Is Pfizer to be charged with mislabeling vaccine side effects?

Is Pfizer to be charged with mislabeling vaccine side effects?

As the U.S. Food and Drug Administration continues to release Pfizer’s clinical trial documentation,1 we’re finding more and more evidence that very little has been done on the up-and-up, and the COVID jab trials may be among the most fraudulent in medical history.

Can All Serious Adverse Effects Be Written Off?

Pfizer considered almost every severe adverse event that happened during Phase 3 of its trials unrelated to the injection. As reported by The Defender, June 21, 2022: 2

“The latest release by the U.S. Food and Drug Administration (FDA) of Pfizer-BioNTech COVID-19 vaccine documents reveals numerous instances of participants who sustained severe adverse events during Phase 3 trials. A few of the participants withdrew, others were dropped or died during Phase 3 trials.

The 80,000-page document cache includes an extensive set of Case Report Forms (CRFs) from Pfizer Phase 3 trials conducted at various locations in the U.S., in addition to other documentation pertaining to participants in Pfizer-BioNTech vaccine trials in the U.S. and worldwide …

The CRFs included in this month’s documents contain often vague explanations of the specific symptoms experienced by the trial participants. They also reveal a trend of classifying almost all adverse events — and in particular severe adverse events (SAEs) — as being ‘not related’ to the vaccine.”

The Defender article includes 11 examples3 of trial participants who experienced severe adverse effects that were classified as “unrelated” to the experimental gene transfer technology they’d received just days or weeks earlier.

A 2,566-page document4 catalogues the serious adverse events and six deaths that occurred during the trial. All of these events were classified as toxic level 4, which means they were the most severe, but none were related to injections.

This is simply not possible. This is impossible, particularly when multiple serious events happen. A handful of examples of Level 4 adverse events listed in this document — all of which were written off as “not related” to the mRNA injection — include: 5

  • Acute respiratory failure
  • Cardiac arrest
  • Brain abscess
  • Adrenal carcinoma (adrenal cancer)
  • Chronic myeloid leukemia (blood and bone marrow cancer)

The six deaths were attributed to arteriosclerosis and cardiac arrest. 6 Many participants also dropped out or were excluded from the trial due to serious side effects involving the heart, cardiovascular system, cancer, stroke, hemorrhage and neurological impacts.

Examples for Level 3 Abhorrent Events

Most level 3 adverse reactions were dismissed also as not related to the shot. According to The Defender, only “a few” of the Level 3 side effects were listed. Examples of Level 3 side effects include: 7

  • Deafness/hearing loss
  • Tachycardia (disruption of the normal electrical impulses that control your heart rate — the very problem that underlies most cases of “sudden adult death syndrome” or SADS)
  • Ventricular arrhythmia (abnormal heart rhythm that makes the lower chambers twitch rather than pump — another underlying cause of SADS)
  • Neutropenia (low neutrophil level in your blood; neutrophils are a type of white blood cell made by your bone marrow that fight infections by destroying viruses and bacteria)
  • Vertigo

45% Experienced One or More Adverse Events

Another document8 that raises suspicions of bias is one admitting that “40% to 45% of participants who received BNT162b1 and BNT162b2 across age groups and across dose levels reported one or more AEs [adverse events] from Dose 1 through 28 days (i.e., 1 month) after Dose 2.”

BNT162b2 was the candidate injection that went on to receive Emergency Use Authorization (EUA) from the FDA. Among those who got the highest dose (30 micrograms) of BNT162b2, 50% of younger participants 25% in the older age group reported one or more adverse events.

The most frequent adverse events were those involving the nervous system, closely followed by those affecting the musculoskeletal or connective tissues. Yet despite high rates of side effects across dose levels, this document also insists that “most AEs were considered by the investigator as not related to study intervention.”

During the open-label period of the study, 12,006 participants were followed for a minimum of six months, and among those, 28.8% reported at least one adverse event at some point during that follow-up, and 2.1% reported one or more severe adverse events.

Incidence in Treatment Group Far Higher than Placebo

As reported by The Defender: 9

“The review provides data for participants from dose 3 … to the data cutoff date. The severe adverse event incidence rate (IR) was 6.0 per 100 PY (patient-years), with specific conditions reported including pulmonary embolisms, thrombosis, urticaria, a cerebrovascular accident and COVID-19 pneumonia.

Here, the review adds that the IR for original placebo participants who had at least 1 life-threatening AE from Dose 3 to the data cutoff date was 0.5 per 100 PY.

