There follows an open letter from 76 medics, scientists and healthcare professionals to the Medical and Healthcare products Regulatory Agency (MHRA) and other Government officials setting out comprehensive reasons why the recent U.S. FDA decision authorising Covid vaccinations in infants must not happen here.
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 Health & Social Care
June 30th 2022
Dear Dr. Raine,
Re: COVID-19 vaccines for six months to four years age group
We are writing to you urgently concerning the announcement that the FDA has granted an Emergency Use Authorisation for both Pfizer and Moderna COVID-19 vaccines in preschool children.
We would urge you to consider very carefully the move to vaccinate ever younger children against SARS-CoV-2 despite the gradual but significant reducing virulence of successive variants, the increasing evidence of rapidly waning vaccine efficacy, the increasing concerns over long-term vaccine harms, and the knowledge that the vast majority of this young age group have already been exposed to SARS-CoV-2 repeatedly and have demonstrably effective immunity. Thus, the balance of benefit and risk which supported the rollout of mRNA vaccines to the elderly and vulnerable in 2021 is totally inappropriate for small children in 2022.
We also strongly challenge the addition of COVID-19 vaccination into the routine child immunisation programme despite no demonstrated clinical need, known and unknown risks (see below) and the fact that these vaccines still have only conditional marketing authorisation.
It is noteworthy that the Pfizer documentation presented to the FDA has huge gaps in the evidence provided:
- The protocol was changed mid-trial. The original two-dose schedule exhibited poor immunogenicity with efficacy far below the required standard. A third dose was added by which time many of the original placebo recipients had been vaccinated.
- There was no statistically significant difference between the placebo and vaccinated groups in either the 6–23-month age group or the 2-4-year-olds, even after the third dose. Astonishingly, the results were based on just three participants in the younger age group (one vaccinated and two placebo) and just seven participants in the older 2–4-year-olds (two vaccinated and five placebo). Indeed, for the younger age group the confidence intervals ranged from minus-367% to plus-99%. The manufacturer stated that the numbers were too low to draw any confident conclusions. Moreover, these limited numbers come only from children infected more than seven days after the third dose.
- Over the whole time period from the first dose onwards (see page 39 Tables 19 and 20), there were a total of 225 infected children in the vaccinated arm and 150 in the placebo arm, giving a calculated vaccine efficacy of only 25% (14% for the 6-23 months, and 33% for 2-4s).
- The additional immunogenicity studies against Omicron, requested by the FDA, only involved a total of 66 children tested one month after the third dose (see page 35).
It is incomprehensible that the FDA considered that this represents sufficient evidence on which to base a decision to vaccinate healthy children. When it comes to safety, the data are even thinner: only 1,057 children, some already unblinded, were followed for just two months. It is noteworthy that Sweden and Norway are not recommending the vaccine for 5-11s and Holland is not recommending it for children who have already had COVID-19. The director of the Danish Health and Medicines Authority stated recently that with what is now known, the decision to vaccinate children was a mistake.
We summarise below the overwhelming arguments against this vaccination.
A. Extremely low risk from COVID-19 to young children
- In the whole of 2020 and 2021, not a single child aged 1-9 died where COVID-19 was the sole diagnosis on the death certificate, according to ONS data.
- A detailed study in England from March 1st 2020 to March 1st 2021 found only six children under 18 years died with no comorbidities. There were no deaths aged 1-4 years.
- Children clear the virus more easily than adults.
- Children mount effective, robust, and sustained immune responses.
- Since the arrival of the Omicron variant, infections have been generally much milder. That is also true for unvaccinated under-5s.
- By June 2022 it is now estimated that 89% of 1-4-year-olds had already had SARS-CoV-2 infection.
- Recent data from Israel show excellent long-lasting immunity following infection in children, especially in 5-11s.
B. Poor vaccine efficacy
- In adults, it has become apparent that vaccine efficacy wanes steadily over time, necessitating boosters at regular intervals. Specifically, vaccine efficacy has waned more rapidly against the latest Omicron variants.
- In children, vaccine efficacy has waned more rapidly in 5-11s than in 12-17s, possibly related to the lower dose used in the paediatric formulation. One study from New York showed efficacy against Omicron falling to only 12% by 4-5 weeks and to negative values by 5-6 weeks post second dose.
