Dr Ros Jones | 26 Nov 2021
Dr Ros Jones, a Fellow of the Royal College of Paediatrics and Child Health, has, with senior medical and scientist colleagues, written four times since May to the watchdog MHRA (Medicines and Healthcare products Regulatory Agency) to express their serious concerns about the safety and necessity of the Government’s child vaccination programme, and asking for it to be halted. Tragically, they have been all but ignored.
We published the first three of these letters here, here and here. To say that the replies received from Dr June Raine, the CEO of the MHRA, have been inadequate is to understate it.
To the most recent of these letters, sent on November 14 and published in full below, Dr Raine has, as yet, made no reply at all.
In view of the political decision to roll out a second Pfizer dose to 16 and 17 year-olds despite the evidence of the JCVI (Joint Committee on Vaccination and Immunisation) that the health benefits do not outweigh the risks for those under 18, this is negligent beyond belief.
Only yesterday, the European Medicines Agency followed the FDA in authorising the Pfizer injection for children aged 5-11. Comirnaty COVID-19 vaccine: EMA recommends approval for children aged 5 to 11 | European Medicines Agency (europa.eu) This is alarming indeed. Dr Jones has appealed to the MHRA not to follow this route before they have even completed a systematic safety review on the rollout to 12-17-year-olds. As she says children do not need this.
How the JCVI came to sanction this second dose rollout, given that it is fraught with the same risk as discussed in its committee minutes of July 29, is the subject of a further letter, sent by Dr Jones to the JCVI on November 23. We publish this too.
Dr Jones’s letter to the MHRA, November 14:
Dr June Raine, CEO, MHRA,
cc Professor Lim, Chairman, JCVI
Sajid Javid MP, Secretary of State for Health & Social Care
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 on November 20, 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 to 17-year-olds.
Following the FDA (the US Food and Drug Administration) and CDC authorisation (the US Centres for Disease Control and Prevention) of the Pfizer vaccine for five to 11-year-olds, we are also concerned that emergency use authorisation will be granted here before the outcomes in 12 to 17-year-olds 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 five to <12 years of age will be studied in five post-authorisation safety studies, including a five-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 to 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?
Yours sincerely,
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’s 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 1990-1992, 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.
(And others).
Dr Jones’s open letter to the JCVI, chaired by Professor Wei Shen Lim, November 23:
Dear Professor Lim and colleagues,
Last week a group of 50 British doctors and scientists wrote to the MHRA, copy to the JCVI, regarding ongoing concerns about the safety of the current children’s Covid-19 vaccination programme and the possibility it might be extended to five to 11s, as in the US. We are now writing urgently to you because of the announcement of a second dose of Pfizer to 16 and 17-year-olds
The JCVI’s initial statement on 19th July, that ‘any decision on deployment of vaccines must be made on the basis that the benefits of vaccination outweigh the risks to those people who are vaccinated’ was welcomed, placing the safety of the young in a primary position and drawing attention to ‘rare but serious adverse events’: Based on a balanced view of the available evidence, you stated clearly that ‘the health benefits in this population are small, and the benefits to the wider population are highly uncertain. At this time, JCVI is of the view that the health benefits of universal vaccination in children and young people below the age of 18 years do not outweigh the potential risks’.
We were therefore extremely puzzled when on August 4, new guidance was issued for the rollout to include healthy 16-17 year-olds, but with no new data presented to explain the decision and wrote at the time to Professors Pollard and Finn and to the RCPCH (Royal College of Paediatrics and Child Health) expressing our concern.
It is now clear from the minutes of your meeting of 29th July, published belatedly on October 29, that the committee was fully aware of the increased risk of myocarditis in young males after the 2nd dose of Pfizer.
The minutes note that ‘active surveillance’ ongoing in Israel, may explain ‘why higher risk was seen than the UK or USA’. You also noted ‘the increased number of first dose cases in the UK might be due to the proportion of children who were seropositive’.
Also minuted, the series of children with vaccination-associated myocarditis, showing significant abnormalities on Cardiac Magnetic Resonance imaging. ‘Follow up of such cases (including MRI scans) was considered important for at least 3-6 months to check for cardiac fibrosis and to predict potential arrythmia risk’. The JCVI’s decision to only recommend one dose in the first instance (presumably out of concern for this risk) at least appeared to have some logic.
Despite all the concerns voiced by your committee, you have now recommended that 16-17 year-olds be offered a second dose of Pfizer vaccine, with all the attendant risks.
The latest ONS data suggests that 96 per cent of 16 to 24 year-olds already have antibodies to Sars-CoV-2, obviating the need for any vaccination of these healthy young people, let alone two doses. JCVI minutes confirm that ‘immunisation from natural infection was likely to give broader protection than vaccination’.
There is also increasing concern that a normal broad immune response to infection is impaired by prior vaccination. You have now widened the time delay between infection and vaccination from four to 12 weeks, but surely the correct advice would be to say those with prior infection should avoid vaccination.
We have focused here on the myocarditis risk, but there are also reports of microvascular clotting following mRNA vaccines, raising the possibility of pulmonary hypertension in future, plus the many adverse neurological effects reported on Yellow Cards and still no long-term safety data.
A number of authors have also highlighted a worrying increase in all-cause mortality in young men in recent months. Sudden deaths have been reported in the Press, leading to speculation of vaccine adverse events, but without the rigorous active surveillance required.
The following questions require replies as a matter of urgency:
- What additional information has led the JCVI to change their advice for 16-17s?
- Were more vaccine adverse events seen in those children with recent infection, leading to your decision to increase the advised time-lag?
- What is the estimated risk posed by Covid-19 and the absolute risk reduction/benefit from a second dose, including calculations taking into account existing immunity in this cohort?
