV-2 infection is extremely low, with only 6 deaths in England in the 1-4s age group from Covid-19 in the whole of 2020 and 2021. Most infected toddlers remained asymptomatic or with trivial upper respiratory symptoms, even prior to the arrival of the much milder omicron variants. This alone makes it incomprehensible as to why any medical body would decide that a vaccine would be indicated.
Secondly, it is clear that the currently available vaccines have a very poor efficacy over time. For adults, this lack of durable efficacy has resulted in the need to recommend ongoing boosters, given every few months, with efficacy apparently reducing further for each new variant. This was largely predictable, since these are not sterilising vaccines, and provide no upper airway immunity, necessary to provide effective immunity against respiratory viruses. Vaccine efficacy also wanes more quickly after the paediatric dose (which is lower than the adult dose), with negative efficacy in 5-11s within only 6 weeks of the second dose of Pfizer. This weakness and brevity of protection negates any notion that adults will be protected by the vaccination of children. Adults will be better protected if children have natural infection, thereby deriving longer-lasting and broader immunity.
Thirdly, it is well established that young children have a much more effective innate immune system than adults and at this point the vast majority of under 5-year-olds have already been immunologically exposed to SARS-CoV-2 repeatedly, whether or not actively infected. Meeting these viruses early in life will allow protective immunity to develop for the decades ahead. A degree of immune imprinting has been recognised with the adult vaccines, rendering vaccine escape inevitable. Observed alterations in IgG responses with repeated doses have unknown implications for the developing immune system. Due to the lack of long-term data, concerns about antibody dependant enhancement (ADE) remain unanswered, making this an unacceptable future risk for children.
Fourthly, the safety profile of the novel, gene-based mRNA vaccines is very far from perfect. The balance of benefit and risk, used to support the rollout of mRNA vaccines to the elderly and vulnerable in 2021, is inappropriate and inapplicable for healthy children in 2022, especially given the negligible hazard that the virus poses to them. In adults, adverse event reports in all official safety surveillance systems, eg VAERS, Yellow Card and EudraVigilance, have reached unprecedented levels, with the VAERS reporting systems showing reported fatalities after Covid-19 vaccines several-fold higher than any previous vaccine. Reports of myocarditis in adolescents have been shrugged off as ‘mild and settle quickly’, despite reports to the contrary. No evidence is available to support the confident assertion that the inevitable heart tissue scarring resulting from myocarditis will not lead to serious heart problems and dysfunction 5-10 years down the line. Indeed, Pfizer and Moderna are only now embarking on 5-year follow-up studies which should have been required from the outset. Adverse event reports in the US, where vaccination has already begun in the pre-school age-group, have tragically included 11 deaths in this cohort to date, likely to be an underestimate. There is evidence of a complex functional reprogramming of the innate immune response. Most concerning for a children’s vaccine is the total lack of any long-term safety data to rule out any unexpected negative impact on long-term health or fertility, which should make it unethical to even consider administration to healthy children.
Fifthly, these novel-technology gene products were given an exemption from standard reproductive toxicity, genotoxicity and carcinogenicity animal studies before being rolled out to humans, and indeed have not even had published biodistribution and pharmacokinetic studies. The manufacturers have provided no data on how much spike protein is produced by different people and for how long – this is of great concern as the dose of and duration of exposure to the spike protein may differ by orders of magnitude between individuals, resulting in huge variance in individual susceptibility to adverse events and harm. The initial claim that the vaccine would remain at the injection site is also, clearly, totally without foundation, which raises the concern that the mRNA lipid nanoparticles or the subsequently produced spike protein may cross the blood-brain barrier or placenta, resulting in inflammation and cell destruction in the brain or fetus by the host immune system. Also of concern, published studies have clearly shown that these products negatively affect T-cell function, and hence the ability of the body to fight not only infections but also to clear cancerous cells. At this point, there is far too much evidence of harm to multiple systems and organs to ignore, and we have an ethical duty of care to protect our healthy children from iatrogenic harm.
Finally, the research basis for the toddler vaccines was woefully inadequate. Follow-up was for a median of 70 days after the second dose; this is contrary to international guidelines which recommend at least one year follow-up. Efficacy was estimated at only 37% for 2-4-year-olds, bringing it far below what is usually considered an acceptable efficacy to justify use of a vaccine, and in the younger group prevention of asymptomatic infection at a mere 3.8% with confidence intervals from -111 to +53% should have made this vaccine a complete non-starter for this cohort. The use of ‘immuno-bridging’ (presence of an antibody response) was relied upon as a proxy for preventing symptomatic disease and gives no real-world data to ascertain true effectiveness. Local and systemic side effects were common, especially after the second dose, with post-vaccine fever more common in those with previous SARS-CoV-2 infection. Shockingly, several severe adverse events including a case of Type 1 diabetes, a lifelong, life-limiting disease, were hidden in the supplementary appendix, which brings into question the transparency of the data.
