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FDA Ignores Warnings of High Incidence of Serious Injury and Death Following Injections

by Tobin Owl

· Health,Fraud,Vaccines

Above: 12 year old Maddie de Garay was left paralized during the Pfizer trials for kids. Her injury from the Pfizer inoculation was omitted from Pfizer Covid-19 vaccine trial results.

Last revised, Oct. 9, 2021

On September 17, 2021, the FDA held a virtual meeting to discuss Pfizer-BioNTech's application for the administration of a third dose, or booster shot, of their Covid vaccine.

After the open public hearing session began at around 4 hours into the meeting, things got interesting...

No evidence Covid vaccines are safe 

At 4 hours 17-19 minutes, emergency medical physician Dr. Joseph Fraiman expressed his urgent concern about vaccine hesitancy, that intelligent people who scrutinize the data, like the nurses he works with, are not convinced that their risk of dying from Covid-19 outweighs the risk from taking the vaccines. He underlines the lack of clinical data showing that the vaccines contribute to a reduction in hospitalizations:

 

"Demand the booster trials are large enough to find a reduction in hospitalizations. Without this data, we the medical establishment cannot confidently call out anti-Covid-vaccine activists who publicly claim the vaccines harm more than they save, especially in the young and healthy.  The fact that we do not have the evidence to say these activists are wrong should terrify us all."

All evidence to the contrary

Following Mr. Fraiman was Dr. Steve Kirsch, executive director of the Covid-19 Early Treatment Fund (min. 4:21-24). While Mr. Fraiman's concern about the lack of clinical evidence for a reduction in hospitalizations was real, he neglected to mention what Kirsh called "the elephant in the room that nobody likes to talk about," the fact that all the data is already there to show that those menacing anti-Covid-vaccine activists Fraiman and others would like to get rid of are right, that "the vaccines kill more people than they save." Fraiman wants a large vaccine trial "to find" that the vaccines are safe and effective. In other words, he wants a trial with pre-described results so the establishment can continue to sweep aside the inconvenient data it already has.

Says Kirsch,

"Today we focus on Covid-death-saves and vaccine efficacy because we were led to believe that vaccines were perfectly safe, but this is simply not true.

 

"For example, there are four times as many heart attacks in the treatment group in the six-month Pfizer trial report. That wasn’t bad luck, VAERS shows heart attacks happen 71 times more often following these vaccines compared to any other vaccine. In all, 20 people died who got the drug, 14 people died who got the placebo--few people notice that. If the net all-cause mortality from the vaccines is negative, vaccines, boosters and mandates are all nonsensical. This is the case today."

 

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Later Kirsch adds:

"It's pretty clear that the Pfizer trial results were gamed. It's statistically impossible for protocol violations to be 5 times higher in the treatment group. Why hasn't this been investigated?

 

...Maddie de Garay was 12 when she enrolled in the Pfizer phase 3 trial for kids. Now she's paralyzed for life. It wasn't recorded in the Pfizer results... it was never investigated. Please tell us why this fraud wasn't investigated."

If you think it's something odd and new that vaccine manufacturers would falsify data and cover up injuries and deaths caused by their products, think again.  Why would a mega-billion dollar industry do anything else? Ethical concerns? Nonsense.

Above: Before Maddie's injury, her parents were enthusiastically pro-vaccine and enrolled all three of their children in the Pfizer trials. The vaccine left Maddie not only paralized, but with other serious injuries she and her parents must now cope with every day of their lives.

Kirsch finished up his comments with the following:

"Early treatments are much better alternative to boosters. The proof is that in Israel cases are at an all-time high. In India, Butar Pradesh is now Covid-19 free, as of today. Almost nobody there is vaccinated."

What is VAERS data? What does it show?

During his presentation, Kirsch makes reference to VAERS data, something the general public may be unfamiliar with. VAERS is the Center for Disease Control and Prevention's (the CDC's) system for collecting reports on vaccine-related injuries: the Vaccine Adverse Event Reporting System (VAERS). 

