Main Study Used by FDA to Approve Covid-19 Vaccine Found No Significant Effect on the Risk of Death

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APA
Agresti, J. D. (2021, October 23). Main Study Used by FDA to Approve Covid-19 Vaccine Found No Significant Effect on the Risk of Death. Retrieved from https://www.justfactsdaily.com/main-study-fda-approve-covid-19-vaccine-risk-death
MLA
Agresti, James D. “Main Study Used by FDA to Approve Covid-19 Vaccine Found No Significant Effect on the Risk of Death.” Just Facts. 23 October 2021. Web. 7 December 2021.<https://www.justfactsdaily.com/main-study-fda-approve-covid-19-vaccine-risk-death>.
Chicago (for footnotes)
James D. Agresti, “Main Study Used by FDA to Approve Covid-19 Vaccine Found No Significant Effect on the Risk of Death.” Just Facts. October 23, 2021. https://www.justfactsdaily.com/main-study-fda-approve-covid-19-vaccine-risk-death.
Chicago (for bibliographies)
Agresti, James D. “Main Study Used by FDA to Approve Covid-19 Vaccine Found No Significant Effect on the Risk of Death.” Just Facts. October 23, 2021. https://www.justfactsdaily.com/main-study-fda-approve-covid-19-vaccine-risk-death.

By James D. Agresti
October 23, 2021
Correction appended

Overview

Buried 23 pages into the FDA’s approval summary for Pfizer’s Covid-19 vaccine is data that cuts to the core of the vaccination debate. Presented in a place and manner where it has been almost completely overlooked until now, the data reveals the number of deaths among people who received the C-19 vaccine and people who received a placebo in Pfizer’s largest clinical trial.

Those figures provide the only reliable measure of the vaccine’s greatest benefits and risks because they are unambiguous (death), enumerate the worst possible outcome (death), and control for every conflating factor (due to the design of the study).

These critical findings reveal that “there were a total of 38 deaths” during the trial, including 21 people who received the vaccine and “17 in the placebo group.” Considered together with the fact that about half of the 40,000 people in the trial received a placebo, these results show no statistically significant impact on the risk of death.

However, they do show that the range of potential impacts is likely minimal. With 95% statistical certainty, the results indicate that the vaccine could prevent up to one death or cause up to five deaths per year among every 1,000 people.

Beyond six months, the effects of the vaccine are much more uncertain because Pfizer and other vaccine manufacturers removed participants from their most-rigorous studies after a maximum of six months. They did this in defiance of government healthcare regulatory agencies who recommended that the subjects be enrolled for at least one year.

The benefits and harms to young children are even more murky because Pfizer’s primary study of them enrolled only 2,268 children with a current average follow-up time of 2.2 months.

 The Necessity of Randomized Controlled Trials

In approving Pfizer’s Covid-19 vaccine for adults and older children, the FDA mainly relied on a large randomized controlled trial (RCT). These are studies in which people are randomly assigned to receive or not receive a certain treatment.

When properly conducted, RCTs are the “gold standard“ for clinical research because they provide “a rigorous tool to examine cause–effect,” which “is not possible with any other study design.” Thus, the medical textbook Rutherford’s Vascular Surgery calls RCTs “the pinnacle in clinical design.”

The defining feature of RCTs is that they control for every factor but the medical treatment that is studied. This is a natural outcome of randomly giving the treatment to some people and not to others. Combined with the use of a placebo so that people don’t alter their mindsets or behaviors as a result of knowing they received the treatment, quality RCTs ensure that any major differences between the groups who received and did not receive the treatment are due to the treatment and not some other variable.

That level of certainty cannot be obtained by observing people “in the wild” where non-random factors determine who receives and does not receive a treatment. For example, comparing the death rates of people who are vaccinated and unvaccinated against C-19 cannot prove whether the vaccines are more helpful than harmful because the odds of death are impacted by variables like these:

  • Older people—who are more likely to die than younger people—have much higher C-19 vaccination rates than younger people.
  • Immunocompromised people—who have conditions like cancer and HIV that increase their risk of death—are “plausibly more likely to be offered and seek vaccination” because they are very vulnerable to C-19.
  • People who get vaccinated may feel invincible to C-19 and take fewer precautions like social distancing.

