FOLLOWING the announcement that kids aged six months to 4 years within the US may be vaccinated towards Covid 19, a bunch of 78 UK docs have written an open letter to the Medical and Healthcare merchandise Regulatory Company (MHRA) and others setting out complete explanation why this motion should not be taken right here. If, as we count on, the mainstream media ignore this letter, it will likely be additional proof that they aren’t concerned with reporting the reality about this experimental gene remedy however solely in protecting it up. We’ve got two different posts on this extremely vital subject as we speak.
Dr June Raine, CEO MHRA
Professor Lim Wei Shen, Chairman JCVI Covid-19 vaccines sub-committee
Professor Chris Whitty, Chief Medical Officer
Dr Jenny Harries, CEO, UKHSA
Hon Sajid Javid, MP, Secretary of State for Well being & Social Care
30th June 2022
Expensive Dr Raine,
Re: Covid-19 vaccines for six months to 4 years age group
We’re writing to you urgently regarding the announcement that the FDA [the US Food and Drug Administration] has granted an Emergency Use Authorisation for each Pfizer and Moderna Covid-19 vaccines in preschool kids.
We might urge you to contemplate very rigorously the transfer to vaccinate ever youthful kids towards SARS-CoV-2 regardless of the gradual however important lowering virulence of successive variants, the growing proof of quickly waning vaccine efficacy, the growing issues over long-term vaccine harms, and the information that the overwhelming majority of this younger age group have already been uncovered to SARS-CoV-2 repeatedly and have demonstrably efficient immunity. Thus, the steadiness of profit and danger which supported the rollout of mRNA vaccines to the aged and weak in 2021 is completely inappropriate for young children in 2022.
We additionally strongly problem the addition of Covid-19 vaccination into the routine youngster immunisation programme https://www.nhs.uk/circumstances/vaccinations/nhs-vaccinations-and-when-to-have-them/ regardless of no demonstrated medical want, recognized and unknown dangers (see under) and the truth that these vaccines nonetheless have solely conditional advertising and marketing authorisation.
It’s noteworthy that the Pfizer documentation offered to the FDA has big gaps within the proof supplied:
· The protocol was modified mid-trial. The unique 2-dose schedule exhibited poor immunogenicity with efficacy far under the required customary. A 3rd dose was added by which period lots of the authentic placebo recipients had been vaccinated.
· There was no statistically important distinction between the placebo and vaccinated teams in both the 6–23-month age group or the 2-4-year-olds even after the third dose. Astonishingly the outcomes have been primarily based on simply three members within the youthful age group (1 vaccinated and a pair of placebo) and simply seven members within the older 2–4-year-olds (2 vaccinated and 5 placebo). Certainly, for the youthful age the boldness intervals ranged from minus 367 per cent to plus 99 per cent. The producer acknowledged that the numbers have been too low to attract any assured conclusions. Furthermore, these restricted numbers come solely from kids contaminated greater than seven days after the third dose.
· Over the entire time interval from the primary dose onwards (see web page 39 Tables 19 & 20), there have been a complete of 225 contaminated kids within the vaccinated arm and 150 within the placebo arm, giving a calculated vaccine efficacy of solely 25 per cent (14 per cent for the 6-23 months, and 33 per cent for 2-4s).
· The extra immunogenicity research towards Omicron, requested by the FDA, solely concerned a complete of 66 kids examined one month after the third dose (see web page 35).
It’s incomprehensible that the FDA thought of that this represents ample proof on which to base a choice to vaccinate wholesome kids. Relating to security, the information is even thinner: solely 1057 kids, some already unblinded, have been adopted for simply 2 months. It’s noteworthy that Sweden and Norway are usually not recommending the vaccine for 5-11s and Holland just isn’t recommending it for kids who’ve already had Covid-19. The director of the Danish Well being and Medicines Authority acknowledged just lately that with what’s now recognized, the choice to vaccinate kids was a mistake.
