FDA official admits myocarditis ‘fivefold’ in vaccinated children

Food and Drug Administration Center for Biologics Evaluation and Research (CBER) Director Dr. Peter Marks , M.D., Ph.D. last week said Pfizer’s mRNA vaccine is linked to a fivefold increase in myocarditis among children 12-17.

According to the FDA, “the center is responsible for assuring the safety and effectiveness of biological products, including vaccines, allergenic products, blood and blood products, and cellular, tissue, and gene therapies.” 

While the mainstream media have not reported on Dr. Marks’ remarks, Senator Ron Johnson (R-WI) shared the clip on Twitter. 

“[Myocarditis] is a known phenomena in the 12-17 year-old age range,” said the CBER director. “And the rate that it was seen in the 12-17 year-olds who are vaccinated seem to be fivefold higher than the baseline rate that we would expect. And that’s why this is not a slam dunk.” 

He went on to compare Pfizer’s mRNA vaccine to the Johnson & Johnson COVID-19 vaccine. 

“For the J&J vaccine there was the thrombosis thrombocytopenia syndrome. There, in the absence of getting vaccinated, the chances of having that was vanishingly small, zero basically. So there, anything you saw, you knew was real.” 

But the official then appeared to downplay the danger by obfuscating the cause. 

“Here, it’s very challenging. When something’s only three to five times more common in a vaccinated population, you don’t know whether it’s cases that would have been there, that aren’t really associated with the vaccine that have come up, or how much actually the vaccine has increased that risk.” 

Dr. Marks assured his colleagues that he was not denying that the vaccine has a myocarditis safety signal. 

“I’m not trying to deny that there’s some signal here. I’m just trying to say the magnitude of this over what we might be seeing is baseline, summertime, viral myocarditis is hard to know exactly. But just to give you an idea of the order of magnitude, we’re seeing about fivefold more than you might expect if this were normal summertime.” 

“Why on earth are they pushing the COVID vaccine on babies?” questioned Sen. Johnson. “We still don’t know the long-term safety profile of these vaccines.”