Researchers commonly use statistical techniques to “control” for such variables, but these methods cannot rule out the possibility that other factors are at play. Also, the techniques used to perform such analyses are prone to pitfalls.

Underscoring the reality that observational studies cannot match the reliability of RCTs, a 2018 paper in European Heart Journal compares RCT and non-RCT studies on drugs to prevent heart failure and finds that:

  • the observational studies routinely conflict with the RCTs.
  • “it is not possible to make reliable therapeutic inferences from observational associations.”
  • RCTs “clearly remain the best guide to the treatment of patients.”

The root weakness of observational studies is that they can only measure associations, and association does not prove causation. Although commonly taught in high school math, this vital fact of medical and social science is routinely ignored by commentators, journalists, and Ph.D.’s.

None of this means that observational studies are clinically useless. They can illuminate paths for additional research, and in rare cases where their results are mathematically and logically overwhelming, they can estimate the effects of a treatment. However, their results should be taken with a grain of salt, especially if there are RCTs to the contrary.

Risk of Death

The Pfizer-BioNTech Covid-19 vaccine, which is being marketed under the name “Comirnaty,” is the only Covid-19 vaccine that is actually “approved” by the U.S. Food and Drug Administration and not merely “authorized for emergency use.” The primary basis for that approval was an RCT that enrolled 43,847 subjects aged 16 to 85. Per the FDA, these “participants were randomized 1:1 to receive 2 doses of either Comirnaty or placebo, 3 weeks apart.”

After monitoring the subjects for up to six months beyond their second dose of the vaccine or placebo, the study found “there were a total of 38 deaths, 21 in the Comirnaty group and 17 in the placebo group.”

That crucial statement, which has been almost completely overlooked until now, is disclosed on page 23 of the FDA’s vaccine approval summary in a paragraph that claims “none of the deaths were considered related to vaccination.”

In reality, only the RCT can objectively determine how many deaths were related to vaccination, since there are untold ways in which this may occur beyond potential direct effects like cardiac events, embolisms, fevers, and seizures. For example, many fatal car accidents are triggered by fatigue, and the RCT found that 70.1% of subjects under the age of 55 reported “fatigue” after receiving the vaccine. This is why the only way to accurately measure the net effects of all risks and benefits is via an RCT.

On a superficial basis, the mortality figures from Pfizer’s RCT suggest that the vaccine increased the risk of death by 24%. However, the death rate in both groups is so small (0.1%) that the difference between them is statistically insignificant.

Put precisely, the RCT found that the vaccine may decrease the risk of death by as much as 34% or increase the risk of death by as much 136%. Because the vast majority of people had a very low risk of death during the average enrollment time of the trial (0.3 years), these results indicate that the vaccine could prevent up to one death or cause up to five deaths per year among every 1,000 people. This range has a statistical certainty of 95%, meaning there is a 5% chance that the actual rate is outside of this range due to mathematical chance.

Ninety-five percent certainty is the standard threshold used by scientists to label a result “statistically significant,” but more than 800 scientists and the American Statistical Association have warned that this practice is fraught with risks. For instance, it can lead people to make life-or-death decisions based on data that has 5% odds of being inaccurate due to mere chance.

For added perspective, if 10 more deaths occurred among the 20,000+ people who received the vaccine, the study would show with 95% confidence that the vaccine increased the risk of death by at least 1% and as much as 232%. Conversely, if 20 more deaths occurred among the 20,000+ people who received the placebo, the study would show with 95% confidence that the vaccine reduced the risk of death by at least 1% and as much as 199%.

Some may argue that the study was “underpowered,” a medical term for clinical trials that don’t enroll enough participants to detect an effect. However, Pfizer’s trial enrolled more than 40,000 people, and 10 more deaths in the vaccine group, or 0.05% of the vaccinees, would have yielded a statistically significant result.

