____________________________________________________________________________________________
Since the authorization of COVID-19 vaccines for children and adolescents in 2021, health officials have reassured the public that vaccine-related heart inflammation–myocarditis and pericarditis–is rare and claimed children were at a higher risk1 of developing myocarditis from the virus.
However, in a recent preprint study2 involving over 1.7 million children, researchers found that myocarditis and pericarditis occurred only in vaccinated children, raising serious questions about the risk-benefit analysis used to justify widespread vaccination in younger populations.
The large-scale study utilized data from the OpenSAFELY-TPP database, a resource that tracks health outcomes in a large population of children and adolescents across England. Researchers followed children aged 5 to 15 and compared those who received one vaccine dose to unvaccinated controls and those who received two vaccine doses with those who received a single dose.
The study assessed both the vaccine’s effectiveness in preventing COVID-19 outcomes, such as positive tests, emergency visits, hospitalizations, and death, as well as its safety concerning non-COVID-related events, including heart inflammation, emergency department visits, and hospitalizations.
Waning Vaccine Effectiveness
Amongst 820,926 previously unvaccinated adolescents, researchers found that vaccinated adolescents were initially 26% less likely to test positive for COVID-19 compared to their unvaccinated peers. However, by 20 weeks post-vaccination, the likelihood of testing positive was nearly the same for both groups.
Similarly, among 441,858 adolescents who received one vaccine dose compared to those who received two doses, the second dose initially reduced the rate of positive tests by 33%. Yet, by 14 weeks post-vaccination, infection rates between the two groups were nearly identical. This presents important questions about the long-term efficacy of COVID-19 vaccination in children.
While the vaccine appeared to reduce the risk of emergency visits and hospitalizations due to COVID-19, these outcomes were already rare in children, vaccinated or not. In the 5 to 11 age group, COVID-related outcomes were so rare that the researchers were unable to calculate precise estimates of vaccine effectiveness. Hospitalizations and emergency department visits related to COVID-19 were minimal across both vaccinated and unvaccinated children, highlighting the low risk of severe disease in this age group.
Moreover, the vaccine had little to no effect on non-COVID outcomes like fractures, indicating it did not influence general healthcare utilization. The study did not report any COVID-19-related deaths for either vaccinated or unvaccinated children.
Heart Inflammation Observed Only in Vaccinated Children
The most concerning finding of the study relates to myocarditis and pericarditis, which were observed exclusively in vaccinated children and primarily after their first vaccine dose.
Myocarditis is heart muscle inflammation that can lead to cardiac arrhythmia, cardiac arrest, stroke, and death. The National Organization for Rare Disorders3 states that myocarditis can result from infection but is more commonly a result of the body’s immune reaction to the initial heart damage. Pericarditis4 is inflammation of the sac surrounding the heart.
According to the study, 27 cases of myocarditis occurred per million vaccinated individuals following the first vaccine dose. The rate dropped to 10 cases per million after the second dose. Not a single unvaccinated child in the study was diagnosed with myocarditis or pericarditis, raising serious concerns about the safety of COVID-19 vaccines in younger populations.
“It is as we suspected, unfortunately,” pediatric cardiologist Dr. Kirk Milhoan told Reform Pharma in an email.
Dr. Milhoan5 believes that even a small risk of heart inflammation for adolescents who are not at risk from COVID-19 is too much.
Before administering a medication, vaccination, or performing a medical procedure, Milhoan checks to see if the benefits outweigh the risk or if there’s any benefit at all. According to an April 2023 paper published by the Cleveland Clinic,6 more vaccines come with an increased risk of experiencing COVID-19, suggesting that there isn’t a benefit to vaccination for most people.
Myocarditis Numbers Are Likely Much Higher
In the preprint study, researchers monitored for myocarditis and pericarditis by tracking diagnoses recorded in medical records through the OpenSAFELY-TPP database. The data were gathered from hospitalizations, emergency department visits, and primary care records to capture the diagnosis of heart inflammation.
