Researchers with the Food and Drug Administration concluded after an analysis of the agency’s data that there is an elevated risk of myocarditis in children as young as 12 after taking the Pfizer COVID-19 shot.
The researchers looked for safety signals requiring further investigation in their examination of the data from the FDA’s Biologics Effectiveness and Safety Initiative, the Epoch Times reported.
Targeting data for children aged 5 to 17 between 2021 and mid-2022, the preprint study found that myocarditis, a form of heart inflammation, and the related condition pericarditis met the threshold for a safety signal for children aged 12 to 17 after the second and third doses of the mRNA vaccine.
A safety signal isn’t proof that a vaccine caused an adverse event. The purpose is to prompt investigation of the cause and determine whether or not the risks of a vaccine outweigh the benefits.
Safety signals are the reason the FDA and the Centers for Disease Control and prevention launched the Vaccine Adverse Events Reporting System. But CDC Director Rochelle Walensky and White House health adviser Dr. Anthony Fauci have dismissed the VAERS safety signals, which include 31,696 reports of deaths related to the COVID-19 vaccines among 1.4 million total adverse events as of Oct. 21.
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The CDC has acknowledged myocarditis as a vaccine side effect but insists it’s rare. In August 2021, the CDC reported 42.6 cases of myocarditis or pericarditis per million males ages 12-15 after vaccination. However, in September, the CDC’s analysis of its own Vaccine Safety Datalink surveillance data showed the incidence of myocarditis after vaccination was three to five times higher for young men than what the agency was reporting in 2021.
The first prospective cohort study on the subject – by researchers in Thailand looking at 301 teens 13-18 – estimated an astonishing 23,000 cases per million.
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Last month, a Swiss study found elevated levels of the protein troponin in all of the mRNA COVID-19 vaccine recipients it analyzed, indicating the shots are routinely causing heart injury. Further, up to 1 in 27 of the vaccinated people in the study showed levels associated with subclinical myocarditis.
Denmark and Norway have recommended that people under 50 and under 65, respectively, not get a booster shot. And Sweden is no longer recommending them for ages 12 to 17.
Members of the FDA’s vaccine advisory panel last fall reluctantly recommended approval of the Pfizer-BioNTech COVID-19 vaccine for children ages 5-11 despite concerns about myocarditis.
A panel member, Dr. Eric Rubin, editor of the New England Journal of Medicine, famously said during the hearing, “We’re never going to learn about how safe the vaccine is unless we start giving it – that’s just the way it goes.”
In May, despite Pfizer trial data showing the chance of death in children from the shot is 107 times higher than death from COVID-19, the FDA approved Pfizer booster shots for children 5-11.
In the new study, researchers analyzing the FDA data said they didn’t detect a signal for myocarditis or pericarditis for children aged 5 to 11. However, they said “the signal detected for myocarditis/pericarditis is consistent with published peer-reviewed publications demonstrating an elevated risk of myocarditis/pericarditis following mRNA vaccines, especially among younger males aged 12-29 years.”
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