We summarise under the overwhelming arguments towards this vaccination.
A. Extraordinarily low danger from Covid-19 to younger kids
· In the entire of 2020 and 2021, not a single youngster aged 1-9 died the place Covid-19 was the only analysis on the loss of life certificates, in accordance with ONS information.[1]
· An in depth examine in England from 1st March 2020 to 1st March 2021 discovered solely 6 kids underneath 18 years died with no comorbidities. There have been no deaths aged 1-4 years.[2]
· Kids clear the virus extra simply than adults.[3]
· Kids mount efficient, strong, and sustained immune responses.[4]
· For the reason that arrival of the Omicron variant, infections have been usually a lot milder. That can also be true for unvaccinated underneath 5s.[5]
· By June 2022 it’s now estimated that 89 per cent of 1-4-year-olds had already had SARS-CoV-2 an infection.[6]
· Latest information from Israel exhibits wonderful long-lasting immunity following an infection in kids, particularly in 5-11s.[7]
B. Poor vaccine efficacy
· In adults it has develop into obvious that vaccine efficacy wanes steadily over time, necessitating boosters at common intervals. Particularly, vaccine efficacy has waned extra quickly towards the most recent Omicron variants.
· In kids vaccine efficacy has waned extra quickly in 5-11s than in 12-17s, probably associated to the decrease dose used within the paediatric formulation. One examine from New York confirmed efficacy towards Omicron falling to solely 12 per cent by 4-5 weeks and to unfavorable values by 5-6 weeks put up second dose.[8]
· Within the Pfizer 0-4s trial,1 the efficacy after two doses fell to unfavorable values, necessitating a change to the trial protocol. After a 3rd dose there was a suggestion of efficacy from 7-30 days however there is no such thing as a information past 30 days to see how shortly this can wane.
C. Potential harms of Covid-19 vaccines for kids
· There was nice concern about myocarditis in adolescents and younger adults, particularly in males after the second dose, estimated at 1/2600 in energetic put up advertising and marketing surveillance in Hong Kong.[9] The rising proof of persistent cardiac abnormalities[10] in adolescents with put up mRNA vaccine myopericarditis, as demonstrated by cardiac MRI at 3-8 months observe up, suggests that is removed from ‘gentle and shot-lived’. The potential for long run results requires additional examine and requires the strictest software of the precautionary precept in respect of the youngest and most weak kids.
· Though post-vaccination myocarditis seems to be much less frequent in 5-11-year-olds than older kids, it’s, nonetheless, elevated over baseline.[11]
· Within the Pfizer examine 50 per cent of vaccinated kids had systemic adversarial occasions, together with irritability and fever. Analysis of myocarditis is rather more tough in youthful kids.[12] No troponin ranges or ECG research have been documented. Even a vaccinated youngster within the trial, hospitalised with fever, calf ache and a raised CPK, had no report of D-dimers, antiplatelet antibodies or troponin ranges.
· In Pfizer’s 5-11s post-authorisation circumstances, they’re required to conduct research searching for myocarditis and are usually not as a result of report outcomes till 2027.
· Of equal concern are, as but unknown, unfavorable results on the immune system. Within the 0-4s trial, solely 7 kids have been described as having ‘extreme’ Covid-19 – 6 vaccinated and 1 given placebo. Equally, for the 12 kids with recurrent episodes of an infection, 10 have been vaccinated towards solely 2 who acquired placebo. These are all tiny figures and far too small to rule out any adversarial influence comparable to antibody dependant enhancement (ADE)[13] and different impacts on the immune system.
· Additionally unanswered is the query of Unique Antigenic Sin.[14] It’s of word that in a big Israeli examine, these contaminated after vaccination had poorer cowl than these vaccinated after an infection.[15] Within the Moderna trial, N antibodies have been seen in solely 40 per cent of these contaminated after vaccination, in contrast with 93 per cent of these contaminated after placebo.[16]
· There’s proof of vaccine-induced disruption of each innate and adaptive[17],[18] immune responses. The potential for creating an impaired immune operate could be disastrous for kids, who’ve probably the most competent innate immunity, which by now has been successfully educated by the circulating virus.