With relation to the following slide, Kirsch says, "Only the VAERS numbers are statistically significant, but the other numbers are troubling. Even if the vaccines had 100% protection, it still means we killed two people to save one life." 

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He continues:

"Four experts did analysis using completely different non-US data sources, and all of them came up with approximately the same number of excess vaccine-related deaths: about 411 deaths per million doses. That translates into, 150,000 people have died."

I'm pretty sure he means in the U.S. 150,000 people have died from the vaccines:

411 deaths per million doses X 365 million doses =

 ˜150,000 vaccine-related deaths

While this number is much higher than VAERS death reports for the vaccines (tallying at nearly 16,000 Covid-vaccine-related deaths at the time of this writing and an astounding, unprecedented number on it's own), it should be noted that a large majority of vaccine adverse events are never reported. According to the Lazarus report, covering data between 2007 and 2010, (p. 6):

Adverse events from drugs and vaccines are common, but underreported. Although 25% of ambulatory patients experience an adverse drug event, less than 0.3% of all adverse drug eventsand 1-13% of serious events are reported to the Food and Drug Administration (FDA). Likewise, fewer than 1% of vaccine adverse events are reported. Low reporting rates preclude or slow the identification of “problem” drugs and vaccines that endanger public health. New surveillance methods for drug and vaccine adverse effects are needed. Barriers to reporting include a lack of clinician awareness, uncertainty about when and what to report, as well as the burdens of reporting: reporting is not part of clinicians’ usual workflow, takes time, and is duplicative.

(Emphasis added)

In fact, while CDC guidelines require adverse events to be reported by corresponding physicians or institutions, the truth is that hospitals de-incentivize reporting, even threatening jobs of those who might take it upon themsleves to do so.   

Of note in the meeting, Dr. Jessica Rose (beginning at 4:09:50), a viral immunologist and computational biologist, analyses the extremely atypical VAERS data for 2021. Below is the first slide in her presentation:

"This is a bar plot that shows the past ten years of VAERS data plotted against the total number of adverse event reports, for all vaccines for the years 2011 to 2020, and for Covid-associated products only for 2021. The left bar plot represents all adverse event reports, and the right bar plot represents all death adverse event reports. There's an over 1000% increase in the total number of adverse events for 2021, and we're not done with 2021. This is highly anomalous ... These increased reportings are not due to increased rates of infection, and are not due to stimulated reporting."

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She goes on to say that the FDA, the CDC and policy makers must address these issues that, in her opinion, "outweigh any potential benefits from these products, especially for children."

A peer-reviewed study was published by Dr. Rose earlier this year showing that the FDA's hypothosis, that there is "no relationship" between VAERS death reports and Covid vaccines, does not explain the clustering of deaths shortly after administration. A brief article summarizes Dr. Rose's study:

"Do the data support non-causality? No. A new peer-reviewed study has found deaths clustered near the day of vaccine exposure, which is inconsistent with non-causality, and a dramatic increase in the autoimmune reports associated with COVID19 vaccination, consistent with predictions made by earlier studies predicting specific autoimmmune-related reactions based on the SARS-CoV-2 virus proteins."

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Above graph: J. Rose (2021)

Study published in Toxicology confirms Kirsch's conclusions

In a post-meeting letter, Kirsch stated:

"All my emails have been disregarded by committee members, CDC, FDA, and NIH. 

 

Politifact rated my remarks 'Pants on fire!'

 

Nobody cited any evidence that disputed my analysis. Nobody ever has. My analysis was dismissed with hand-waving arguments without data. The FDA said 'we don't agree' and refused to engage further."

To Kirsch's favor, he tells of his late discovery of a paper published in Toxicology that confirms his own findings (excerpt from Kirsh's letter below):

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The Toxicology article, titled "Why are we vaccinating children for Covid-19?", states in the abstract:

"...Most importantly, the clinical trials did not address long-term effects that, if serious, would be borne by children/adolescents for potentially decades.

