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Despite the known side effects of mRNA COVID-19 vaccines, some studies (here, here and here) and health websites (here, here and here) argue that whatever vaccination’s adverse outcomes, being unvaccinated is worse.
In one such study, Dr. Christian Mueller and his co-authors concluded the COVID-19 virus — not the vaccine — was responsible for more myocarditis, or heart muscle damage, than the vaccine.
However, when Rainer Johannes Klement, Ph.D., a physicist at Leopoldina Hospital in Schweinfurt, Germany, and Harald Walach, a clinical psychologist and head of the Change Health Institute in Basel, Switzerland, reanalyzed Mueller’s data they found that while coronaviruses might cause myocarditis, the COVID-19 vaccines cause at least as much or more.
The Klement paper appeared in the Feb. 1 edition of The Egyptian Health Journal.
Mueller’s study
Mueller set out to quantify and compare myocarditis in vaxed versus unvaxed subjects and to explain possible mechanisms.
To explore these mechanisms, the researchers tested subjects for antibodies against interleukin-1 receptor antagonist (IL-1RA), the SARS-CoV-2-nucleoprotein, the viral spike protein and 14 inflammatory cytokines.
Since none of these measures differed between study groups, the “mechanism” issue was unresolved.
To assess myocarditis investigators tested 777 hospital workers (median age 37, 69.5% women) for cardiac troponin T one and three days after they received an mRNA-1273 booster. Cardiologists typically prescribe this test after a suspected heart attack to quantify the extent and duration of heart damage.
Of the 40 subjects (5.1%) with elevated troponin on Day 3, 22 (2.8%) were diagnosed with myocarditis, with 20 cases occurring in women and two in men.
The researchers reported that among these subjects troponin elevations were mild and temporary and did not involve abnormalities as determined by electrocardiogram. No patients experienced “major adverse cardiac events” within 30 days of receiving the shot.
- COVID-19 associates with a substantially higher risk for myocarditis that [sic] mRNA vaccination …
- Myocarditis related to COVID-19 infection has shown a higher mortality than myocarditis related to mRNA vaccination.
- Before the COVID-19 vaccine were [sic] available, the incidence and extent of myocardial injury associated with COVID-19 infection was [sic] much higher than observed in this active surveillance study after booster vaccination.
One of the Mueller co-authors had commercial ties to diagnostics companies. Another had previously been compensated by diagnostics and vaccine manufacturers. Mueller had relationships with diagnostics, pharmaceutical and vaccine companies at the time he wrote the paper.
Where did Mueller go wrong?
One way to measure treatment effects is to compare an outcome, for example, blood pressure, in the same subjects before and after the treatment and report before-and-after results.
Although this option was known to medical researchers and available to him, Mueller did not take advantage of it — either because he did not think to measure pre-booster troponin levels or chose not to report them for some reason, perhaps because they did not align with his other results.
Instead, his team took an approach that required two well-matched study groups. Although Mueller claimed placebos and controls met this requirement they differed on the feature that mattered most: heart health.
Vaccinated subjects with current or recent heart issues were excluded from the study, while all control subjects had just entered the hospital with heart symptoms and were therefore already at greater risk for myocarditis.
Klement and Walach found more anomalies in the Mueller paper.
They began their critique by citing three 2021 studies on COVID-19 vaccine-induced myocarditis (here, here and here). All three studies showed myocarditis became a concern shortly after the COVID-19 vaccine introductions.
They discussed three papers in some detail:
- A 2023 German autopsy study on 25 unexpected deaths within 20 days of COVID-19 vaccination identified acute myocarditis as the most probable cause of death in four cases.
- A 2023 report on myocarditis in 303 non-vaccinated and 700 vaccinated asymptomatic subjects found significantly higher damage in the vaccinated persisting for up to 180 days post-vaccination.
- One of the first autopsy papers, an Indian-led study based on World Health Organization pharmacovigilance data reported 2.1 times the risk for cardiac arrest, 2.7 times the risk for acute heart attack, 2.6 times the risk for elevated troponin, and 7.3-fold higher levels of D-dimer for COVID-19 vaccinations compared with the use of other medications.
These studies strongly suggest that myocarditis became an issue only after the mRNA vaccine rollouts. They contradict Mueller’s statement that the “extent of myocardial injury associated with COVID-19 infection was much higher than observed in this active surveillance study after booster vaccination.”
According to Klement and Walach, this statement is wrong for two reasons.
First, in addition to the non-equivalence of controls’ and subjects’ heart-health status, Mueller ignored the much larger number of COVID-19-infected, unhospitalized, unvaccinated individuals with (presumably) much lower troponin levels compared with patients entering the hospital with heart symptoms.
Second, Klement and Walach argued that the public health impact of myocarditis depends not only on the incidence or rate among study groups but the size of those groups. The significance is that a lower incidence in a very large group (vaccinated) is more meaningful than a slightly higher rate in a very small group (individuals infected with COVID-19).
On that basis, Klement and Walach estimated the number of myocarditis cases among all German COVID-19 hospitalizations at 27,467, and among those who were vaccinated at 1.97 million.
As a result, regardless of myocarditis severity, there were 71.7 times as many myocarditis cases among the vaccinated as among those hospitalized for COVID-19.
A similar analysis for Switzerland estimated 169,960 cases of myocarditis among vaccinated compared with 8,179 among those hospitalized for COVID-19. Although not as dramatic as the German estimates this still shows a much higher occurrence of heart damage among vaccinated versus hospitalized.
In a June 2021 paper, Walach, Klement and Dutch data analyst Wouter Aukema concluded that based on 700 adverse reactions, 16 serious side effects and 4.11 deaths for every 100,000 vaccinations, COVID-19 vaccines were released with insufficient safety data.
The authors said the risk-benefit ratio for mRNA vaccines did not add up because “for three deaths prevented by vaccination we have to accept two inflicted by vaccination.”
Mueller told The Defender via email:
“Our study reveals an important lack of prospective safety data concerning COVID-19 vaccines. Given the magnitude of the vaccinated population compared to the much smaller proportion of the population that became infected and developed symptoms, including a small percentage with possible heart damage, our findings should remain qualitatively robust.”
