THE ignorance underlying the reckless decision to vaccinate over-12s who are at no risk of fatality from Covid-19 is near-incomprehensible. So much for ‘following the science’: the Government is blind to it.
A study of Swedish schools published in January should have been enough to confirm conclusively that children are not the viral vector risk to adults that the blinkered teachers’ unions believe them to be. There were no deaths among nearly 2million children, with no mask mandates, and only a few instances of transmission.
If you think there is ‘evidence’ for the idea now mooted that vaccination is needed to drop the mask mandate, think again. There is none. On the other hand there is a disturbing amount of evidence that schools and teachers are fast becoming a threat to children.
This serious threat to children is underlined by a letter to the MHRA (Medicine and Health products Regulatory Agency) at the weekend signed by numerous deeply concerned doctors and biomedical scientists that details the very serious risks the vaccine subjects children to. We publish it in full below.
An open letter led by Dr Ros Jones sent earlier this May to MHRA signed by more than 40 scientists – professors, medics and academics – on the profound ethical and safety concerns associated with child Covid vaccination reported on here was met with bland denial. The text of the MHRA reply to Dr Jones can be read at the end of this article.
It was sent after, as reported here, the MHRA chief executive Dr June Raine, giving approval for 12 – 17 year olds, despite the serious concerns of so many doctors and scientists, while absolving herself of responsibility by passing the buck to the Government on the decision to act on it or not.
On Sunday the redoubtable Dr Jones wrote an urgent letter back to Dr Raine, raising and detailing terrifying gaps in the MHRA process of consideration. We publish the full text below and ask all readers to send a copy to their MPs to make them realise the serious and unjustifiable risk to children that they will be party to unless they protest in the most vigorous of terms in Parliament and elsewhere.
The critical concern they need to understand is that vaccinating children is certain to kill many tens of them soon after vaccination, and there is also no way of knowing what other long-terms harms (infertility, cancer, auto-immune disorders, shortened lifespan for example) these new technology genetic vaccines might cause. Against this, the risk of covid for children is virtually zero.
Let us all say this clearly and out loud: the risk of Covid for children is virtually zero. So the MHRA’s statement that the benefits outweigh any risks makes no sense whatsoever.
Here is Dr Jones’s letter dated Sunday, June 6, 2021, to Dr June Raine, chief executive of the MHRA:
Dear Dr Raine,
Re safety of COVID-19 vaccines for children
Many thanks for your reply to our letter received yesterday after the approval had gone ahead. We are all extremely disappointed by this decision and indeed very puzzled by the statement it makes, regarding both safety and efficacy.
The Pfizer trial which you kindly linked, has 1134 children given the vaccine and 2 months follow-up. How does this equate to ‘rigorous’ assessment of safety in this age group? The introduction states that “adolescents may play an important role in SARS-CoV-2 transmission. Thus, their vaccination may prevent disease and contribute to herd immunity.” Immediate systemic side effects such as fever and ‘chills’ appear to be more common in the younger cohorts and it is certainly possible that more serious side effects will have the same propensity to affect the young. There was seven unspecified severe and one life-threatening event reported in the trial arm, obviously not sufficient to reach statistical significance in this very small study, but if rolled out to 5 million children, could result in 5000 children suffering significant harm.
Have these events been included in your review of safety, if not why not?
You also appear to have ignored the post-marketing reports from Israel and US of myocarditis now described by the Israeli health authority as 1 in 44,000 16-30 year-olds, but with higher incidence in the youngest groups.
What calculations of the risk of myocarditis have you included?
Similarly, in terms of rigorous post marketing surveillance, it took several months for the MHRA to withdraw AstraZeneca for <40s in spite of warnings, and only after significant numbers of healthy young adults had suffered from cerebral venous strokes, some fatal. Again, your own website states that the incidence of VITT is 1 in 77,000 but with higher rates in the younger age groups. Why have you not published the data delineated by age band so that young adults can make properly informed choices?
We know from the VAERS reporting system that some young adolescents in the US have already died shortly after vaccination. In the UK healthy children are not dying of COVID-19, so even a handful of deaths following the vaccine would be a travesty of ‘First do no Harm’.
How have these been factored into your deliberations?
Have you seen pharmacokinetic animal studies for Pfizer showing concentration in liver, spleen and ovaries?
