Researchers have published a study in the peer-reviewed Journal of the American Medical Association (JAMA) highlighting a heart-related risk observed in adolescents following the administration of the BNT162b2 (Pfizer) COVID-19 vaccine.
The safety signal pertains to myocarditis or pericarditis, inflammations of the heart or its lining, respectively.
“The signal detected for myocarditis or pericarditis is consistent with that reported in peer-reviewed publications demonstrating an elevated risk of myocarditis or pericarditis following mRNA vaccines, especially among younger males aged 12 to 29 years,” the researchers noted.
“Of the 153 cases of myocarditis or pericarditis among children aged 12 to 17 years, medical record review was conducted for a sample of 37 cases whose records were obtainable. Twenty-seven of these cases (73.0%) were confirmed as true cases of myocarditis or pericarditis, of which 25 patients were male, and 19 were hospitalized with a mean length of hospital stay of 2.8 days (median, 2 days). The mean time from vaccination to presentation for care for myocarditis or pericarditis was 6.8 days (median, 3 days).”
Myocarditis or pericarditis carries “an average incidence of 39.4 cases per million doses administered in children aged 5 to 17 years within 7 days after BNT162b2 COVID-19 vaccination.”
The study used extensive databases and rigorous monitoring to track any adverse outcomes following vaccination.
“We conducted monthly sequential testing using the Poisson maximized sequential probability ratio test8 and generated incidence rate ratios (RRs) of observed outcome rates compared with database-specific historical (expected) rates,” the authors explained.
Nevertheless, the team was clear to state the study’s limitations, which include its focus on a commercially insured pediatric population, its limited scope for establishing causal relationships between the vaccine and health outcomes, and its inability to conduct record reviews for all outcomes due to resource constraints.
Researchers stressed the need for the continuous monitoring and evaluation of vaccines.
The study’s findings serve to enhance the understanding of vaccine-related risks, thereby enabling more informed decision-making around vaccine administration in the younger demographic.
Despite the signal detected for myocarditis or pericarditis, the authors believe in the overall safety of the BNT162b2 COVID-19 vaccine for children and adolescents.