Any argument to dismiss the death data as the result of an underpowered study raises the question of why Pfizer would design an RCT that is incapable of detecting the primary objective of the vaccine: saving lives. It also raises the question of why the FDA would approve a vaccine based on a study that was underpowered in this manner.

In short, the main RCT for Pfizer’s Covid-19 vaccine found no statistically significant effect on the risk of death. And if there is an effect, the results show that it is likely minimal.

Longer-Term Effects

All studies have their limitations, and a major one of Pfizer’s RCT is that none of the participants were enrolled for more than six months after their second dose of the vaccine. In fact, Pfizer began removing people from the RCT (through a process called “unblinding”) as soon as they became eligible to receive the vaccine under “local recommendations.”

That decision was made in defiance of guidance issued by a global association of 24 healthcare regulatory agencies called the International Coalition of Medicines Regulatory Authorities. This group includes the FDA and its counterparts in Canada, Australia, China, France, Germany, Mexico, Japan, Nigeria, India, and other nations.

In a statement released in November 2020, this international coalition of government agencies made the following points (and others) about why longer-term RCTs are necessary for C-19 vaccines:

  • “To determine that the benefit of a vaccine outweighs its potential risk, regulators need robust and convincing evidence of the safety and efficacy that is obtained from well-designed randomised and controlled trials.”
  • “Thus, continued evaluation of the vaccinated and the unvaccinated” participants “for as long as feasible will provide invaluable information.”
  • Such information includes but is not limited to “additional and more precise information on longer-term safety,” “potential risks of vaccine-induced enhanced disease,” and “whether protection against Covid-19 disease wanes over time.”
  • “Therefore, unless maintaining participants in their randomised treatment groups (vaccinated or control) after a vaccine is approved is clearly infeasible, we recommend that clinical trials should proceed as initially planned with a follow-up of at least one year or more from completion of assigned doses.”

Pfizer and other vaccine manufacturers directly flouted that guidance. As a result, an analysis published in August 2021 by the journal BMJ Evidence-Based Medicine reported that “placebo controlled follow-up, originally planned for 2 years in many trials, was eliminated after a few months, when manufacturers began offering vaccine to placebo recipients within weeks of receiving emergency use authorisations.”

Decisions to end the RCTs also hindered their ability to detect any effects of herd immunity as the broader society became vaccinated.

Medical ethics require that RCTs be barred or ended if they would undoubtedly harm people. Thus, some may argue that the RCTs should have been shortened based on their findings that the vaccines have large and statistically significant effects on reducing the risk of severe Covid-19. The Pfizer RCT, for example, found that the vaccine decreases the incidence of severe Covid-19 among people aged 16 and older by 70.9% to 100.0% (with 95% confidence).

However, those results don’t account for any side effects of the vaccine or long-term complications of C-19, and they don’t account for “whether protection against Covid-19 disease wanes over time,” as requested by the International Coalition of Medicines Regulatory Authorities.

Decisions to hastily end the RCTs are proving to be ill-advised given that a wide range of studies are finding that the immunity conferred by the current C-19 vaccines wanes over time. This includes but is not limited to:

Since all of those are observational studies, they don’t have the surety of RCTs and are therefore tentative. This is precisely why Dr. Doran Fink, Deputy Director of the FDA’s Division of Vaccines and Related Products Applications, warned at an FDA committee meeting in October 2020:

Once a decision is made to unblind an ongoing placebo-controlled trial, that decision cannot be walked back. And that controlled follow up is lost forever.

Vaccinating Children

Given the indeterminate results of Pfizer’s RCT on adults and older teens, a larger and longer trial seems advisable for children. However, Pfizer has asked the FDA for an emergency authorization to administer its vaccine to children aged 5 to 11 mainly based on a study that enrolled only 2,268 children with a current average follow-up time of 2.2 months.

