Maddie de Garay was a 12-year-old participant in Pfizer's COVID-19 vaccine trial who developed severe neurological and gastrointestinal injuries that Pfizer classified as "functional abdominal pain" in its regulatory submissions.
Maddie de Garay was a healthy 12-year-old girl who participated in Pfizer's Covid-19 vaccine clinical trial for children 12–15 years of age. According to Siri, her case exemplifies how pharma companies misrepresent and suppress serious adverse events during clinical trials, and how the FDA accepts self-serving conclusions from pharma's own paid investigators.
Before the trial, Maddie was a typical healthy pre-teen — described as making dance videos on TikTok and "living the carefree life of a tween."
She was among the 1,131 children who received the vaccine in Pfizer's pediatric Covid-19 clinical trial for ages 12–15.
- Requiring a wheelchair for mobility
- Needing a feeding tube
- Multiple other serious health issues
Pfizer originally reported Maddie's injuries to the FDA as effectively "functional abdominal pain" — characterizing a case resulting in wheelchair dependence and a feeding tube as essentially a stomach ache.
The full scope of Maddie's injuries only became known to the FDA after:
1. Steve Kirsch (a tech entrepreneur, not an FDA official) emailed the then-acting FDA Commissioner
2. The FDA asked Pfizer for more information
3. Pfizer disclosed more of the injuries — but Pfizer's paid principal investigator (Dr. Robert Frenck, director of Gamble Vaccine Research Center, Cincinnati Children's Hospital) concluded he did not "feel" that Maddie's symptoms were "consistent with a vaccine related adverse event"
The FDA accepted this conclusion. Siri's firm sent numerous detailed letters to the FDA about Maddie's case. The FDA ignored them.
Siri's firm, on behalf of ICAN, sued the FDA in federal court to obtain internal FDA communications regarding how the agency handled Maddie's case. The resulting documents showed:
Siri uses Maddie's case to illustrate several systemic failures:
1. Underpowered trials: With only 1,131 vaccinated participants, the trial could not detect harms that might occur in 1 in 1,000 children — Maddie's type of injury could have occurred at that rate and remained statistically invisible
2. Pharma self-reporting: The pharma company seeking licensure (and billions in revenue) determines which adverse events are "related to the vaccine" — using the "judgment" of its own paid investigators rather than objective statistical comparison
3. FDA capture: The FDA accepted a self-serving conclusion from Pfizer's paid investigator with no independent review
4. Asymmetric treatment: For efficacy (symptom reduction), the FDA permitted a statistical comparison. For safety (deaths and serious injuries), the FDA permitted Pfizer to explain each case away individually
Maddie de Garay's mother, Stephanie de Garay, has testified before the U.S. Senate about her daughter's injuries. Siri cites her case as one of the clearest documented examples of the FDA's vaccine injury concealment system in action.
Pre-Licensure Safety Testing, FDA, Pfizer, VICP, ICAN, Aaron Siri, Post-Licensure Safety Monitoring
Maddie's case is an emblem of how the medical community treats vaccine-injured individuals. Her parents signed her up for a clinical trial out of trust in the medical system — and after she was injured, the same medical community "all but abandoned this family, even refusing Maddie treatment for her injuries." This pattern — dismissing, ignoring, or gaslighting families of vaccine-injured patients — is central to the argument that the system is not designed to care for the injured.
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