Tag: vaccine injury

A Young Child Died During Moderna Covid Vaccine Clinical Trial — Did FDA Know?

A preschool-aged child died of cardio-respiratory arrest after getting a COVID-19 booster in a Moderna clinical trial. However, Moderna didn’t reveal the death to the public and only recently reported it on a European regulatory agency database, Alex Berenson reported.

The death occurred in late 2022 or early 2023, Berenson said, when children under 5 who had already received Moderna’s original mRNA-1273 COVID-19 vaccine in the trial’s main phase were offered the “1273.214” booster against an early Omicron variant.

Berenson, a former New York Times reporter who now reports on his Unreported Truths Substack, today said the U.S. Food and Drug Administration (FDA) has declined to tell him whether the U.S. agency knew that a child died during Moderna’s clinical trial.

The failure of the FDA to provide a straightforward answer about whether it knew that a young child in a Moderna clinical trial died from cardiac-respiratory arrest is “vitally important,” Berenson told The Defender.

“Of all the mistakes public health authorities made around COVID, their insistence on pressing mRNA vaccines on children was probably the worst,” Berenson said.

By the time the COVID-19 vaccines were available for kids, it was clear that children were at almost no risk of serious illness or death from COVID-19, he said. “The shots had significant side effects, so the only rationale for giving them shots — even theoretically — was to reduce transmission.”

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British doctor has medical license revoked over warning of COVID shot dangers

British doctors continue to be removed from medical practice for warning patients of the dangers of the so-called mRNA COVID “vaccines.”

In December 2024, consultant psychiatrist Dr. Daniel Armstrong was struck off the medical register following his description of pharmaceutical companies as “evil.”

Armstrong had appeared in a video shared on BitChute in which he described the COVID regime and the attendant “vaccines” as part of a “deception on a grand scale” – saying the injections put people’s lives at risk. In the video, titled Navigating the Truth-Deception Duality, he said:

My message is clear to everyone: don’t take any more. You’ve a doctor here, he’s got his licence on the line – given it up. Don’t take any more of the injections. These guys are evil.

The tribunal which deprived Armstrong of his right to practice medicine concluded he was “highly likely in future to act so as to put patients at unwarranted risk of harm” – as the Daily Mail reported on January 2.

According to the minutes of the tribunal, an anonymous email alerted the General Medical Council to Armstrong’s video – which had been initially released on July 17, 2023.

The tribunal has found that Armstrong’s use of his medical credentials to warn the public of the dangers of the so-called vaccines is a violation of medical ethics, stating the physician had “undermined public health information and posed a serious risk to members of the public who may have placed reliance on his opinions.”

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Did COVID Vaccines Cost More Lives Than They Saved? Public Deserves a Rigorous, Truthful Evaluation

“Do you think there would have been less deaths overall if we hadn’t had a vaccine?”

This question was posed to Dr. Aseem Malhotra by Steven Bartlett during an interview on Bartlett’s podcast “Diary of a CEO.” To which Malhotra responded simply “Yes.”

Full Fact, a fact-checking organization, has written a verdict on Malhotra’s answer, claiming: “False. There is clear evidence that the vaccines saved far more lives than they cost.”

Part I: The illusion of certainty — Deconstructing claims of vaccine efficacy

The assertion that “There is clear evidence” of COVID-19 vaccines’ benefits outweighing their harms” exemplifies a dangerous oversimplification of complex medical realities.

This claim, often propagated by fact-checkers and mainstream narratives, fails to acknowledge the fundamental limitations in our current understanding and the methodological flaws inherent in much of the existing research.

The missing gold standard: Randomized controlled trials (RCTs)

In evidence-based medicine, properly conducted RCTs measuring all-cause mortality are the gold standard for determining an intervention’s overall impact. For COVID-19 vaccines, no such trials have demonstrated an all-cause mortality benefit.

The original trials were not designed or powered to detect differences in all-cause mortality, and follow-up periods were too short to capture long-term effects. Without this crucial evidence, claims of clear benefit are premature at best and misleading at worst.

