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

[mystery-ak]

By Zachary Stieber
May 25, 2023Updated: May 26, 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.

more
https://www.theepochtimes.com/fda-detects-serious-safety-signal-for-covid-19-vaccination-among-kids_5288229.html?utm_source=Morningbrief&src_src=Morningbrief&utm_campaign=mb-2023-05-26&src_cmp=mb-2023-05-26&utm_medium=email&est=Tkhvzwtmya8wKX1QK7fyEwmkT%2FzyPP3A1swJHp1%2FQAPtVdmegIbMWJbu1BpVE8Qu

[Kamaji]

Geez.

[Smokin Joe]

Well, no shit, Sherlocks!

This is why many of us have been objecting to forced "vaccinations" of children (or anyone else, for that matter) with the mRNA shots.

Pull the damned jabs off the recommended list for kids.

[mountaineer]

Cleveland clinic study which found that "The higher the number of vaccines previously received, the higher the risk of contracting COVID-19" has been peer review published.
Oxford Academic

The purpose of this study was to evaluate whether a bivalent COVID-19 vaccine protects against COVID-19.

Employees of Cleveland Clinic in employment when the bivalent COVID-19 vaccine first became available, were included. Cumulative incidence of COVID-19 over the following 26 weeks was examined. Protection provided by vaccination (analyzed as a time-dependent covariate) was evaluated using Cox proportional hazards regression, with change in dominant circulating lineages over time accounted for by time-dependent coefficients. The analysis was adjusted for the pandemic phase when the last prior COVID-19 episode occurred, and the number of prior vaccine doses.

Among 51017 employees, COVID-19 occurred in 4424 (8.7%) during the study. In multivariable analysis, the bivalent vaccinated state was associated with lower risk of COVID-19 during the BA.4/5 dominant (HR, .71; 95% C.I., .63-.79) and the BQ dominant (HR, .80; 95% C.I., .69-.94) phases, but decreased risk was not found during the XBB dominant phase (HR, .96; 95% C.I., .82-.1.12). Estimated vaccine effectiveness (VE) was 29% (95% C.I., 21%-37%), 20% (95% C.I., 6%-31%), and 4% (95% C.I., -12%-18%), during the BA.4/5, BQ, and XBB dominant phases, respectively. Risk of COVID-19 also increased with time since most recent prior COVID-19 episode and with the number of vaccine doses previously received. ...

[Kamaji]

"The higher the number of vaccines previously received, the higher the risk of contracting COVID-19"

Should come as no surprise, as the causal mechanism was already well identified.

[mountaineer]

I suspect many of us could provide anecdotal evidence of people we know who received the vax and its multiple "boosters" and still got Covid multiple times.