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Pfizer “Vaccine” Clinical Trials Poorly Designed From the Start, Analysis Shows

The Canadian COVID Care Alliance assembled a presentation that demonstrates how Pfizer’s purported randomized placebo-controlled, double-blinded study veered away from methodologies that would have definitively answered questions about the vaccine’s safety and efficacy.

by Madhava Setty, M.D.
December 23, 2021
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Pfizer _Vaccine_ Clinical Trials Poorly Designed From the Start, Analysis Shows

The disagreements around whether COVID-19 vaccinations are “safe and effective” stem not only from the subjective nature of such descriptors but also from the lack of consensus around the data used to substantiate or refute such a claim.

The Centers for Disease Control and Prevention’s (CDC) Morbidity and Mortality Weekly Reports (MMWR) often draw from limited observations, and their assessment of vaccine effectiveness is based on relatively small subsets of our population.

Their conclusions are sometimes reflective of outdated data and conflict with their own recommendations.

For example, here the CDC’s latest estimation of vaccine effectiveness is upwards of 80% in preventing COVID-19 (i.e. the risk of becoming infected is 5 times less if vaccinated). Why then the recommendation for boosters?

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Note that this latest metric is based on the CDC’s most recent data from more than one month ago and represents data drawn only from 27 jurisdictions.

Eric Topol, a professor of molecular medicine at Scripps Research, is a former advisory board member of the Covid Tracking Project, a team that worked to collect and synthesize local COVID-19 during the peak of the pandemic.

Politico recently quoted Topol:

“I think we’ve done a horrible job from day one in data tracking for the pandemic. We’re not tracking all the things that we need to to get a handle on what’s going on. It is embarrassing.”

Meanwhile, vaccine injuries continue to accumulate in the Vaccine Adverse Event Reporting System (VAERS) and go unacknowledged, making any constructive discussion around risk impossible.

In order to find common ground, it is perhaps most appropriate to focus on published data from the vaccine trials themselves.

Was Emergency Use Authorization justified? Was the current confusion around vaccine effectiveness and safety predictable from the beginning?

A presentation by the Canadian COVID Care Alliance

Canadian COVID Care Alliance (CCCA) is a group of “Independent Canadian doctors, scientists and healthcare professionals committed to providing top quality and balanced evidence-based information to the Canadian public about COVID-19 so that hospitalizations can be reduced, lives saved and our country restored as safely as possible.”

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CCCA assembled a presentation that comprehensively demonstrates how Pfizer’s purported randomized placebo-controlled, double-blinded study veered away from methodologies that would have answered the safety and efficacy questions definitively.

In this concise slide deck with an explanatory video, CCCA powerfully summarized why Pfizer’s trial was not designed to adequately demonstrate its product’s safety and efficacy.

Here are a few key points from the CCCA presentation:

  • Initial data demonstrated a high relative risk reduction of infection yet this amounted to an absolute risk reduction of only 0.84%. It is the absolute risk reduction that determines the risk-benefit ratio required to make informed decisions around inoculation.
  • Early unblinding: Several months before publishing six-month observational results Pfizer opted to offer its product to those participants who received the placebo. By eliminating nearly all participants in the placebo wing Pfizer effectively closed the curtain on its experiment because long-term comparisons can no longer be made.
  • All-cause mortality and morbidity, the only sensible outcomes to use in determining efficacy and risk, were not considered. Indeed, all-cause mortality was higher in the vaccinated group after six months.
  • Severe adverse events outnumbered cases of severe COVID prevented after six months of observation.
  • Trial participants were not reflective of the most vulnerable members of our population — more than 50% of people dying from COVID are 75 years of age or older. This age group made up only 4.4% of trial participants. Also, 95% of those who have died from COVID had one or more comorbidities. Nearly 80% of trial participants had none.
  • Not every trial participant was tested for COVID. Asymptomatic or paucisymptomatic (presenting few symptoms) cases were missed.

Questions regarding unblinding and data integrity

The CCCA presentation also resurrects a puzzling observation mentioned in a briefing document Pfizer submitted only to the FDA’s Vaccine and Related Biologic Products Advisory Committee (VRBPAC) of the FDA, but nowhere else — including the widely cited summary of the trial reported in New England Journal of Medicine.

