The vaccination program has had to live with the reality that some individuals, albeit fewer than 2 per 100,000, develop myocarditis following vaccination with mRNA vaccine. A distorted version of the reality has been used by the anti-vax lobby to argue the case against vaccination, claiming that it is responsible for killing large numbers of healthy young people.
This new article insideprecisionmedicine.com... describes and references a study which, while leaving a few questions unanswered, shows a link between myocarditis and raised levels of spike protein in the blood of vaccinated subjects. Note that it remains to be seen whether this is a causative link.
Selected highlights:
The authors also noted it remains unclear whether the circulating spike protein was the cause of the myocarditis observed in these patients. Rare cases of myocarditis can occur after receiving vaccines for other conditions such as smallpox, so the spike protein could have been a biomarker of underlying immune dysregulation leading to the symptoms.
Previously suggested causes for post-vaccine myocarditis include aberrant immune responses to the vaccine, the production of autoantibodies, or potentially spike protein mimicking self-antigens, leading the immune system to attack heart tissue.
In any case, the study continues to hammer home the point that vaccination for COVID-19 carries much fewer risks than infection by the virus, including for adolescents and young adults.
“In most cases, post-vaccination myocarditis is mild and self-resolving,” said Yonker. “But new insights about its cause could further help us to improve patients’ symptoms or prevent this complication from occurring.”
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Of note, this was a sample size of just 16 children, “This was a precious sample set because these cases are so rare,”
While Reuters debunked the claim that “Spike protein is very dangerous, it’s cytotoxic (Robert Malone, Steve Kirsch, Bret Weinstein).”
reuters.com/article/factche..."The research team discovered that the myocarditis patients had indistinguishable antibody responses and T cell responses to those of the controls, such as antibody production, autoantibodies and T cell profiles. However, they found that the myocarditis patients had elevated levels of the spike protein in their blood, which had seemingly evaded the immune response. In contrast, the healthy controls showed no detectable levels of spike protein in their blood." Soit seems that a very small proportion of the population may have difficulty eliminating the SARS-COV-2 spike protein from their system.
With the later variants of SARS-CoV-2 being so infectious and the virus being so prevalent nowadays, as the article notes, with my emphasis, “While this finding helps us better understand this potential complication, it does not alter the risk benefit ratio of receiving the COVID vaccines. The incidence of myocarditis and other heart-related complications among children infected with SARS-CoV-2 is much higher than the risk of post-vaccination myocarditis.”
Neil, wouldn't one expect a healthy immune system to produce antibodies in sufficient quantity to neutralise the antigen including circulating unbound spike protein?
I agree and given that over 13,170,000 COVID-19 vaccinations have been given to more than 5,470,000 people worldwide, equal to about 70% percent of the world population, you are going to discover a few people with very rare immune system conditions. As you quoted, "the spike protein could have been a biomarker of underlying immune dysregulation leading to the symptoms." and we don't know if this is a causative link. We've learned so much more about how our immune systems work from SARS-CoV-2 studies, which will be used to further improve vaccination safety and how we manage infections. I suspect these children would have had far less favourable outcomes if they had succumbed to a COVID-19 infection without prior vaccination.
I've been following this issue for a year now, because my son is 25 years old.
I hate articles that use the word "linked." This misleads the reader into thinking that there must be a cause connection. It very well could be that there is more spike protein - from vaccination or infection. But inflammation is indirectly caused by spike or other proteins through a long sequence of events. Spike protein may go up along with other proteins.But spike sounds like a gangster's dog's name, so it gets the press. 😂
The anti-vaxx pundits try to spin numbers based on incidence of myocarditis, and do their best to confuse it with death. They will try to spin any death or diagnosis of myocarditis at any time after a vaccine as being caused by the vaccine. This is the famous Post Hoc, Ergo Propter Hoc fallacy used to inflate numbers for causality in all kinds of studies.
The actual cases of myocarditis due to vaccine happen within a few days. The usual assumption for causality in this case is within 21 days of vaccination, because by then the immune system effects are maximized. People of all age groups suffered myocarditis even before the pandemic. So we need to see how much myocarditis increased in which age groups. Try as I might, I couldn't find a reference for pre-pandemic incidence of myocarditis that wasn't paywalled. I've seen numbers like 2 in 100,000 quoted for pre-pandemic, but without age or gender qualifications. I've also seen 17 in 100,000 amongst Finnish military conscripts.
A recent JAMA review of multiple studies looked into severity and incidence of myocarditis connected to mRNA vaccines:
Myopericarditis After COVID-19 mRNA Vaccination Among Adolescents and Young Adults
December 5, 2022
"The primary outcomes of this study were the clinical features and early outcomes of myopericarditis in adolescents and young adults following COVID-19 vaccination, including incidence, cardiac findings, in-hospital mortality, hospitalization, ICU admission, and treatments."
