Open letter to the MHRA regarding child mortality data
More than 80 doctors in the United Kingdom are sounding the alarm. The open letter from hartgroup.org speaks volumes: based on observations, they consider it possible that 3 children per week die from the Covid-19 vaccines. There are no hard figures because, just like in the Netherlands, they are hidden. Also in the UK they don't show the back of the tongue. Hence, among other things, the requirement for disclosure. The letter mentions, among other things, ONS, which stands for Office for National Statistics, MHRA: Medicines and Healthcare products Regulatory Agency and Yellow Card: Yellow Card, the adverse event reporting system in the UK. It is a recognizable call, in the Netherlands we do not get to see the data despite FOI requests, parliamentary questions, judicial rulings and the ongoing motion by Pieter Omtzigt.
What is going on with our governments? Why does everyone need to be jabbed!? And if it's so good for everyone, why so secretive?
Original: https://www.hartgroup.org/open-letter-to-the-mhra-regarding-child-death-data/
Signs that Covid-19 vaccines may have caused death in children and young adults
Dated 19 January 2022
At:
- Dr June Raine, Chief Executive, MHRA
- Professor Lim, Chair of the JCVI COVID-19 Subcommittee
- Hon Sajid Javid, Secretary of State for Health and Social Care
- Professor Sir Chris Whitty, Chief Medical Officer for England
- Sir Patrick Vallance, Scientific Adviser to the Government
- Dr Jenny Harries OBE, Chief Executive, UKHSA
Dear Dr. Raine, Professor Lim, Mr Javid, Professor Whitty, Sir Patrick Vallance and Dr. Harries,
URGENT
RE: Signs that Covid-19 vaccines may have caused death in children and young adults
We are writing to demand an immediate, urgent investigation to determine whether the Covid-19 vaccines are the cause of significant numbers of deaths recently seen in male children and young adults.
We also ask that anonymised data and information known to be available, showing how many children have died following a Covid-19 vaccine and within how many days, be published for full transparency, in the public interest.
On Thursday 13 January 2022, during a hearing in the Supreme Court1 in London, evidence was presented showing a significant increase in the number of young male deaths following the rollout of the Covid-19 vaccinations compared to the previous five-year average between 2015 and 2019. It is important to look at male deaths separately, given what is known about higher risks of myocarditis in young men.
Between 1 May and 24 December 2021, there were
- 402 registered deaths in 15-19-year-old men, 65 more than the five-year average of 337;
- In contrast, 163 deaths in women recorded, 12 fewer than the five-year average of 175; and
- Together, there were a total of 565 deaths of men and women, 53 more than expected.
The Office for National Statistics has found that the increase in young male deaths is a statistically significant increase, with the death rate falling outside the expected confidence intervals of previous years' data.
Even more worrisome is the fact that the actual number of deaths of young men during this period is likely to be significantly higher than those recorded. This is because the ONS estimates that due to delays in registration, registered deaths in the period represent on average only 62% of actual deaths. Any death where there was uncertainty as to the cause will have been referred to the coroner and it can take a long time for such deaths to be recorded. The fact that a signal is already visible in registered deaths is therefore a major concern.
Taking into account the ONS estimate, the 65 excess male deaths would 105 additional deaths of these young men assuming that the proportion of deaths referred to the coroner is comparable to previous years. If there have been more coroner referrals this year, the figure could be higher.
Since at least October 13, 2021, the Secretary of State and JCVI have been notified of this increase in male deaths through their representation by the government's legal department in Supreme Court proceedings. In addition, the ONS itself has now acknowledged that more work can be done to examine youth mortality rates in 2021 and has confirmed in writing that it intends to undertake that work "when more reliable data is available."
There are already signs of risk
The incidence of higher mortality in young men in 2021, coinciding with the rollout of Covid-19 vaccines, cannot be dismissed as a coincidence, as there have already been warning signs of serious side effects in this age group. For this reason, the decision to offer the Covid-19 vaccine to young people under the age of 18 has not been without controversy.
