Child Injured in COVID Jab Trial Is Ignored
- February 19, 2024
Story at-a-glance
- Maddie de Garay signed up to participate in Pfizer’s COVID-19 clinical trial for 12- to 15-year-olds in early 2021. Within 12 hours of her second dose, she suffered a severe systemic adverse reaction that left her wheelchair-bound and on a feeding tube
- Maddie’s severe adverse reactions have been ignored by Pfizer, the U.S. Food and Drug Administration and the Centers for Disease Control and Prevention. She’s received no help from any of them, financial or medical, and Pfizer even went so far as to lie about her status, describing it as “functional abdominal pain” in a report to the FDA
- One government official who isn’t turning a blind eye to the devastating effects of the COVID shots is Florida Surgeon General Dr. Joseph Ladapo. In a January 3, 2024, press release, Ladapo is calling for an end to the use of COVID-19 mRNA shots, citing concerns about DNA fragments in the products
- According to the FDA’s guidance on DNA in vaccines, “DNA integration could theoretically impact a human’s oncogenes — the genes which can transform a healthy cell into a cancerous cell,” and “may result in chromosomal instability”
- The FDA has not provided any evidence that DNA integration assessments have been conducted to address the health risks listed in its own guidance on DNA in vaccines, published in 2007. Consequently, the mRNA shots are “not appropriate for use in human beings,” Ladapo says
When Stephanie de Garay allowed her three children to sign up for Pfizer’s COVID-19 clinical trial for 12- to 15-year-olds, she assumed the worst that could happen was anaphylactic shock — and in that case, they’d be treated with an EpiPen and be fine. From her daughter’s perspective, the trial was a way to keep up with a close friend who had already signed up for it.
It also didn’t hurt that the trial offered monetary compensation of $119 per visit.1 This is what prompted all three of de Garay’s children to sign up for the COVID-19 shot trial, which changed the life of de Garay’s daughter Maddie. A healthy 12-year-old girl prior to the trial, Maddie loved to dance, play soccer and spend time with her friends.
She suffered a severe systemic adverse reaction to her second dose of the shot and struggled through 11 ER visits and four hospital admissions in the year and a half that followed. Injuries from the shot have left her unable to walk or eat — she receives her nutrition via a feeding tube — and suffering from constant pain, vision problems, tinnitus, allergic reactions and lack of neck control.2
As though the physical trauma weren’t enough, Maddie and her family were continually dismissed by the medical professionals put in place to help, ignored by the U.S. Food and Drug Administration and denied the care needed. Instead, the family was told Maddie’s problems were psychological, and she underwent cognitive-behavioral therapy, to no avail, as one might expect.
Broken Trust
In the January 21, 2024, “Full Measure” report above, investigative journalist Sharyl Attkisson reviews Maddie’s case. Maddie received her second dose January 20, 2021. Within 12 hours, frightful symptoms set in. Electric shocks were shooting up her spine and it felt like her heart was being “ripped out.”
She suffered chest and abdominal pains. Her toes and fingers turned white and ice cold. In short order, she lost feeling in her legs and could no longer walk. She started passing out and lost her swallow reflex. Despite what happened to Maddie, Pfizer announced the children’s trial had been a success, and that their COVID shot had a “favorable safety profile.”
According to de Garay, Pfizer and U.S. regulators refused to acknowledge that Maddie had been injured by the shot. They also failed to properly record her injuries in an apparent effort to downplay the severity of them. For example, in an April 2021 disclosure to the FDA, Pfizer described Maddie’s side effects as “functional abdominal pain,”3 even though she was wheelchair bound and couldn’t even swallow food.
Maddie has now been diagnosed with chronic inflammatory demyelinating polyneuropathy (CIDP) — a rare autoimmune disease in which the immune system attacks and destroys the myelin sheaths around nerve cells. Maddie has not received any help — financial or medical — from Pfizer, the FDA or the Centers for Disease Control and Prevention.
When asked what her daughter’s ordeal has taught her, de Garay says it has opened her eyes. She used to trust government officials, doctors and hospitals, but “What I thought they were is not what they are,” she says.
Indeed, if anything, Maddie’s story should serve as a warning to all. It shows just how callous the vaccine industry and its protectors are. You are the guinea pig, and if something goes wrong, you’re on your own. You won’t even get an apology, let alone any actual aid.