There has been a stated concern from public health bodies about an increase in vaccine hesitancy. Rolling out a rushed pharmaceutical product with known short-term risks and unknown long-term risks to an age group that cannot benefit in any meaningful way can only fuel public doubt in the scientific rigour of the authorisation process. This could undermine the entire childhood immunisation programme and lead to further vaccine hesitancy. It can already be seen in the US that uptake for this young age is extremely low – parents are voting with their feet.
Until all these short- and long-term safety concerns have been rigorously investigated and ruled out, and a significant need and benefit for the vaccine in this cohort has been demonstrated, the precautionary principle and fundamental ethical principles of science and medicine must preclude any further authorisations.
Dr Rosamond Jones, MBBS, MD, FRCPCH, retired consultant paediatrician, on behalf of members of CCVAC (Children’s Covid Vaccines Advisory Council) and many others, including:
Professor Anthony J Brookes, Professor of Genomics & Health Data Science, University of Leicester
Professor Angus Dalgleish, MD, FRCP, FRACP, FRCPath, FMedSci, Professor of Oncology, St George’s Hospital, London
Professor Richard Ennos, MA, PhD. Honorary Professorial Fellow, University of Edinburgh
Professor John A Fairclough, BM BS, BMed Sci, FRCS, FFSEM(UK), Professor Emeritus, Honorary Consultant Orthopaedic Surgeon
Professor Norman Fenton, CEng, CMath, PhD, FBCS, MIET, Professor of Risk Information Management, Queen Mary University of London
Professor David Livermore, BSc, PhD, retired Professor of Medical Microbiology
Professor Dennis McGonagle, PhD, FRCPI, Consultant Rheumatologist, University of Leeds
Professor Roger Watson, FRCP Edin, FRCN, FAAN, Professor of Nursing
Professor Keith Willison, PhD, Professor of Chemical Biology, Imperial, 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 Najmiah K Ahmad, BM MRCA FCARCSI, Consultant Anaesthetist
Dr Shiraz Akram, BDS, Dental surgeon
Dr Victoria Anderson, MBChB, MRCGP, MRCPCH, DRCOG, General Practitioner
Julie Annakin, RN, Immunisation Specialist Nurse
Helen Auburn, Dip ION MBANT NTCC CNHC RNT, registered Nutritional Therapist
Dr Ian Barros D’Sa, BM, MRCS, FRCR, PGCMEd, Consultant Radiologist
Dr David Bell, MBBS, PhD, FRCP(UK)
Dr Michael D Bell, MBChB, MRCGP, retired General Practitioner
Dr Mark A Bell, MBChB, MRCP(UK), FRCEM, Consultant in Emergency Medicine, UK
Dr Alan Black, MBBS, MSc, DipPharmMed, Retired Pharmaceutical Physician
Dr Gillian Breese, BSc, MB ChB, DFFP, DTM&H, General Practitioner
Dr Emma Brierly, MBBS, MRCGP, General Practitioner
Mr John Bunni, MBChB (Hons), DipLapSurg, FRCS, Consultant Colorectal and General Surgeon
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
Dr Marco Chiesa, MD, FRCPsych, Consultant Psychiatrist, Visiting Professor
Michael Cockayne MSc, PG Dip, SCPHNOH, BA, RN Occupational Health 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 Clare Craig, BM BCh FRCPath
Dr David Critchley, BSc, PhD, 32 years in pharmaceutical R&D as a clinical research scientist
Dr Jayne LM Donegan, MBBS, DRCOG, DCH, DFFP, MRCGP, Homeopathic Practitioner
Dr Jonathan Eastwood, BSc, MBChB, MRCGP, General Practitioner
Dr Jonathan Engler, MBChB, LlB (hons), DipPharmMed
Dr Elizabeth Evans, MA(Cantab), MBBS, DRCOG, Retired Doctor, Director UKMFA
Dr Chris Exley, PhD FRSB, retired professor in Bioinorganic Chemistry
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
Sophie Gidet, RM, Midwife
Dr Ali Haggett, Mental health community work, 3rd sector, former lecturer in the history of medicine
Mr David Halpin, MBBS, FRCS, Orthopaedic and trauma surgeon, retired
