In a significant shift in federal vaccine safety policy, the U.S. Food and Drug Administration (FDA) has updated its safety warning regarding long-term cardiac injury linked to Covid mRNA “vaccines,” particularly in young males.
The revised warning reflects increasing concerns over persistent and possibly irreversible cardiac injury following vaccination.
Dr. Vinay Prasad, the newly appointed Director of the Center for Biologics Evaluation and Research (CBER), led the release of the updated label, which provides a sobering look at the ongoing risks posed by the “vaccines.”
The new warning draws attention to two crucial findings.
First, the incidence of myocarditis in young males aged 12-24 remains significantly higher than initially acknowledged, with 27 cases per million, or roughly 1 in 37,000, following the 2023-2024 vaccine formulation.
More alarmingly, the FDA has found evidence that the cardiac damage is not short-lived, as previously claimed.
A substantial number of patients, even those who have been hospitalized, show ongoing signs of cardiac injury, specifically late gadolinium enhancement (LGE), on their MRI scans.
This marker suggests that the damage could be non-benign and possibly irreversible, highlighting the seriousness of the condition.
Dr. Prasad’s presentation underscored the long-term impact of these injuries.
A 2024 FDA-funded study revealed that 60% of patients with vaccine-induced myocarditis still exhibited LGE five months after their hospitalization.
This is not an isolated finding; other global studies showed that as many as 72% of myocarditis patients demonstrated persistent LGE.
For context, LGE is associated with severe cardiac conditions, including heart failure and even death, in other scenarios.
The study also highlighted how U.S. surveillance systems, such as the Vaccine Safety Datalink (VSD), had underestimated the scale of the problem due to coding and reporting delays.
In some studies, the true risk for young males after their second “vaccine” dose was found to be as high as 1 in 2,000 to 3,000.
The release of this updated warning comes after years of delays and a troubling history of suppressed safety signals, especially in the early days of “vaccine” distribution.
Despite alarming reports from Israel and the U.S. Department of Defense in 2021, both the CDC and FDA initially downplayed the risks of myocarditis, only to revise their stance under growing pressure.
The Biden White House even intervened, issuing talking points minimizing the risks of myocarditis, while an official CDC Health Alert Network advisory was blocked, downgraded to a mere website notice.
These actions have raised serious concerns about political interference in public health decisions during a time of mass vaccination.
The situation in Europe contrasts sharply with the U.S.’s response.
European regulators acted swiftly, implementing longer intervals between vaccine doses and imposing age-based restrictions on mRNA vaccines.
These measures were introduced long before the CDC even considered such steps, which many argue was a missed opportunity to protect vulnerable populations, particularly young people.
The real-world consequences of vaccine-related myocarditis have been stark.
According to CDC data from 2022, 25% of affected youth were admitted to intensive care units (ICUs), and over 30% experienced lasting activity restrictions months after their diagnosis.
Worse yet, at least one fatal case was reported in the New England Journal of Medicine, with other potential fatalities likely going unreported.
Even those who experienced mild symptoms were not spared, as LGE, a marker of severe cardiac damage, was present in many, regardless of the apparent severity of the condition.
In response to these mounting concerns, the FDA is taking decisive steps to ensure that future mRNA “vaccine boosters” are subject to more rigorous scrutiny.
The agency is now calling for randomized controlled trials (RCTs) for future “booster” doses in healthy individuals under 65, particularly young men, and recommending tailored dosing based on an individual’s infection history and demographic risk.
Additionally, the FDA promises more transparent safety surveillance, including ongoing label updates as new data emerges.
This signals the end of a one-size-fits-all approach to vaccination, with a shift toward more personalized, risk-aware strategies.
The June 2025 update represents a pivotal moment in vaccine safety, as it marks the FDA’s recognition of long-standing concerns that were previously downplayed or ignored.
For thousands of young Americans suffering from the consequences of myocarditis and other vaccine-related injuries, this late acknowledgment may be too little, too late.
Yet, the questions remain of how such crucial warnings could go unheard for so long.
The American people deserve to know why opportunities for early mitigation were ignored, and, most importantly, who will be held accountable for the delays that have cost lives and health.
The FDA’s latest stance is a significant, though belated, step in reclaiming its role as a safeguard for public health.
However, the full scope of the damage done, both to public trust and to the individuals affected, will take much longer to assess.
As more data becomes available, we must demand accountability and ensure that such mistakes are never repeated.
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