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FDA Announces New Safety Warning on All mRNA COVID Vaccines — Cites “Extremely High” Risk of Myocarditis and Long-Term Heart Damage in Young Men
Gateway Pundit, ^ | Jul. 3, 2025 | Jim Hᴏft

Posted on 07/03/2025 5:20:22 PM PDT by george76

The U.S. Food and Drug Administration (FDA) under the Trump administration has formally updated the safety labeling on all mRNA COVID-19 vaccines to reflect what many Americans have been warning about for years: a disturbingly high risk of myocarditis—particularly in young men—and the possibility of long-term, irreversible heart damage.

The revised warnings apply to both Pfizer’s Comirnaty and Moderna’s Spikevax vaccines and follow months of mounting pressure over transparency and accountability regarding the true risks of these experimental injections.

The update stems from new studies and data showing persistent cardiac abnormalities months after vaccination—especially among males aged 12 to 24.

During a presentation of the new FDA safety data on Tuesday, Dr. Vinay Prasad, Director, Center for Biologics Evaluation & Research Chief Medical and Scientific Officer, walked the public through the harrowing evidence behind the label change.

Prasad detailed how FDA data reveals a myocarditis rate of 27 per million in young men—a figure that experts say is significantly underreported due to passive surveillance methods and political suppression of adverse event reports.

More troubling, Dr. Prasad cited late gadolinium enhancement (LGE) on cardiac MRIs as proof of sustained, potentially irreversible myocardial injury. According to Prasad, in one FDA-funded study, 60% of patients who suffered post-vaccine myocarditis still showed signs of LGE five months later.

After denying and downplaying the risks for years, the FDA is now requiring both Pfizer and Moderna to update their Prescribing Information, Adverse Reactions sections, and Fact Sheets for patients and caregivers.


TOPICS:
KEYWORDS: biologicalwarfare; bioweapon; coronavirus; covidvaccines; fda; genocide; heartattacks; hoftisafairy; mrna; mrnacovidvaccine; mrnacovidvaccines; mrnainjections; mrnashots; mrnavaccine; myocarditis; pericarditis; spikeprotein; strokes

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1 posted on 07/03/2025 5:20:22 PM PDT by george76
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To: george76

You don’t say…….


2 posted on 07/03/2025 5:22:26 PM PDT by rdcbn1 (TV )
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To: george76

bttt


3 posted on 07/03/2025 5:22:51 PM PDT by linMcHlp
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To: george76

When will someone be arrested?


4 posted on 07/03/2025 5:23:05 PM PDT by Qwapisking ("The left will rue the day they cheated Trump out of the 2020 election forever" L.Star )
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To: george76; pookie18

5 posted on 07/03/2025 5:24:21 PM PDT by Tell It Right (1 Thessalonians 5:21 -- Put everything to the test, hold fast to that which is true.)
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To: george76

We really need gallows.


6 posted on 07/03/2025 5:27:15 PM PDT by Secret Agent Man (Gone Galt; not averse to Going Bronson.)
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To: Secret Agent Man

We do indeed


7 posted on 07/03/2025 5:34:58 PM PDT by rdcbn1 (TV )
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To: george76

Why not just ban it? It doesn’t work except, as designed, to kill people.


8 posted on 07/03/2025 5:35:44 PM PDT by HYPOCRACY (Wake up, smell the cat food in your bank account. )
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To: george76

Dogdoo Duke ain’t gonna like this.


9 posted on 07/03/2025 5:35:50 PM PDT by E. Pluribus Unum (Democrats are the Party of anger, hate and violence.)
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To: george76

I guess they had it in mind that this would extend the SS trust fund.


10 posted on 07/03/2025 5:38:15 PM PDT by damper99
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To: rdcbn1; Secret Agent Man

That’s why this fake news website exists, I think.
For things that should be, but are not.

The gallows you describe are there.

https://realrawnews.com/


11 posted on 07/03/2025 5:40:05 PM PDT by Norski
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To: george76

Just young men?


12 posted on 07/03/2025 5:40:16 PM PDT by Old Yeller (On judgement day, you’ll wish you were biblically correctly, not politically correct.)
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To: george76

Yeah, but who believes anything they say anymore?


13 posted on 07/03/2025 5:41:43 PM PDT by BenLurkin (The above is not a statement of fact. It is opinion or satire. Or both.)
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To: george76

Who knew RFK would do such a great job? He sacrificed so much to realize his almost life-long goal of helping American’s health.


14 posted on 07/03/2025 5:47:34 PM PDT by MayflowerMadam (It's hard not to celebrate the fall of bad people. - Bongino)
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To: george76
Here’s the actual FDA warning that was issued on June 25

Based on analyses of commercial health insurance claims data from inpatient and outpatient settings, the estimated unadjusted incidence of myocarditis and/or pericarditis during the period 1 through 7 days following administration of the 2023-2024 Formula of mRNA COVID-19 vaccines was approximately 8 cases per million doses in individuals 6 months through 64 years of age and approximately 27 cases per million doses in males 12 through 24 years of age.

Follow-up information on cardiovascular outcomes in hospitalized patients who had been diagnosed with COVID-19 vaccine-associated myocarditis is available from a longitudinal retrospective observational study. Most of these patients had received a two-dose primary series of an mRNA COVID-19 vaccine prior to their diagnosis. In this study, at a median follow-up of approximately 5 months post-vaccination, persistence of abnormal cardiac magnetic resonance imaging (CMR) findings that are a marker for myocardial injury was common. The clinical and prognostic significance of these CMR findings is not known.[Emphasis mine]

15 posted on 07/03/2025 5:47:38 PM PDT by thegagline (Sic semper tyrannis! Trump & Vance, 2024! (Formerly) Goldwater & Thomas Sowell)
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To: george76
Then maybe it should apply to ALL mRNA type of vaccines.
16 posted on 07/03/2025 5:50:21 PM PDT by airborne (Thank you Rush for helping me find FreeRepublic! )
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To: Tell It Right

Thanks, Tell It Right!


17 posted on 07/03/2025 5:50:26 PM PDT by pookie18 (You don’t have to be high on crack to enjoy Pookie’s Toons! - Tell It Right)
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To: george76

Why would a healthy young male, age 12-24 need the mRNA vaccine anyway?


18 posted on 07/03/2025 5:51:11 PM PDT by The_Media_never_lie
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To: george76

Time is showing one thing, mRNA jabs kill and disable.


19 posted on 07/03/2025 5:52:25 PM PDT by delta7
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To: george76

It’s important to note that the risk of developing myocarditis is significantly higher after COVID-19 infection than after receiving the COVID-19 vaccine.


20 posted on 07/03/2025 5:58:09 PM PDT by Bob Wills is still the king
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