The JCVI previously refused torecommendthat the Covid-19 vaccines would be administered to healthy 12-15 year olds, as the benefit-risk balance was only marginal at best in light of the very low risk for children with severe illness or death from Covid-19 disease, the significant uncertainty about the potential harm of the Covid-19 vaccines, the known signs of harm from the vaccines already identified, and the lack of complete and long-term safety data in circumstances in which the vaccines have been rapidly brought to market, long before the normal phase III clinical trials used to assess safety have been completed. On 3 September 2021, the JCVI said:
About Overall, the Commission considers that the benefits of vaccination are marginally greater than the potential known harm (Tables 1 to 4), but acknowledges that there is considerable uncertainty as to the extent of the potential harm. The margin of benefit, based primarily on a health perspective, is considered too small at this time to support advice on a universal vaccination program of otherwise healthy 12- to 15-year-old children. As longer-term data on potential side effects increases, more certainty may allow for a reconsideration of the benefits and drawbacks. Such data may not be available for several months."
The JCVI's decision wasdestroyedby the four chief medical officers of England, Wales, Scotland and Northern Ireland, not because they felt there was a health benefit to children with regard to the Covid-19 vaccines, but because they because based on modeling analyses, they concluded that the Covid-19 vaccines were likely to reduce school absenteeism. Despite the fact that theoretically preventing several days of absence for mild, cold-like symptoms could never reasonably be considered as justification for administering vaccines with unknown long-term effects, this was the justification given for the vaccination of school-age children. Since then, data must have been available and collected and reviewed to determine whether vaccinations have in fact reduced school absenteeism and the extent to which absences have occurred due to (a) administration of the vaccination program and (b) adverse reactions to the vaccines.
In addition, on August 4, 2021, the JCVI initially recommended only one dose to healthy 16-17-year-olds, acknowledging that there was an increased risk in young men for myocarditis from the Covid-19 vaccines, especially after a second dose, as identified by the FDA in the U.S. and from data emerging in Israel. It is noteworthy that when the JCVI recommended in November 2021 that 16-17-year-olds should be administered a second dose, it did so without including an explicit statement that it considered that the benefits of the Covid-19 vaccine outweighed the risks in that age group. Instead, it acknowledged that information about the longer-term risks (months to years) of myocarditis was unclear and would only become available over time.
The risk benefit with regard to the rollout of vaccines to young people under the age of 18 had been carefully weighed, according to the Secretary of State and those who advised him. Several months have passed, and data on recorded deaths and school absences, along with the reduced risk of Omicron, should give reason to consider whether that trade-off is still justified.
An investigation should be launched
In light of the increase in deaths among young men and the known safety concerns, an investigation should be conducted. It is not suggested that the observed increase in mortalityProvesthat the Covid-19 vaccines cause death, either via myocarditis or some other mechanism, but a link cannot be ruled out. The potential signal is strong enough that urgent investigations should be launched immediately to rule out that possibility. Every recipient of this letter has a duty to investigate. It would be a grave dereliction of duty not to do so.
The JCVI has an ongoing duty to monitor its opinions with the emergence of new data. It has explicitly stated on several occasions that more data is needed or that more data is needed or that more is still awaited.
The MHRA is charged with the responsibility of real-time vaccine surveillance and has a duty to check Covid-19 vaccine data for safety signals. It does this through the yellow card reporting system, but its role should not be limited to one passive surveillance system alone. The Committee of Experts on Medicinal Products for Human Use, which was set up to advise the MHRA on its safety monitoring strategy for Covid-19 vaccines, accepts that passive surveillance relies on someone suspecting or 'establishing a link' between the medicine or vaccine and an unexplained disease, and then reporting it, and that it is therefore important that other forms of vigilance are included in addition to the yellow card scheme.
