
MHRA have authorised Pfizer for infants. But will the JCVI recommend its use?
Will Professor Lim and colleagues follow this baby’s view on the Precautionary Principle?!
Professor Wei Shen Lim and all members, Joint Committee of Vaccinations and Immunisations
Cc: Dame June Raine, CEO, Medicines Healthcare products Regulatory Authority
Professor Sir Munir Pirmohamed, Chair, Commission on Human Medicines
Rt Hon Stephen Barclay, Secretary of State, Dept of Health & Social Care
6th December 2022
Dear Professor Lim,
Re: 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[i]), but are also shocked to learn today that Pfizer has been granted authorization for the infant formulation.
We are writing to urge you not to introduce any Covid-19 vaccines for this age-group 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[ii]:
Firstly, as for other paediatric age-groups, the risk from SARS-CoV-2 infection is extremely low[iii], 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[iv].
Secondly, it is clear that the currently available vaccines have a very poor efficacy over time. For adults, this lack of durable efficacy[v] 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[vi]. 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[vii], here[viii] and here[ix]) Moreover, 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.[x] 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.[xi] Due to the lack of long-term data, concerns about antibody dependant enhancement (ADE) remain unanswered, making this an unacceptable future risk for children.[xii]
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.[xiii] Reports of myocarditis in adolescents have been shrugged off as ‘mild and settle quickly’, despite reports to the contrary.[xiv] 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[xv] 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,[xvi] likely to be an underestimate. There is evidence of a complex functional reprogramming of the innate immune response[xvii] and [xviii]. 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.[xix] 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[xx], 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[xxi]. 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[xxii]. For Moderna 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.[xxiii] 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 ‘Immunobridging’ (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[xxiv], which brings into question the transparency of the data.
The Pfizer trial[xxv] for this age-group was even more chaotic, with the trial originally planned for only two doses, which then turned out not to produce a decent antibody response, but by then many of the placebo children had been vaccinated, requiring new recruits to act as controls for a third dose. The efficacy studies were based on immunobridging. Even antibody testing, however, showed reduced efficacy against omicron variants. Clinical infections occurred after the third dose in only 10 children whether active or placebo, nine of whom had been seronegative at trial entry, the 10th with unknown status. Thus, there were no clinical cases in children who already had naturally-acquired immunity. “Seven cases in participants 2-4 years of age met the criteria for severe COVID-19: 6 in the BNT162b2 group, of which 2 cases occurred post unblinding, and 1 in the placebo group.” This hardly suggests efficacy, it could even represent ADE. Twelve children had repeated infections, ten of whom were vaccinated. As for safety, “the median duration of blinded follow-up for participants 6-23 months of age after Dose 3 was 35 days”.
There has been a stated concern from public health bodies about a general 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. It is hard to believe that authorising let alone recommending vaccines with such a poor track record, could do anything other than further increase scepticism of all vaccines.
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 administration to healthy children.
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 Taylor, 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 Stefanie Williams, Dermatologist
Dr Julia Wilkens, FRCOG, MD, Consultant in Obstetrics & Gynaecology
Dr Ruqia Zafar, MBChB, MRCGP, General Practitioner
[i] FOI response, personal communication
[ii] Second Open Letter to all members of the FDA vaccines committee – HART (hartgroup.org)
[iii] https://journals.plos.org/plosmedicine/article/figure?id=10.1371/journal.pmed.1004118.t002
[iv] https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(22)01245-4/fulltext?dgcid=raven_jbs_etoc_email
[v] 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
[vi] https://www.medrxiv.org/content/10.1101/2022.02.25.22271454v1.full-text
[vii] Shared B cell memory to coronaviruses and other pathogens varies in human age groups and tissues | Science
[viii] https://www.nature.com/articles/s41590-021-01089-8.pdf
[ix] Pre-activated antiviral innate immunity in the upper airways controls early SARS-CoV-2 infection in children | Nature Biotechnology
[x] https://www.mrc-bsu.cam.ac.uk/now-casting/nowcasting-and-forecasting-21st-november-2022/
[xi] https://www.medrxiv.org/content/10.1101/2022.07.05.22277189v1
[xii] 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
[xiii] https://openvaers.com/covid-data
[xiv] https://www.thelancet.com/journals/lanchi/article/PIIS2352-4642(22)00244-9/fulltext
[xv] https://www.dailymail.co.uk/health/article-11426007/Pfizer-Moderna-launch-trials-track-issues-arise-YEARS-getting-vaccines.html
[xvi]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
[xvii] https://www.medrxiv.org/content/10.1101/2021.05.03.21256520v1
[xviii] Original Antigenic Sin: the Downside of Immunological Memory and Implications for COVID-19 (nih.gov)
[xix]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
[xx] https://www.cell.com/cell/fulltext/S0092-8674(22)00076-9?rss=yes#
[xxi] https://www.mdpi.com/1999-4915/13/10/2056/htm
[xxii] https://www.nejm.org/doi/full/10.1056/NEJMoa2209367
[xxiii] https://www.icmra.info/drupal/en/covid-19/statement_on_continuation_of_vaccine_trials
[xxiv] nejmoa2209367_appendix.pdf
[xxv] https://www.fda.gov/media/159195/download