FDA Detects Serious Safety Signal for COVID-19 Vaccination Among Children | TET

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The Epoch Times published this article yesterday, thought it was interesting and perhaps worth a constructive comment or 2...

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By Zachary Stieber

May 25, 2023

Children of certain ages who received Pfizer’s COVID-19 vaccine face an elevated risk of heart inflammation, according to a new federally funded study.

Vaccinated children aged 12 to 17 face a heightened risk of myocarditis, a form of heart inflammation, and a related condition called pericarditis, U.S. Food and Drug Administration (FDA) researchers found.

The number of myocarditis and pericarditis events in that age group met the threshold for a safety signal, the researchers reported in the Journal of the American Medical Association on May 22.

The elevated risk was present within seven days of vaccination, according to the data.

Researchers identified 89 cases among 12- to 15-year-olds and 64 cases among 16- and 17-year-olds after reviewing records from commercial databases run by CVS Health, HealthCore, and Optum.

The claims were made between Dec. 11, 2020, when Pfizer’s vaccine was cleared by the FDA, and mid-2022.

Researchers looked at data to determine whether any of the 20 health problems were experienced at higher rates by the vaccinated. The problems included myocarditis or pericarditis, Bell’s palsy, appendicitis, and stroke.

Only myocarditis or pericarditis met the criteria for a safety signal, which may be related to vaccination.

U.S. officials have already concluded that the conditions are caused by the Pfizer and Moderna COVID-19 vaccines, although the vaccines didn’t carry a warning for months after authorization. One possible mechanism is excessive immune responses triggered by lipid nanoparticles. Novavax’s vaccine, authorized in 2022, can also cause the heart conditions, authorities say.

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Full article:
FDA Detects Serious Safety Signal for COVID-19 Vaccination Among Children | The Epoch Times
 
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