It is therefore indisputable that the MHRA has a duty to investigate the incidence of excess mortality in young men within the data held by ONS, regardless of whether or not yellow card reports have been submitted.
As the person responsible for the government's vaccination programme, the State Secretary also has an important task in the public interest to monitor the safety and effectiveness of the Covid-19 vaccines.
The data are available and can be easily examined
These concerns shouldn't be difficult to examine. The ONS has confirmed (to the Court) that it is able to provide accurate anonymised data, including the number of days between vaccination and death. It has not been suggested that it is difficult to collect or analyze the data. For example, if the data shows that there is a concentration of deaths near the date of vaccination, this could reinforce concerns about a positive causal relationship (e.g., under the Bradford Hill criteria) and further, more detailed research would be warranted. A higher incidence of mortality in children after vaccination is a major cause for concern and may indicate the need to pause the vaccination program immediately. If there is no evidence of a causal relationship, this can help to reassure the public about the safety of the vaccines.
Although a halt to the Covid-19 vaccination programme in children has been requested through the Supreme Court, the courts have so far taken the position that mass roll-out to under-18s has been a political decision by the Secretary of State that the judiciary cannot interfere with. This position of the court, which relates to certain legal principles of judicial review, does not in any way impede the investigation we require. The honourable Member, Mr Justice Jay, commented at a hearing, at which the Secretary of State was represented, that he expected the JCVI to "cry out for the data" regarding the incidence of death following vaccination.
Information has already been requested from and promised by the State Secretary
This request for information on post-vaccination deaths is not new. This issue has been raised in the House of Commons on several occasions. For example, on 25 March 2021, in response to questions from Mr William Wragg MP and Sir Christopher Chope MP on the incidence of deaths within three weeks of Covid-19 vaccination, the then Foreign Secretary,Matt Hancock, Parliamentthat this was exactly the kind of thing he was looking at and that, if no data had been published, he would look at publication because the government wanted to be completely open and transparent to reassure people that the risks are extremely low.
It is extremely worrisome that the data on deaths following Covid-19 vaccination do not appear to have been collected and analysed or, if they have, it has been decided not to publish them. Unfortunately, the impression that is given is not one of transparency, but rather of information being hidden. The long-term impact on trust in elected representatives and in regulatory bodies advising them cannot be underestimated. Nor is the potential significance of the data signals that are apparently emerging.
Our question and request
In light of the above and in all circumstances, you will want to confirm the following at a time:
- That each of you will examine the increase in mortality in the period from May 1, 2021 to December 24, 2021 (and thereafter) in young men as recorded by the ONS, to determine the reason for the increase and whether causation with the Covid-19 vaccines can be reasonably excluded.
- What steps have been taken so far to carry out the required investigation and if such an investigation has already begun, please confirm when that investigation started, what its scope is, at what stage it is and when it should be completed. If no steps have been taken yet, explain why.
- That you will now obtain from the US, without delay, the following data for all deaths aged 12-19 that have occurred to date on or after May 1, 2021:
a. Age (in the age group 12-15 or 16-19 years)
b. Gender
c. Whether the individual had dose 1 of a Covid-19 vaccine
(and whether Moderna or Pfizer) d. Whether the individual had dose 2 of a Covid-19 vaccine
(and whether Moderna or Pfizer) e. If applicable, the number of days of death after dose 1 (if dose 2 was not administered) or the number of days of death after dose 2 (if administered) - That the Secretary of State will make the data obtained public or that he will arrange for the ONS to publish such data.
- Whether you have concluded, and if so when, that a causal link with the Covid-19 vaccines can be ruled out or considered a negligible possibility, and on what basis.
- Which, according to you, could be the explanation for the statistically significant increase in deaths among young men in the period from May 1, 2021 to December 24, 2021, other than a possible causal relationship with the Covid-19 vaccines.
- That you will provide the main sources of evidence on which you rely, in relation to any explanation provided, to support and explain why this increase was not also seen in other periods (for example, in 2020, when the pandemic occurred and when the mortality of young men was below average).