Such sample sizes and study periods are severely underpowered to determine if the vaccine will save more children than it kills. This is because less than one out of every 250,000 children in the U.S. aged 5 to 14 have died from Covid-19 since the outset of the pandemic more than 19 months ago.

For comparison, the main RCT conducted for the polio vaccine in the 1950s enrolled more than 400,000 children, or 177 times more than Pfizer’s primary study. Moreover, clinical studies generally require greater numbers of participants when the ultimate purpose of a treatment is to prevent a rare outcome, as is the case for childhood C-19 deaths. Polio-induced childhood paralysis—the ultimate target of the polio vaccine—was roughly 139 times more common in the 1950s than the current risk of childhood death from Covid-19.

Those weaknesses of Pfizer’s study are especially concerning because the risk of being harmed by Covid-19 greatly declines at younger ages, while the major known risks of the vaccine increase.

In fact, the FDA’s approval summary for Pfizer’s Covid-19 vaccine explains that under a “worst-case” scenario, the risk of vaccine-related heart problems called myocarditis and pericarditis “would exceed Covid-19 hospitalizations and deaths” among males 16-17 years of age. Still, the FDA approved the vaccine because the FDA’s “most likely” scenario showed that C-19 posed a greater risk than these heart problems and because of “additional factors” outlined in the summary.

That analysis addresses only one type of risk from the vaccine, and it only applies to older children, who are much more vulnerable to Covid-19 than younger children. Indeed, the odds of dying from C-19 are about nine times greater among people aged 15 to 24 than children aged 5 to 14:

Some scholars argue that decisions to vaccinate children should not be based solely on the well-being of the children but to protect older people. Beyond the moral issue of using children as human shields, such rationalizations fail to consider the following facts:

  • Most children have asymptomatic cases of Covid-19, and a meta-analysis published by the journal JAMA Network Open in 2020 found that less than 1% of people with asymptomatic or pre-symptomatic C-19 infect other members of their households.
  • A 2021 paper in the Proceedings of the National Academy of Sciences reported that a key driver of C-19 contagiousness decreases dramatically with age and body-mass index.
  • The currently known risks and benefits of Pfizer’s C-19 vaccine led four of the 22 people on the FDA’s panel to vote against approving it for adults and older children.
  • The primary RCT for the only C-19 vaccine that is actually approved by the FDA found no statistically significant effect on the risk of death among adults and older children.

While bearing in mind that association does not prove causation, it is also noteworthy that:

  • a recent paper in the European Journal of Epidemiology found “no discernable association” between vaccination rates and new C-19 cases in 68 nations and 2,947 U.S. counties during late August/early September of 2021.
  • there were about 54,487 C-19 deaths in the U.S. during September 2021 when 52% of the population was fully vaccinated, while in contrast, there were 23,189 deaths (less than half as many) in September 2020 when 0% of the population was vaccinated.

Summary

The U.S. Occupational Safety and Health Administration has decided not to enforce a federal regulation that requires employers to “record worker side effects from Covid-19 vaccination.” In the words of the agency, this is because it “does not wish to have any appearance of discouraging workers from receiving Covid-19 vaccination, and also does not wish to disincentivize employers’ vaccination efforts.”

Compare that “close your eyes” approach to the candor of the United Kingdom’s Medicines & Healthcare Products Regulatory Agency, which explains that “all vaccines and medicines have some side effects,” and “these side effects need to be continuously balanced against the expected benefits in preventing illness.”

RCTs are the only reliable way to accurately measure those risks and benefits. Buried 23 pages into its approval summary for Pfizer’s C-19 vaccine, the FDA reports that 38 people died in the main RCT for this vaccine, including 17 who received the placebo and 21 who received the vaccine. With 95% statistical certainty, this data shows that the vaccine could prevent up to one death or cause up to five deaths per year among every 1,000 people.

Those results are subject to limitations that could have been lessened if Pfizer and other vaccine manufacturers had not ejected participants from their RCTs after a maximum of six months. Yet, the manufacturers did this in defiance of government healthcare regulatory agencies who recommended that the subjects be enrolled for at least one year.