...
"The pooled estimate of the mean interval from vaccination to the onset of myopericarditis was 2.6 (95% CI, 1.9-3.3) days."
...
"Overall, 92.6% (95% CI, 87.8%-97.3%) of patients were hospitalized and 23.2% (95% CI, 11.7%-34.7%) of patients required ICU admission,mainly for arrhythmia monitoring; however, inotropic support was used in only 1.3% (95% CI, 0%-2.7%) of patients (Table 2 and Figure 3; eFigure 1 in the Supplement). No patients received extracorporeal membrane oxygenation and no deaths were observed. In all the studies available, the pooled estimate of the hospital length of stay was 2.8 (95% CI, 2.1-3.5) days."
In regard to incidence, I can see that one Israeli reference appears to use an open ended age - 16 and older - which would possibly minimize the incidence, and I think confuses 100,000 persons with 100,000 person years:
"The highest incidence of myocarditis (10.69 cases per 100,000 persons; 95% CI, 6.93 to 14.46) was reported in male patients between the ages of 16 and 29 years."
Another Israeli reference does a better job, providing a table showing the normal, non-vaccinated incidence per year compared to the COVID vaccinated incidence within 21 days:
"Table 4. Standardized Incidence Ratios for 151 Cases of Myocarditis, According to Vaccine Dose, Age, and Sex."
That table shows the risk of incidence of myocarditis after (mostly 2nd dose) mRNA vaccine was roughly 2.4 the annual risk of incidence for the 20-24 year old male group, and 1.62 in the 16-19 and group, and 1.39 in the 25-29 group.
They also note:
" In our study, definite or probable cases of myocarditis among persons between the ages of 16 and 19 years within 21 days after the second vaccine dose occurred in approximately 1 of 6637 male recipients and in 1 of 99,853 female recipients."
1 of 6637 recipients looks very different from 10.69 cases per 100,000 persons, but if you do the arithmentic, they're very close to the same number.
A YouTube and Twitter pundit, Vinay Prasad, recently wrote a paper about it:
COVID-19 vaccine induced myocarditis in young males: A systematic review
First published: 28 December 2022
He pointed out - rightly so - that how other scientists and pundits lump together ages within statistics can give a false impression of risk. But he doesn't deal with severity at all. So, he's in effect talking only about a risk of diagnosis of myocarditis. With the focus on the younger age group, I think this can result in underdiagnosis in older age groups, because doctors don't think they need to ask about chest pain. Chest pain could be lower end of the subjective scale or very high. Prasad's paper doesn't look at this at all. We also don't see how awareness of the risk changed the rate of diagnosis.
Prasad also does not look at how long the symptoms last - how long does the risk last. His assumption is apparently that myocarditis is a serious adverse event. But we know that it is a lot more serious in older people and the very young. Prasad highlights the peak number from a single, small study of insured patients (selection bias) - 53 cases per 100,000 in males ages 18-24:
Risk of myopericarditis following COVID-19 mRNA vaccination in a large integrated health system: A comparison of completeness and timeliness of two methods
11 April 2022
"The encounter methodology identified 14 distinct patients who met the confirmed or probable CDC case definition for acute myocarditis or pericarditis with an onset within 21 days of receipt of COVID-19 vaccination. When we extended the search for relevant diagnoses to 30 days since vaccination, we identified two additional patients (for a total of 16 patients) who met the case definition for acute myocarditis or pericarditis, but those patients had been misdiagnosed at the time of their original presentation.
...
Among those who received a second dose of vaccine (n = 146 785), we estimated a risk as 95.4 cases of myopericarditis per million second doses administered (95% CI, 52.1–160.0)."
I don't have access to the full paper. So I don't know if the cases still matched the profile of average time of diagnosis in less than 3 days of vaccine (usually, second dose of the vaccine).
Prasad maximizes the number for even fewer cases from the study by looking at 53 cases per 100,000 in males age 18-24. Since the original n = 146,785, roughly 2/3's of the insurance cases were age 18-24 - about 10 or 11 cases. Should we even use such a small group to create a shock number?
How shocking is 53 cases in 100,000, anyway? It's 1 in 1886. We'd probably see 20 or so cases in 100,000 before the pandemic - about 1 in 5000.
Happy New Year and thanks for your respective thoughts.
Most people are cleaning up after New Year. For us this is Christmas Eve - according to the orthodox churches of eastern Europe and the Ukrainian couple who lodge with us, and because tomorrow is the first chance of a full family get-together since early December. Until 13:00 tomorrow I will spend most of my waking hours cooking.