Notwithstanding the fact that we do not accept that certain missing data in the modelled data could have justified the decision to roll out the vaccines to school-age children, you also confirm each time:
- That each of you will take steps to examine the available data since the decision of 13 September 2021 on the advice of the Chief Medical Officers, with regard to
(a) the level of absenteeism from school
(b) whether the modelled benefit of avoiding school absenteeism has been achieved, and
(c) the extent to which absence has been caused by each of (i) administration of the vaccination programme and (ii) adverse reactions of the vaccination programme. - What steps have been taken so far to examine the data related to school absenteeism since that decision of 13 September 2021 and, if such an investigation has already started, please confirm when that investigation was started, what its scope is, at what stage it is and when it should be completed. If no steps have been taken yet, explain why.
Publication of data
We do not see any obstacle to publishing the requested data. The ONS expressed in court its concern that publication of the requested data could be public, in the sense that it would be possible to identify the individuals involved when they are related to news reports and other information in the public domain. However, we don't understand how this would even be conceptually possible given the general nature of the data requested. We also note the regional and daily data published by the ONS regarding Covid-19 deaths.
No names, regional data, date of birth or date of death data are requested. With the help of the ONS, provide an example so that we and the public can understand why the requested data may be withheld on the grounds that it may be public.
Highest urgency
Finally, the government's current message to children remains 'get vaccinated'. It used to be 'every life counts'. If the likelihood of a causal relationship between an increased incidence of death and the Covid-19 vaccines were to be established, it would be a very serious matter. The death of even one child from a Covid-19 vaccine would be a tragedy. It is therefore obvious that an investigation is of the utmost importance.
It can't be ignored that65 deaths in young men above normal average deaths amount to2 deaths per weekbetween 1StMay and 24þDecember 2021. Taking into account the estimated 38% of unregistered deaths,itactual figure may be at least 3 per week.Of course, this is only for the 15-19 age group. In the same period, only 2 deaths were registered in the same age group as 'with' Covid.
We look forward to receiving your response as soon as possible and in any case within 7 days.
This letter has been published openly and we hope it will be widely shared, along with any responses.
Sincerely,
Dr Jonathan Engler, MBChB, LlB (hons), DipPharmMed and Dr Clare Craig, BM BCh FRCPath
Co-voorzitters van HART (Health Advisory & Recovery Team,www.hartgroup.org)
Signatories of HART:
- Professor Richard Ennos, MA, PhD. Honorary Professorial Fellow, University of Edinburgh
- John Collis, RN, Specialist Nurse Practitioner
- Dr Elizabeth Evans, MA, MBBS, DRCOG, Retired Physician
- 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
