Drug Companies Hide Covid-19 Vaccine Injuries, Scientist Tells FDA
Agency Ignores Public Pleas to Spare the Children
Note to Readers: I am a licensed elementary school teacher, a researcher, and a child safety advocate. I am not a doctor. The information provided in this newsletter is not intended as medical advice and should not be interpreted as such. Consult your child’s doctor on all matters related to the health and well-being of your child.
In explosive testimony at a major FDA meeting on Tuesday, the husband of a vaccine-injured woman accused pharmaceutical companies of hiding serious injuries suffered by participants in the clinical trials of Covid-19 vaccines.
Utah scientist Dr. Brian Dressen, PhD, urged the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) not to approve Pfizer’s Covid-19 vaccine for children ages 5 to 11.
"Your decision is being rushed, based on incomplete data from underpowered trials. The Pfizer vaccine fails any reasonable risk-benefit calculus in connection with children,” Dressen told the panel.
In arguing against emergency use authorization for this age group, Dressen was joined by numerous other scientists and lay people. Dressen’s plea was based on his professional knowledge as a chemist as well as his personal experience as a husband. Dressen told the panel that his wife, Brianne, was severely injured in a Covid-19 vaccine clinical trial during the fall of 2020. Because she suffered a serious reaction to her first dose of the experimental vaccine, she was unable to take the second dose. He said the company, AstraZeneca, responded by dropping her from the trial and blocking her access to the study app, where participants were instructed to report their side effects.
Dressen said that when the company published its final report of the clinical trial, his wife’s severe adverse reaction was nowhere to be found. He noted that the drug company’s clinical trial report listed 266 participants who were dropped, with little explanation, from the trial following an adverse reaction, including 56 who had neurological reactions. AstraZeneca’s Covid-19 vaccine subsequently was approved and has been used extensively in Europe.
Dressen said he has since been in touch with other Covid-19 vaccine clinical trial participants – adults as well as teens – who suffered severe reactions that were likewise swept under the rug.
The vaccine-injured, who now number in at least the tens of thousands and have formed support groups,[1] are being ignored, he said, not just by the vaccine makers, but by the FDA and CDC. "I do not wish this nightmare on my worst enemy, let alone a child," he said.
Dressen’s claims of being ignored were subsequently validated, when not a single member of the FDA committee acknowledged his wife’s injury or any of the numerous neurological injuries described to them during public comments that day.
Among others with a personal story to share was dental hygienist Kristi Dobbs, who received the Pfizer vaccine. Dobbs said that immediately after her first dose, she suffered tingling in her arm, difficulty breathing and a spike in blood pressure that was so severe it could have caused a stroke. Three days later, her body was ravaged with sharp stabbing pain, paresthesia, full-body tremors, a sensation of internal vibration, tinnitus, extreme fatigue, and insomnia. Many of her symptoms persist to this day. She has seen 15 doctors and corresponded with officials at the FDA and CDC, among others, seeking help, but to no avail.
Dobbs said she has since met countless Americans with serious injuries from a Covid-19 vaccine. “Because of the intentional suppression of these reactions, the injured have been unable to get essential medical care or research for treatment, and there is no clear recovery plan or financial support. We are being silenced, abandoned, and cast aside as collateral damage,” she said.
With permission from the family, Dobbs also shared the story of 12-year-old Maddie de Garay, who was critically injured in Pfizer's Covid-19 vaccine clinical trial for children ages 12 to 17. In its final report, Pfizer coded Maddie’s injury as “functional abdominal pain,” when in fact she was wheelchair-bound with a feeding tube. She remains so to this day.[2] Dobbs said Maddie has had no help from Pfizer or the FDA and no real medical assistance of any kind. She noted that the directors of both the FDA and CDC have been aware of these injuries for many months but remain silent.
Dobb’s testimony followed that of Amy Alvo, whose healthy 17-year-old daughter, Abigail, received the Pfizer vaccine in March 2021 and immediately felt faint. The next day she passed out at work. She subsequently lost the use of her legs. She ended up in the hospital, where she was diagnosed with a serious neurological reaction to the vaccine. Doctors have been unable to help her. They have no answers, short-term or long-term, about her prospects for recovery. She lives in California, where the governor is demanding that all students be "fully vaccinated" to attend school. Her family has applied for a medical exemption so that she does not have to get the second dose. Their request has been denied. The Alvo family is being told they should try one of the other Covid-19 vaccines.
The Sound of Silence
In the follow-up question-and-answer period, not one FDA committee member bothered to ask Pfizer’s Senior Vice President for Vaccine Clinical Research and Development, Dr. William Gruber, MD, about these injuries. Nor was Gruber asked whether the company ever drops vaccine-injured participants from its clinical trials and/or fails to report the true extent of their injuries. Such activity would constitute criminal scientific misconduct and would invalidate all of the company’s Covid-19 vaccine trial results.
Instead, VRBPAC members continually thanked the perpetually smirking, sometimes laughing, Pfizer vice president for his presence at the meeting and his presentation of the vaccine clinical trial results, which, incidentally, showed no meaningful benefit in the 5 to 11 age group. No child in either the experimental (vaccinated) or control group (unvaccinated) suffered serious illness, hospitalization, or death from Covid-19. Gruber acknowledged that the company did not test the vaccine’s ability to reduce transmission, even while he falsely claimed that vaccinating all the children with Pfizer’s vaccine would help the United States achieve herd immunity. Unless a vaccine halts transmission, it can play no role in helping a nation to achieve herd immunity.