But there's just time to pose the most intriguing (to me) question from the study paper ahajournals.org/doi/epdf/10... cited by Inside Precision Medicine:
WHY did these young persons with myocarditis have relatively high levels of free (unbound), full-length spike protein floating around in their bloodstream, when a comprehensive set of tests* clearly showed that their humoral immune responses were comparable with those of healthy controls? Approx 94% of controls had undetectable levels of free spike antibodies in their blood.
* Tested, and no significant difference found, between myocarditis group and controls in:
It's a really interesting article! Oh how much the pandemic is teaching immunologists about immunology!
I can see that they have a spike theory and a T-cell theory.
The presence of spike not bound to antibodies is the obvious thing, but it's not by itself a smoking gun. Free spike doesn't cause damage. Excess free spike may indicate a lack of an immune response that allows some of it to do dirty deeds not seen in people with no free spike.
The free spike shows some sort of difference in immune response in these individuals that hasn't been seen in adults in general or in kids with MIS-C (Multisystem Inflammatory Syndrome in Children) - itself still a mystery!
I think it's possible that after checking more adults and younger kids, they may yet find unbound spike. They only had 45 controls to compare with, and of them, it's not clear how many were adult, except that they were between 12 and 21 years of age. There were only 13 adults to compare with in this study.
There were other differences than the spike:
1. "... individuals with myocarditis had slightly higher frequencies of effector memory cells (t test, P=0.047; Figure S2A and S2B)."
2. "The only noticeable difference in the T-cell signature was a higher frequency of PD-1–expressing bulk CD4+ T cells in the individuals with postvaccine myocarditis (unpaired t test, P=0.02; Figure S2H and S2I), likely reflecting variability in expansion after immunization but potentially also suggesting a higher level of exhaustion in this cell subset. "
3. "... individuals with myocarditis displayed distinct cytokine profiles reminiscent of the profile seen in MIS-C, [17–19] suggesting likely innate inflammatory activa-tion, with significantly elevated levels of interleukin (IL)-8, IL-6, tumor necrosis factor-α, IL-10, interferon-γ, and I L- 1β and lower IL-4 levels compared with healthy vaccinated control subjects (Figure 3A–3G) "
"... IL-8 was most prominent, mirroring cardiac troponin T and antigen levels most closely."
4. "... neutrophils, were significantly increased in individuals with postvaccine myocarditis compared with vaccinated control subjects (unpaired t test, P=0.007 and P=0.01, respectively), whereas platelet counts were decreased compared with vaccinated control subjects (unpaired t test, P=0.03; Figure S3). These results suggest that postvaccine myocarditis is associated with normal adaptive and T-cell immunity but modest innate activation."
5. The persistence of circulating spike in patients with postvaccine myocarditis is similar to the SARS-CoV-2 antigenemia previously reported to be a pathogenic feature of MIS-C. [18,21]
Now, it's hard to separate cause from effect. That's why I rant on the word "linked" being so casually used in the popular press. It's probable that most of the above is effect, too. The unbound spike is an effect. Teasing it all apart will require some careful observations - like this paper - applied to some careful in-vitro experiments, followed by in-vivo verification.
There was a sentence that I found odd, that may end up being edited after publication:
" In postvaccine myocarditis, the spike protein appears to evade antibody recognition because the antispike antibodies that are generated are produced in adequate quantities with normal functional and neutralization capacity. "
I think that should have said "produced in inadequate quantities, but "
They hint how the possible mechanism that excess spike may work:
"There is growing in vitro evidence that spike itself can stimulate cardiac pericytes dysfunc-tion23 or inflame the endothelium, potentially by down-regulating angiotensin-converting enzyme 2 expression [ACE2], by impairing endothelial nitric oxide bioavailability, [24] or by activating integrin-mediated inflammation with hyperper-meability of the endothelial cell layer. [25]"
But then, why did the spike not get neutralized?
They admit: "we cannot rule out T-cell involvement on the basis of this analysis alone. " and "... although we did not detect any autoantibodies as has been seen in other forms of myocarditis, this does not necessarily rule out the potential for T-cell involvement."
Just in case someone was worried that this is inherent to mRNA vaccines: "Vaccine-related myocarditis is not unique to the mRNA vaccines; myocarditis can also occur after other vaccines, [27,28] including non–mRNA COVID-19 vaccines, such as influenza and smallpox vaccines. Therefore, it is possible that circulating spike is a biomarker of immune dysregulation leading to myocarditis rather than a causal agent."