The pitfalls of observational studies

In the absence of robust RCT data, fact-checkers often turn to observational studies. However, these studies are fraught with potential biases that consistently overestimate benefits and underestimate harm:

Selection distortion: Healthy user bias and time-dependent effects inflate apparent vaccine benefits and mask potential harms due to inherent differences in vaccinated groups and changing study conditions.

Temporal misclassification: Survivorship bias and miscategorization of vaccination status in early post-injection periods artificially inflate efficacy estimates and underestimate potential harms.

Classification bias: Vaccine status classification errors occur in a single direction, with the vaccinated often misclassified as unvaccinated. This results in infections and harms in the vaccinated being misattributed to the unvaccinated group, overestimating benefits and underestimating harms.

Reporting bias: Systematic underreporting of adverse events following vaccination due to factors like lack of recognition, dismissal of potential vaccine-related causes, or fear of professional repercussions leads to underestimation of vaccine risks and overstates safety.

Publication bias: The preferential publication and promotion of studies showing positive vaccine effects, coupled with the suppression or non-publication of studies showing no effect or negative effects, skews the overall body of evidence and public perception.

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Key senator says U.S. vaccine safety system failing, urges reforms to testing and liability

Sen. Ron Johnson, R-Wis., who next month will begin overseeing the Senate’s most powerful investigative body, says the government’s vaccine safety system is no longer protecting Americans adequately because of conflicts of interest and lack of transparency, and he is vowing to work with the incoming Trump administration to press for sweeping reforms.

Those reforms could range from changing the vaccine liability protections of drug makers to taxpayer funding and other changes to insure the independence of safety testing, he told Just the News.

“The best solution for this is actually make these products safer, and do real science to determine whether there are certain conditions that make you more vulnerable,” Johnson said in a wide-ranging interview on the Just the News, No Noise television show.

Asked whether the current safety system led by the Food and Drug Administration and Centers for Disease Control and Prevention was adequately protecting Americans, Johnson answered: “I would say absolutely not.”

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Shocking report in the UK finds 95% of COVID-19 deaths were among the vaccinated

The devastating truth behind the worldwide rollout of COVID-19 mRNA vaccines continues to come out, exposing a staggering reality that governments and corporations have either ignored or deliberately concealed. Official data released by the UK government has revealed an alarming surge in deaths among those who received the vaccination, starkly contrasting with the negligible impact on the unvaccinated population.

According to the UK Health Security Agency (UKHSA), as of July 2022, over 18.9 million people had refused the first dose of the COVID-19 injection, with another 21.5 million people refusing the second dose. Furthermore, a significant portion of those who received the first dose later refused additional injections, with 2.6 million people refusing the second and 30.4 million refusing the third shot. These figures indicate a widespread rejection of the vaccine, yet the ramifications for those who did comply with this “lifesaving” intervention were ultimately catastrophic.

The data, published by the UK government’s Office for National Statistics (ONS) in the “Deaths by Vaccination Status” dataset, is unequivocal. Between July 2021 and May 2023, there were 965,609 deaths among the vaccinated, compared to just 60,903 deaths among the unvaccinated. This stark disparity is a damning indictment of the policies that mandated and promoted these vaccines.

The UK’s vaccinated population, which accounted for 95% of all COVID-19 deaths, has suffered disproportionately high death rates in each age group since July 2021. The most dramatic increases were observed among the 80 to 89-year-old age group, with the highest number of vaccinated all-cause deaths soaring to 19,914 in December 2022.

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DO VACCINES CAUSE CHRONIC DISEASE?