Despite the lack of meaningful benefits, and the many reports of critical injuries, VRBPAC proceeded to rubber stamp the Biden Administration’s decision to vaccinate children ages 5 to 11 against Covid-19. The committee members, a shocking number of whom had financial ties to Pfizer or other serious conflicts of interest,[3] embraced fuzzy math to help Pfizer claim that “the benefits outweigh the risks” of vaccinating school-age children against this virus.
In his presentation of the clinical trial data for the 5 to 11 age group, Gruber reported no serious adverse reactions in the vaccinated group. Yet, 49 children in this group were dropped from the study for what were described as “important protocol violations.” Philanthropist and Covid-19 early treatment advocate Steve Kirsch noted during his public comments that this number was six times higher than the number of children who were dropped from the control group. “The odds of that happening are one in 10,000,” he said. Pfizer has offered no adequate explanation for this important deviation, Kirsch said, and none of the FDA panelists bothered asking Gruber about it.
Did some or all of these children suffer serious reactions? This question demands an immediate answer. The children now urgently need to be located and their health independently assessed, along with all of the 1,518 children who were vaccinated in this grossly abbreviated and underpowered clinical trial. Pfizer has a long history of criminal fraud and deceit.[4] None of its trial results should be accepted without independent verification.
While VRBPAC’s discussion of possible adverse events in children focused exclusively on the risk of vaccine-induced myocarditis, most of the injuries described during public comments were neurological. They echoed the complaints of hundreds of thousands of vaccine recipients whose injuries have been reported to both the CDC’s Vaccine Adverse Event Reporting System (VAERS) and its European counterpart, EudraVigilance, but are now being ignored by the FDA and CDC.
During closing remarks, committee member Dr. Eric Rubin, who is also Editor-in-Chief of the New England Journal of Medicine, momentarily seemed to forget that members of the public were listening when he said the quiet part out loud: “We're never going to learn how safe this vaccine is unless we start giving it.” Rubin casually noted that this is how the FDA has learned about serious side effects in other vaccines.
Apparently, pharmaceutical companies no longer need to design and execute proper clinical trials, since tens of millions of children in the U.S. are always just one mandate away from becoming part of a large vaccine experiment themselves.
The FDA clearly has abdicated its role as watchdog to protect the public from dangerous drugs and vaccines. Who will step up to fill the void? Where is Congress? Where are the nation’s governors and attorneys general?
Please see Dr. Toby Roger’s Call to Action, Part 2, for what you can do to help stop this runaway train.
Let's go! Call to action, part 2, CDC - by Toby Rogers - uTobian (substack.com)
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[3] FDA Committee Members Reviewing Pfizer Vaccine For Children Have Worked For Pfizer, Have Big Pfizer Connections - National File
[4] https://www.justice.gov/opa/pr/justice-department-announces-largest-health-care-fraud-settlement-its-history
Here is the letter I sent, via email today, to the members of the CDC committee that will determine the fate of millions of our nation's children on Tuesday.
To the members of ACIP:
Why is 12-year-old Maddie de Garay, who bravely participated in Pfizer's Covid-19 clinical trial and was critically injured as a result, listed in Pfizer's report as having suffered only "functional abdominal pain?" Maddie now has a feeding tube and is wheelchair-bound.
In the recent Pfizer clinical trial for children 5-11, why were six times as many children in the treatment arm dropped from the trial, relative to the control group. What happened to these 49 children? Did they suffer serious side effects? Is that why they were dropped?
During Tuesday's public comments, one person after another told VRBPAC that they or a loved one had suffered serious neurological injuries from a Covid-19 vaccine -- injuries that included paralysis, sharp stabbing pain, paresthesia, full-body tremor, internal vibration, headache, tinnitus, extreme fatigue, and insomnia. Many of these injuries have not subsided even after many weeks or months. They appear to be permanent. The clinical trials did not report these possible side effects of Covid-19 vaccination, even though they appear to be anything but rare. Yet, not a single member of VRBPAC acknowledged these injuries or asked about any of these conditions.
Will it be okay with you if children under the age of 12 now develop these chronic, debilitating conditions from vaccination? Who will take care of them? Who will pay for all their medical treatment? Will you?
These are not rhetorical questions. We expect an answer. You will not be able to hide behind the censors at Twitter, Facebook, and Google forever. Those of us who care about our nation's children, and fear for them under a regime that is so obviously indifferent to their safety, are finding each other. We are talking. We are talking about you. And we are on to you.
This is why you must vote NO to emergency use authorization of the Pfizer vaccine for children 5 - 11. This farce has gone on long enough.
You can read more about yourself here:
Fauci's Glaring Cohort Problem - by Darby Shaw - Kids, Covid, and Covid Vaccines (substack.com)
and here:
Drug Companies Hide Covid-19 Vaccine Injuries, Scientist Tells FDA - by Darby Shaw - Kids, Covid, and Covid Vaccines (substack.com)
Sincerely,
Darby Shaw
This is very well put, your summary is very accurate. The FDA members listened to these impassioned, factual, or deeply personal stories from members of the public, did not give them even a single remark, talked about "minimizing school disruption" (which is caused by Covidiot quarantine rules, not by Covid cases), ignored waning immunity and future need for boosters, and rubber stamped the approval.