Only one such life-threatening event, an instance of anaphylactoid reaction, was considered to be related to the vaccination. Other life-threatening, serious adverse events included cardio-respiratory arrest, gastrointestinal necrosis, deep vein thrombosis and pulmonary embolism …

Notably, according to the review, ‘all … events of facial paralysis were considered by the investigator as related to study intervention.” [Editor’s note: these specifically refer to events that occurred during the open-label follow-up period when BNT162b2 Dose 3 or Dose 4 was offered to both placebo and initial treatment groups. ]

Young children have a very low risk of dying from COVID

In the end, everyone knows what happened. Pfizer deemed the shot safe and effective despite all evidence. The FDA also agreed with Pfizer. Both the FDA and vaccine makers decided that it was not worth invoking precautionary principles for children under five years old. This is a criminal offense.

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In mid-June 2022, against strong objections from physicians, scientists and researchers, the FDA’s vaccine advisory panel — the Vaccines and Related Biological Products Advisory Committee (VRBPAC) — unanimously agreed to grant EUA to both Pfizer’s and Moderna’s COVID shots for infants and young children. 10,11

Pfizer’s EUA is for a three-dose regimen (3-microgram shots) for children 6 months to 5 years old, while Moderna’s EUA is for a two-dose regimen (25-microgram shots) for children 6 months to 6 years.

According to the U.S. Centers for Disease Control and Prevention,12 an estimated 75% of American children ages birth to 11 already have some level of immunity, having been exposed to one of the several variants that have come into circulation over the past two-plus years.

This immunity makes EUAs for COVID shots doubtful. The EUAs are also questionable because of the low rate of COVID-related deaths and hospitalizations in young children, according to CDC data.

Data13 published in mid-March 2022 suggest babies and young children under the age of 4 have had a peak hospitalization rate for COVID of 14.5 per 100,000. This peak was reached after Omicron took over. The hospitalization rate for the Delta variant in this age group was 2.9 per 100,000.

In all, since March 2020, a total of 2,562 infants and young children (6 months to 4 years) have been hospitalized WITH COVID. Of those, 2,068 had COVID listed as the primary reason for admission (84.7% of the total), and only 624 required ICU admission.

The median hospital stay was 1.5 days. (range: 1 to 3 days). Of the 2,562 children with suspected COVID infection, 16 of them (0.6%) died in the hospital. This number is slightly higher according to death certificate data. The Vaccine Reaction notes,14 “According to death certificate data,15 202 deaths have been attributed to COVID-19 among children 6 months to 4 years of age through May 11, 2022.”

While any death is tragic, it’s worth noting that 923 (35.8%) of the children hospitalized with suspected COVID also had one or more underlying medical conditions. 16 We don’t know for sure, but it’s quite possible that those who died with a COVID diagnosis actually died from whatever underlying condition was present or had brought them to the hospital in the first place.

What I’m trying to say is that 16 to 202 deaths over two-plus years aren’t cause for panic, and that’s true even if COVID was the primary cause of those deaths. Your child’s chance of being injured from the mRNA shots is much greater than their COVID risk.

Jab is more likely to put you in the hospital than keep you out

The same applies to adults. A June 2022 analysis17,18 of Pfizer and Moderna trial data found the shots are more likely to put you in the hospital than keep you out of it. As reported by The Daily Sceptic: 19

“A new paper20 by BMJ Editor Dr. Peter Doshi and colleagues has analyzed data from the Pfizer and Moderna COVID vaccine trials and found that the vaccines are more likely to put you in hospital with a serious adverse event than keep you out by protecting you from COVID.

The pre-print (not yet peer-reviewed) focuses on serious adverse events highlighted in a WHO-endorsed ‘priority list21 of potential adverse events relevant to COVID-19 vaccines.’ The authors evaluated these serious adverse events of special interest as observed in ‘phase III randomized trials of mRNA COVID-19 vaccines’ …

Dr. Doshi and colleagues found that the Pfizer and Moderna mRNA COVID-19 vaccines were associated with an increased risk of serious adverse events of special interest of 10.1 events per 10,000 vaccinated for Pfizer and 15.1 events per 10,000 vaccinated for Moderna …

When combined, the mRNA vaccines were associated with a risk increase of serious adverse events of special interest of 12.5 per 10,000 vaccinated … The authors note that this level of increased risk post-vaccine is greater than the risk reduction for COVID-19 hospitalization in both Pfizer and Moderna trials, which was 2.3 per 10,000 participants for Pfizer and 6.4 per 10,000 for Moderna.

This means that on this measure, the Pfizer vaccine results in a net increase in serious adverse events of 7.8 per 10,000 vaccinated and the Moderna vaccine of 8.7 per 10,000 vaccinated.”