 

A novel best-case scenario cost-benefit analysis showed very conservatively that there are five times the number of deaths attributable to each inoculation vs. those attributable to COVID-19 in the most vulnerable 65+ demographic. The risk of death from COVID-19 decreases drastically as age decreases, and the longer-term effects of the inoculations on lower age groups will increase their risk-benefit ratio, perhaps substantially."

(Emphasis in original)

The Introduction (Section 1) briefly discusses VAERS results up to June 2021 and also qualifies that Covid "vaccines" do not meet the legal criteria for vaccines since they do not prevent infection or transmission:

"In the remainder of this article, we use the term ‘inoculated’ rather than vaccinated, because the injected material in the present COVID-19 inoculations prevents neither viral infection nor transmission. Since its main function in practice appears to be symptom suppression, it is operationally a 'treatment'."

What do Covid-19 death statistics mean?

Section 2.1 of the article in Toxicology reviews the history of the pandemic. The following seems important to note:

"By the end of May 2021, the official CDC death count attributed to COVID-19 was approaching 600,000, as stated previously. This number has been disputed for many reasons. First, before COVID-19 testing began, or in the absence of testing, after it was available, the diagnosis of COVID-19 (in the USA) could be made by the presumption of the healthcare practitioner that COVID-19 existed [4,18]. Second, after testing began, the main diagnostic used was the RT-PCR test. This test was done at very high amplification cycles, ranging up to 45 [19–21]. In this range, very high numbers of false positives are possible [22]. Third, most deaths attributed to COVID-19 were elderly with high comorbidities [1,22]. As we showed in a previous study [22], attribution of death to one of many possible comorbidities or especially toxic exposures in combinations [23] is highly arbitrary and can be viewed as a political decision more than a medical decision. For over 5 % of these deaths, COVID-19 was the only cause mentioned on the death certificate. For deaths with conditions or causes in addition to COVID-19, on average, there were 4.0 additional conditions or causes per death [24]. These deaths with comorbidities could equally have been ascribed to any of the comorbidities [22]. Thus, the actual number of COVID-19-based deaths in the USA may have been on the order of 35, 000 or less, characteristic of a mild flu season. Even the 35,000 deaths may be an overestimate. ... If pre-clinical conditions had been taken into account and coupled with the false positives as well, the CDC estimate of 94% misdiagnosis would be substantially higher."

(Emphasis added)

Unfortunately, this last statement about the "CDC estimate of 94% misdiagnosis" is somewhat misleading. I don't believe the CDC, a subsidiary of the FDA, ever admitted misdiagnosis. What is true is that the CDC reported that 94% of deaths it attributed to Covid-19 involved an average of 4 other underlying causes of death. The fact remains that if the CDC had not unilaterally, without authorization, warning, or opportunity for public comment (i.e. illegally on all acounts), changed the way deaths were recorded, then it would not be counting those 94% as Covid deaths: Covid would have been listed as a secondary contributor to death on the death certificates, if at all. 

In section 3.2, the Toxicology study notes:

"In contrast to the pandemic buildup phase, where many who died with COVID-19 were assumed to have died from COVID-19 by the medical community and the CDC, the post-inoculation deaths reported in VAERS are assumed by the CDC to be mostly from causes other than the inoculations."

Comparing Covid death reporting with potential deaths caused by vaccines

Finally, in the Conclusion (section 5), the study notes:

“Additionally, VAERS historically has under-reported adverse events by about two orders-of-magnitude, so COVID-19 inoculation deaths in the short-term could be in the hundreds of thousands for the USA for the period mid-December 2020 to the end of May 2021, potentially swamping the real COVID-19 deaths. Finally, the VAERS deaths reported so far are for the very short term. We have no idea what the death numbers will be in the intermediate and long-term; the clinical trials did not test for those.”

