Young teens who received the mRNA COVID-19 vaccine have a higher risk of heart inflammation, according to a new U.S. Food and Drug Administration study — researchers said the study’s results provide “additional evidence for the safety of the COVID-19 vaccines in the pediatric population.”
Children ages 12 to 17 who received the mRNA COVID-19 vaccine face a heightened risk of heart inflammation, according to a new U.S. Food and Drug Administration (FDA) study.
But because the study only identified a safety signal for two heart conditions — myocarditis and pericarditis — in children “these results provide additional evidence for the safety of the COVID-19 vaccines in the pediatric population,” FDA researchers concluded.
Cardiologist Dr. Peter McCullough said he disagreed. “My concern is that these data represent a gross under-reporting of the frequency and severity of COVID-19 vaccine-induced myocarditis,” McCullough told The Epoch Times.
“There have been > 200 papers in the peer-reviewed literature and over 100 fatal documented cases largely among young men, peak ages 18-24 years, some with autopsy-proven COVID-19 vaccine heart inflammation resulting in death,” McCullough added.
In the study, published Monday in JAMA Pediatrics, FDA researchers examined health outcomes in more than 3 million children who received the Pfizer mRNA vaccine through mid-2022.
They found the number of cases of both myocarditis, a form of heart inflammation, and pericarditis, inflammation of the tissue surrounding the heart, were high enough to meet the criteria for a safety signal.
The researchers also found reports of myocarditis and pericarditis cases among vaccinated children ages 5 to 11, but not enough to trigger a safety signal, they said.
Conclusions ‘pretty ludicrous’ and ‘political,’ experts say
Norman Fenton, Ph.D., professor emeritus of risk at the Queen Mary University of London, called the claim that the results provide additional evidence that the vaccines are safe in children “pretty ludicrous.”
Read More: FDA Finds Evidence of Serious Safety Signal for COVID Vaccines in Young Kids — Says It Proves Shots Are ‘Safe’