Have you seen any data which can predict the quantity of spike protein produced by individuals following a specified dose of mRNA?
What potential long term side effects have been considered?
In terms of efficacy, it is not surprising that children have good immune responses but, of course, they could safely obtain even broader immunity from naturally acquired infection. Positive PCR tests in children are only clinically meaningful if they result in hospitalisations or deaths, as opposed to asymptomatic infection or mild symptoms. From the data already known about the rarity of hospitalisations or deaths from SARS-CoV-2 in children, the numbers needed to treat/vaccinate (NNT) to prevent one significant clinical outcome would be huge, putting all those vaccinated at risk from known and unknown short and long-term harm from the vaccine, with no direct benefit. We believe the numbers harmed would far exceed the numbers who would benefit. What NNT have you used in your calculations?
Further, you state in your letter that subjects in clinical trials will continue to be monitored for long-term protection and safety for two years after vaccination. If serious, long-term health impacts emerge, it will be too late for those who are vaccinated now, who will have to live with the consequences. This is not responsible medicine and is a reckless approach to children‘s health.
How will you ensure that the children’s placebo group do not receive the vaccine as has occurred with the adult trials, thus nullifying the long term RCT follow-up?
Why are you not recommending waiting for this long-term safety data before granting the emergency authorisation?
We understand that a decision on the full rollout will lie with the JCVI and/or the Prime Minister but we have already seen 16 & 17 year-olds in greater Manchester being offered vaccination which was licenced but not recommended by either the JCVI or indeed the RCPCH, and talk of extending the rollout to infants and primary school children in the near future. If local health authorities roll this out to adolescents against JCVI or RCPCH advice, then the responsibility for any harm done to children receiving it will clearly rest with the MHRA alone.
How have you arranged indemnity for any children harmed by the vaccine?
How will they be compensated for injury or death and what figure is considered to be appropriate?
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 this authorisation?
We the undersigned doctors and biomedical scientists strongly urge you to revoke this decision, as you risk being responsible for a wholly avoidable, unnecessary, and unforgivable act of iatrogenic harm to the children of the UK..
In view of the critical urgency of this, we require answers to all of the above questions within 48 hours.
Dr Rosamond Jones, MD, FRCPCH, retired consultant paediatrician
Prof Anthony Fryer, PhD, FRCPath, Professor of Clinical Biochemistry, Keele University
Professor Anthony J Brookes, Department of Genetics & Genome Biology, University of Leicester
Professor John A Fairclough, BM BS, BMed Sci, FRCS, FFSEM(UK), Professor Emeritus, Honorary
Consultant Orthopaedic Surgeon
Professor David Livermore, Professor of Virology, 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 Karen Horridge, MB ChB(Hons), MSc, MRCP, FRCPCH, Consultant Paediatrician (Disability)
Dr Alan Mordue, MBChB, FFPH (ret). Retired Consultant in Public Health Medicine & Epidemiology
Mr Malcolm Loudon, MB ChB, MD, FRCSEd, FRCS (Gen Surg). MIHM, VR. Consultant Surgeon
Dr David Critchley, BSc, PhD, 32 years in pharmaceutical R&D as a clinical research scientist.
Mr Anthony Hinton, MBChB, FRCS, Consultant ENT surgeon, London
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
Michael Cockayne, MSc, PGDip, SCPHNOH, BA, RN, Occupational health practitioner
Dr C Geoffrey Maidment, MD, FRCP, retired consultant physician
Dr Christina Peers, MBBS, DRCOG, DFSRH, FFSRH, Consultant in Contraception & Reproductive
Mr T James Royle MBChB, FRCS(Ed), MMedEd, Consultant colorectal surgeon
Noel Thomas, MA, MB ChB, DCH, DObsRCOG, DTM&H, MFHom, retired doctor
Dr Scott McLachan,FAIDH,MCSE,MCT,DSysEng,LLM,MPhil(Sc), Risk & Information Management Group
Dr Holly Young, BSc, MBChB, MRCP, Consultant physician, Croydon University Hospital
Dr David Critchley, BSc, PhD, 32 years in pharmaceutical R&D as a clinical research scientist.