· Completely unknown is whether or not there shall be any adversarial impact on T-cell operate resulting in a rise in cancers.[19]
· Additionally, by way of reproductive operate, restricted animal biodistribution research confirmed lipid nanoparticles focus in ovaries and testes.[20] Grownup sperm donors have confirmed a discount in sperm counts notably of motile sperm, falling by 3 months post-vaccination and remaining depressed at 4-5 months.[21]
· Even for adults, issues are rising that severe adversarial occasions are in extra of hospitalisations from Covid-19.[22]
D. Knowledgeable consent
· For five-11s, the JCVI, in recommending a ‘non-urgent provide’ of vaccination, particularly famous the significance of absolutely knowledgeable consent with no coercion.[23]
· With the low uptake on this age group, the presence of ‘remedy canine’,[24] ads together with superhero photos[25] and details about youngster vaccination defending family and friends, all clearly run opposite to the idea of consent, absolutely knowledgeable and freely given.[26]
· The whole omission of data explaining to the general public the totally different and novel know-how utilized in Covid-19 vaccines in comparison with customary vaccines, and the failure to tell of the dearth of any long-term security information, borders on misinformation.[27]
E. Impact on public confidence
· Vaccines towards rather more severe ailments, comparable to polio and measles, should be prioritised.[28] Pushing an pointless and novel, gene-based vaccine on to younger kids dangers severely undermining parental confidence in the entire immunisation programme.
· The poor high quality of the information offered by Pfizer dangers bringing the pharmaceutical trade into disrepute and the regulators if this product is authorised.
In abstract, younger wholesome kids are at minimal danger from Covid-19, particularly because the arrival of the Omicron variant. Most have been repeatedly uncovered to SARS-CoV-2 virus, but have remained properly, or have had brief, gentle sickness. As detailed above, the vaccines are of temporary efficacy, have recognized short- to medium-term dangers and unknown long-term security. Information for clinically helpful efficacy in young children are scant or absent. In older kids, for whom they’re already licensed, they’ve been promoted by way of ethically doubtful schemes to the potential detriment of different, and very important, components of the childhood vaccination programme.
For a tiny minority of youngsters for whom the potential for profit clearly and unequivocally outweighed the potential for hurt, vaccination may have been facilitated by restrictive licences. Whether or not following the precautionary precept or the instruction to First Do No Hurt, such vaccines haven’t any place in a routine childhood immunisation programme.
Professor Angus Dalgleish, MD, FRCP, FRACP, FRCPath, FMed Sci, Principal, Institute for
Most cancers Vaccines & Immunotherapy (ICVI)
Prof Anthony Fryer, PhD, FRCPath, Professor of Medical Biochemistry, Keele College
Professor David Livermore, BSc, PhD, Retired Professor of Medical Microbiology, UEA
Professor John Fairclough FRCS FFSEM retired Honorary Marketing consultant Surgeon