- In the Pfizer 0-4s trial, the efficacy after two doses fell to negative values, necessitating a change to the trial protocol. After a third dose there was a suggestion of efficacy from 7-30 days but there is no data beyond 30 days to see how quickly this will wane.
C. Potential harms of COVID-19 vaccines for children
- There has been great concern about myocarditis in adolescents and young adults, especially in males after the second dose, estimated at one per 2,600 in active post-marketing surveillance in Hong Kong. The emerging evidence of persistent cardiac abnormalities in adolescents with post-mRNA vaccine myopericarditis, as demonstrated by cardiac MRI at 3-8 months follow up, suggests this is far from ‘mild and short-lived’. The potential for longer term effects requires further study and calls for the strictest application of the precautionary principle in respect of the youngest and most vulnerable children.
- Although post-vaccination myocarditis appears to be less common in 5-11-year-olds than older children, it is, nonetheless, increased over baseline.
- In the Pfizer study, 50% of vaccinated children had systemic adverse events, including irritability and fever. Diagnosis of myocarditis is much more difficult in younger children. No troponin levels or ECG studies were documented. Even a vaccinated child in the trial, hospitalised with fever, calf pain and a raised CPK, had no report of D-dimers, antiplatelet antibodies or troponin levels.
- In Pfizer’s 5-11s post-authorisation conditions, it is required to conduct studies looking for myocarditis and is not due to report results until 2027.
- Of equal concern are, as yet unknown, negative effects on the immune system. In the 0-4s trial, only seven children were described as having “severe” COVID-19 – six vaccinated and one given placebo. Similarly, for the 12 children with recurrent episodes of infection, 10 were vaccinated against only two who received placebo. These are all tiny figures and much too small to rule out any adverse impact such as antibody dependant enhancement (ADE) and other impacts on the immune system.
- Also unanswered is the question of Original Antigenic Sin. It is of note that in a large Israeli study, those infected after vaccination had poorer cover than those vaccinated after infection. In the Moderna trial, N-antibodies were seen in only 40% of those infected after vaccination, compared with 93% of those infected after placebo.
- There is evidence of vaccine-induced disruption of both innate and adaptive immune responses. The possibility of developing an impaired immune function would be disastrous for children, who have the most competent innate immunity, which by now has been effectively trained by the circulating virus.
- Totally unknown is whether there will be any adverse effect on T-cell function leading to an increase in cancers.
- Also, in terms of reproductive function, limited animal biodistribution studies showed lipid nanoparticles concentrate in ovaries and testes. Adult sperm donors have showed a reduction in sperm counts particularly of motile sperm, falling by three months post-vaccination and remaining depressed at four to five months.
- Even for adults, concerns are rising that serious adverse events are in excess of hospitalisations from COVID-19.
D. Informed consent
- For 5-11s, the JCVI, in recommending a “non-urgent offer” of vaccination, specifically noted the importance of fully informed consent with no coercion.
- With the low uptake in this age group, the presence of ‘therapy dogs’, advertisements including superhero images and information about child vaccination protecting friends and family all clearly run contrary to the concept of consent, fully informed and freely given.
- The complete omission of information explaining to the public the different and novel technology used in COVID-19 vaccines compared to standard vaccines, and the failure to inform of the lack of any long-term safety data, borders on misinformation.
E. Effect on public confidence
- Vaccines against much more serious diseases, such as polio and measles, need to be prioritised. Pushing an unnecessary and novel, gene-based vaccine on to young children risks seriously undermining parental confidence in the whole immunisation programme.
- The poor quality of the data presented by Pfizer risks bringing the pharmaceutical industry into disrepute and the regulators if this product is authorised.
In summary, young healthy children are at minimal risk from COVID-19, especially since the arrival of the Omicron variant. Most have been repeatedly exposed to SARS-CoV-2 virus, yet have remained well, or have had short, mild illness. As detailed above, the vaccines are of brief efficacy, have known short- to medium-term risks and unknown long-term safety. Data for clinically useful efficacy in small children are scant or absent. In older children, for whom the vaccines are already licensed, they have been promoted via ethically dubious schemes to the potential detriment of other, and vital, parts of the childhood vaccination programme.
For a tiny minority of children for whom the potential for benefit clearly and unequivocally outweighed the potential for harm, vaccination could have been facilitated by restrictive licences. Whether following the precautionary principle or the instruction to First Do No Harm, such vaccines have no place in a routine childhood immunisation programme.