The situation with young children is even murkier because Pfizer is mainly relying on a study that enrolled only 2,268 children. This is less than 1% of the 400,000+ children who were enrolled in the main RCT for the polio vaccine. Based primarily upon this statistically underpowered evidence, the FDA has scheduled a meeting on October 26th to consider authorizing the use of this vaccine in children aged 5 to 11.

Correction (11/4/21): The original version of this article incorrectly stated that “Pfizer has asked the FDA for an emergency authorization to administer its vaccine to children aged 5 to 11 without conducting any type of RCT on them.” This statement was based on two Pfizer press releases (September 20 and September 28) that announced “positive topline results from the pivotal trial” for this vaccine in young children and that Pfizer was submitting these results to the FDA to seek “authorization” for this age group. Both press releases said nothing about an RCT or placebo. Instead, they reported  that the vaccine showed a “favorable safety profile” and “robust neutralizing antibody responses.”

  • October 25, 2021 at 7:19 PM
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    Unfortunately, I think this article is guilty of cherry picking information to skew perception.

    The easiest example for me to use is the last bullet point in which Covid fatalities are compared using the months of Sept. 2020 and Sept. 2021 with the intent of undermining the vaccines. The comparison for any purpose would be bogus. 1) Given the dynamics of viral outbreaks there is almost a bell curve in the climb in infections/mortality; a peak and the decline. You compare the “trough” between the Summer and Fall spikes in 2020 to the summer “peak” in Sept. 2021. 2) It is clear we are now effectively dealing with a new virus in the Delta Variant in terms of its infectivity and viral load and the degradation of vaccine efficacy as opposed to Sept. 2020. This has been acknowledged widely. 3) Social controls, governmental controls etc. have been modified between Sept. 2020 and Sept. 2021. There are simply too many confounding variables to make the comparison you use to infer the lack of efficacy of the vaccines. Notwithstanding, that said efficacy has declined for a number of reasons.

    This is either sloppy analysis or intentional deception. I am sorry to be pointed. I like your site. As a conservative, I am always seeking good facts and analysis that I consider credible. Regrettably, you have dropped on my credibility index.

    Reply
    • October 26, 2021 at 10:22 AM
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      You ignored the context of the quote you criticize. In the very same sentence, the article states, “While bearing in mind that association does not prove causation….” This condenses every point you raised, and the article repeatedly emphasizes this fact.

      Moreover, the article documents numerous facts that constrain the impacts of the confounding variables you mention and proves that they could have been totally constrained if Pfizer didn’t eject people from its RCT after 6 months.

      To accuse the article of cherry picking is unjustified. Like all of our research, it is comprehensive, but one has to carefully read the entire article to see that.

      As an important aside to your point about the delta variant, a paper published in The Lancet this month found that the Pfizer vaccine had “high effectiveness” in preventing “hospital admissions up until around 6 months after being fully vaccinated, even in the face of widespread dissemination of the delta variant. Reduction in vaccine effectiveness against SARS-CoV-2 infections over time is probably primarily due to waning immunity with time rather than the delta variant escaping vaccine protection.”

      Numerous other facts support that finding and show that the delta variant is a convenient excuse for misguided public policies and waning vaccine efficacy.

      Reply
  • October 26, 2021 at 3:46 PM
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    Re: “However, the death rate in both groups is so small (0.1%) that the difference between them is statistically insignificant.”

    That sounds exactly right based on those numbers. I did some quick “back-of-the envelope” calculations on a TI-84 Calculator. With n = 43847, I assumed the treatment group and placebo group each had 21923 participants (that’s how I interpreted the 1:1 ratio) with 21 deaths in the treatment group and 17 deaths in the placebo group.

    A 2-sample z-test for a difference in proportions reveals a P-value of 0.516 = 51.6%. Following the standard interpretation provided in “The Practice of Statistics” by Starnes, this means: Assuming the null hypothesis is true (i.e. the treatment had no effect on the number of deaths), the probability of getting a difference in proportions this as large or larger than the observed difference 21/21923 – 17/21923 is 51.6%. Since 51.6% > 5% (by a large margin!), the results are very plausibly due to chance and we do NOT have evidence to reject the null hypothesis.