FIRST, let’s start with a few relevant indisputable widely known FACTS:

  1. There has been a rise in unexplained all-cause-mortality (deaths from all causes) since the rollout of the COVID-19 “vaccines” (but not in 2020 when the virus was most virulent and there were no COVID “vaccines”.
  2. Vaccines, in general, are not subjected to properly designed long-term clinical trials to determine if they actually do more harm than good and/or cause chronic disease and increased mortality.
  3. It is possible to design a clinical trial to claim a vaccine is safe when it is not.
  4. The assessment of vaccine safety falls mainly on prescribing doctors to voluntarily report safety issues post-vaccination but most doctors are reluctant to do so – the under reporting factor for vaccine adverse events could be as high as 100x.With regard to Point 1. (above), I have addressed this issue in many Substacks. Up to now, there is no plausible and credible explanation except that the COVID “vaccines” are to blame based on the timing of the rise of the Excess Deaths and the introduction of the “vaccines”, autopsy reports linking the vaccines to deaths and established pharmacological mechanisms of toxicity of the spike protein and lipid nanoparticle.

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Bombshell Study Exposes Toxic Effects of Covid mRNA ‘Vaccines’; A troubling new study has exposed the “toxic effects” of administering repeated doses of Covid mRNA “vaccines.”

“A troubling new study has exposed the “toxic effects” of administering repeated doses of Covid mRNA “vaccines.”

The researchers found that the injection caused severe damage that could cause a range of deadly diseases and trigger sudden death.

The study was conducted by leading South Korean researchers at the Seoul National University Hospital.

Led by professors Jae-Hun Ahn and Byeong-Cheol Kang, the team set up a preclinical laboratory-based study to evaluate the toxicological effects of Covid mRNA “vaccines.”

Their findings were published in the Archives of Toxicology.

The researchers tested the vaccines in six-week-old mice, focusing on repeated dosing and administration routes.

The mice were administered the vaccines intramuscularly twice at two-week intervals or up to five doses.

The intervals sought to replicate the vaccine schedules for humans as advised by most government health officials.

The study found that “toxic effects” started to emerge two days after the second injection.

According gto the study, these toxic effects were recorded as reduced lymphocyte and reticulocyte counts, anemia-related changes, and elevated cardiac damage markers (troponin-I and NT-proBNP).

Histopathological analyses revealed inflammation and necrosis at injection sites, bone marrow suppression, thymic cortical atrophy, and spleen enlargement.

They noted that some of the effects had resolved by 14 days after the injection.

However, many of the toxic effects persisted.

The researchers noted spleen damage and injection site injury appeared to be impacted long-term, possibly permanently.

Repeated doses led to cumulative toxicity, and intravenous and intramuscular routes resulted in distinct toxicological profiles.

These findings highlight potential toxicological risks, emphasizing the need for careful consideration of administration routes and dosage regimens in vaccine safety assessments.

The researcher also note that “multiple side effects of mRNA vaccines have been reported, including myocarditis, thrombosis with thrombocytopenia syndrome, and Guillain–Barré syndrome (Bozkurt et al. 2021; García-Grimshaw et al. 2021; Hanson et al. 2022; Kadali et al. 2021; Sangli et al. 2021).

“Therefore, safety assessments for mRNA vaccines should differ from those for conventional drugs or vaccines.”

Published in Archives of Toxicology, the authors report:

“In summary, our investigation into the toxicological effects of four SARS-CoV-2 mRNA vaccine candidates revealed various toxicological changes.

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A Systematic Review Of Autopsy Findings In Deaths After COVID-19 Vaccination

Background: The rapid development of COVID-19 vaccines, combined with a high number of adverse event reports, have led to concerns over possible mechanisms of injury including systemic lipid nanoparticle (LNP) and mRNA distribution, Spike protein-associated tissue damage, thrombogenicity, immune system dysfunction, and carcinogenicity. The aim of this systematic review is to investigate possible causal links between COVID-19 vaccine administration and death using autopsies and post-mortem analysis.

Methods: We searched PubMed and ScienceDirect for all published autopsy and organ-restricted autopsy reports relating to COVID-19 vaccination up until May 18th, 2023. All autopsy and organ-restricted autopsy studies that included COVID-19 vaccination as an antecedent exposure were included. Because the state of knowledge has advanced since the time of the original publications, three physicians independently reviewed each case and adjudicated whether or not COVID-19 vaccination was the direct cause or contributed significantly to death.

