FDA Finds Evidence of Serious Safety Signal for COVID Vaccines in Young Kids; Says It Proves Shots Are ‘Safe’ – Children’s Health Defense 5/25/23

Source: ChildrensHealthDefense.org

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.”

He said that conclusion didn’t make sense given that the signal was both strong and “likely underestimated given some obvious weaknesses of the study” and also that children of that age are at no risk from COVID-19 but at higher risk of getting COVID-19 if they are vaccinated.

Dr. Kirk Milhoan, a pediatric cardiologist, also told The Defender the safety claim didn’t hold up because the study identified two safety signals. “The signal is what indicates they are not safe,” he said.

He said with previous children’s vaccines such as RotaShield, the first vaccine to prevent rotavirus gastroenteritis, about 100 vaccine-related cases of intussusception, or folding of the intestine, led to the conclusion that it was unsafe and it was withdrawn from the market. But with myocarditis in young people, he said, “we’re at thousands,” and the cases are likely undercounted….

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