    Also, as I see it, the power of the test cannot plausibly be called into question with a sample size as large as n = 43847.

    Reply
  • October 27, 2021 at 10:26 AM
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    Not knowing any further specifics of the test than are presented in this article, the only conclusion I can infer is that persons who receive the vaccine are unlikely to die from adverse reactions in the first six months.

    Reply
    • October 27, 2021 at 10:42 AM
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      Your conclusion is partly true but misleadingly narrow. A more accurate statement is that people who receive or don’t receive the vaccine are unlikely to die from anything in the first six months.

      If you’d like “further specifics” beyond the reams of facts in this article, the article provides comprehensive links to the primary sources, just like all research by Just Facts.

      Reply
      • October 27, 2021 at 12:33 PM
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        My point is that since essentially there was no difference in the death rates between vaxxed and unvaxxed, and we weren’t told what the causes of the deaths were, the only thing one can conclude about the vaccine is that it did not *increase* the death rate. Assuming both groups had the same rate of covid infection, this would mean that the vaccine seemingly did nothing beneficial, but also nothing adverse.

        Reply
        • October 27, 2021 at 2:02 PM
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          No assumption about the rate of Covid infection or anything else is needed to know that the vaccine had little-to-no effect on saving or taking lives. This is because RCTs, by their very nature, control for every conflating factor but the treatment.

          As the article documents, such certainty cannot be obtained by any means but an RCT. Even fine details about each and every death can’t provide this surety because the impacts of the vaccine can manifest in untold ways, and it is often impossible to know for certain if the vaccine was the cause of death.

          For some prime examples, examine these four medical journal publications where C-19 vaccines are directly implicated in serious medical issues and deaths, but the researchers can’t be sure if the vaccines are to blame because other factors could be at play:

          https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8330960/
          https://pubs.rsna.org/doi/full/10.1148/radiol.2021211430
          https://www.bmj.com/content/372/bmj.n149
          https://www.mdpi.com/2075-4426/11/4/285/htm

          Also, there are potential indirect lethal impacts from the vaccines like this example from the article: Many fatal car accidents are triggered by fatigue, and the RCT found that 70.1% of subjects under the age of 55 reported “fatigue” after receiving the vaccine.

          This is why the only way to accurately measure the net effects of all risks and benefits is the bottom line results of an RCT. This is all you need if the RCT is conducted properly.

          Reply
  • October 27, 2021 at 11:49 AM
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    “The Pfizer-BioNTech Covid-19 vaccine, which is being marketed under the name “Comirnaty,” is the only Covid-19 vaccine that is actually “approved” by the U.S. Food and Drug Administration and not merely “authorized for emergency use.””

    … And is not yet available to the public, as it is a different formulation than the one under the EUA.

    Reply
  • October 29, 2021 at 12:37 AM
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    Very good article overall. There are no problems except for one error you made.

    You said that RCTs are the “gold standard” but this is not true. Dr. Harvey Risch said:

    “In Sepsis studies nobody uses RCTs for medication to treat sepsis. That’s standard and the whole field knows that.”

    There have been RCTs conducted for sepsis treatment, but “There is no specific treatment for patients with sepsis, and management therefore relies on infection control.” Partly because of the clinical challenges in identifying/monitoring sepsis.

    So according to Dr. Risch, RCTs are not the most reliable form of measurement.

    Reply
    • October 29, 2021 at 10:09 AM
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      I searched and was unable to find such a quote. If Dr. Risch did say this, he was probably referring to the following point made in the article above: “Medical ethics require that RCTs be barred or ended if they would undoubtedly harm people”

      None of this changes the thoroughly documented fact that RCTs are the gold standard for clinical research.