- What led you to downgrade your safety concerns regarding the estimated risk of myocarditis?
- What plans were put in place for full post-marketing surveillance for side-effects, such as providing a prepaid card to be returned at 30 days from every vaccine recipient, recording all symptoms and illnesses experienced post-vaccination?
- Have you considered a sample of 16 to 17-year-olds who will be invited to have blood tests before and after their second dose to include platelet count, D-dimers and troponin levels to monitor for incidence of microvascular clotting and myocarditis?
- What guidelines on myocarditis are being sent to paediatricians, emergency medicine departments and cardiologists; specifically, is cardiac MRI scanning recommended?
- What efforts are being made to counter inappropriate advertising and inducement which undermines the process and ethics of informed consent?
- How will you ensure that vaccination of children remains voluntary with no requirement to use vaccine certification to access any services or events?
Yours sincerely,
Dr Rosamond Jones, MD, FRCPCH, retired consultant paediatrician.
Professor Anthony J Brookes, Department of Genetics & Genome Biology, University of Leicester.
Professor Richard Ennos, MA, PhD. Honorary Professorial Fellow, University of Edinburgh.
Professor John Fairclough FRCS FFSEM retired honorary consultant surgeon.
Prof Anthony Fryer, PhD, FRCPath, Professor of Clinical Biochemistry, Keele University.
Professor Angus Dalgleish, MD, FRCP, FRACP, FRCPath, FMed Sci, Professor of Oncology, St George’s Hospital, London.
Professor David Livermore, BSc, PhD, Professor of Medical Microbiology, University of East Anglia.
Lord Moonie, MBChB, MRCPsych, MFCM, MSc, House of Lords, former parliamentary under-secretary of state 2001-2003, former consultant in Public Health Medicine.
Dr Theresa Lawrie, MBBCh, PhD, Director, Evidence-Based Medicine Consultancy Ltd, Bath.
Dr Alan Mordue, MBChB, FFPH. Retired consultant in Public Health Medicine and Epidemiology.
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 Gerry Quinn, PhD. Postdoctoral researcher in microbiology and immunology.
Dr Christopher Exley, PhD, FRSB, Retired professor in bioinorganic chemistry.
Mr Anthony Hinton, MBChB, FRCS, Consultant ENT surgeon, London.
Dr Geoffrey Maidment, MD, FRCP, retired consultant physician.
Mr Malcolm Loudon, MBChB, MD, FRCSEd, FRCS(Gen Surg), MIHM,VR, consultant surgeon.
Dr Christina Peers, MBBS, DRCOG, DFSRH, FFSRH, menopause specialist.
Dr Noel Thomas, MA, MBChB, DCH, DObsRCOG, DTM&H, MFHom, retired doctor.
Dr David Critchley, BSc, PhD, 32 years in pharmaceutical R&D as a clinical research scientist.
Dr Elizabeth Evans MA(Cantab), MBBS, DRCOG, retired doctor.
Katherine MacGilchrist, BSc (Hons), MSc, CEO/Systematic Review Director, Epidemica Ltd.
Dr Greta Mushet, MBChB, MRCPsych, retired consultant psychiatrist in psychotherapy.
Mr James Royle, MBChB, FRCS, MMedEd, colorectal surgeon.
Mr Ian F Comaish, MA, BM BCh, FRCOphth, FRANZCO, consultant ophthalmologist.
Dr M, BSc(Hons) Medical Microbiology & Immunobiology, MBBCh BAO, MSc in Clinical Gerontology, MRCP(UK), FRCEM, FRCP(Edinburgh), NHS Emergency Medicine & Geriatrics.
Dr Helen Westwood MBChB MRCGP DCH DRCOG, general practitioner.
Dr David Morris, MBChB, MRCP(UK), general practitioner.
Dr Jonathan Engler, MBChB, LlB (hons), DipPharmMed.
Dr Elizabeth Burton, MBChB, retired general practitioner.
Dr Renée Hoenderkampf, general practitioner.
Dr Clare Craig, BMBCh, FRCPath, pathologist.
Dr Alan Black, MBBS, MSc, DipPharmMed, retired pharmaceutical physician.
Dr Ruth Wilde, MB BCh, MRCEM, AFMCP, integrative and functional medicine doctor.
Dr Mark Bell, MBChB, MRCP(UK), FRCEM, consultant in Emergency Medicine.
Dr Livia Tossici-Bolt, PhD, NHS clinical scientist.
Dr Zac Cox, BDS, LCPH, holistic dentist, homeopath.
Dr Branko Latinkic, BSc, PhD, molecular biologist.
Dr Kulvinder Singh Manik, MBBS, general practitioner.
Dr Rohaan Seth, Bsc (hons), MBChB (hons), MRCGP, general practitioner.
Dr Jessica Robinson, BSc (Hons), MBBS, MRCPsych, MFHom, psychiatrist and integrative medicine.
Michael Cockayne, MSc, PGDip, SCPHNOH, BA, RN, occupational health practitioner.
Dr Jenny Goodman, MA, MB ChB, ecological medicine.
Dr Michael D Bell, MBChB, MRCGP, retired general practitioner.
Dr Franziska Meuschel, MD, ND, PhD, LFHom, BSEM, nutritional, environmental and integrated medicine.
Dr Charles Forsyth, MBBS, BSEM, independent medical practitioner.
Margaret Moss, MA (Cantab), CBiol, MRSB, director, The Nutrition and Allergy Clinic, Cheshire.
Julia Annakin, RN, immunisation nurse specialist.
Dr Stefanie Williams, dermatologist.
Dr Holly Young, BSc, MBChB, MRCP, consultant palliative care medicine.
(And others).