According to the document, 3,410 participants were suspected from their clinical presentation of having COVID but they were excluded from efficacy calculations because a diagnosis could not be confirmed through PCR testing.

The CCCA presentation presumes this large group of participants was never tested. The wording in the VRBPAC briefing document is indeed vague, stating the participants were “not PCR-confirmed” in one sentence and “unconfirmed” in another.

Assuming Pfizer’s investigators followed their study protocol, these participants were in fact tested. Yet that forces us to accept that more than 3,400 participants who had symptoms of COVID were suffering from other illnesses, not COVID.

In other words, there were 3,580 participants who clinically presented with COVID (3,410 suspected and 170 confirmed). Of these, more than 95% tested negative. This is difficult to accept in a group where clinical suspicion is high.

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However, with no further testing by the investigators, we are left to accept these numbers as reported.

Peter Doshi, Ph.D., senior editor at The BMJ, explained the implications of this result in detail, in an opinion piece published nearly one year ago.

In his widely discussed commentary, Doshi noted another baffling finding in the Pfizer data. Within 7 days of administration of the second of two doses, 371 (310 in the vaccinated group and 61 in the placebo group) trial participants were withdrawn from the study due to “important protocol deviations.”

Of course, protocol deviations occur, but why were five times more vaccine recipients excluded than placebo recipients at that point in the study?

Although there were nearly 40,000 participants in the evaluable population, only 170 contributed to the efficacy calculation with regard to protection from infection, and only 10 with regard to protection from severe infection.

In other words, just a handful of incorrectly diagnosed and categorized participants could easily result in a substantially different estimation of the vaccine’s efficacy and safety.

Statistician and educator Mathew Crawford pointed out the likelihood of such a disparity between groups is exceedingly unlikely. However, because the investigators should have been blinded, we must accept this as an extraordinary coincidence.

Incredibly, the very same disparity occurred in the pediatric trials (ages 5 to 11). Table 12 from the corresponding summary to the FDA’s VRBPAC indicated 3.1% of children were removed from the trial if they received the vaccine compared to 0.5% if they received the placebo.

Once again, there is a factor of 5 difference at exactly the same point in the trial (within 7 days of dose 2). It is true that the vaccine formulation requires steps prior to administration that are not required with the placebo, but why didn’t these protocol deviations happen with the first dose as well? What happened to these vaccine recipients soon after they received their second dose?

These remarkable “coincidences” can be best explained if we are willing to consider the possibility that the investigators were not, in fact, blinded. This is precisely the most damning allegation by whistleblower Brook Jackson, formerly a regional director at Ventavia, one of several clinical research organizations conducting Pfizer’s vaccine trials in 2020.

In addition to the unblinding of investigators, Jackson also accused Ventavia of falsifying data.

These are weighty accusations. Why should we believe her? Because her story is corroborated by the trial data themselves.

She was fired within a day of reporting her concerns directly to the FDA. Her story was covered in The BMJ Nov. 2. Mainstream media has yet to report on it.

Conclusion

Though public health authorities continue to proclaim these products are safe and effective, every week brings more and more evidence to the contrary.

A thorough analysis of data from Pfizer’s vaccine trials reveals more questions than answers. Claims the vaccine maker’s product is performing “as expected” may not be so far from the truth.

© 2021 Children’s Health Defense, Inc. This work is reproduced and distributed with the permission of Children’s Health Defense, Inc. Want to learn more from Children’s Health Defense? Sign up for free news and updates from Robert F. Kennedy, Jr. and the Children’s Health Defense. Your donation will help to support us in our efforts.

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Image by Marco Verch Professional Photographer via Flickr, CC BY 2.0.



Most “Conservative” News Outlets Are on the Big Tech Teat

Not long ago, conservative media was not beholden to anyone. Today, most sites are stuck on the Big Tech gravy train.

I’ll keep this short. The rise of Pandemic Panic Theater, massive voter fraud, and other “taboo” topics have neutered a majority of conservative news sites. You’ll notice they are very careful about what topics they tackle. Sure, they’ll attack Critical Race Theory, Antifa, and the Biden-Harris regime, but you won’t see them going after George Soros, Bill Gates, the World Economic Forum, or the Deep State, among others.

