More people died in the key clinical trial for Pfizer’s Covid vaccine than the company publicly reported

Guest Post by Alex Berenson

Pfizer told the world 15 people who received the vaccine in its trial had died as of mid-March. Turns out the real number then was 21, compared to only 17 deaths in people who hadn’t been vaccinated.

On July 28, Pfizer and its partner BioNTech posted a six-month data update from their key Covid vaccine clinical trial, the one that led regulators worldwide to okay the shot.

At a time when questions about vaccine effectiveness were rising, the report received worldwide attention. Pfizer said the vaccine’s efficacy remained relatively strong, at 84 percent after six months.

It also reported 15 of the roughly 22,000 people who received the vaccine in the trial had died, compared to 14 of the 22,000 people who received placebo (a saline shot that didn’t contain the vaccine).

These were not just Covid deaths. In fact, they were mostly not from Covid. Only three of the people in the trial died of Covid-related illnesses – one who received the vaccine, and two who who received the saline shot. The other deaths were from other illnesses and diseases, mostly cardiovascular.

Researchers call this datapoint “all-cause mortality.” Pfizer barely mentioned it, stuffing the details of the deaths in an appendix to the report.

But all-cause mortality is arguably the MOST important measure for any drug or vaccine – especially one meant to be given prophylactically to large numbers of healthy people, as vaccines are.

(SOURCE: Appendix to “Six Month Safety and Efficacy of the BNT162b2 mRNA COVID-19 Vaccine,” available at https://www.medrxiv.org/content/10.1101/2021.07.28.21261159v1.supplementary-material)

Although the researchers released their update in July, the data was already more than four months old. They had stopped collecting information about deaths as of March 13, the “data cut-off.”

But even at the time, their figures were somewhat troubling.

In their initial safety report to the FDA, which contained data through November 2020, the researchers had said four placebo recipients and two vaccine recipients died, one after the first dose and one after the second. The July update reversed that trend. Between November 2020 and March 2021, 13 vaccine recipients died, compared to only 10 placebo subjects.

Further, nine vaccine recipients had died from cardiovascular events such as heart attacks or strokes, compared to six placebo recipients who died of those causes. The imbalance was small but notable, considering that regulators worldwide had found that the Pfizer and Moderna mRNA vaccines were linked to heart inflammation in young men.

(I reported accurately on this study on Twitter on July 29, and the next day Twitter suspended me for a week for doing so, the fourth of my five defamatory “strikes” for Covid “misinformation.”)

At best, the results suggested that the Pfizer/BioNTech vaccine – now pushed on nearly a billion people worldwide at a cost of tens of billions of dollars and ruinous and worsening civil liberties restrictions – did nothing to reduce overall deaths.

Worse, Pfizer and BioNTech had vaccinated almost all the placebo recipients in the trial shortly after the Food and Drug Administration okayed the vaccine for emergency use on Dec. 11, 2020.

As a result, they had destroyed our best chance to compare the long-term health of a large number of vaccine recipients with a scientifically balanced group of people who had not received the drug. The July 28 report appeared to be the last clean safety data update we would ever have.

But now the FDA has given us one more.

On November 8, the agency released its “Summary Basis for Regulatory Action,” a 30-page note explaining why on August 23 it granted full approval to Pfizer’s vaccine, replacing the emergency authorization from December 2020.

SOURCE: https://www.fda.gov/media/151733/download

And buried on page 23 of the report is this stunning sentence:

From Dose 1 through the March 13, 2021 data cutoff date, there were a total of 38 deaths, 21 in the COMIRNATY [vaccine] group and 17 in the placebo group.

Pfizer said publicly in July it had found 15 deaths among vaccine recipients by mid-March. But it told the FDA there were 21 – at the same data cutoff end date, March 13.

21.

Not 15.

The placebo figure in the trial was also wrong. Pfizer had 17 deaths among placebo recipients, not 14. Nine extra deaths overall, six among vaccine recipients.

Could the discrepancy result from some odd data lag? Maybe, but the FDA briefing book also contains the number of Covid cases that Pfizer found in vaccine recipients in the trial. Those figures are EXACTLY the same as those Pfizer posted publicly in July.

Yet the death counts were different.

Pfizer somehow miscounted – or publicly misreported, or both – the number of deaths in one of the most important clinical trials in the history of medicine.

And the FDA’s figures paint a notably more worrisome picture of the vaccine than the public July numbers. Though the absolute numbers are small, overall deaths were 24 percent higher among vaccine recipients.

The update also shows that 19 vaccine recipients died between November and March, compared to 13 placebo recipients – a difference of almost 50 percent.

Were the extra deaths cardiac-related? It is impossible to know. The FDA did not report any additional details of the deaths, saying only that none “were considered related to vaccination.”

But with tens of thousands of post-vaccine deaths now reported in the United States and Europe – and overall non-Covid death rates now running well above normal in many countries – a fresh look at that vague reassurance cannot happen soon enough.