Lord Moonie, MBChB, MRCPsych, MFCM, MSc, Home of Lords, former parliamentary under-
secretary of state 2001-2003, former guide in Public Well being Medication
Dr Abby Astle, MA(Cantab), MBBChir, GP Principal, GP Coach, GP Examiner
Dr Michael D Bell, MBChB, MRCGP, retired Normal Practitioner
Dr Alan Black, MBBS, MSc, DipPharmMed, Retired Pharmaceutical Doctor
Dr David Bramble, MBChB, MRCPsych, MD, Marketing consultant Psychiatrist
Dr Emma Brierly, MBBS, MRCGP, Normal Practitioner
Dr David Cartland, MBChB, BMedSci, Normal practitioner
Dr Peter Chan, BM, MRCS, MRCGP, NLP, Normal Practitioner, Purposeful drugs
practitioner
Michael Cockayne, MSc, PGDip, SCPHNOH, BA, RN, Occupational Well being Practitioner
Julie Coffey, MBChB, Normal Practitioner
John Collis, RN, Specialist Nurse Practitioner, retired
Mr Ian F Comaish, MA, BM BCh, FRCOphth, FRANZCO, Marketing consultant Ophthalmologist
James Cook dinner, NHS Registered Nurse, Bachelor of Nursing (Hons), Grasp of Public Well being
Dr Clare Craig, BMBCh, FRCPath, Pathologist
Dr David Critchley, BSc, PhD in Pharmacology, 32 years’ expertise in Pharmaceutical R&D
Dr Jonathan Engler, MBChB, LlB (hons), DipPharmMed
Dr Elizabeth Evans, MA (Cantab), MBBS, DRCOG, Retired Physician
Dr John Flack, BPharm, PhD, retired Director of Security Analysis at Beecham Prescribed drugs and retired Senior Vice-president for Drug Discovery SmithKline Beecham
Dr Simon Fox, BSc, BMBCh, FRCP, Marketing consultant in Infectious Illnesses and Inner Medication
Dr Ali Haggett, Psychological well being group work, third sector, former lecturer within the historical past of
drugs
David Halpin, MB BS FRCS, Orthopaedic and trauma surgeon (retired)
Dr Renée Hoenderkampf, Normal Practitioner
Dr Andrew Isaac, MB BCh, Doctor, retired
Dr Steve James, Marketing consultant Intensive Care
Dr Keith Johnson, BA, DPhil (Oxon), IP Marketing consultant for Diagnostic Testing
Dr Rosamond Jones, MBBS, MD, FRCPCH, retired guide paediatrician
Dr Tanya Klymenko, PhD, FHEA, FIBMS, Senior Lecturer in Biomedical Sciences
Dr Charles Lane, MA, DPhil, Molecular Biologist
Dr Branko Latinkic, BSc, PhD, Molecular Biologist
Dr Felicity Lillingstone, IMD DHS PhD ANP, Physician, Pressing Care, Analysis Fellow
Dr Theresa Lawrie, MBBCh, PhD, Director, Proof-Based mostly Medication Consultancy Ltd, Tub
Katherine MacGilchrist, BSc (Hons), MSc, CEO/Systematic Assessment Director, Epidemica Ltd.
Dr Geoffrey Maidment, MBBS, MD, FRCP, Marketing consultant doctor, retired
Ahmad Okay Malik FRCS (Tr & Orth) Dip Med Sport, Marketing consultant Trauma & Orthopaedic Surgeon
Dr Kulvinder Singh Manik, MBBS, Normal Practitioner
Dr Fiona Martindale, MBChB, MRCGP, Normal Practitioner
Dr S McBride, BSc (Hons) Medical Microbiology & Immunobiology, MBBCh BAO, MSc in Medical Gerontology, MRCP(UK), FRCEM, FRCP (Edinburgh). NHS Emergency Medication & geriatrics
Mr Ian McDermott, MBBS, MS, FRCS(Tr&Orth), FFSEM(UK), Marketing consultant Orthopaedic Surgeon
Dr Franziska Meuschel, MD, ND, PhD, LFHom, BSEM, Dietary, Environmental and Built-in Medication
Dr Scott Mitchell, MBChB, MRCS, Emergency Medication Doctor
Dr Alan Mordue, MBChB, FFPH. Retired Marketing consultant in Public Well being Medication & Epidemiology
Dr David Morris, MBChB, MRCP(UK), Normal Practitioner