- Dr. Ali Haggett, Mental Health Community Work, 3rd Sector, Former History Lecturer in Medicine
- Mr Anthony Hinton, MBChB, FRCS, Consultant ENT Surgeon, London
- Dr Keith Johnson, BA, D.Phil (Oxon), IP Diagnostic Testing Consultant
- Dr. Rosamond Jones, MD, FRCPCH, Retired Consultant Pediatrician
- Dr. Tanya Klymenko, PhD, FHEA, FIBMS, Associate Professor of Biomedical Sciences
- De heer Malcolm Loudon, MB ChB, MD, FRCSEd, FRCS (Gen Surg), MIHM, VR. Consultant Chirurg
- Dr. Alan Mordue, MBChB, FFPH (ret). Gepensioneerd consultant in public health medicine & epidemiologie
- Sue Parker Hall, CTA, MSc (Counseling & Supervisie), MBACP, EMDR. Psychotherapeut
- Ds. Dr. William J U Philip MB ChB, MRCP, BD, Senior Minister The Tron Church, Glasgow, voorheen arts gespecialiseerd in cardiologie
- Dr. Gerry Quinn, PhD, Microbioloog
- Dr Jon Rogers, MB ChB (Bristol), gepensioneerd huisarts
- Natalie Stephenson, BSc (Hons) Kinderaudioloog
Verdere ondertekenaars
- Professor Anthony J Brookes, hoogleraar Genomics & Health Data Science, Universiteit van Leicester
- Professor Angus Dalgleish, MD, FRCP, FRACP, FRCPath, FMedSci, hoogleraar oncologie, St George’s Hospital, Londen
- Professor John A Fairclough, BM BS, BMed Sci, FRCS, FFSEM (UK), Professor Emeritus, Honorary Consultant Orthopaedic Surgeon
- Professor Martin Neil, BSc PhD, hoogleraar informatica en statistiek
- Professor Keith Willison, PhD, Hoogleraar Chemische Biologie, Imperial, Londen
- Lord Moonie, MBChB, MRCPsych, MFCM, MSc, House of Lords, voormalig parlementair staatssecretaris 2001-2003, voormalig consultant in Public Health Medicine
- Julie Annakin, RN, Immunisatie Specialist Verpleegkundige
- Dr Michael Bazlinton, MBCHB MRCGP DCH
- Dr David Bell, MBBS, PhD, FRCP(UK)
- Dr Mark A Bell, MBChB, MRCP (UK), FRCEM, Consultant in Emergency Medicine, UK
- Dr. Michael D Bell, MBChB, MRCGP, gepensioneerd huisarts
- Dr Dave Cartland, MBChB, BMedSci, Huisarts
- Dr Alan Black, MBBS, MSc, DipPharmMed, gepensioneerd farmaceutisch arts
- Dr David Bramble, MBChB, MRCPsych, MD. Consulent Psychiater
- Dr. Emma Brierly, MBBS, MRCGP, Huisarts
- Kim Bull, Foundation Degree in Paramedische Wetenschap, Paramedicus
- Dr. Elizabeth Burton, MB ChB, gepensioneerd huisarts
- Dr. Peter Chan, BM, MRCS, MRCGP, NLP, Huisarts, Functional Medicine Practitioner, Huisarts
- Michael Cockayne MSc, PG Dip, SCPHNOH, BA, RN Occupational Health Practitioner
- De heer Ian F Comaish, MA, BM BCh, FRCOphth, FRANZCO, Consultant oogarts
- James Cook, NHS-geregistreerde verpleegster, Bachelor of Nursing (Hons), Master of Public Health (MPH)
- Dr Zac Cox, BDS, LCPH, Tandarts
- Dr. David Critchley, BSc, PhD, 32 jaar in farmaceutische R&D als klinisch onderzoekswetenschapper
- Dr Damien Downing, MBBS, MRSB, Private Physician
- Mr. Christian Duncan, MB BCh, BAO, MPhil, FRCSI, FRCS (Plast), Plastic Surgeon Consultant
- Dr. Chris Exley, PhD FRSB, Retired Professor of Bioinorganic Chemistry
- Dr Charles Forsyth, MBBS, BSEM, Independent Physician
- Dr Jenny Goodman, MA, MBChB, Ecological Medicine
- Dr Catherine Hatton, MBChB, General Practitioner
- Dr. Renee Hoenderkamp, General Practitioner
- Dr Andrew Isaac, MB BCh, MD, retired
