Why give a second dose to children?
Professor Lim, Chairman, JCVI COVID-19 subcommittee
Dr June Raine, Chief Executive, MHRA
Rt Hon Sajid Javid, Secretary of State for Health and Social Care
Professor Chris Whitty, Chief Medical Officer for England
Sir Patrick Vallance, Government Chief Scientific Adviser
Dr Jenny Harries, Chief Executive, UKHSA
9th December 2021
Dear Professor Lim, Dr Raine, Mr Javid, Professor Whitty, Sir Patrick Vallance & Dr Harries
URGENT re (I) latest government guidance re myocarditis
(II) decision to offer a second dose of Pfizer to 12-15s
(III) reckless disregard for the benefits of natural immunity in children
As a group of senior scientists and clinicians, we wrote to you only two weeks ago regarding your decision to offer a second dose of the Pfizer COVID-19 vaccine to 16-17-year-olds despite lack of detailed safety data. We still await a reply, but are compelled to write again after this week’s UKHSA publication of guidance on myocarditis, coinciding with your latest unexpected advice to widen the age range for the second dose to include 12-15 year-olds. We also still awaiting a reply as to why the JCVI continue to recommend vaccination for those children who already have naturally-acquired immunity and for whom there is no possibility of any benefit from the COVID-19 vaccines.
I. Myocarditis guidelines The following statements (in italics) from the UKHSA document require urgent clarification regarding our points (in red).
- “myocarditis and pericarditis following vaccination is usually mild or stable and most patients typically recover fully without medical treatment”
This unsubstantiated assertion is not compatible with the statement made in the bullet point below. Unless these children had cardiac MRI scans and follow-up, it is impossible to state that they ‘typically recover fully’
- “myocarditis – significant left ventricular (LV) fibrosis has been described in a high percentage of children admitted to hospital, with a small percentage of these having non-sustained ventricular tachycardia (VT)”
According to the authors, these children were not clinically distinguishable from children in other case series, also with an apparently ‘mild’ clinical course. The concerning findings on MRI were only discovered because the authors thoroughly investigated all children with serious VAEs.
- “no follow-up data is available yet on hospitalised patients”
This point undermines the claim made in the first bullet point.
- “the long-term consequences of this condition secondary to vaccination are yet unknown, so any screening recommendations need to be balanced against the frequency and severity of the disease with the aim to prevent complications, in particular of myocarditis (arrhythmias, long term myocardial damage or heart failure)”
As Pfizer have admitted, the children’s trials are too small to look for myocarditis, but long term studies are in progress due to report in 2025
Recommendations in paediatric patients: Why was there no consultation with the RCPCH?
- “Where appropriate, the patient should be seen face to face and this assessment should include their vital signs.”
When would it be ‘inappropriate’ to see face to face and check vital signs, in a child with any of the concerning symptoms listed?
- “If patients have mild symptoms, they do not require referral to secondary care at this point.”
How would you expect a GP to determine whether myocarditis was ‘mild’ in the absence of an ECG and a Troponin level? How does such an approach match up with rigorous post-marketing surveillance of a vaccine still under emergency use authorisation?
(II) Decision to offer a second dose of Pfizer to 12-15s
There has been no new follow-up data disclosed since the JCVI decision to offer only one dose to 12-15s regarding the outcome for children with vaccine-induced myocarditis. The suggestion that the MHRA has seen no new adverse event reports of myocarditis, is perhaps not surprising given that the UK has not proceeded to a second dose known to be associated with a greatly increased risk. How does the JCVI look at the concerns outlined in the government’s own myocarditis guidance and reconcile them with their duty of care to First do no Harm?
A systematic study from Hong Kong linking all vaccinations to health records has revealed myocarditis occurring 1 in 2,680 in young males after their second dose of Pfizer, and they have now dropped the second dose from their schedule. The latest FDA data similarly report 1 in 5000 for males age 16-17. How is it ethical to recommend a second dose to this cohort knowing the risks to the individual will far outweigh any benefits?
How will effective pharmacovigilance and real-time data be obtained on every child admitted with a diagnosis of myocarditis by vaccine status? How many child fatalities have you factored in as acceptable collateral damage resulting from your decision to recommend the second dose of this vaccine for a condition which poses no significant threat to this age group? The answer surely must be zero.
III. Naturally acquired immunity in children
Perhaps most pressing of all, why does the JCVI continue to disregard the obvious benefits of naturally acquired immunity? This has now been conclusively shown in adults to be much longer lasting and robust than that following vaccination . It is already known that children have good crossover immunity from previous coronaviruses, with excellent T-cell function. And it is widely recognised that their strong innate immune systems are the reason for Covid-19 being extremely mild in children. It is estimated that in England, 5.47 million 5-14-year-olds have already had SARS-CoV-2 infection (which represents 79% of the population of this age group). An international meta-analysis of re-infections post natural infection reported only 577 cases of reinfection from 22 countries over a 15-month period, including only 10 deaths, with not a single death in younger adults let alone in children. Numerous other publications have affirmed that naturally acquired immunity is robust, comprehensive and long-lasting.
