Japanese Study Reveals Myocarditis 20x+ to 50x+ Greater Association After mRNA Vaccin

[revelarts]

Another Study...

but no one should draw any conclusions...
more study should be done


Bombshell—Japanese Study Reveals Myocarditis 20x+ to 50x+ Greater Association After mRNA Vaccination--Consider Withdrawing from Market?
https://www.trialsitenews.com/a/bomb...arket-240866c0

Keisuke Takada at Keio University Faculty of Pharmacy, Division of Pharmacodynamics, as well as Yokohama General Hospital and colleagues, calculated reporting odds ratios (RORs) and 95 % confidence intervals (95 % CIs) for the association between the vaccines and myocarditis/pericarditis based on data from the vaccine adverse event database (April 2004–December 2023). The Japanese team evaluated age, sex, onset time, and outcomes in symptomatic patients. What’s the underlying mission of this study? The authors hoped to clarify any associations between COVID-19 mRNA vaccines (Pfizer BNT162b2 and Moderna’s mRNA-1273) and myocarditis/pericarditis plus any influencing factors. And did this study bring some clarity—a disturbingly high rate of association between mRNA vaccination and myocarditis and pericarditis, especially in known risk cohorts! The associations are so high under normal conditions, the product would likely be withdrawn for study.

The researchers involved in this study are affiliated with Keio University, Yokohama General Hospital, and Teikyo Heisei University.

In Japan, the Pharmaceuticals and Medical Devices Agency (PMDA) manages the Japanese Adverse Drug Event Report (JADER), a large-scale database for spontaneous reporting of adverse events.

The database includes information such as adverse events and outcomes associated with vaccination. Large-scale databases for spontaneous reporting of adverse events, including JADER, are effective resources for studies that systematically explore the association between drugs and adverse events, and they contribute to the accumulation of evidence for safe medication.

Findings
Japan, with a population of $125.1 million, had a high vaccination rate of nearly 80%. 880,999 safety incidents were reported, of which there were 1846 myocarditis and 761 pericarditis reports.

Takada and colleagues report in the Journal of Infection and Chemotherapy:

“The adverse events associated with the vaccines included myocarditis (919 cases) and pericarditis (321 cases), with the ROR [95 % CIs] being significant for both (myocarditis: 30.51 [27.82–33.45], pericarditis: 21.99 [19.03–25.40]) Furthermore, the ROR [95 % CIs] of BNT162b2 and mRNA-1273 were 15.64 [14.15–17.28] and 54.23 [48.13–61.10], respectively, for myocarditis, and 15.78 [13.52–18.42] and 27.03 [21.58–33.87], respectively, for pericarditis."

RORs cited above mean that the odds of the adverse event (or outcome) occurring in the vaccinated group are troublingly higher than in the non-vaccinated (control) group. This is a substantial increase in risk.

Vaccines are generally expected to have ORs close to 1, indicating no significant increase in the risk of adverse events.

As many studies point to for these cardiovascular incidents, “most cases were ≤30 years or male.”

The period from vaccination to onset was ≤8 days, corresponding to early failure type based on analysis using the Weibull distribution. Outcomes were recovery or remission for most cases; however, they were severe or caused death in some cases.

In the outcomes section the authors report recovery and remission in 78 % (595 cases) and 87 % (222 cases) of cases, respectively. However, a “severe outcome (sequela or non-recovery) after the onset of myocarditis and pericarditis was noted in 11 % (80 cases) and 8 % (20 cases) of cases, respectively.” And troubling, death was reported in 11 % (84 cases), and 5 % (13 cases), respectively. Similar tendencies were observed in the subgrouping analysis associated with BNT162b2 and mRNA.

Danger
TrialSite reviewed this study with grave concern. Typically, an ROR of 10 is considered very high, suggesting a substantial increase in risk. In this case, we are over 15 and over 50 for Moderna. Of course, impacting this study is study design, size and other parameters.

TrialSite’s founder Daniel O’Connor said of these statistics, “This finding should lead to immediate public health actions, including the potential to halt the use of the vaccine pending further investigation, at least in the high-risk segment, in this case, younger men.”

O’Connor continued, “The output means here that the high-risk group faces a 20+ to 50+ times more likely myocarditis outcome, for example.”

Of course, this is not a randomized controlled trial, meaning that the study is not designed to prove causation. Yet the association magnitude is quite troubling.

Vaccine safety reporting systems are passive surveillance systems, so assumptions may be made about the entries—some may not be from the vaccine even though temporarily associated. Yet the investigators here report these astronomically high rates.....

SARS-CoV-2 mRNA vaccine-related myocarditis and pericarditis: An analysis of the Japanese Adverse Drug Event Report database
https://pubmed.ncbi.nlm.nih.gov/39103148/