6-month cardiac follow-up data finally arrives
6-month cardiac follow-up data finally arrives
A salutary lesson on rushed approvals
Dr Ros Jones, HART member and retired consultant paediatrician
It is over three years since I and many other doctors and academics first wrote in May 2021 to the MHRA about our serious concerns over the wisdom or indeed the necessity of approving the covid-19 vaccines for use in healthy children. A succession of letters ensued, first to the MHRA, and in the absence of any serious attention to our safety concerns, letters followed to the JCVI with a copy to the Chief Medical Officer. This latter, seemed to result in most if not all of the signatories being reported by the Department of Health & Social Care to the Counter Disinformation Unit, a shadowy organisation previously countering potential illegal online child pornography or terrorism.
By June 2021, the MHRA had given a conditional marketing authorisation to Pfizer for their mRNA vaccine, despite them only studying 1131 vaccinated children and following them for two months. The JCVI to their credit (well briefly) held out against the media calls and messages of ‘Don’t Kill your Granny’ and announced they were not recommending the vaccines for healthy under 18s because the balance of benefit and risk was too close, especially when taking into account the as yet unknown risks from this new vaccine technology. But the pressure continued and according to JCVI minutes, within 48 hours of that announcement they were asked by the Chief Medical Officer, Professor Chris Whitty, to call an emergency meeting to “reconsider” their decision. Mission creep began, with a single dose recommended for 16s and 17s but still nothing for healthy under 16s.
Meanwhile, Israel and the US had already started rolling out vaccines to children and reports of myocarditis soon followed. Seeing reports on Reuters, I contacted the lead author of the Israeli report, who very helpfully replied immediately putting me in touch with his research fellow, asking him to give me the same data they had provided to “the other English group” (ie the JCVI), and who then arranged a Zoom call for me plus Norman Fenton, Martin Neill, Scott McLachlan and Jonathan Engler. They gave us very worrying data, Table 1, showing that the risk of post-vaccination myocarditis was inversely related to age (a more than ten-fold higher incidence in the 16–19-year-old males than in the over 30s) ie the exact opposite of the risk from covid. This immediately put a lie to the one size fits all ‘SAFE AND EFFECTIVE’ mantra.
Table 1. Incidence of myocarditis in young males per vaccination doses. Israel, August 2021
The Israeli team noted that symptoms had settled quickly but they had not performed cardiac MRI scans to seek for evidence of scarring. Also, consider those numbers beside the JCVI estimate of the number needed to vaccinate (NNV) to prevent one severe covid hospital admission.
Table 2. Number needed to vaccinate to prevent severe hospitalisation (JCVI)
If you were a 16-19 year old, would you prefer a primary course of an mRNA vaccine which effectively gave you a 1 in 106,500 chance of avoiding a serious hospital admission (deaths too small for JCVI to calculate a NNV), or conversely decline the two jabs that might have given you at least a 1 in 6,230 risk of myocarditis? If you are not sure, you might want to read to the end of this article to see what the follow-up cardiac scans look like.
In August 2021, an American multicentre study of children with post-vaccination myocarditis was published, reporting on 63 patients aged 13-20 presenting to 16 cardiology centres with cardiac symptoms following an mRNA Covid vaccine (all but one were after the second dose); 43% required admission to intensive care. The children underwent cardiac MRI scanning which revealed significant changes in no fewer than 88% of those studied. Although symptoms settled quickly, the authors concluded, “Close follow-up and further studies are needed to understand the long-term implications and mechanism of these myocardial tissue changes.”
Meanwhile, the JCVI committee met again, and members were clearly concerned about myocarditis in adolescents. They undertook a Zoom call with cardiologists from the US and they minuted a wish for at least a further 6 months in order to look at follow-up data from this group.
I contacted Supriya Jain, the lead author on the American study, which yielded a very friendly response and a Zoom call. A senior coauthor also joined the meeting. They confirmed that they had been on the call to the JCVI. They noted that although the children in their study had relatively mild symptoms which were settling, they had been surprised by the level of abnormalities on the cardiac scans. The test they used, Late Gadolinium Enhancement (LGE), is known to be predictive of late deaths in the first 6 years following viral myocarditis. In their published paper at that time they had only got follow-up scans on 6 children, showing 2 with no change, 2 with some improvement and 2 which complete resolution. They were planning a full 6-month follow-up and she promised to send me the results when available.
At this point, the political pressure on the JCVI seems to have become too great and they referred the decision to the four chief medical officers (CMOs). Hence an urgent letter to them here. It will not surprise readers to learn we got no reply.
After 10 days deliberating, the advice from the CMOs was bizarre, recommending the vaccine to 12-15s on grounds of promoting their mental health. Yes, you did read that correctly. The argument was that vaccination would reduce school disruption which was by then acknowledged to be bad for children’s mental health. They calculated an average reduction in missed schooling of around 15 minutes per pupil, which is of course the same as the time required to sit and wait after your vaccination. The calculations took no account of time out of class for the whole process, let alone any time off school for vaccine adverse events.
Indeed the JCVI had already highlighted this in their statement, “Delivery of a COVID-19 vaccine programme for children and young people is likely to be disruptive to education in the short term, particularly if school premises are used for vaccination and there is potential for a COVID-19 vaccine programme to impact on the efficiency of roll-out of the influenza programme. Adverse reactions to vaccination (such as fevers) may also lead to time away from education for some individuals.”
