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Will Pfizer Be Charged for Mislabeling Vaccine Side Effects?

By Dr. Joseph Mercola | July 5, 2022

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?

Importantly, Pfizer classified almost all severe adverse events that occurred during its Phase 3 trials as 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. Some of these participants withdrew from the trials, some were dropped and some died.

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. These events were all classified as “toxicity level 4,” which is the most serious, yet none of them were deemed related to the injection.

This simply isn’t believable. It’s completely unrealistic, especially when serious events occur in multiple participants. 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 reported were listed as being caused by arteriosclerosis, cardiac arrest, hemorrhagic stroke and myocardial infarction.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 of Level 3 Adverse Events

Most Level 3 adverse events were also dismissed as unrelated to the shot. As reported by The Defender, only a “small number” were listed as being related to the injection. 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 common adverse events were nervous system disorders, followed by musculoskeletal and connective tissue disorders. 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 Rate 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 Extremely Low Risk of Death From COVID

In the end, we all know what happened. Despite all the evidence to the contrary, Pfizer concluded the shot was safe and effective for everyone and the FDA went along with it. The vaccine manufacturers and the FDA have decided it isn’t even worth invoking the precautionary principle for the very youngest of children, which is nothing short of reprehensible, criminal maleficence.

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 level alone makes EUA for COVID shots questionable. CDC data also prove young children have a very low risk of hospitalization and death from COVID, which makes the EUAs even more questionable.

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. That peak occurred after Omicron became predominant. 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 length of hospital stay was 1.5 days (range: one to three days). Of the 2,562 children with suspected COVID infection, 16 of them (0.6%) died in the hospital. Death certificate data push that number a bit higher. 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. The likelihood of your child getting injured by the mRNA shot is undoubtedly significantly greater than their risk of dying from COVID.

Jab More Likely to Put You in the Hospital Than Keep You Out

The same is true for adults, by the way. A June 2022 analysis^17,18 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’s team wasn’t the first to reanalyze Pfizer’s 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 Have Neglected Important Duties

Doshi and his coauthors also note the FDA also watered down results by including “thousands of additional participants with very little follow-up, of which the large majority had only received one dose.”

They then further diluted the appearance of risk by counting only the number of people affected rather than counting the total number of individual adverse events. This makes a big difference, as twice as many people in the treatment group reported multiple serious adverse events, as compared to the placebo group.

The FDA and CDC have both also failed to produce promised 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), but no study or report showing what that protocol might have found has ever been published.

As it turns out, the CDC hasn’t been looking for safety signals in VAERS — not with the proportional ratios protocol or any other. So, while they’ve publicly claimed they haven’t seen any signals of concern, the reason they haven’t seen any signals is very simple: They never looked at the data!²⁴

That’s how ridiculous things are now. When a drug company or health agency claims they haven’t found a problem, you actually have to ask them, “where, when, how and how often did you look?” But of course, virtually no one would ever ask such questions because they would assume these agencies are competent, which of course is a false assumption.

Their Fraudulent Behavior Could Be Their Undoing

As you probably know, the makers of the COVID shots are indemnified against legal liability for any injuries and all deaths stemming from their products. No one is able to sue them for damages.

The only way to hold them responsible is to prove they’ve committed fraud. This would remove their liability immunity. As detailed at the beginning of the article, their consciously choosing to miscategorize adverse events during the initial trials and concealing the harms should be a slam dunk to convict them of fraud.

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. If convicted of fraud, Pfizer, Moderna and Janssen would likely face liabilities in the trillions of dollars in damages.

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. It’s a catastrophe of unprecedented 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).

Research^30,31 from Israel now also reveals the shot deteriorates sperm count and sperm motility in men for about three months. Considering the multidose mRNA shots are recommended at three-month intervals, you can see how this can really decimate a man’s prospects of fathering 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

Other countries are also seeing a drop in birth rate, nine months after the start of the mass vaccination 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 could possibly be appropriate for company heads and health agency leaders responsible for causing massive depopulation worldwide through products that were based on fraudulent science and fictional claims? I doubt if there’s enough money in the world to set that right.

Future Trials To Be Skipped Altogether

As if matters weren’t already beyond horrible, the FDA is considering allowing manufacturers to reformulate their COVID injections in perpetuity without conducting any additional 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. What more evidence could you want?

