Open Letter to MHRA on vaccines for 0-5s

Moderna apply for a conditional marketing authorisation for infants

Will Dame June Raine follow this baby’s view on the Precautionary Principle?!

Dame June Raine, CEO, Medicines Healthcare products Regulatory Authority

Cc:       Professor Lim Wei Shen, Joint Committee of Vaccinations and Immunisations

Professor Sir Munir Pirmohamed, Chair, Commission on Human Medicines

Rt Hon Stephen Barclay, Secretary of State, Dept of Health & 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 (personal FOI)[1].

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[2]:

Firstly, as for other paediatric age-groups, the risk from SARS-CoV-2 infection is extremely low[3], 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[4].   

Secondly, it is clear that the currently available vaccines have a very poor efficacy over time.  For adults, this lack of durable efficacy[5] 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[6]. 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, see here[7], here[8] and here[9].  Moreover, the vast majority of under 5-year-olds have already been immunologically exposed to SARS-CoV-2 repeatedly, whether or not actively infected.[10] 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.[11] Due to the lack of long-term data, concerns about antibody dependant enhancement (ADE) remain unanswered [12], 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.[13]  Reports of myocarditis in adolescents have been shrugged off as ‘mild and settle quickly’, despite reports to the contrary.[14] 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[15] 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,[16] likely to be an underestimate. There is evidence of a complex functional reprogramming of the innate immune response here[17]and here[18]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.[19]  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[20], 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[21].  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[22]. 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.[23] 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[24], 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..

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, retired member of 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

Wendy Armstrong, Practice 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 Ashvy Bhardwaj, MBBS, DRCOG, DFFP, MRCGP(2018), General Practitioner

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 Matthew Dennison, MBBS, MRCGP, Dip IBLM, General Practitioner

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

Gayle Gerry, BSc(Hons), RGN, NHS registered Nurse

Sophie Gidet, RM, Midwife

Dr Sheena Fraser, MBChB, MRCGP (2003), Dip BSLM, General Practitioner

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

Dr Stephen Hartley, resigned Emergency Medicine consultant.

Mr Anthony Hinton, MBChB, FRCS, Consultant ENT surgeon, London

Dr Renee Hoenderkamp, General Practitioner

Dr Liesel Holler, Medical Doctor

Dr Richard House, MA, PhD, CPsych, AFBPsS, former Senior Lecturer in Psychology

Dr Andrew Isaac, MBBCh, Physician, retired

Dr Keith Johnson, BA, DPhil (Oxon), IP Consultant for Diagnostic Testing

Fiona Jones, BScHons, DipPreSci, PgCertMed Ed, MFRPSII, FRPharmS, retired Clinical lead pharmacist

Dr Pauline Jones MB BS retired general practitioner 

Dr Ancha Bala Joof, MBChB, MRCGP, General Practitioner

Dr Timothy Kelly, MBBCh BSc, NHS doctor

Dr Gemma Kemp, MBBS FRCPath, Consultant Forensic Pathologist

Dr Tanya Klymenko, PhD, FHEA, FIBMS, Senior Lecturer in Biomedical Sciences

Dr Caroline Lapworth, MBChB, 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 

Dr Nichola Ling, MBBS, MRCOG, Consultant obstetrician and digital advisor to NHS England

Dr Joseph Lingham, MBBS, Medical Practitioner

Mr Malcolm Loudon, MBChB, MD, FRCSEd, FRCS(Gen Surg), MIHM,VR, Consultant Surgeon

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

Dr Sam 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

Dr Franziska Meuschel, MD, ND, PhD, LFHom, BSEM, Nutritional, Environmental and Integrated Medicine

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

Theresa Ann Mounsey, BSc Hons in midwifery studies 

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

Sue Parker Hall, CTA, MSc (Counselling & Supervision), MBACP, EMDR. Psychotherapist

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 

Dr Sheila Richards GP MBBS MRCGP

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 Alison Sabine MBChB MRCPConsultant Rheumatologist

Dr Salmaan Saleem, MBBS, BMedSci, MRCGP, General Practitioner

Dr Alia Sarwar, MBChB, General Practitioner

Dr Charlie Sayer MBBS FRCR (consultant radiologist )

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)

Matt Thomas, Paramedic

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 Jannah van der Pol, MBBS, MRCGP

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 Stefanie Williams, Dermatologist

Dr Ruqia Zafar, MBChB, MRCGP, General Practitioner

[1] FOI response, personal communication

[2] Second Open Letter to all members of the FDA vaccines committee – HART (hartgroup.org)

[3] https://journals.plos.org/plosmedicine/article/figure?id=10.1371/journal.pmed.1004118.t002

[4] https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(22)01245-4/fulltext?dgcid=raven_jbs_etoc_email

[5] Short term, relative effectiveness of four doses versus three doses of BNT162b2 vaccine in people aged 60 years and older in Israel: retrospective, test negative, case-control study | The BMJ

[6] https://www.medrxiv.org/content/10.1101/2022.02.25.22271454v1.full-text

[7] Shared B cell memory to coronaviruses and other pathogens varies in human age groups and tissues | Science

[8] https://www.nature.com/articles/s41590-021-01089-8.pdf

[9] Pre-activated antiviral innate immunity in the upper airways controls early SARS-CoV-2 infection in children | Nature Biotechnology

[10] https://www.mrc-bsu.cam.ac.uk/now-casting/nowcasting-and-forecasting-21st-november-2022/

[11] https://www.medrxiv.org/content/10.1101/2022.07.05.22277189v1

[12] Reevaluation of antibody-dependent enhancement of infection in anti-SARS-CoV-2 therapeutic antibodies and mRNA-vaccine antisera using FcR- and ACE2-positive cells | Scientific Reports

[13] https://openvaers.com/covid-data

[14] https://www.thelancet.com/journals/lanchi/article/PIIS2352-4642(22)00244-9/fulltext

[15] https://www.dailymail.co.uk/health/article-11426007/Pfizer-Moderna-launch-trials-track-issues-arise-YEARS-getting-vaccines.html

[16]https://medalerts.org/vaersdb/findfield.php?TABLE=ON&GROUP1=AGE&EVENTS=ON&VAX[]=COVID19&VAX[]=COVID19-2&DIED=Yes&WhichAge=range&LOWAGE=0&HIGHAGE=18

[17] https://www.medrxiv.org/content/10.1101/2021.05.03.21256520v1

[18] Original Antigenic Sin: the Downside of Immunological Memory and Implications for COVID-19 (nih.gov)

[19]https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/1112667/COVID-19_mRNA_Vaccine_BNT162b2__UKPAR___PFIZER_BIONTECH_ext_of_indication_11.6.2021.pdf

[20] https://www.cell.com/cell/fulltext/S0092-8674(22)00076-9?rss=yes#relatedArticles

[21] https://www.mdpi.com/1999-4915/13/10/2056/htm

[22] https://www.nejm.org/doi/full/10.1056/NEJMoa2209367

[23] https://www.icmra.info/drupal/en/covid-19/statement_on_continuation_of_vaccine_trials

[24] nejmoa2209367_appendix.pdf

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