In looking at one of the adult studies cited in comparison, I see very few subjects were examined:
"It has previously been shown that after the first inocula-tion of the mRNA-1273 vaccine, the cleaved S1 sub-unit of spike can be detected in the plasma of healthy adults.[16] However, after the second dose, no antigen was detected, [16] presumably because there are higher levels of circulating anti–SARS-CoV-2 antibodies, which quickly bind any circulating antigen, facilitating its clearance. "
My thoughts are that myocarditis in young males (mostly) is due to them not being exposed to something else that ultimately protects older and younger people. It could be that they are a unique cohort that missed an outbreak. It could also be hormonal.
They suggest: "However, when antigenemia is detected in severe COVID-19 [29] or MIS-C, [18,21] a more pronounced hyperinflammatory, superantigen-like response is typically seen, with spike immune complexes triggering hyperactivation of mono-cyte phagocytosis [30] and neutrophil extracellular trap for-mation. [31] "
Who is to say that what is typical excludes myocarditis in severe COVID or MIS-C? Diagnosis of myocarditis is not that good, actually. Sure, people get hospitalized, but often as a precaution for monitoring, and few die. I can certainly imagine that many cases are unreported. But to be honest, I'm not that worried about myocarditis due to vaccination now that I've read so much that the outcome is usually mild.
Finally, I'll beat on one of my favorite rant topics - the lack of T-cell research standards. We know tons about antibodies because they are easily isolated and categorized. We know much less about antibodies bound to B-cells (BCR's - B-cell receptors) and about TCR's (T-Cell Receptors). T-cell research lately as been relying a lot on ELISA methods. But what we need is TCR sequencing into open source databases. Similar sequencing is done via ClonoSEQ for CLL patients, though for BCR's, but the database is proprietary. Antibody databases have been open source from the beginning, and it greatly helped research into drugs and diagnostics. T-cells are the dark matter of immunology.
Again, some interesting points, a lot to take in, now that I've finished cooking and should be sleeping to prepare for the mob's arrival.
The authors seem to be clutching at straws to explain why free spike circulates in immune-competent subjects. I don't agree they made the mistake you attribute to them. Their investigations showed that anti-spike antibodies are produced in adequate quantities with normal functional and neutralization capacity.
Maybe the answer to the puzzle lies not in immune dysregulation but in gut dysregulation. The authors drew more distinctions than parallels between the respective forms of myocarditis due to MIS-C and vaccines. Nonetheless, could the two forms of inflammatory syndrome share an underlying cause? Look at the title of reference 18: Multisystem inflammatory syndrome in children is driven by zonulin-dependent loss of gut mucosal barrier. One of the authors is Alessio Fasano, who wrote a seminal paper on zonulin, a protein that regulates the operation of the tight junctions controlling the passage of molecules etc across the gut's mucosal barrier. He is also an author of the present paper, so it surprises me that more was not made of this in the discussion, and that serum zonulin levels were not measured as part of the investigation.
"Zonulin-dependent loss of gut mucosal barrier" essentially means a leaky gut, whereby molecules, and sometimes pathogens, can pass unregulated from the gut into the bloodstream. Just maybe, those youngsters with myocarditis got mRNA vaccine in their gut, where it found cells to make spike protein, which was then exported, on a more or less continuous basis, through the dysfunctional mucosal barrier, into the bloodstream. Other nasties that get into the bloodstream the same way cause the inflammation leading to myocarditis.
> For us this is Christmas Eve - according to the orthodox churches of eastern Europe and the Ukrainian couple who lodge with us, and because tomorrow is the first chance of a full family get-together since early December.
For us in New Orleans, as well as in Hispanic culture, and elsewhere today is King's Day, the day that follows the 12th Night.
So, many of us take our Christmas Tree down, and we eat King Cake. And we'll probably keep eating King Cake until Mardi Gras, because by then, we'll be trés gros! King Cake is something I simply must resist. It's gone from being a quaint custom based on a not terribly caloric brioche with a bean inside to all manner of sweet pastry made into a circle, with a plastic baby Jesus concealed (and now marked, to prevent accidental ingestion). I think the season that starts today is responsible for the increased rate of subsidence of land between the river and the lake!
However you celebrate, do remember that viruses don't care what day it is or how the staffing is at hospitals. Ventilate. Hold your breath at a safe distance before you hug. Paint funny things on your mask to celebrate.
I think a lot of times, young men think they are immune to all manner of disease. They don't realize that the flu or an enterbacteria could trigger chest pain. It's not always football players and track stars getting sudden cardiac problems, and even for athletes, a stomach virus could be a more likely cause of a heart problem.
In the UK the issue is - more than ever - funding the delivery of services. Meanwhile medical science presses ahead and makes breakthrough discoveries utilising cutting edge technology. Minor revolutions are taking place in every field of medicine. Every now and then expect a really big one.
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Strange thing - COVID-19 vaccination booking
Swollen lymph nodes following Covid-19 vaccine
Two things. White blood count creeping up. And waiting for results from spike protein test.
