New Study Links Heart Inflammation Exclusively to Vaccinated Children

During the COVID-19 “pandemic,” public health officials and medical experts broadly promoted mRNA vaccines as being “safe and effective” for all eligible populations, including children.

Despite ongoing public and professional skepticism, recommendations for the vaccination of healthy children and pregnant women have remained in place and are now being actively defended in court by a coalition of medical organizations seeking to legally compel the government to maintain those guidelines.

That legal push is drawing renewed scrutiny following the publication of a peer-reviewed study that found cases of heart inflammation occurred only among vaccinated children, with none recorded in the unvaccinated comparison group.

The study, conducted by researchers at the University of Oxford, the University of Bristol, and the Harvard T.H. Chan School of Public Health, was published in January in the scientific journal Epidemiology. It examined the safety and effectiveness of the Pfizer-BioNTech BNT162b2 COVID-19 vaccine in healthy children between the ages of 5 and 15, covering the period following the vaccine’s rollout in late 2021.

Drawing on data from the OpenSAFELY-TPP database with authorization from NHS England, researchers evaluated two comparisons: vaccinated versus unvaccinated children, and children who received a second dose versus those who received only one.

The study included 141,711 children ages 5–11 and 410,463 adolescents ages 12–15 who received a first vaccine dose, each matched with an equal number of unvaccinated peers from the same age groups.

To say the least, the findings were mixed. Researchers identified an initial protective effect against COVID-19 that diminished by the 14-week mark, along with a lower rate of emergency room visits among vaccinated children compared to unvaccinated ones. However, cases of myocarditis and pericarditis, forms of cardiac inflammation, were documented only within the vaccinated groups, at rates of 27 and 10 cases per million following the first and second doses, respectively.

The study’s authors were careful to note the limitations of this finding: “That there were no cases of myocarditis or pericarditis in the unvaccinated group does not mean that such events cannot occur without COVID-19 vaccination, only that these events were not observed in the unvaccinated groups in our specific matched analyses.”

For context, the U.K. Health Security Agency reported as recently as January 2023 that heart inflammation rates among those under 18 receiving the Pfizer-BioNTech vaccine stood at 13 per million first doses and 8 per million second doses.

The risk-benefit picture also differed by age group. Among adolescents, the reduction in COVID-19 hospitalization risk from vaccination outweighed the increased risk of myocarditis and pericarditis. That balance didn’t hold for younger children.

According to the study, the reduction in COVID-19 hospitalization risk for children ages 5–11 receiving a first dose was 0.02, while the corresponding increase in pericarditis risk was 0.22, suggesting the cardiac risk exceeded the hospitalization benefit in that age group.

The study has drawn responses from prominent critics of current vaccine policy. Senator Rand Paul (R-KY), who recently introduced the End the Vaccine Carveouts Act, which is legislation that would remove liability protections for COVID-19 vaccine manufacturers, cited the study as further justification for the bill.

“As it stands right now, families are limited as to how they can seek justice due to legal carveouts for COVID-19 vaccine manufacturers,” Paul said, adding that pharmaceutical companies should be held accountable through proper legal channels.

Additionally, the FDA took steps last year to increase transparency around cardiac risks, requiring Pfizer and Moderna to include in their labeling the estimated incidence of heart conditions following administration of the 2023–2024 formulas of the BNT162b2 and Spikevax vaccines, as well as results from a 2024 study examining cardiac outcomes associated with vaccine-related myocarditis in American youth.

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