An internal FDA memo reportedly confirms that at least 10 American children died directly from COVID-19 vaccines, potentially triggering the agency’s most severe safety warning for pediatric use.
Story Highlights
- FDA reviewers allegedly determined 10 out of 96 reported child deaths were causally linked to COVID vaccines
- Internal memo proposes black box warning and possible halt of vaccine sales to children and teens
- Megyn Kelly claims independent confirmation of leaked document showing government cover-up
- Deaths reportedly occurred between 2021-2024 in children aged 7-16, primarily from vaccine-induced myocarditis
The Bombshell Internal Document
Dr. Vinay Prasad, director of the FDA’s Center for Biologics Evaluation and Research, authored a memo stating that FDA reviewers concluded at least 10 children died “after and because of receiving” COVID-19 mRNA vaccines. The analysis covered 96 deaths reported to the Vaccine Adverse Event Reporting System between 2021 and 2024 in children aged 7 to 16 years old.
The memo criticizes the agency’s delayed response, asking why these deaths “were not actively reviewed in real time” and why it took until 2025 to conduct this analysis. Prasad reportedly argues that COVID-related myocarditis risk from infection was overstated compared to vaccine-induced myocarditis, particularly in younger populations where COVID poses minimal mortality risk.
Regulatory Earthquake in the Making
The document proposes two unprecedented actions that would shake public confidence in pediatric vaccination programs. First, adding a black box warning to COVID-19 mRNA vaccines for children and adolescents. This represents the FDA’s most serious safety warning, reserved for medications with significant or life-threatening risks.
Second, the memo suggests considering a complete halt of vaccine sales to the pediatric and adolescent population. Such a move would mark a dramatic reversal from the aggressive promotion of childhood vaccination that characterized the Biden administration’s pandemic response. The memo indicates this represents “the first time the US FDA will acknowledge that COVID-19 vaccines have killed American children.”
Media Confirmation and Political Firestorm
Journalist Alex Berenson first reported the memo’s existence and contents through his Substack newsletter in late November 2025. Megyn Kelly subsequently claimed her team independently confirmed the reporting, amplifying the story to her large conservative audience. Kelly directly accused the Biden administration of actively covering up vaccine-related child deaths while misleading the public about safety.
Kelly’s coverage frames the memo as vindication for vaccine skeptics who faced censorship and ridicule for questioning pediatric vaccination policies. Her show featured venture capitalist Chamath Palihapitiya discussing the document as evidence of systemic regulatory failure requiring accountability measures. The story gained traction primarily through conservative media outlets and social media channels.
Questions About Timing and Transparency
The memo raises troubling questions about regulatory oversight during the pandemic’s most critical phase. If FDA reviewers could determine causal relationships between vaccines and child deaths, why did this analysis take nearly four years to complete? The document suggests political pressure may have influenced the agency’s aggressive pediatric vaccination stance despite emerging safety signals.
The timing appears particularly damaging for public health authorities who consistently promoted vaccines as safe and effective for children. Parents were assured that myocarditis risks from COVID infection exceeded those from vaccination, a claim the memo apparently challenges. This discrepancy between public messaging and internal analysis could fundamentally alter how Americans view government health recommendations in future emergencies.