Margaret Moss, MA (Cantab), CBiol, MRSB, Director, The Diet and Allergy Clinic, Cheshire
Dr Alice Murkies, MD FRACGP MBBS, Normal Practitioner
Dr Greta Mushet, MBChB, MRCPsych, retired Marketing consultant Psychiatrist in Psychotherapy
Dr Sarah Myhill, MBBS, retired GP and Naturopathic Doctor
Dr Rachel Nicholl, PhD, Medical researcher
Sue Parker Corridor, licensed transactional analyst (CTA, psychotherapy); MSc (Counselling &
Supervision) MBACP (senior accredited practitioner); EMDR practitioner, Psychotherapist
Dr Christina Friends, MBBS, DRCOG, DFSRH, FFSRH, Menopause specialist
Rev Dr William J U Philip MB ChB, MRCP, BD, Senior Minister The Tron Church, Glasgow, previously doctor specialising in cardiology
Dr Angharad Powell, MBChB, BSc (hons), DFRSH, DCP (Eire), DRCOG, DipOccMed, MRCGP, Normal Practitioner
Dr Gerry Quinn, PhD. Postdoctoral researcher in microbiology and immunology
Dr Johanna Reilly, MBBS, Normal Practitioner
Jessica Righart, MSc, MIBMS, Senior Crucial Care Scientist
Mr Angus Robertson, BSc, MB ChB, FRCSEd (Tr & Orth), Marketing consultant Orthopaedic Surgeon
Dr Jessica Robinson, BSc(Hons), MBBS, MRCPsych, MFHom, Psychiatrist and Integrative Medication Physician
Dr Jon Rogers, MB ChB (Bristol), Retired Normal Practitioner
Mr James Royle, MBChB, FRCS, MMedEd, Colorectal surgeon
Dr Roland Salmon, MB BS, MRCGP, FFPH, Former Director, Communicable Illness Surveillance Centre Wales
Sorrel Scott, Grad Dip Phys, Specialist Physiotherapist in Neurology, 30 years in NHS
Dr Rohaan Seth, BSc (hons), MBChB (hons), MRCGP, Retired Normal Practitioner
Dr Gary Sidley, retired NHS Marketing consultant Medical Psychologist
Dr Annabel Good, MBBS, retired Normal Practitioner
Natalie Stephenson, BSc (Hons) Paediatric Audiologist
Dr Zenobia Storah,MA (Oxon), Dip Psych, DClinPsy, Senior Medical Psychologist (Youngster and Adolescent)
Dr Julian Tompkinson, MBChB MRCGP, Normal Practitioner GP coach PCME
Dr Noel Thomas, MA, MBChB, DCH, DObsRCOG, DTM&H, MFHom, retired physician
Dr Stephen Ting, MB CHB, MRCP, PhD, Marketing consultant Doctor
Dr Livia Tossici-Bolt, PhD, Medical Scientist
Dr Carmen Wheatley, DPhil, Orthomolecular Oncology
Dr Helen Westwood MBChB MRCGP DCH DRCOG, Normal Practitioner
Mr Lasantha Wijesinghe, FRCS, Marketing consultant Vascular Surgeon
Dr Damian Wilde, PhD, (Chartered) Specialist Medical Psychologist
Dr Ruth Wilde, MB BCh, MRCEM, AFMCP, Integrative & Purposeful Medication Physician
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[3] Kevin J. Selva, Carolien E. van de Sandt, Melissa M. Lemke, et al., Programs Serology Detects Functionally Distinct Coronavirus Antibody Options in Kids and Aged, Nature Communications 12, no. 2037 (2021), https://doi.org/10.1038/s41467-021-22236-7.
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[26] NHS South East London Medical Commissioning Group. FAQs – Vaccinating 5 to 11 12 months olds. https://selondonccg.nhs.uk/what-we-do/covid-19/covid-19-vaccine/faqs/faqs-vaccinating-5-to-11-year-olds/
[27] What’s within the vaccine and the way does it work? | NHS. 30-04-2021. https://www.youtube.com/watch?v=zgtWpwkS9u4&record=PLnhASgDToTktp2HIjdyeo2fsI6Agcn1ul&index=6
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