Mr Anthony Hinton, MBChB, FRCS, Consultant ENT surgeon, London
Dr Renee Hoenderkamp, General Practitioner
Dr Andrew Isaac, MB BCh, Physician, retired
Dr Keith Johnson, BA, D.Phil (Oxon), IP Consultant for Diagnostic Testing
Dr Pauline Jones MB BS retired general practitioner
Ancha Bala Joof, MBChB, MRCGP, General Practitioner
Dr Timothy Kelly, MB BCh BSc, NHS doctor
Dr Gemma Kemp, MBBS FRCPath, Consultant Forensic Pathologist
Dr Tanya Klymenko, PhD, FHEA, FIBMS, Senior Lecturer in Biomedical Sciences
Dr Sheena Fraser, MBChB, MRCGP (2003), Dip BSLM, General Practitioner
Dr Caroline Lapworth, MB ChB, General Practitioner
Dr Branko Latinkic, BSc, PhD, Molecular Biologist
Dr Theresa Lawrie, MBBCh, PhD, Director, Evidence-Based Medicine Consultancy Ltd, Bath
Dr Felicity Lillingstone, IMD DHS PhD ANP, Doctor, Urgent Care, Research Fellow
Katherine MacGilchrist, BSc (Hons) Pharmacology, MSc Epidemiology, CEO, Systematic Review
Director, Epidemica Ltd
Dr C Geoffrey Maidment, MD, FRCP, retired consultant physician
Mr Ahmad K Malik, FRCS (Tr & Orth), Dip Med Sport, Consultant Trauma & Orthopaedic Surgeon
Dr Ayiesha Malik, MBChB, General Practitioner
Dr Imran Malik, MBBS, MRCP, MRCGP, General Practitioner
Dr Kulvinder S. Manik MBChB, MRCGP, MA(Cantab), LLM, Gray’s Inn
Dr Fiona Martindale, MBChB, MRCGP, General Practitioner
Mr Ian McDermott, MBBS, MS, FRCS(Tr&Orth), FFSEM(UK), Consultant Orthopaedic Surgeon
Dr Graham Milne, MBChB, MRCGP, DRCOG, General Practitioner
Dr Scott Mitchell, MBChB, MRCS, Associate Specialist, Emergency Medicine
Dr Alan Mordue, MBChB, FFPH (ret). Retired Consultant in Public Health Medicine & Epidemiology
Margaret Moss, MA(Cantab), CBiol, MRSB, Director, The Nutrition and Allergy Clinic, Cheshire
Dr Claire Mottram, BSc Hons, MBChB, Doctor in General Practice
Dr Greta Mushet, retired Consultant Psychiatrist in Psychotherapy. MBChB, MRCPsych
Dr Angela Musso, MD, MRCGP, DRCOG, FRACGP, MFPC, General Practitioner
Dr Sarah Myhill, MBBS, Dip NM, Retired GP, Independent Naturopathic Physician
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
Anna Phillips, RSCN, BSc Hons, Clinical Lead Trainer Clinical Systems (Paediatric Intensive Care)
Dr Angharad Powell, MBChB, BSc (hons), DFRSH, DCP (Ireland), DRCOG, DipOccMed, MRCGP, General Practitioner
Dr Gerry Quinn, PhD, Microbiologist
Jessica Righart, MSc, MIBMS, Senior Biomedical Scientist
Mr Angus Robertson, BSc, MBChB, FRCSEd (Tr & Orth), Consultant Orthopaedic Surgeon
Dr Susannah Robinson, MBBS, BSc, MRCP, MRCGP, General Practitioner
Dr Jon Rogers, MB ChB (Bristol), Retired General Practitioner
Mr James Royle, MBChB, FRCS, MMedEd, Colorectal Surgeon
Dr Salmaan Saleem, MBBS, BMedSci, MRCGP, General Practitioner
Dr Alia Sarwar, MBChB, General Practitioner
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 Haleema Sheikh, MRCGP, General Practitioner
Dr Magdalena Stasiak-Horkan MBBS, MRCGP (2017), DCH, General Practitioner
Natalie Stephenson, BSc (Hons) Paediatric Audiologist
Marco Tullio Suadoni, RN, BSc (Hons) Adult Nursing, MSc, Specialist Palliative Care Lead
Dr Mashhood Syed, MBChB, DRCOG, MRCGP(2018), LFHom(Med)
Dr Noel Thomas, MA, MBChB, DObsRCOG, DTM&H, MFHom, Retired Doctor
Dr Stephen Ting, MBChB, MRCP, PhD, Consultant Physician
Dr Livia Tossici-Bolt, PhD, NHS Clinical Scientist
Dr Fodhla Treacy, MBBS, MRCGP, General Practitioner
Dr Helen Westwood, MBChB (Hons), MRCGP, DCH, DRCOG, General Practitioner
Dr Carmen Wheatley, DPhil, Orthomolecular Oncology
Mr Lasantha Wijesinghe, FRCS, Consultant vascular surgeon
Dr Ruth Wilde, MBBCh, MRCEM, AFMCP, Integrative & Functional Medicine Doctor
Dr Lucie Wilk, MD, MRCP, Rheumatologist
Dr Julia Wilkens, FRCOG, MD, Consultant in Obstetrics & Gynaecology
Dr Ruqia Zafar, MBChB, MRCGP, General Practitioner