Dr Alan Black, MB BS MSc DipPharmMed, retired pharmaceutical physician
Dr K Singh, MBChB, MRCGP, general practitioner
Mr Ian F Comaish, MA, BM BCh, FRCOphth, FRANZCO, Consultant ophthalmologist
Dr David Bramble, MBChB, MRCPsych, MD. Consultant Psychiatrist
Dr Theresa Lawrie, MBBCh, PhD, Director, Evidence-Based Medicine Consultancy Ltd, Bath
Dr Fiona Martindale, MbChB, MRCGP, GP, Out of hours
Dr Gerry Quinn, PhD, Postdoctoral Researcher, Microbiology and Immunology
Dr Elizabeth Evans, MA, MBBS, DRCG, Retired doctor
Dr Greta Mushet, retired Consultant Psychiatrist in Psychotherapy. MBChB, MRCPsych
and 30 others
Dear Dr Jones,
Use of COVID-19 vaccines in children and young people
Thank you for your email of 17th May 2021 and for your letter setting out your concerns surrounding use of COVID-19 vaccines in children.
It may be helpful to first outline the regulatory position. The approval of the Pfizer/BioNTech COVID-19 vaccine on 2nd December 2020 was for people aged 16 years and over. Since then substantial experience has been gathered on effectiveness and safety. The results of randomised, placebo- controlled clinical trials in over 2000 children aged 12 to 15 years have now been rigorously reviewed by our teams of scientific and clinical assessors. In terms of efficacy, there were no cases of COVID-19 from 7 days after dose 2 in the vaccinated group compared with 16 cases in the placebo group. In addition, neutralising antibodies were examined in approximately 200 children, and the data showed the vaccine working at the same level as seen in adults aged 16-25 years. Taken together, efficacy and immunogenicity data strongly support a positive benefit in adolescents 12-15 years of age for the same two-dose regimen as in adults.
The data on the safety of the vaccine in the 12 to 15 year olds have also been reviewed carefully. No new adverse events were identified and the safety data in adolescents was comparable with that seen in young adults. As in the young adults, the majority of adverse events were mild to moderate and related to reactogenicity. These data have recently been published by the company in the New England Journal of Medicine paper, ‘Safety, Immunogenicity, and Efficacy of the BNT162b2 Covid-19 Vaccine in Adolescents’: Safety, Immunogenicity, and Efficacy of the BNT162b2 Covid-19 Vaccine in Adolescents
We have sought independent advice from the Commission on Human Medicines and its Paediatric Medicines Expert Advisory Group, who concluded that the expected standards of safety, quality and effectiveness have been met in this age group and that the benefits outweigh any risks. On this basis the Pfizer/BioNTech vaccine has now been approved for use in children aged 12-15 years and you will no doubt have seen today’s announcement from MHRA.
Whether 12 to 15 year-old children will be included in the UK vaccination programme will be for the Government to decide and they will call on the Joint Committee on Vaccination and Immunisation (JCVI) to advise them. There are a broad range of considerations to take into account which go beyond the regulatory role and remit of the MHRA.
Medicines & Healthcare products Regulatory Agency
10 South Colonnade Canary Wharf London
+44 (0) 20 3080 6000
We have in place a program of proactive surveillance to monitor the medium and long-term safety profile of COVID-19 vaccines in adults and, depending on policy decisions, in the paediatric population. In this program our scientific and clinical teams will proactively identify any potential age-specific risks relevant to children and adolescents We will also use global data sources for continuously collecting important safety data on COVID-19 vaccines in the paediatric population. In addition, several Post Authorisation Safety Studies will also collect long term safety data.
We note the ethical debate around the use of any vaccine or medicine in the paediatric population while evidence on the benefit:risk profile is still accumulating. A number of international COVID-19 vaccine clinical trials in children and adolescents have been approved by ethics committees globally. These trials have recruited a significant number of children, indicating that families and more importantly children and adolescents themselves have been informed and expressed their consent or assent to receiving the vaccines, generating much-needed safety and efficacy data. Subjects in clinical trials will continue to be monitored for long-term protection and safety for two years after vaccination.
I hope this helps clarify our regulatory responsibilities and our independent role in ensuring that the balance of benefits and risks remains positive for COVID-19 vaccines in relation to their approved use.
Dr June M Raine CEO, MHRA