- Dr Pauline Jones MB BS gepensioneerd huisarts
- Dr. Charles Lane, molecular biologist
- Dr Branko Latinkic, BSc, PhD, Molecular Biologist
- Dr Theresa Lawrie, MBBCh, PhD, Director, Evidence-Based Medicine Consultancy Ltd, Bath
- Dr. Jason Lester, MRCP, FRCR, Consultant Clinical Oncologist
- Dr Felicity Lillingstone, IMD DHS PhD ANP, Doctor, Urgent Care, Research Fellow
- Katherine MacGilchrist, BSc (Hons) Farmacologie, MSc Epidemiologie, CEO, Systematic Review Director, Epidemica Ltd
- Dr C Geoffrey Maidment, MD, FRCP, gepensioneerd adviserend arts
- De heer Ahmad K Malik, FRCS (Tr & Orth), Dip Med Sport, Consultant Trauma & Orthopedisch Chirurg
- Dr Kulvinder S. Manik MBChB, MRCGP, MA (Cantab), LLM, Gray’s Inn
- Dr. Dee Marshall, MBBS, MFHom, Voedingsgeneeskunde
- Dr. Julie Maxwell, MBBCh, MRCPCH, Associate Specialist Community Paediatrician
- Dr S McBride, BSc (Hons) Medische Microbiologie & Immunobiologie, MBBCh BAO, MSc in Klinische Gerontologie, MRCP (UK), FRCEM, FRCP (Edinburgh). NHS Spoedeisende Geneeskunde & Geriatrie
- De heer Ian McDermott, MBBS, MS, FRCS (Tr & Orth), FFSEM (UK), Consultant Orthopedisch Chirurg
- Dr. Niall McCrae RMN, PhD Mental Health Researcher en Officer van de Workers of England Union
- Dr Franziska Meuschel, MD, ND, PhD, LFHom, BSEM, Nutritional, Environmental & Integrated Medicine
- Dr. Scott Mitchell, MBChB, MRCS, Associate Specialist, Spoedeisende Geneeskunde
- Dr. David Morris, MBChB, MRCP (UK), Huisarts
- Dr. Greta Mushet, gepensioneerd consulent psychiater psychotherapie. MBChB, MRCPsych
- Dr Sarah Myhill, MBBS, Dip NM, Gepensioneerde huisarts, onafhankelijke natuurgeneeskundige arts
- Dr Christina Peers, MBBS, DRCOG, DFSRH, FFSRH, Menopauze Specialist
- Anna Phillips, RSCN, BSc Hons, Clinical Lead Trainer Clinical Systems (Pediatrische Intensive Care)
- Jessica Righart, BSc MSc, Senior Critical Care Scientist
- De heer Angus Robertson, BSc, MB ChB, FRCSEd (Tr & Orth), Consultant Orthopedisch Chirurg
- Dr Jessica Robinson, BSc (Hons), MBBS, MRCPsych, MFHom, Psychiater, Integrative Medicine Doctor
- De heer James Royle, MBChB, FRCS, MMedEd, Colorectale chirurg
- Dr Rohaan Seth, Bsc (Hons), MBChB (Hons), MRCGP, Gepensioneerd Huisarts
- Dr Noel Thomas, MA, MBChB, DObsRCOG, DTM&H, MFHom, Gepensioneerd Arts
- Dr Julian Tompkins, MBChB, MRCGP, Huisarts, huisarts trainer PCME
- Dr. Livia Tossici-Bolt, PhD, NHS Clinical Scientist
- Dr Helen Westwood, MBChB (Hons), MRCGP, DCH, DRCOG, Huisarts
- Dr Carmen Wheatley, DPhil, Orthomoleculaire Oncologie
- De heer Lasantha Wijesinghe, FRCS, Adviseur vaatchirurg
- Dr Ruth Wilde, MB BCh, MRCEM, AFMCP, Integrative & Functional Medicine Doctor
- Dr Stefanie Williams, dermatologist
- Gordon Wolffe, BDS (Hons), MSc, FDSRCS, Consultant Periodontist (Retired), Director of the Master's Program in Periodontology (Retired), University of Nijmegen Netherlands.
- Dr Holly Young, BSc, MBChB, MRCP, Consultant Palliative Care Medicine
[1]In the caseFrom the Queen (at the request of AB and CD, by their mother and Procesvriend EF) against The Secretary of State for Health and Social Care and The Joint Committee on Vaccination and Immunisation, CO-3001-2021, a request was made by the ONS for disclosure of information as set out in this letter.