Since the launch of vaccination in the general population, numerous scientific studies have confirmed a risk of myocarditis occurring after anti-Covid vaccination. Inflammation of the myocardium would mainly affect young men, adolescents or children. However, the myocarditis studied are generally the most serious cases that required hospital treatment. What about patients who present with mildly symptomatic or asymptomatic myocarditis lesions, and who, therefore, have not received any medical treatment? If no diagnosis is made on these people, how can any preventive and protective measures be applied? Finally, how to assess the real incidence of cases of myocarditis occurring after an injection of anti-Covid-19 vaccine in the population?
To compensate for the lack of clinical data in subjects without symptomatic lesions, researchers have published a prospective study, the results of which were presented on October 24, 2022 to the European Society of Cardiology. The purpose of this study was to assess the increased likelihood of myocarditis after the third dose of vaccine against Covid-19. In the report of this study published on the cardio online site, it is reported that taking into account all cases of post-vaccination myocarditis, the real incidence would not be 0.0035%, but 2.8% , a figure 800 times higher than the usual incidence of myocarditis.
Vaccination against Covid-19 and heart problems
Since the start of the vaccination campaign against Covid-19, a large number of heart problems have been reported and registered with the various pharmacovigilance agencies around the world. In the United States, VAERS data show an exponential explosion of cases of myocarditis and pericarditis, which are potentially fatal inflammations of the heart.
However, contrary to what has sometimes been claimed to minimize the seriousness of these pathologies, they cannot be considered benign, especially since 90% of the cases recorded in the VAERS have stayed in a health establishment with heart support. Indeed, as Dr. Steven Hatfill explains, the ” myocarditis causes scarring of the heart tissue, scarring that can lead to conduction defects, especially as the child grows and then ages “. Therefore, there is always a risk of deterioration of the general condition of the patient with visceral failure, or even cardiac arrest.
If the imputability of the proof is not always established between a cardiac accident and a vaccination, many scientific studies published in recent months have shown that there could be links between vaccination and post-vaccination myocarditis or pericarditis.
Furthermore, the assertion that cases of post-vaccination myocarditis are rare seems a little more false every day. Since the start of vaccination in the general population, the number of cases has exploded. According to VAERS data, nearly 25,000 cases of myocarditis or pericarditis could be identified for the year 2021. In 2022, as of February 25, more than 10,000 reports were already recorded in this database.
Please note that it is data only for the 3 months of 2022#myocarditis
Please note that this data is only for the first 3 months of 2022#myocarditis#Pogrom pic.twitter.com/0gePDEPA9w
— Sebastian Kowalski2????????????????TruthNews ???????????????? (@xenosstinkriti2) April 7, 2022
The number of myocarditis and pericarditis recorded on the European pharmacovigilance site EudraVigilance also increased rapidly when the young population began to be vaccinated against Covid, that is to say from the months of June-July 2021, with an impressive acceleration at the end of 2021 and the beginning of 2022.
The number of myocarditis reported for 3-64 year olds on Eudravigilance worldwide exceeds the maximum number expected for the population concerned. 100% of myocarditis should be declared in pharmacovigilance so that there is no excess risk.
Impossible pic.twitter.com/kUOLEM4iOG— marco nius (@NiusMarco) April 21, 2022
Notifications on EudraVigilance for myocarditis and pericarditis give the impression that the 2021 record could be broken in 2022… https://t.co/NJQi180S5Q
— Save Science Collective (@GabinJean3) August 11, 2022
Myocarditis recognized as an adverse effect of messenger RNA vaccines Pfizer and Moderna
In November 2021, Public Health France recognized myocarditis as an adverse effect of messenger RNA anti-Covid vaccines (Comirnaty or Spikevax).
Epi-Phare, a scientific interest group formed by the ANSM and the Cnam, set up to assess the risks of health products affected by the Covid-19 crisis, conducted a pharmacoepidemiology study on the risk of myocarditis after the third dose of vaccine.