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Ken31
Ken31

They disregarded so many every safety protocol ever devised. How can you conclude the purpose of these alleged vaccines had anything to do with keeping people healthy?

2smartforlibs
2smartforlibs

Like the grim reaper telling you to trust him.

Saxons Wrath
Saxons Wrath

The purpose of the jab is mass “Vaxecutions”.

Once you understand the intent is to kill you,
it all makes perfect sense.

YMMV.

Good luck, take some out with you,
if you’ve already had the “lethal injection”.

American_League

I believe that the #1 reason people are hesitant to get the vaccination, is because they have been lied to from the start. Dr. Fauci, and the CDC will say anything to scare people into submission. Since that didn’t produce the results that they wanted, they have turned to coercion and mandates which threaten the livelihoods of those who resist.

American_League

“Psychological manipulation of a person usually over an extended period of time that causes the victim to question the validity of their own thoughts, perception of reality, or memories and typically leads to confusion, loss of confidence and self-esteem, uncertainty of one’s emotional or mental stability, and a dependency on the perpetrator.”
I believe that we as a country are being subjected to this by the Mainstream Media, the Government control of our Educational Systems, the Entertainment Industry, and the Marxist leaders of the New World Order.

So, if you were confused as to the definition of “Gaslighting”, this is it.

Martin
Martin

Appendix study, if you look at the supplementary materials, actually records 20 deaths in the vaccine group, and 14 in the placebo, because several additional deaths occurred after unblinding when people who got placebo initially went on to get a vaccine. The supplementary tables list cause of death as well. Still 21 vs 17 is a numerical imbalance, but creating the end of the world on it, means you are not looking for the truth.

Oz Guy
Oz Guy

I think you provided the answer in your article, as to why the vaccinated group has a higher overall death count.
After December, everyone in the placebo group got the vaccine.

Therefore, vaccine group outnumbered the placebo group by like 5 to 1 (just guessing), so it means nothing if there were a few extra deaths in that (much larger) group.

Daniel
Daniel

You need to put these numbers in relation to the total number of participants. Saying that there were 24% or 50% more deaths than in the control group makes it sound obvious and scary, but once you consider that we’re talking about a few dozen cases out of a total of 44,000 subjects here, it’s clear that this difference is not at all statistically significant. People don’t die deterministically.

I.C. Thruit

Maybe you don’t understand how to interpret controlled signals. The assumption with placebo is that the control group represents the expected outcome, in this case, mortality. Excess deaths are, de facto, attributable to the intervention.

If you look at the data, there are a total of 2 COVID-attributed deaths in the placebo group, compared with one in the intervention group, for a net savings of one life. The groups had 22,000 participants, so the NNV is 22K. 22,000 people must be vaccinated to save a single life. This is the basis for the claim that the injection saves lives.

If, however, the net excess deaths favor the intervention group, as they do even according to the original submission showing 15 vs. 14, then the opposite conclusion must be made. There are two additional deaths in this group, compensating for the one COVID death prevented, and an additional one as well. That means, at minimum, there are expected two deaths for every life saved by the intervention.

One might say this study is under-powered to produce a strong signal on the mortality outcomes of the injection, as you have suggested. If so, however, it’s hard to substantiate a claim that this product saves lives, since even a minimal reckoning of the data shows the opposite. If the trial isn’t strong enough to determine a clear signal on safety, how is it strong enough to predict efficacy? You can’t have it both ways.

Actual data, from health systems, insurance actuaries, and reporting collections, all reflect this outcome as a very conservative estimate of what is suggested by this Pfizer license submission. I do not know how anyone could approve based on this data, let alone claim safety and efficacy in saving lives.

xyzzy

Excess deaths in vaccine group totaled more than in control group.
Small numbers, but suggesting vaccine did not save net lives, rather took more lives than it saved from Covid.
However. Out of the 22,000 in the vaccine group, 100% got the vaccine. So side effects and deaths from the shot represent 100% uptake.
This was not a “challenge” test. Precautions were still being practiced and small number of people in either vaccine or control group was exposed to the virus. Out of 22,000, about (from memory) 150 control group and 8 vaccine group contracted Covid. Representing just 0.68%
Had exposure been 100%, expect 22,000/150 times the infections (100% of control group, 5% of vaccine group).
Expect same multiple for deaths, 293 in control group, 147 in vaccine group.
Then, you’ve got 147 lives saved from Covid, vs. 5 unfortunately lost due to the vaccine.
That is a very strong net benefit (sucks for the unluck.)
(The 2 vs. 1 deaths isn’t enough to have much confidence in the ratio but I assumed 2:1 in this math. Could have been 2:2 or 3:1)
The weakness of this study, and the weakness of many anti-vax talking heads, is that only a small fraction of the participants were exposed to the virus. Later field results, in a world with 95% Covid uptake, gives better data.
(I’m neither pro- nor anti- vaccine. I’m agnostic and a data digger.)

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