Meanwhile, Dr Jain was awarded an FDA grant for a full 5-year followup programme and I was somewhat concerned that this might delay these vital results. Who knows where the equivalent UK study is hiding.
HART wrote repeatedly on our concerns about the vaccination of healthy children, particularly after noting a rise in excess deaths in males aged 15-19 from May 2021, data which was also presented in the High Court and acknowledged by the Office of National Statistics (ONS) to be correct. The Children’s Covid Vaccine Advisory Council, of which I am the convenor, organised a campaign to try and get the vaccines paused, presenting a petition to the JCVI offices which had been signed by several hundred healthcare professionals.
HART wrote about myocarditis, particularly about the dearth of UK prospective data to ascertain the incidence of this life threatening condition. It took two schools in Thailand to do the study we should have done here, with symptom diary cards and before and after ECGs and cardiac enzyme blood tests. Scarily, they found 1 in 43 children with evidence of clinical or sub clinical myopericarditis after their second dose of Pfizer BioNTech. Similar high numbers were reported from another prospective study from Switzerland, where 1 in 35 hospital emplyees developed raised cardiac troponin levels 3 days post vaccination.
Further letters went to the UKHSA, who blandly put out information that post-vaccination myocarditis was not only rare but also mild and self-limiting.
However, eventually last month, almost 3 years to the day since our letter to the Four CMOs, Dr Jain’s follow-up paper was published in the Lancet. It does not make for happy reading, with no less than 60% of the children and young people having persistent abnormalities on their cardiac scans. What the long term clinical outcome will be for these young people with their whole lives ahead of them, only time will tell.
My full statement to the People’s Vaccine Inquiry is available here, logging the whole sordid saga in detail. This has all been submitted to Module 4 of the UK Covid-19 Inquiry, where it will finally be considered by Baroness Hallett and her team in January 2025.
Meanwhile we have written an update to Chris Whitty and his 3 colleagues just in case they’ve been asleep at the wheel. The full text of our letter is shown below.
Open letter to the Chief Medical Officers of the 4 nations of the UK
Professor Chris Whitty – CMO England: Email c.whitty@nhs.net
Sir Michael McBride – CMO Northern Ireland: Michael.McBride@health-ni.gov.uk
Dr Gregor Smith – CMO Scotland: cmo@gov.scot
Dr Frank Atherton – CMO Wales: pschiefmedicalofficer@gov.wales
30th September 2024
Dear Professor Whitty, Dr McBride, Dr Smith and Dr Atherton,
Sixty doctors and scientists wrote to you on 6th September 2021 urging you against rolling out Covid-19 vaccines to healthy children. We had written previously to Professor Whitty in May and again in June of that year to flag up our concerns. As you know, the JCVI in their statement on 3rd September 2021, had decided against recommending these products for children’s direct benefit in view of the mild nature of SARS-CoV-2 infection for their age range coupled with concerns about the known and as yet unknown adverse effects.
They had held a conference call with cardiologists from the USA and also Israel, both countries which had started vaccinating children ahead of the UK. These groups had both reported on vaccine-induced-myocarditis, with the US group having studied a case series of 63 children and finding 89% of affected children showing Late Gadolinium Enhancement (LGE) on cardiac MRI scanning. This finding is known to be indicative of cardiac scarring and to be a predictor of deaths in the 5-years following. The group were planning a follow-up study and members of the JCVI specifically requested a delay of 6 months to await this data before making a decision.
Finally, almost 3 years later, this study has been published and it does not make for happy reading, especially if you are a parent of a child or young person who was affected. Of the 333 children and young adults enrolled, and despite an apparently mild clinical course, 82% showed LGE on their initial cardiac MRI scans, and in 60% these changes were still present at the 6 months follow-up scan. Long-term data is still awaited and risk of cardiac failure sudden death is still unquantified. A new systematic review has confirmed that LGE is a risk factor for all cause mortality, cardiac deaths, arrhythmias and heart failure.
This letter is to put on record the failure of due diligence which you, as a group of chief medical officers, showed when recommending these products for use in healthy children. “The view of the UK CMOs is that the additional likely benefits of reducing educational disruption, and the consequent reduction in public health harm from educational disruption, on balance provide sufficient extra advantage in addition to the marginal advantage at an individual level identified by the JCVI to recommend in favour of vaccinating this group.” The argument that vaccinating children would reduce school disruption seemed to ignore the fact that most of the disruption was arising from the combined policy of (a) routine testing of asymptomatic children and (b) the quarantining of whole classes or in some cases even whole year groups if one child tested positive. In England, this policy had been discontinued on 19 July 2021 just 2 days before the end of the summer term and with no time to assess the likely improvement in school attendance. It was also admitted that the calculations of possible school time saved were not balanced against any potential for school time lost, even for the vaccination process itself, let alone any possible adverse events.
When you advised the rollout of the vaccines to children, did you also advise a prospective study of cardiac health to be carried out in any of the four nations?
If the answer is yes, we would be very grateful to see the results.
If the answer is no, this surely should be organised as a matter of urgency.
Yours sincerely,