Pfizer Classified Severe Reactions as ‘Not Related’ to Shots
The FDA and Pfizer tried to hide the COVID-19 shot clinical trial data for 75 years, but the FDA was eventually ordered by the U.S. District Court for the Northern District of Texas to release trial documents on a much faster schedule. As part of the court order, 80,000 pages of documents related to the FDA’s approval of Pfizer’s COVID-19 shots were released June 1, 2022.4
Among those documents were case report forms (CRFs) revealing that deaths and severe adverse events took place during Phase 3 trials, most of which were classified as “not related” to the shot.5
Examples include a woman in her early 50s who died from a heart attack five days after she’d received the second dose of Pfizer’s experimental COVID-19 shot. Her death was listed as “not related” to the shots. The death of a teenage girl who suffered deep vein thrombosis two months after her second dose was also deemed “not related.” As reported by independent journalist Michael Nevradakis, for Children’s Health Defense:6
“The many serious adverse events — and several deaths — recorded during the Phase 3 trials are also apparent in a separate, massive document exceeding 2,500 pages, cataloging such adverse events.
This document lists a wide range of adverse events suffered by trial participants classified as toxicity level 4 — the highest and most serious such level.
However, not one of the level 4 (most severe) adverse events listed in this particular document is classified as being related to the vaccination … Similarly, only a small number of toxicity level 3 adverse events were indicated as having been ‘related’ to vaccination.”
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Download PDFThe FDA Ignored Maddie’s Case
Just as it ignored the many red flags in Pfizer’s clinical trial data, the FDA also ignored Maddie’s case, even when attorneys got involved. In August 2021, the de Garays reached out to ICAN’s legal team; ICAN’s Aaron Siri now represents them. According to Siri:7
“What happened to Maddie is not only the story of an injury to a child, which is heartbreaking in and of itself. But Maddie was in a clinical trial that only had 1,000 children in the age bracket of 12 to 15 years old that got the COVID-19 vaccine.
When she suffered that reaction, there should have been every medical expert at Cincinnati and at the FDA that should have descended to study what happened to Maddie, because if that could happen to one in 1,000 children, the repercussions could be really devastating, especially for an infection that doesn’t harm children anywhere near that rate.”
After ICAN’s team got Maddie’s medical records and reviewed them, they believe the causal connection to Pfizer’s COVID-19 shot is extraordinarily strong. In October 2021, they sent a letter to the FDA, including all of Maddie’s medical records and highlighting how Pfizer downplayed the condition in their disclosure, describing Pfizer’s move as “at best dishonest. To regulators, it should be criminal.”8
In February 2022, the FDA finally responded, incredulously by saying to file a VAERS report or send a letter to CISA, the Clinical Immunization Safety Assessment Project, which is run by Dr. Kathryn Edwards, who sits on the data safety monitoring board for Pfizer’s COVID-19 shot trials. In other words, they did nothing.9
Maddie’s story is ongoing and, sadly, is only one of many cases of people being seriously injured or killed by COVID-19 shots and not being taken seriously — or outright discredited — by health care providers and health officials. However, there is hope, and it comes in the form of protecting your right to informed consent and the freedom to make your own medical choices. As Siri put it:10
“The hope is that we make sure that we always have the choice to say no. As long as we can say no, that is the safeguard. That is the stopgap to all of this bad conduct. It’s not going to protect those who don’t know better to say no in certain situations, but it will protect those who do …
Freedom of speech, the ability to have individual liberties. That is what will save us … The ability to become educated, to have access to information and to make informed decisions … the ability to say no about something, or a medical procedure, that we don’t want to have on our bodies or our children’s bodies.”
Florida Surgeon General Calls for Halt to COVID Shots
One government official who isn’t turning a blind eye to the devastating effects of the COVID shots is Florida Surgeon General Dr. Joseph Ladapo. Early on in the pandemic, he published articles criticizing lockdown measures and calling for the adoption of early treatment.11
In March 2022, he recommended against COVID-19 shots for healthy children,12 making Florida the first state to break with official CDC guidance.
In February 2023, he issued an official health alert13 warning that the COVID mRNA shots were associated with a “substantial increase” in reports of adverse events in Florida, and that fall, he again broke off from the official policy by urging people under 65 to avoid further boosters.14
Now, in a January 3, 2024, press release, Ladapo is calling for an end to the use of COVID-19 mRNA shots, citing concerns about DNA fragments in the products.15
In a December 6, 2023, letter sent to the FDA and CDC, Ladapo outlined findings showing the presence of lipid nanoparticle complexes and simian virus 40 (SV40) promoter/enhancer DNA in the COVID shots. As noted in the Florida Health January 3 press release:16
“Lipid nanoparticles are an efficient vehicle for delivery of the mRNA in the COVID-19 vaccines into human cells and may therefore be an equally efficient vehicle for delivering contaminant DNA into human cells. The presence of SV40 promoter/enhancer DNA may also pose a unique and heightened risk of DNA integration into human cells.”
