Dr. Philp McMillan,  John McMillan

Ten children. That number now sits at the center of the largest regulatory admission in modern vaccine history. On November 29, 2025, Dr. Vinay Prasad, Chief Medical and Scientific Officer for the FDA’s Center for Biologics Evaluation and Research, sent an internal memo to his staff that would have been unthinkable three years ago. Career scientists at the agency, led by Senior Advisor for Clinical Sciences Dr. Tracy Beth Høeg, had completed a review of 96 pediatric deaths reported to the Vaccine Adverse Event Reporting System between 2021 and 2024. Their conclusion: no fewer than 10 were causally related to COVID-19 vaccination. “For the first time, the US FDA will acknowledge that COVID-19 vaccines have killed American children,” Prasad wrote. “Healthy young children who faced tremendously low risk of death were coerced, at the behest of the Biden administration, via school and work mandates, to receive a vaccine that could result in death.” The memo, obtained by multiple news organizations, represents an institutional pivot that demands examination. Not because it validates conspiracy theories, but because it raises an uncomfortable question: What did the data show us years ago that we chose not to see?

The Thailand Study Nobody Wanted

In August 2022, researchers at Mahidol University in Thailand published findings that should have stopped anyone paying attention. Their prospective cohort study enrolled 314 adolescents aged 13 to 18 from two schools who had received their second dose of the Pfizer BNT162b2 vaccine. Unlike passive surveillance systems that wait for problems to be reported, the Thai researchers went looking for them. They collected baseline ECGs, echocardiography, and cardiac enzyme measurements, then followed up at days three, seven, and fourteen. Of the 301 participants who completed follow-up, 29.24 percent exhibited cardiovascular manifestations. Nearly 8 percent developed tachycardia. Seven participants showed elevated cardiac biomarkers. Four cases of suspected subclinical myocarditis emerged, along with two cases of suspected pericarditis and one confirmed case of myopericarditis. One in forty-three children in that cohort showed evidence of heart involvement. The study appeared in Tropical Medicine and Infectious Disease with remarkably little fanfare. Its authors, seemingly aware of the political climate, concluded that adolescents receiving mRNA vaccines “should be monitored for side effects.” They did not recommend halting vaccination. They did not sound any particular alarm. But consider the implications. If one small cohort of 301 teenagers in Bangkok could yield these numbers through active surveillance, what was happening across millions of vaccinated children worldwide who were never screened?

The Silent Scar

The challenge with myocarditis in children is deceptively simple: they cannot tell you what hurts. Dr. Mary Talley Bowden, appearing recently on Joe Rogan’s podcast, articulated what physicians working with this population have long understood. “If you’ve got a kid who’s not even speaking yet, you have no idea if they have myocarditis,” she explained, “and myocarditis can leave a permanent scar on the heart and then lead to a lifelong increased risk of sudden cardiac death.” Clinical myocarditis presents with chest pain. It gets diagnosed because it forces itself into view. Subclinical myocarditis operates differently. The inflammation occurs. The healing response follows. Fibrotic scar tissue forms where healthy muscle once existed. And the child feels nothing. Perhaps some fatigue. Perhaps a racing heart that passes. Perhaps nothing at all until, years or decades later, that scar tissue disrupts the heart’s electrical conduction during a moment of stress or exertion. This is the mechanism that haunts cardiologists: a substrate for fatal arrhythmias laid down in childhood, triggered years later by catecholamine surges during sports, stress, or stimulant use. The endpoint appears sudden and inexplicable. But the architecture was altered long before. Standard pre-participation sports physicals will not detect this. The required tools, high-sensitivity troponin and cardiac MRI, sit far outside the scope of school athletic programs. Which means a generation of children may be carrying invisible damage that reveals itself only under pressure.

What They Said Then

The contrast between public messaging and internal reality defines this story. On April 27, 2021, then-CDC Director Dr. Rochelle Walensky stated in a press briefing: “We have not seen a signal and we’ve actually looked intentionally for the signal in the over 200 million doses we’ve given.” This was weeks before the agency would acknowledge a pattern of myocarditis in young men. It was more than a year before the Thailand study would document cardiovascular effects in nearly a third of vaccinated adolescents. And it was four years before FDA career staff would conclude that at least 10 children died as a result of vaccination. Dr. Philip McMillan, a physician who has followed these developments closely, frames the situation starkly: “If you haven’t found any other cause, usually in the context of medicine, we say the most likely cause, therefore, is so-and-so. That’s how we usually do a death certificate.” The regulatory timeline raises questions that extend beyond American borders. If the FDA is only now conducting this analysis, what have equivalent agencies in Europe, the United Kingdom, and Australia been doing? The Medicines and Healthcare products Regulatory Agency, the European Medicines Agency, the Therapeutic Goods Administration: each relies on similar passive surveillance systems. None has replicated the active surveillance model the Thai researchers employed.

The Liability Shield

There is another dimension to this story that complicates accountability. Vaccine manufacturers operate under liability protection for COVID-19 products. The burden of proof falls not on companies but on families seeking recourse. The system that might have corrected course faster operates without the usual market incentives for caution. Prasad’s memo acknowledges this structural problem. He notes that the FDA failed to enforce required post-market commitments for COVID-19 vaccines, including studies on pregnant women and documentation of subclinical myocarditis. He flags that concurrent administration of COVID and flu vaccines proceeded without adequate interaction studies. “Putting these facts together,” Prasad wrote, “it is horrifying to consider that the US vaccine regulation, including our actions, may have harmed more children than we saved.”

What Comes Next

The 10 confirmed deaths are not the story. They are the visible portion of an unknown denominator. The real question is how many children carry cardiac scars they do not know about. How many will present in emergency rooms a decade from now with arrhythmias whose origins trace back to 2021 or 2022? How many will be told their condition is idiopathic when the cause was documented in a Thai medical journal years before? The FDA has indicated it will release a public report by the end of December. The details will matter: ages, underlying conditions, temporal relationships, manufacturers. But even the most complete accounting cannot undo what passive surveillance missed. What it can do is change what happens next. Risk-benefit calculations for low-risk pediatric populations require re-examination. Future vaccine rollouts need active surveillance protocols, not passive reporting systems that rely on motivated physicians completing tedious forms. And unexplained sudden cardiac death in young people demands autopsy protocols that consider vaccination history. The signal was there. The question now is whether anyone is finally willing to listen.