Doshi wasn’t alone in analyzing Pfizer trial data. The Canadian COVID Care Alliance has also published a clear and easy-to-read summary22 of the Pfizer trial results, and the many questions raised by it. As noted by Dr. Robert Malone: 23

“The bottom line is that the Pfizer Phase 3 trial which was used by NIAID [the National Institutes of Allergy and Infectious Diseases], FDA and CDC to justify the emergency use authorization is pretty much a junk clinical trial which was inappropriately halted long before it even got close to meeting the intended follow up period, did not provide a sufficiently long follow up analysis of vaccination-associated adverse events, and in which the control group was intentionally eliminated.

This resulted in basically erasing any opportunity to ever get to the bottom of what the major true risks of the Pfizer mRNA inoculations were. In terms of more minor risks, the study was not powered (not big enough) to evaluate those.”

FDA And CDC Neglected Essential Duties

Doshi, along with his coauthors, also noted that the FDA also diluted results by adding “thousands more participants without very little follow up,” of which the majority only had received one dose .”

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.

They further reduced the risk perception by not counting individual adverse events but only counting those affected. It makes a huge difference as double the number of people who experienced multiple adverse events in treatment compared with the placebo.

Both the FDA and CDC failed to deliver on their promises of follow-up investigations. In July 2021, now a full year ago, the FDA said it would investigate four “potential adverse events of interest following Pfizer vaccination,” namely pulmonary embolism, acute myocardial infarction, immune thrombocytopenia and disseminated intravascular coagulation, but to date, no update has been issued.

Similarly, in early 2021, the CDC published a protocol on how to use proportional reporting ratios to detect signals in the U.S. Vaccine Adverse Event Reporting System, (VAERS), although no report or study proving what the protocol may have revealed has been published.

It turns out that the CDC didn’t look for safety signs in VAERS, not with any protocol other than the proportional ratios protocol. While they claim they don’t see any signs of concern, their secret is that they never examined the data. 24

That’s the absurdity of things now. If a health agency or drug company claims that they don’t have a problem, then you should actually ask the question “where, when and how frequently did you look?” This is because virtually nobody would ask these questions, as they assume they are competent.

Their Fraudulent Conduct Could be Their Undoing

As you may know, COVID shot makers are protected from legal liability in the event of any injury or death resulting from the use of their product. They are not liable for any damages.

The only way to make them accountable is to show that they have committed fraud. They would lose their immunity to liability. This would remove their immunity to liability.

But there is also another fact they concealed: There’s evidence showing they knew the mRNA doesn’t stay in the injection site but, rather, distributes throughout the body,25 and this too could be a smoking gun that proves fraud. Pfizer and Moderna, as well as Janssen, could be held responsible for billions in damages if they are convicted.

When I exposed Merck’s Vioxx scandal in 1999 in this newsletter, before they even released their drug on the market, I thought that was huge. Their drug killed more than 60,000 people, and they could have been liable for $25 billion in damages, but their clever lawyers reduced it to $5 billion.

Well, that catastrophe is a drop in the bucket compared to the COVID scam, which has likely killed between 600,000 and 750,000 Americans, disabled as many as 5 million, and injured an estimated 30 million Americans in one way or another. 26,27 That’s just the estimated toll in the U.S., so you can imagine what the global numbers might be. This is a disaster of unimaginable proportions. A June 2022 survey by Steve Kirsch also found: 28

  • 6.6% of COVID jabbed respondents suffered heart injury (about 10 million Americans, based on the national vaccination rate)
  • 6.3% had to be hospitalized for their side effects (another 10 million Americans)
  • 9.2% of those who took the jab had to seek medical help for their injury, which translated over the whole country would be about 18 million doctor’s visits
  • People who got the shot were more likely to die from COVID than the unvaccinated
  • 2. 63% of the responders had lost someone in their household to COVID infection, and 2. 03% had lost someone in their household to the COVID jab

Expect Depopulation

Whether intentional or not, mounting evidence now indicates the COVID-19 injections will result in depopulation through premature death and adverse effects on fertility in women and men alike. I’ve previously discussed the risk of pregnancy loss and infertility in women who get the shot, as the mRNA has an affinity for accumulating in the ovaries29 (as well as the adrenals, liver and bone marrow).

Research30,31 from Israel now also reveals the shot deteriorates sperm count and sperm motility in men for about three months. You can clearly see that multidose mRNA injections are advised at every three months. This can seriously impact a man’s chances of having a child.

Fertility has been on a steady decline for decades in most parts of the world,32 but the worldwide COVID jab campaign may massively speed that up. Germany recently released data showing a 10% decline in birth rate during the first quarter of 2022. 33

Germany - First Quarter births by year 2011-2022

Other countries also see a decline in their birth rates nine months after starting the mass vaccine campaign against COVID. Between January and April 2022, Switzerland’s birth rate was 15% lower than expected, the U.K.’s was down by 10% and Taiwan’s was down 20%. 34

What punishment might be appropriate for health officials and company leaders who caused massive population declines worldwide by selling products based on false science and fiction? It’s doubtful that there is enough money to make this right.