The reason is simple. They are beholden to Big Tech, and Big Tech doesn’t allow certain topics to be discussed or they’ll cut you off. Far too many conservative news outlets rely on Google, Facebook, and Twitter for the bulk of their traffic. They depend on big checks from Google ads to keep the sites running. I don’t necessarily hold it against them. We all do what we need to do to survive. I just wish more would do like we have, which is to cut out Big Tech altogether.

We don’t get Google checks. We don’t have Facebook or Twitter buttons on our stories. We don’t have a YouTube Channel (banned), an Instagram profile (never made one), or a TikTok (no thanks, CCP). We’re not perfect, but we’re doing everything we can to not owe anything to anyone… other than our readers. We owe YOU the truth. We owe YOU the facts that others won’t reveal about topics that others won’t tackle. And we owe America, this great land that allows us to take hold of these opportunities.

Like I said, I don’t hold other conservative sites under too much scrutiny over their choices. It’s easy for people to point fingers when we’re not the ones paying their bills or supporting their families. I just wish there were more who would make the bold move. Today, only a handful of other major conservative news outlets have broken free from the Big Tech teat. Of course, we need help.

The best way you can help us grow and continue to bring proper news and opinions to the people is by donating. We appreciate everything, whether a dollar or $10,000. Anything brings us closer to a point of stability when we can hire writers, editors, and support staff to make the America First message louder. Our Giving Fuel page makes it easy to donate one-time or monthly. Alternatively, you can donate through PayPal or Bitcoin as well. Bitcoin: 3A1ELVhGgrwrypwTJhPwnaTVGmuqyQrMB8

Our network is currently comprised of nine sites:

  • NOQ Report
  • Conservative Playlist
  • Truth. Based. Media.
  • Freedom First Network
  • Based Underground
  • Uncanceled News
  • American Conservative Movement
  • Conservative Playbook
  • Our Gold Guy

We are also building partnerships with great conservative sites like The Liberty Daily and The Epoch Times to advance the message as loudly as possible, and we’re always looking for others with which to partner.

Some of our content is spread across multiple sites. Other pieces of content are unique. We write most of what we post but we also draw from those willing to allow us to share their quality articles, videos, and podcasts. We collect the best content from fellow conservative sites that give us permission to republish them. We’re not ego-driven; I’d much rather post a properly attributed story written by experts like Dr. Joseph Mercola or Natural News than rewrite it like so many outlets like to do. We’re not here to take credit. We’re here to spread the truth.

While donations are the best way to help, you can also support us by buying through our sponsors:

  • MyPillow: Use promo code “NOQ” to get up to 66% off AND you’ll be helping a patriotic, America First company.
  • ZStack: Improve your immune system with the Z-Stack protocol or rejuvenate your body from vaccines or shedding with Z-DTox by Dr. Vladimir Zelenko.
  • OurGoldGuy: Tell them JD sent you in your request to buy gold and it will help us… AND (wait for it) you’ll be helping a patriotic, America First company.
  • MyPatriotSupply: Stock up on long-term food, survival gear, and other things that you’ll need just in case things don’t recover and we keep heading towards apocalypse.

We know we could make a lot more money if we sold out like so many “conservative” publications out there. You won’t find Google ads on our site for a reason. Yes, they’re lucrative, but I don’t like getting paid by minions of Satan (I don’t like Google very much if you couldn’t tell).

Time is short. As the world spirals towards The Great Reset, the need for truthful journalism has never been greater. But in these times, we need as many conservative media voices as possible. Please help keep NOQ Report and the other sites in the network going. Our promise is this: We will never sell out America. If that means we’re going to struggle for a while or even indefinitely, so be it. Integrity first. Truth first. America first.

Thank you and God Bless,
JD Rucker

Bitcoin: 32SeW2Ajn86g4dATWtWreABhEkiqxsKUGn


All ORIGINAL content on this site is © 2021 NOQ Report. All REPUBLISHED content has received direct or implied permission for reproduction.

With that said, our content may be reproduced and distributed as long as it has a link to the original source and the author is credited prominently. We don’t mind you using our content as long as you help out by giving us credit with a prominent link. If you feel like giving us a tip for the content, we will not object!

JD Rucker – EIC
@jdrucker


 

Tags: Children's Health DefenseLedePfizerTop StoryVaccines
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