However, Dr. Milhoan has long voiced concerns,7 about silent myocarditis in those who develop heart inflammation following vaccination but are unaware of it. Standard diagnostic tools like EKGs, troponin levels, and echocardiograms often miss silent myocarditis, making it challenging to diagnose accurately.
The gold standard for detecting this condition is cardiac MRI, which provides more detailed imaging and can reveal scarring or inflammation undetectable by traditional methods. A 2022 study published in The Lancet8 found that 81 out of 151 patients who underwent cardiac MRI showed heart abnormalities, such as late gadolinium enhancement–a marker linked to worse outcomes, including heart failure and sudden cardiac death. Given the limitations of standard tests, the actual number of myocarditis cases following vaccination may be significantly higher than reported.
Although the Centers for Disease Control and Prevention (CDC) claims that myocarditis following COVID-19 vaccination is rare and mild, the agency uses a narrowed case definition.9
This allows it to exclude cases of silent myocarditis, cardiac arrest, ischemic strokes, and deaths from heart problems that occur before the individual reaches the emergency department. It remains unclear how these cases are tracked or whether they are included in the CDC’s myocarditis statistics, raising further questions about the transparency and accuracy of its data.
Debate Grows Over Vaccine Safety
While it is universally acknowledged that COVID-19 vaccines can cause myocarditis, the real debate lies in how common the condition is. Physicians treating vaccine-associated myocarditis and reviewing the data believe U.S. health agencies are underestimating the frequency of the condition.
According to Dr. Peter McCullough, myocarditis occurs in approximately 2.5% of vaccine recipients, and half of these cases10 are asymptomatic.
Dr. Milhoan emphasized that the myocarditis numbers associated with COVID-19 vaccines are reaching levels that many experts consider unacceptable in terms of risk-benefit profiles. He stresses the importance of providing people with accurate data to enable informed decisions about vaccination, especially in populations like children who face minimal risk from COVID-19 itself.
Given the study’s findings, the push for booster doses in children warrants serious reconsideration. With waning immunity, limited protection from severe outcomes, and the risk of myocarditis confined to vaccinated children, the data suggests that boosters expose children to unnecessary risks without benefits.
References
1. Barda N et al. Safety of the BNT162b2 mRNA Covid-19 Vaccine in a Nationwide Setting. N Engl J Med Aug. 25, 2021; 385: 1078-1090
2. Andrews CD et al. OpenSAFELY: Effectiveness of COVID-19 vaccination in children and adolescents. medRXiv May 20, 2024.
3. National Organization for Rare Disorders. Myocarditis. June 9, 2015.
4. National Institutes of Health. Pericarditis. Oct. 10, 2023.
5. Redshaw M. Study Finds Increasing Time Between COVID Vaccine Doses Reduces Risk of Myocarditis, Yet Cardiologists Raise Concerns. The Epoch Times Feb. 26, 2024.
6. Shrestha NK. Effectiveness of the Coronavirus Disease 2019 Bivalent Vaccine. Open Forum Infect Dis Apr. 19, 2023; 10(6): ofad209.
7. Redshaw M. Study Finds Increasing Time Between COVID Vaccine Doses Reduces Risk of Myocarditis, Yet Cardiologists Raise Concerns. The Epoch Times Feb. 26, 2024.
8. Kracalik I et al. Outcomes at least 90 days since onset of myocarditis after mRNA COVID-19 vaccination in adolescents and young adults in the USA: a follow-up surveillance study. The Lancet November 2022; 6(11): p788-798.
9. U.S. Centers for Disease Control and Prevention. Coronavirus Disease 2019 (COVID-19) Vaccine Safety. July 31, 2024.
10. Hulscher N et al. Autopsy findings in cases of fatal COVID-19 vaccine-induced myocarditis. Wiley Online Library Jan. 14, 2024.