      Reply
  • November 1, 2021 at 1:00 PM
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    This is a truly EXCELLENT article, and you get the award for apparently being the first person to write a fact-based article on what is undeniably one of the most important pieces of news for this entire year (no one else dares to report on it, and if they do, they intentionally deceive in order to obfuscate the truth). Being from the medical field, I immediately recognize how tremendously important this information is. Particularly the fact that the double-blind RCTs are the only source of valid data on the vaccine’s true effects, while the non-randomized, non-blinded, cherry-picked, biased, agenda-driven “studies” on the vaccines from the CDC and other entities in the medical establishment, fed to us by the media, are total junk science and horribly misleading. It’s quite astounding how biased the “masses” are in the medical and scientific communities, when you consider that, for example, ivermectin has shown a major mortality reduction based on RCT data, while the vaccine clearly does not show a mortality reduction based on RCT data (and in fact, the trend is in the wrong direction).

    I actually think you are being too generous to the vaccine, given that the RCT data (regardless of statistical significance) shows it is more likely that the vaccine costs lives rather than saves lives. And looking at the NEJM publication on this Pfizer trial, which gives the breakdown of causes of death, if you add up all heart-related deaths, there is clearly a disproportionately high number of heart-related deaths with the vaccine compared to placebo, which is very likely a causal effect given what we already know about the vaccine. See trial publication here: https://www.nejm.org/doi/suppl/10.1056/NEJMoa2110345/suppl_file/nejmoa2110345_appendix.pdf (go to page 12, Table S4). Plus, with the Delta variant it is quite obvious that vaccine effectiveness is inadequate including for COVID mortality protection (the obvious reality supersedes the lies the US government keeps telling us, and just see the COVID mortality data related to vaccination status from UK, Israel, and other places that are more transparent), so the vaccine benefits will be even smaller than seen in the trial, but the risks are the same.

    Finally, perhaps most importantly, going back to the NEJM publication, note that the death count reported there is 15 vaccine vs. 14 placebo. Those numbers certainly tell the same story (vaccine is a bit more likely to cost rather than save lives), but do seem a tiny bit rose-tinted compared to the 21 vaccine vs. 17 placebo result based on the FDA’s own review. What do you think happened there? Is the most likely explanation that Pfizer whitewashed the numbers a bit, or is there a less concerning explanation? And should we place our bets that the FDA-reviewed result is the “real” result, rather than what Pfizer published?

    Reply
    • November 1, 2021 at 2:15 PM
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      Thank you for your kind words and for recognizing the enormous import of this article.

      The media, governments, and big tech have muddied the waters so much that many people don’t have the time to locate or knowledge to grasp what is relevant and true.

      Reply
  • December 4, 2021 at 7:46 PM
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    COVID ANALYSIS AFTER RELEASE OF PFIZER’S FIRST REPORT

    So, 2.9% DIED from the Pfizer drug! THINK OF THAT!!! No sane person will take that jab knowing this!

    As you’ll see from the COVID analysis I did below of USA COVID cases from January 2020 through mid-october 2021, the TOTAL DEATH RATE – 2.03%! – IS LOWER THAN PFIZER’S!!! ***

    So, now, with Pfizer report, we know that WE’RE BEING KILLED AT A 43% HIGHER RATE THAN THE VIRUS KILLS! – and THIS, without treating patients with proven treatments! (HCQ and IVM).

    ***Actually, the Total Death Rate of 2.03% INCLUDES patients jabbed WITH the Pfizer drug! So 2.03% is ELEVATED BECAUSE THE PFIZER’S JAB DEATH RATE IS 2.9%!

    Had these patients been TREATED WITH PROVEN PROTOCOLS, a conservative 60% would be alive today:

    TOTAL DEATH RATE SHOULD AND WOULD HAVE BEEN .812%!!! LESS THAN 1%!!!
    So, now, with Pfizer report, we know that WE’RE BEING KILLED 3.6x the rate of death for patients who receive proven treatment!!!!!

    BODIES SHOULD HANG.

    The analysis:

    I found extremely current USA covid data by age group and did an analysis.