Professor Angus Dalgleish, MD, FRCP, FRACP, FRCPath, FMed Sci, Principal, Institute for Cancer Vaccines & Immunotherapy (ICVI)
Professor Anthony Fryer, PhD, FRCPath, Professor of Clinical Biochemistry, Keele University
Professor David Livermore, BSc, PhD, Retired Professor of Medical Microbiology, UEA
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, formerCconsultant in Public Health Medicine
Dr Abby Astle, MA(Cantab), MBBChir, GP Principal, GP Trainer, GP Examiner
Dr Michael D Bell, MBChB, MRCGP, retired General Practitioner
Dr Alan Black, MBBS, MSc, DipPharmMed, Retired Pharmaceutical Physician
Dr David Bramble, MBChB, MRCPsych, MD, Consultant Psychiatrist
Dr Emma Brierly, MBBS, MRCGP, General Practitioner
Dr David Cartland, MBChB, BMedSci, General practitioner
Dr Peter Chan, BM, MRCS, MRCGP, NLP, General Practitioner, Functional medicine practitioner
Michael Cockayne, MSc, PGDip, SCPHNOH, BA, RN, Occupational Health Practitioner
Julie Coffey, MBChB, General Practitioner
John Collis, RN, Specialist Nurse Practitioner, retired
Mr Ian F Comaish, MA, BM BCh, FRCOphth, FRANZCO, Consultant Ophthalmologist
James Cook, NHS Registered Nurse, Bachelor of Nursing (Hons), Master of Public Health
Dr Clare Craig, BMBCh, FRCPath, Pathologist
Dr David Critchley, BSc, PhD in Pharmacology, 32 years’ experience in Pharmaceutical R&D
Dr Jonathan Engler, MBChB, LlB (hons), DipPharmMedDr Elizabeth Evans, MA (Cantab), MBBS, DRCOG, Retired Doctor
Dr John Flack, BPharm, PhD, retired Director of Safety Evaluation at Beecham Pharmaceuticals and retired Senior Vice-president for Drug Discovery SmithKline Beecham
Dr Simon Fox, BSc, BMBCh, FRCP, Consultant in Infectious Diseases and Internal Medicine
Dr Ali Haggett, Mental health community work, 3rd sector, former lecturer in the history of medicine
David Halpin, MB BS FRCS, Orthopaedic and trauma surgeon (retired)
Dr Renée Hoenderkampf, General Practitioner
Dr Andrew Isaac, MB BCh, Physician, retired
Dr Steve James, Consultant Intensive Care
Dr Keith Johnson, BA, DPhil (Oxon), IP Consultant for Diagnostic Testing
Dr Rosamond Jones, MBBS, MD, FRCPCH, retired consultant 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, Doctor, Urgent Care, Research Fellow
Dr Theresa Lawrie, MBBCh, PhD, Director, Evidence-Based Medicine Consultancy Ltd, Bath
Katherine MacGilchrist, BSc (Hons), MSc, CEO/Systematic Review Director, Epidemica Ltd.
Dr Geoffrey Maidment, MBBS, MD, FRCP, Consultant physician, retired
Ahmad K Malik FRCS (Tr & Orth) Dip Med Sport, Consultant Trauma & Orthopaedic Surgeon
Dr Kulvinder Singh Manik, MBBS, General Practitioner
Dr Fiona Martindale, MBChB, MRCGP, General Practitioner
Dr S 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 Scott Mitchell, MBChB, MRCS, Emergency Medicine Physician
Dr Alan Mordue, MBChB, FFPH. Retired Consultant in Public Health Medicine & Epidemiology
Dr David Morris, MBChB, MRCP(UK), General Practitioner
Margaret Moss, MA (Cantab), CBiol, MRSB, Director, The Nutrition and Allergy Clinic, Cheshire
Dr Alice Murkies, MD FRACGP MBBS, General Practitioner
Dr Greta Mushet, MBChB, MRCPsych, retired Consultant Psychiatrist in Psychotherapy
Dr Sarah Myhill, MBBS, retired GP and 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
Dr Angharad Powell, MBChB, BSc (hons), DFRSH, DCP (Ireland), DRCOG, DipOccMed, MRCGP, General Practitioner
Dr Gerry Quinn, PhD. Postdoctoral researcher in microbiology and immunology
Dr Johanna Reilly, MBBS, General Practitioner
Jessica Righart, MSc, MIBMS, Senior Critical Care Scientist
Mr Angus Robertson, BSc, MB ChB, FRCSEd (Tr & Orth), Consultant Orthopaedic Surgeon
Dr Jessica Robinson, BSc(Hons), MBBS, MRCPsych, MFHom, Psychiatrist and Integrative Medicine Doctor
Dr Jon Rogers, MB ChB (Bristol), Retired General Practitioner
Mr James Royle, MBChB, FRCS, MMedEd, Colorectal surgeon
Dr Roland Salmon, MB BS, MRCGP, FFPH, Former Director, Communicable Disease 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 General Practitioner
Dr Gary Sidley, retired NHS Consultant Clinical Psychologist