(Emphasis added)

Other speakers in the FDA VRBPAC public hearing, including David Weisman, Ph. D. (who followed Kirsch at 4:24), brought out similar concerns involving vaccine injuries;  still others continued to talk about the need to produce vaccines as quickly as possible to "vaccinate the entire world", simply ignoring the fact that the vaccines increase rather than decrease the incidence of disease and death.

Here's what consumer representative Kim Witzak (4:36:50) had to say:

"While boosters may be good for business, let's be real. These m-RNA vaccines were never designed to stop transmission or erradicate the virus...

 

Let's take a step back and look at the bigger picture. First, the government incentivizes--more like bribes--people to get these shots. Then we are told about the possible need for boosters while shaming and blaming the unvaccinated. Now the government is forcing them with mandates. Is there a reason we want everyone to be vaccinated? Is it so adverse events can't be distinguised between vaccines and the virus? ...

 

Politics and fear seem to be in the driver's seat. Facts around data and science can no longer can not be debated or openly questioned without being labeled as misinformation.

 

Just look at what the professional medical societies are collectively doing: threatening vaxxers with losing their license if they deviate from the official protocol or narrative established by CDC and public officials like Dr. Fauci. People are not being allowed to talk about their negative experiences without being harrassed or being called an anti-vaxxer...

 

Finally, I would be remiss if I failed to have mentioned the hundreds of thousands of people who paid the high price by doing the right thing for the greater good. Their lives have been forever changed.

 

I don't have enough time to begin to touch on the currently reported safety issues impacting tens of thousands, including children and young adults, and all the future safety issues not yet realized. Ladies and gentlemen, we are part of the largest pharmaceutical experiment ever conducted on human kind.

 

Media coverage of vaccine injuries

"Private capital tends to become concentrated in few hands... The result of this is an oligarchy of private capital...  Moreover, under existing conditions, private capitalists inevitably control, directly or indirectly, the main sources of information (press, radio, education). It is thus extremely difficult, and indeed in most cases quite impossible, for the individual citizen to come to objective conclusions..."

--Albert Einstien

Has the mainstream media covered vaccine-related injuries with any integrity?

From what I've seen, only Fox News has dared to cover any of it. The rest ignore it or play it down while playing up the pandemic scandal. Not surprisingly, it seems all the MSM care about are the same things as ever: keeping the public convinced vaccines are safe and effective and that the unvaccinated pose a risk to society.

In hopes of pushing that narrative further, WXYZ-TV (an ABC affiliate out of Detroit) asked its audience to contact them with stories of unvaccinated loved ones who had died of Covid. The response they got on Facebook was colossal but, as one commenter puts it, it was "the polar opposite" of what they were asking for. More than 182,000 responses are overwhelmingly stories of loved ones who were injured or killed by the vaccines or otherwise suffered mistreatment by the medical system.

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And on... and on... and on...

 

Related to this article:

The Deadly COVID-19 Vaccine Coverup, by Virginia Stoner (May 4, 2021)

Study Finds Patterns in VAERS Data that Provide Evidence of Causality, by James Lyons Weiler (Summarizes the study by Jessica Rose below. This short article is more accessible to the common reader)

 

Historical precedents of CDC and FDA fraud:

The Swine Flu Fraud of 76, (vintage 60 Minutes documentary)

Vaxxed, From Coverup to Catastrophe, (documentary film): How the CDC falsified study data that would have shown a causal realtionship between DPT vaccine and autism, and how outcries of hundreds of parents of vaccine-injured autistic children have been ignored.

House of Numbers, (documentary film): How questionable science, fautly tests, and an ever-expanding definiton of AIDS diseases has promoted widespread misperception and death-dealing antiviral chemotherapy drugs. House of Numbers documents one filmmaker's journey to try to understand the true meaning of AIDS.