The presence of SV40 promoter and other DNA fragments was first reported17 by microbiologist Kevin McKernan in early April 2023. McKernan is a former researcher and team leader for the MIT Human Genome project. I wrote about these findings in “Monkey Virus DNA Found in COVID-19 Shots,” posted at the end of May 2023.
According to McKernan, “Multiple assays support DNA contamination that exceeds the European Medicines Agency (EMA) 330ng/mg requirement and the FDAs 10ng/dose requirements.” The FDA ought to be well aware of the potential hazards posed by this DNA contamination, considering its own guidance on DNA in vaccines, published in 2007, states that:18
- “DNA integration could theoretically impact a human’s oncogenes — the genes which can transform a healthy cell into a cancerous cell.
- DNA integration may result in chromosomal instability.
- The Guidance for Industry discusses biodistribution of DNA vaccines and how such integration could affect unintended parts of the body including blood, heart, brain, liver, kidney, bone marrow, ovaries/testes, lung, draining lymph nodes, spleen, the site of administration and subcutis at injection site.”
FDA Didn’t Perform DNA Integration Assessments
The FDA responded to Ladapo’s letter December 14, 2023, but provided no evidence indicating that DNA integration assessments had been conducted on mRNA COVID-19 shots to address the risks listed in its own guidance document.
As a result, Ladapo is now calling for a halt in their use:19
“The FDA’s response does not provide data or evidence that the DNA integration assessments they recommended themselves have been performed.
Instead, they pointed to genotoxicity studies — which are inadequate assessments for DNA integration risk. In addition, they obfuscated the difference between the SV40 promoter/enhancer and SV40 proteins, two elements that are distinct.
DNA integration poses a unique and elevated risk to human health and to the integrity of the human genome, including the risk that DNA integrated into sperm or egg gametes could be passed onto offspring of mRNA COVID-19 vaccine recipients.
If the risks of DNA integration have not been assessed for mRNA COVID-19 vaccines, these vaccines are not appropriate for use in human beings ... It is my hope that, in regard to COVID-19, the FDA will one day seriously consider its regulatory responsibility to protect human health, including the integrity of the human genome.”
As noted by board-certified internist and cardiologist Dr. Peter McCullough, Ladapo is hardly alone in this. Tens of thousands of medical professionals and scientists around the world want to see the COVID shots withdrawn from the market:20
“The Florida State Surgeon General’s announcement today is a milestone as more government officials join a chorus calling for recall of COVID-19 vaccines including myself (US Senate, multiple State Senates, EU Parliament, UK Parliament), 17,000 physicians representing the Global COVID-19 Summit, Australian scientists, the World Council for Health, and the Association of American Physicians and Surgeons.”
Resources for Those Injured by the COVID Jab
Based on data from across the world, it’s beyond clear that the COVID shots are the most dangerous drugs ever deployed. In addition to the contamination problem, recent research also shows that flaws in the codon optimization process is causing the shots to produce off-target proteins with unknown health effects and risks.
If you already got one or more COVID jabs and are now reconsidering, you’d be wise to avoid all vaccines from here on, as you need to end the assault on your body. Even if you haven’t experienced any obvious side effects, your health may still be impacted long-term, so don’t take any more shots.
If you’re suffering from side effects, your first order of business is to eliminate the spike protein — and/or any aberrant off-target protein — that your body is producing. Two remedies shown to bind to and facilitate the removal of SARS-CoV-2 spike protein are hydroxychloroquine and ivermectin. I don’t know if these drugs will work on off-target proteins and nanolipid accumulation as well, but it probably wouldn’t hurt to try.
The Front Line COVID-19 Critical Care Alliance (FLCCC) has developed a post-vaccine treatment protocol called I-RECOVER. Since the protocol is continuously updated as more data become available, your best bet is to download the latest version straight from the FLCCC website at covid19criticalcare.com.21
For additional suggestions, check out the World Health Council’s spike protein detox guide,22 which focuses on natural substances like herbs, supplements and teas. Sauna therapy can also help eliminate toxic and misfolded proteins by stimulating autophagy.
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