    Total USA COVID deaths as of 10/13/2021:. 712,930

    Total COVID cases as of 10/14/2021:. 35,176,181

    Total Survival Rate:. 97.97%
    Total Death Rate:. 2.03%

    Two things I wanted to calculate:

    1) Survival and Death Rates by Age Group
    2) Numbers and rates if IVM and HCQ treatment protocols would have been prescribed early to COVID patients who died. I’ve read or heard practicing doctors proclaim various high %s of patients who died would be alive today if they’d been treated. I’ve used 60% as a conservative %.

    1) Survival and Death Rates by Age Group:
    KEY:. SR = Survival Rate
    DR = Death Rate

    0-17 years
    SR: 99.99%
    DR: .01% (1 in 10,000 patients died)

    18-29 years
    SR:. 99.95%
    DR:. .05% (5 in 10,000)

    30-39 years
    SR:. 99.816%
    DR:. .194% (19.4 in 10,000)

    40-49 years
    SR:. 99.45%
    DR:. .55% (55 in 10,000)

    50-64 years
    SR:. 98.15%
    DR:. 1.85% (185 in 10,000)

    65-74 years
    SR:. 93.61%
    DR:. 6.39% (639 in 10,000)

    75-84 years
    SR:. 85.28%
    DR:. 14.72% (1,472 in 10,000)

    85 years +
    SR:. 71.93%
    DR:. 28.07% (2,807 in 10,000)

    Analysis based on data from:

    https://www.statista.com/statistics/1254271/us-total-number-of-covid-cases-by-age-group/

    https://www.statista.com/statistics/1191568/reported-deaths-from-covid-by-age-us/

    ______________________________________________________

    2) HAD COVID PATIENTS BEEN TREATED*, DEATH RATE WOULD HAVE BEEN MUCH LOWER; A CONSERVATIVE ESTIMATE IS 60% OF PATIENTS WHO DIED WOULD BE ALIVE TODAY.
    Total COVID cases as of 10/14/2021:. 35,176,181

    Total Survival Rate:. 99.188%
    Total Death Rate:. .812%

    The following analysis adjusts SR and DR HAD PATIENTS BEEN TREATED. Included by age group is the number of patients killed* by the withholding of treatment.

    0-17 years
    SR: 99.996%
    DR: .004%
    (0.4 in 10,000 = 1 in 25,000)
    (205 dths i/o 513)
    308 were killed
    18-29 years
    SR:. 99.98%
    DR:. .02% !!! (2 in 10,000)
    (1,555 dths i/o 3,888)
    2,333 were killed

    30-39 years
    SR:. 99.92%
    DR:. .08% (8 in 10,000)
    (4,525 dths i/o 11,313)
    6,788 were killed

    40-49 years
    SR:. 99.78%
    DR:. .22% (22 in 10,000)
    (11,276 dths i/o 28,190)
    16,194 were killed

    50-64 years
    SR:. 99.26%
    DR:. .74% (74 in 10,000)
    (50,325 dths i/o 125,812)
    75,487 were killed

    65-74 years
    SR:. 97.44%
    DR:. 2.56% (256 in 10,000)
    (64,238 dths i/o 160,596)
    96,358 were killed

    75-84 years
    SR:. 94.11%
    DR:. 5.89% (589 in 10,000)
    (75,044 dths i/o 187,611)
    112,567 were killed

    85 years +
    SR:. 88.77%
    DR:. 11.23% (1,123 in 10,000)
    (78,003 dths i/o 195,007)
    117,004 were killed

    Total # of people who were killed: 427,758 (60% of the actual deaths)

    Treatment with proven protocols within 7-14 days of COVID symptoms at a minimum reduces death rate by 60%.

    Had all 712,930 COVID patients who have died to-date been treated with IVM and HCQ protocols, 427,758 would be alive today.

    Withholding early treatment with these safe and effective drugs killed almost HALF A MILLION PEOPLE!

    Pfizer’s first report:
    https://phmpt.org/wp-content/uploads/2021/11/5.3.6-postmarketing-experience.pdf

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