Therefore, for the 80% of children who are already immune, there can be no benefit from vaccination and only the potential for serious or even life-threatening harm. For the 20% not yet infected, there are still unanswered questions about the potential for vaccination to interfere with the ability to mount a broad robust and long-lasting immunity and we risk committing these children to the theatre of ever more frequent boosters, each with its own risk of injury, which now seems to be the future for adults. Indeed, this becomes even more important with the new omicron variant. There is no point in vaccinating children with a vaccine which will cause immune imprinting to the Wuhan variant and will impede their ability to make antibodies to the new variants as they present.
We contend that any practitioner who chooses to vaccinate a child in the knowledge that they have recovered from SARS-CoV-2 infection, is in breach of their professional duty of care to put their patient’s best interest first. In addition. failure of the practitioner to disclose the full contents of the UKHSA Myocarditis guidance to the patient and parent would constitute a failure to obtain fully informed consent. See GMC Good Medical Practice Guidelines.
Professor Keith Willison, PhD, Professor of Chemical Biology, Imperial, London
Professor Richard Ennos, MA, PhD. Honorary Professorial Fellow, University of Edinburgh
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, former consultant in Public Health Medicine
Dr Roland Salmon, MBBS, MRCGP, FFPH, former Director, Communicable Disease Surveillance Centre, Wales
Dr Theresa Lawrie, MBBCh, PhD, Director, Evidence-Based Medicine Consultancy Ltd, Bath
Dr John Flack, BPharm, PhD. Retired Director of Safety Evaluation, Beecham Pharmaceuticals 1980-1989 and Senior Vice-president for Drug Discovery 1990-92 SmithKline Beecham
and 40 other senior health professionals and academics…..
Reply received 9th March 2022
Dear Dr Rosamond Jones,
Re: Childhood vaccination
Thank you for your letters of 23 November and 9 December to the Joint Committee on Vaccination and Immunisation (JCVI).
When formulating advice in relation to childhood immunisations, JCVI has consistently held that the main focus of its considerations should be the potential benefits and harms of vaccination to children and young people themselves.
The key evidence that the committee considered in their decision to offer second doses to persons aged between 5 to 17 years who are not in a clinical risk group is provided in the JCVI statements of 15 November 2021 and 22 December 2021.
In summer 2021, when COVID-19 vaccination of children and young people was being considered in the UK, reports of vaccine-related myocarditis were just emerging and there was uncertainty regarding the longer-term prognosis following such events of myocarditis.
Since then, much more data have accrued internationally and in the UK; more vaccine has been administered to children and young people globally and more follow-up time has passed. International colleagues have shared their experience which includes longer term follow-up; for example, the US CDC and ACIP have assessed the follow up of cases of vaccine-related myocarditis out to 90 days. Colleagues from these countries are themselves now much more reassured regarding the lack of any serious sequalae from vaccine-related myocarditis. The following points are relevant:
- The reporting rate of myocarditis following vaccination decreases with decreasing age from 18 years downwards; for instance, in children aged 5 – 11 years, the reporting rate of myocarditis following vaccination in the US is between 1 -2 per million vaccine doses.
- The reporting rate of myocarditis following vaccination is lower with extended intervals between doses (as used in the UK), compared to schedules with shorter dose intervals (as used in the US and Israel).
- The vast majority of confirmed cases of myocarditis following vaccination recover within a short time and no serious longer-term sequelae have been noted.
JCVI takes the potential risk of post-vaccination myocarditis seriously and are continuing to review relevant data as they emerge. JCVI receives regular updates from the Medicines and Healthcare products Regulatory Agency (MHRA) on the safety and use of the COVID-19 vaccines. It is the responsibility of the MHRA to ensure that medicines, medical devices and blood components for transfusion meet applicable standards of safety, quality and efficacy. As well as authorising the use of new vaccines and medicines, the MHRA has statutory responsibility for undertaking post-authorisation safety monitoring in the UK.
Natural immunity following infection with SARS-CoV2 is an important component of immunity that will increase in relevance as more people are exposed to and recovery from SARS-CoV2 infection. The antigenic distances between Omicron, Delta and wild-type virus may influence the ‘specificity’ of immunity that is generated following natural infection. An increasing range of studies demonstrate that the combination of natural and vaccine-induced immunity (hybrid immunity) provides increased strength and breadth of immunity. Such hybrid immunity will add to the protection against future emerging variants.
By Spring 2022, it is anticipated that most people in the UK will have had the opportunity to take up the offer of a primary course of COVID-19 vaccination. The offer is accompanied by relevant information to support voluntary informed consent.
Thus far, the offer of COVID-19 vaccination to children and young people has been made as part of national pandemic responses. As we move towards a steady state of ‘living with COVID-19’, JCVI will be reviewing the COVID-19 vaccination programme for children and young people and will update its advice accordingly.
We note that the letter of 9 December was sent to the Chief Executive of UKHSA. They will be able to provide further information on UKHSA guidance documents.
Professor Wei Shen Lim COVID-19 chair of the Joint Committee on Vaccination and Immunisation.