Conducted on 4,890 cases of myocarditis in people aged 12 and over as well as on 48,900 people admitted to French hospitals between December 27, 2020 and January 31, 2022, this study reveals that the risk of myocarditis is increased after administration of the second vaccine injection and more significantly after the booster dose.
Examination of the study in detail shows that “the excess cases of myocarditis associated with the third dose is globally estimated at 0.25 cases per 100,000 doses of the Comirnaty vaccine and 0.29 cases per 100,000 doses of the Spikevax vaccine, corresponding to 1 case of myocarditis attributable to the vaccination for the administration of 398,000 third doses of Comirnaty and 340,000 third doses of Spikevax. The greatest excess cases were observed in men under 30 years of age, with a maximum of 1.2 cases per 100,000 third doses of Comirnaty, which corresponds to 1 case of myocarditis per 87,000 third doses.“
A prospective study on the risks of myocarditis after the third dose of vaccine
On October 24, 2022, Professor Christian Eugen Mueller, Director of the Institute for Cardiovascular Research Basel came to present a study entitled “Myocardial Inflammation/Myocarditis after Covid-19 mRNA Booster Vaccination” written by Guillaume Le Pessec, proofread by Théo Pezel, both members of the College of Cardiologists in Training, and supervised by Albert Hagège, Chairman of the Cardio-Online Editorial Board.
This study was conducted with the aim of pointing out the flaws that exist in the retrospective studies published in scientific journals in order to better reveal the real incidence of myocarditis lesions, which is much greater in the vaccinated population, according to the researchers. To do this, they explained what was for them the main selection bias in existing studies, namely the under-evaluation of post-vaccination myocarditis lesions due to patients who present with asymptomatic lesions while only people hospitalized because of the severity of the pathology would have been recorded.
This single-center prospective study with a control arm was conducted on 835 people, all employees of Basel University Hospital in Switzerland and vaccinated with either a dose of Pfizer or Moderna vaccine.
In order to assess the occurrence or not of a myocarditis lesion, the researchers used a primary endpoint, namely “elevation of troponinemia above the norm, measured on D3 post vaccination” and two secondary judgment criteria which were on the one hand “the comparison of the total population with patients with ayant was admitted for chest pain without any cardiac cause being found” and on the other hand, the occurrence of MACE (major adverse cardiovascular events) at 30 days (1). These major adverse cardiovascular events are cardiovascular death, hospitalization for heart failure, ventricular arrhythmia and myocardial infarction.
This study reveals surprising results: First, “the incidence of myocardial lesions is 2.8%, 800 times higher than the usual incidence of myocarditis”. Then, unlike the usual viral myocarditis, this pathology, when it occurs after vaccination, is found mainly in the female population which is affected at 3.7% versus 0.8% in men.
Far from being satisfied with their discoveries, the authors do not hesitate to point out the limits of their study by pointing out the points that have not been elucidated. First, performing the troponinemia assay on D3 could, according to them, lead toan underestimation of the incidence of early lesions on D1 potentially already normalized on D3“while a slight attack could not be detected by imaging (cardiac MRI).
Next, the absence of inclusion of patients under 18 years of age in the study population does not allow the estimation of risks among adolescents and children to be specified. Finally, if no MACE has been reported in the population studied for 30 days, the authors think that it would be wise to continue the research by carrying out a long-term randomized trial in order to check whether the repetition of injections could not lead to long-term consequences.
Since the availability of messenger RNA vaccines against Covid-19, myocarditis lesions have been reported with a very low prevalence. This study is the first to advance a major cause of bias with non-exhaustive assessment and reporting of cases. Some questions, by the admission of their authors, have not been resolved, further work should be undertaken to confirm or invalidate these results.
(1): Troponinemia is the measurement of cardiac troponins, which are the cardiac markers that make it possible to establish a diagnosis in patients who suffer from chest pain. Myocardial damage can be defined by the detection of an elevation of these cardiac biomarkers.