2. Okay, well, it depends on what you mean by ‘work.’ These shots do not stop infection, transmission, hospitalization, or death, even though that’s why we licensed them. Any protection wears off fairly quickly, but It’s Not Our Fault(TM) because This Wily Virus(TM) mutates too fast and no one told us that it would ever mutate.

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, the FDA argues that since there are time constraints, evaluation of effectiveness must rely on “measures other than actual health outcomes.” In other words, whether the shots actually lower your risk of severe illness, hospitalization and death will have no bearing.

The only measure they’ll take into account is whether or not the jab triggers a rise in antibody levels, which has never been proven to be beneficial. If anything, the increase in COVID antibodies actually increases your risk of infection. This also means that as long as antibody levels are through the roof, the death rate could be just about anything, because it’s not part of the safety equation.

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 whether the government was lying or guessing when they stated that vaccinated individuals couldn’t catch or 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

So, the government issued mandates and made unequivocal, absolute statements that were not allowed to be questioned because they HOPED the shots would work a certain way — all while insisting they were the ones following and trusting the science and anyone who questioned their logic was a dangerous nut job. Let that sink in. Hope is literally the diametrical opposite of science.

It’s an Insiders’ Plot

As explained by Rogers, the same old players are behind this brazen attempt to eliminate the need for clinical trials: CDC staffers, academics who are in the pockets of Bill Gates and the NIAID, the drug companies themselves and the World Health Organization. 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. The Bill & Melinda Gates Foundation is the biggest voluntary contributor to the WHO. So Gates is likely directing 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). As Naomi Wolf points out, the involvement of the WHO also raises troubling questions about the influence of the Chinese Communist Party over 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.”

No doubt, we live in unprecedented, precarious times. Logic, reason, science and sanity itself has been tossed aside by those who claim the right to make decisions for all mankind. If the FDA goes forward with this “Future Framework” scheme, the only safe assumption is that COVID shots will become more and more dangerous.

Worse, we can expect other vaccines and drugs to be allowed on the market without clinical trials as well. It truly could change the science of medicine as we know it.

Of course the WHO also wants to seize control over health care worldwide, which would eliminate medical rights everywhere. It’s a nightmare scenario with no end in sight as of yet. All we can do is continue to push back, to inform ourselves, to speak out, share facts and data, and refuse to comply with unscientific recommendations based on little more than hope in fabricated conclusions.

Sources and References

• ¹ PHMPT.org Pfizer Documents Released by FDA
• ^{2, 3, 5, 6, 7, 9} The Defender June 21, 2022
• ⁴ PHMPT.org 16.2.7.1 Adverse Events Legend
• ⁸ PHMPT.org 2.5 Clinical Overview for BNT162b2
• ¹⁰ The Defender June 15, 2022
• ^11, 14 The Vaccine Reaction June 21, 2022
• ¹² CDC MMWR April 29, 2022; 71(17): 606-608
• ^13, 16 CDC MMWR March 18, 2022; 71(11): 429-436
• ¹⁵ FDA. Briefing Document on EUA amendment request for Pfizer-BioNTech COVID-19 vaccine for use in children 6 months […]. VRBPAC Meeting June 15, 2022
• ^17, 20 SSRN June 23, 2022
• ^18, 23 Robert Malone Substack June 22, 2022
• ¹⁹ The Daily Sceptic June 22, 2022
• ²¹ SPEAC October 26, 2021
• ²² Canadian COVID Care Alliance, More Harm Than Good
• ²⁴ Jackanapes Substack June 16, 2022
• ^25, 29 Paul Alexander Substack June 27, 2022
• ²⁶ the New American June 27, 2022
• ^27, 28 Steve Kirsch Substack June 25, 2022
• ³⁰ Andrology June 17, 2022 DOI: 10.111/andr.13209
• ³¹ Expose June 26, 2022
• ³² Bloomberg June 21, 2022
• ³³ Twitter Jikkyleaks June 26, 2022
• ³⁴ SWPRS June 2022
• ^{35, 36, 38, 41} The Defender June 27, 2022
• ³⁷ FDA Briefing Document June 28, 2022
• ^39, 40 Daily Caller June 23, 2022

July 5, 2022 Posted by aletho | Corruption, Deception, Science and Pseudo-Science, Timeless or most popular | COVID-19 Vaccine, FDA, United States | Leave a comment