Dr Annabel Smart, MBBS, retired General Practitioner
Natalie Stephenson, BSc (Hons) Paediatric Audiologist
Dr Zenobia Storah,MA (Oxon), Dip Psych, DClinPsy, Senior Clinical Psychologist (Child and Adolescent)
Dr Julian Tompkinson, MBChB MRCGP, General Practitioner GP trainer PCME
Dr Noel Thomas, MA, MBChB, DCH, DObsRCOG, DTM&H, MFHom, retired doctor
Dr Stephen Ting, MB CHB, MRCP, PhD, Consultant Physician
Dr Livia Tossici-Bolt, PhD, Clinical Scientist
Dr Carmen Wheatley, DPhil, Orthomolecular Oncology
Dr Helen Westwood MBChB MRCGP DCH DRCOG, General Practitioner
Mr Lasantha Wijesinghe, FRCS, Consultant Vascular Surgeon
Dr Damian Wilde, PhD, (Chartered) Specialist Clinical Psychologist
Dr Ruth Wilde, MB BCh, MRCEM, AFMCP, Integrative & Functional Medicine Doctor
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Thank you to all of the doctors who signed this letter. At this point, any and all health care professionals who ignore the now overwhelming signals are complicit in one of history’s largest mass murders, and it falls to those of us who are still awake to make sure they are held accountable.
Let’s hope that the memory of the brave Frances Oldham Kelsey will not go in vain.
Strange, that this time it may be the other way around, the UK refusing to authorise something the US did authorise. Hopefully. A world of damage has been done, but infants? Good God, my blood boils…
Couldn’t agree more, our children? Never before has this been known. Targeting infants and babies for Gods sake? If you haven’t already, I urge you to read Robert F Kennedy Jr’s “The Real Anthony Fauci” which exposes what is almost certainly the biggest crime against humanity in history, in no uncertain and entirely provable terms. It should be compulsory reading for anyone in authority.
The doctors who wrote this letter have provided a rational, well-evidenced, and compassionate case for not vaccinating infants. Sadly, the MHRA does not operate by the same values and exists only to serve itself and its big pharma overlords. I suspect the MHRA will, true to form, ignore the letter. We are on our own with this. Neither government nor any of its agencies can be trusted any longer to act in the best interests of the population. It will be up to parents to refuse the jab for their offspring. This government appears to have declared war on the people of this country.
There was a good writeup recently on the funding of the drug regulators.
Amazingly (to me and probably 99% of the population), all of them are funded by the drug industry to a major part, with Australia’s being the most government funded at just over half its budget.
Add in the revolving door and none of that is surprising anymore.
I wonder when and why the states abdicated their core function and responsibility in that regard?!
On the “why” question … “follow the money” and ask “who benefits?”
As to the “when” question, I’d look for the approximately date that Anthony Fauci took effective control of “public health” not just in America but in the world. And/or look for the date he partnered with Bill Gates.
Regarding informed consent for vaccination, ways to bring the refuseniks into the fold by vaccinating without their knowledge are being developed. Beware the PCR test!
https://cosmicworld.site/johns-hopkins-university-confirms-you-can-be-vaccinated-with-a-pcr-test-even-without-knowing
That’s very good to know. Is there no limit to the evil? Good thing I never have and never will take one of their ‘tests’.
Wow.
That is a frightening but well put together article.
Thanks for the link BB.
Argument E – effect on public confidence – is quite likely to be accurate, in the long term. It could have many other health problems in due course.
Yes. How many anti-vaxxers have these so-called vaccines created I wonder?
I believe the negative effects will be much wider CG. I don’t expect I will be on my own in treating any “advice” from a largely ignorant health system and its operatives with a high degree of sceptism if not outright disdain.