Future Trials To Be Skipped Altogether

The FDA may allow manufacturers to continue reformulating their COVID injections without any further clinical trials. 35 In other words, they’d allow drug companies to change the mRNA and/or other ingredients without any safety or efficacy testing whatsoever. As reported by Toby Rogers, Ph.D., in a June 27, 2022, article in The Defender: 36

“FDA released a briefing document37 in connection with this scheme to end science as we know it in connection with future COVID-19 shots … The briefing document is 18 pages of text, 1.5 line spacing, with just 19 references — 9 of which are pre-prints or from the CDC’s in-house newsletter Morbidity and Mortality Weekly Report (MMWR) which means they are not peer-reviewed.

Any true believer in The Narrative(TM) could have written this in a few hours. To base the entire future of COVID-19 shots on this glorified undergrad term paper is madness …

The core argument of the briefing document is hilarious (or rather, it would be hilarious if it was not a plan to permanently institutionalize genocide and hide the evidence). In several places the FDA argues (colloquialisms mine):

1. These COVID-19 shots work great … Boosters too, total home run, the Israelis even have 10-weeks of data showing that they might help old people. You could not ask for more.

2. It all depends on how you define ‘work’. Protection wears out quickly. But, it’s not our fault(TM). This Wily Virus (TM) mutates far too quickly and we were never told that it would.

3. So these shots must be reformulated but we cannot possibly ask Lord Pharma to do proper clinical trials ever again because we already know that these shots work great (see point #1)!”

In short, FDA claims that evaluations of effectiveness have to be based on measures other than the actual outcomes of health. This means that the FDA will not consider whether shots reduce your chance of serious illness or death.

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The only thing they will consider is whether the jab causes an increase in antibodies, something that has not been shown to be helpful. The risk of infection actually rises with an increase in COVID antibodies. It also indicates that your death rate can be as high as it wants, as long as you have high levels of antibodies. This is because safety doesn’t apply to this situation.

Faith in Magic has Officially Replaced Science

As noted by Rogers,38 “The ‘Future Framework’ is a plan to base the entire COVID-19 vaccine program on magical thinking rather than science.” Indeed, Dr. Deborah Birx recently confirmed that the whole vaccine push has been based in faith in magic. 39

June 23, 2022, Birx answered questions from the House Select Subcommittee on the Coronavirus Crisis. Rep. Jim Jordan (R-Ohio) asked if the government was lying when it stated that vaccined individuals could not catch and spread COVID. At first, she claimed she didn’t know, but when pressed, she replied, “I think it was hope that the vaccine would work in that way.”40

The government made unambiguous, absolute statements and issued orders that could not be challenged because they believed the shots would work. They also insisted they followed the science, and any questioning their logic was dangerous. This is what you need to understand. Science is the opposite of hope.

It is an Insiders’ Plot

Rogers explains that the brazen effort to end clinical trials is being made by the same players: CDC staffers and academics. The NIAID and Bill Gates have their backs. So, Rogers writes, “Rogers writes: 41

“I did not understand until just yesterday (as I started to write this article) that this entire ‘Future Framework’ is actually coming from the WHO. Bill & Melinda Gates Foundation makes up the largest voluntary donor to the WHO. It is probable that Gates will direct the play.

Gates requires that WHO use the McKinsey consulting firm so this is probably a McKinsey operation (and McKinsey also works for Pharma so this is a huge conflict of interest). Naomi Wolf says that the WHO involvement raises serious questions regarding the Chinese Communist Party’s influence on this process.

As far back as January, the WHO/Gates/McKinsey junta realized that these shots were terrible and so they decided to use that as an opportunity to seize even more power and control.

The WHO set up a Technical Advisory Group on COVID-19 Vaccine Composition (TAG-CO-VAC) to implement these Orwellian ‘Future Frameworks’ across the developed world to lower manufacturing costs for Pharma and avoid bothersome health data that might hurt profits. All the messaging we have seen from the FDA and leaked to the press was initially developed and released by TAG-CO-VAC.”

We live in precarious and unprecedented times. People who have the power to decide for everyone, including logic, reason, science, and sanity, have thrown out all that is good, logical, reason, and science. The FDA will continue to use this “Future Framework” plan, which is a safe assumption. COVID shots could become increasingly dangerous if they do.

Worse, other drugs and vaccines will be permitted to market in the absence of clinical trials. This could truly change medicine’s science.

The WHO wants control over global health care, and would also eliminate all medical rights. This is a terrible scenario that has no clear end. We can only continue to fight back and to educate ourselves.

Originally published July 05, 2022 on Mercola.com

Sources and References

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