FDA Finds Evidence of Serious Safety Signal for COVID Vaccines in Young Kids — Says It Proves Shots Are ‘Safe’

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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.

Experts question study’s methodology

The researchers reviewed medical records from healthcare claims filed in three commercial health insurance claims databases run by Optum, HealthCore and CVS Health.

They examined insurance claims made for different possible vaccine-related adverse events within a window of time following vaccination that varied for the different events studied.

They found 153 cases of myocarditis or pericarditis among children ages 12 to 17. The children sought care for their symptoms within seven days of vaccination on average.

The researchers’ study period began in December 2020, when the FDA authorized Pfizer’s vaccine for emergency use and ran through May or June 2022, depending on the database.

The FDA also monitored the databases for 18 other potential adverse events that included anaphylaxis, Bell’s palsy, Guillain-Barré syndrome hemorrhagic stroke and others, but the study reported that none of the other conditions met the criteria for a safety signal.

The researchers reported their findings were consistent with other findings in peer-reviewed publications that demonstrated an elevated risk of myocarditis and pericarditis following mRNA vaccines, especially among younger males ages 12 to 29.

Some experts questioned the study’s methodology, noting that the risk windows were short given that some effects can take time to express themselves and that the signal threshold for some criteria was set so high they would have to occur at double the rate in the unvaccinated to be recognized as a signal.

They also said categories of outcomes were sometimes overly narrow, and some adverse events were not even considered.

“I think the idea that they look at only 20 very specific AEs [adverse events] then declare them safe upon not finding anything is very myopic,” Hebrew University lecturer Joshua Guetzkow, Ph.D., wrote in an email.

Experts also said the study didn’t account for the effects of the “healthy user bias,” where people who take up certain treatments tend to be healthier than people who don’t, usually related to socio-economic factors.

Research has shown that people who decide to get vaccinated tend to be healthier than people who don’t.

In this case, all of the people in the study were vaccinated, fully insured for the entire duration of the study and able to visit a doctor who maintained their continuous health records.

Milhoan added that prior to COVID-19, it wasn’t common practice for scientific papers to make public health acknowledgments at the end of the papers.

Previously, he said, researchers wouldn’t imply recommendations, they would just say, “This is what we found medically.” He added, “These public health claims aren’t scientific, they’re political.”