True – as I’ve said elsewhere, I don’t even trust vets any more!
Strange you mention vets…..ours have been one of the most enthusiastic establishments regarding restrictions we have come across, with all kinds of crazy “measures” put in place.
Even so, I was still quite surprised to see amongst their “updated guidance” this gem……”we will continue to strongly encourage our staff to remain fully vaccinated”
I smell a law suit coming from soon to be injured employees!
Not enough.
To my mind the whole programme of the jabs should be abandoned immediately.
Further unknown damage to peoples immune system will surely follow.
And here is why the jabs are injurious to health.
Spread far and wide.
https://www.sciencedirect.com/science/article/pii/S027869152200206X
At last 76 brave healthcare professionals making their concerns known to June Raine. One question, where the hell are the thousands of other healthcare professionals. The ones witnessing the serious severe adverse events, deaths and ineffectiveness of the experimental biologicals.
Thank you brave brave Doctors brilliant brilliant letter, unfortunately I feel it will fall on deaf ears. These people are only interested in one thing – lining their pockets climbing their corrupt greasy pole.
I would love to refer less sceptical acquaintances to this open letter (with all the links), but if I give them a link on this site they won’t even open it. Does anyone have a link to a copy of the letter on a “neutral” site? I can’t immediately find one.
I’m heartened these authors cited the UK study that “in England from March 1st 2020 to March 1st 2021 found only six children under 18 years died with no comorbidities. There were no deaths aged 1-4 years.”
I wrote an article on this same study, which (bizarrely) was largely if not completely ignored by the mainstream press.
One can go further in these extrapolations. From parsing this study, it seems that of the six deaths among “healthy” children (in the entire country), at least half probably occurred among minority children.
This means the probability a “healthy” white child in the UK would die “from” Covid was even more infintesimal than the 1-in-2 million “risk” I found (from my extrapolations).
If memory serves, 86 percent of children in the UK are white. The group pushing the hardest for vaccines for children would be white parents (and white “experts.”). I argue that in making a decision on whether your child should receive these jabs, one needs to look at the specific mortality probabilities related to your own children’s particular demographic group.
If one is the parent of “healthy” children who happen to be Caucasian (as my two children happen to be), I would calculate the mortality risk not from the entire population, but from the white population.
I think there are about 12 million children aged 0 to 18 in the UK of which 10.32 million (86 percent) would be white. The vast majority of these children would NOT suffer from “severe” or “life-limiting” co-morbidities. I’ve (conservatively) estimated that only 1-in-100 children suffer from such severe or “life-limiting” pre-existing conditions. This would mean there are approximately 10.2 million white children who do NOT suffer from such life-limiting severe medical conditions.
If only three (3) of the children from this cohort of 10.2 million died from Covid, the odds a “healthy”” white child would die from Covid proper would be 3/10.2 million = 1-in-3.4 million annualized mortality risk.
Of course, the odds a “healthy” minority child would die from Covid would also be minuscule, but not nearly as minuscule as that of healthy white children.
I keep reading acknowledgments that the Covid “risk” to children is “low” or “very low.” But even this characterization is nowhere close to accurate. A much fairer characterization would be that the mortality risk is either “virtually non-existent” or literally 0.0000 percent. (For the population of healthy white children, from my extrapolations one gets 3 deaths divided by 10.2 million healthy children in this racial cohort = 0.00002 percent … which is a 0.0000 percent mortality risk.
The only “risk” that math can pick up has to go out to the fifth decimal point.
It’s sad, but not particularly surprising unfortunately, that you immediately assume that the reason that non-white children seem to be at more risk of death from/with Covid is somehow genetic rather than the, to me, far more likely reason that non-white Britons are, on average, poorer, less healthy, and more reluctant/unable to access timely healthcare than white Britons.
Do you have any evidence at all to support your assertion “Of course, the odds a “healthy” minority child would die from Covid would also be minuscule, but not nearly as minuscule as that of healthy white children.”? Or is that just out and out racism?
I didn’t make any racist comments. I just pointed out that deaths from Covid occur at a higher rate among minority children than white children. I don’t know the reasons. But this is scientific and observable fact.
Healthy black children have nothing to worry about from Covid (regarding mortality risks) … and healthy white children have even less to worry about … per the mortality statistics.
You can read the study yourself.
https://www.medrxiv.org/content/10.1101/2021.07.07.21259779v1.full