Results: We initially identified 678 studies and, after screening for our inclusion criteria, included 44 papers that contained 325 autopsy cases and one organ-restricted autopsy case (heart). The mean age of death was 70.4 years. The most implicated organ system among cases was the cardiovascular (49%), followed by hematological (17%), respiratory (11%), and multiple organ systems (7%). Three or more organ systems were affected in 21 cases. The mean time from vaccination to death was 14.3 days. Most deaths occurred within a week from last vaccine administration. A total of 240 deaths (73.9%) were independently adjudicated as directly due to or significantly contributed to by COVID-19 vaccination, of which the primary causes of death include sudden cardiac death (35%), pulmonary embolism (12.5%), myocardial infarction (12%), VITT (7.9%), myocarditis (7.1%), multisystem inflammatory syndrome (4.6%), and cerebral hemorrhage (3.8%).

Conclusions: The consistency seen among cases in this review with known COVID-19 vaccine mechanisms of injury and death, coupled with autopsy confirmation by physician adjudication, suggests there is a high likelihood of a causal link between COVID-19 vaccines and death. Further urgent investigation is required for the purpose of clarifying our findings. 

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Two undisclosed deaths in Pfizer Covid vaccine trials

Pfizer-BioNTech did not disclose the deaths of two participants in its COVID-19 vaccine clinical trials before the FDA granted emergency use authorization (EUA) in December 2020. Documents released nearly three years later revealed the deaths of a 63-year-old Kansas woman and a 58-year-old Georgia woman, both classified as “sudden cardiac death.” Researchers have criticized Pfizer for failing to report these incidents within the required 24-hour timeframe, with one case taking 37 days to be filed.

Dr. Jeyanthi Kunadhasan, an Australian anesthesiologist and researcher with the watchdog group Daily Clout, called for an investigation by Kansas Attorney General Kris Kobach. She raised concerns that withholding this information may have impacted the perception of the vaccine’s safety profile.

“If the additional two deaths had been disclosed at the time of the EUA, it would have shown that the BNT162b2 mRNA COVID vaccine intervention provided no reduction in deaths.”
— Dr. Jeyanthi Kunadhasan, Anesthesiologist, Daily Clout

These revelations are part of a broader controversy surrounding transparency. In 2022, a federal court ordered the FDA to release 1.2 million pages of clinical trial documents after rejecting a 75-year delay request. This included the trial data that Pfizer had an opportunity to disclose to the FDA’s Vaccines and Related Biological Products Advisory Committee but did not.

Kansas Attorney General Kobach has also filed a lawsuit against Pfizer, accusing the company of misleading the public about the vaccine’s safety and effectiveness. The suit alleges the company failed to disclose risks like myocarditis, pericarditis, failed pregnancies, and deaths while promoting the vaccine as “safe and effective.”

Pfizer classified the deaths as unrelated to the vaccine and omitted them from a December 2020 New England Journal of Medicine paper that lauded the vaccine’s safety and efficacy. Critics say this omission reflects a troubling pattern of selective reporting.

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The CFR from the Pfizer trial show the vaccines make you 14x more likely to die from COVID

The case fatality rate (CFR) from the Pfizer trial shows you are 10X more likely to die if you get COVID and you are vaccinated.

Pfizer just forgot to point this out.

Same with the CDC and FDA. I’m sure they just forgot.

So I’m going to show you that the CFR is 10X higher for Pfizer and when you combine that with a 40% higher likelihood of being infected, we can now estimate that the COVID vaccine makes you 14X more likely to die from COVID. And that’s not counting your risk of all-cause mortality from the vaccine itself!

The Pfizer Phase 3 study CFR calculation

Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine through 6 Months showed for COVID deaths/cases:

Vaccinated: 1/8=.125
Unvaccinated: 2/162=.0123
Note: the deaths are in Table S4 in the Supplementary material

You were actually 10X more likely to die from COVID if you were vaccinated and you got COVID.

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