Surprise—Pfizer Untruthful—Berenson

From Alex Berenson now writing on substack

On July 28, Pfizer researchers offered updated results from the company’s pivotal Covid vaccine clinical trial – the 44,000-person study providing the key data supporting use of the vaccine worldwide.

Last week’s report is the final clean update we will ever have on the vaccine’s safety and efficacy. Unless Pfizer is convinced or forced to run another big trial, we will never again have the chance to compare how a large group of people who received the vaccine fared against a matched group who instead received a placebo (no treatment).

Pfizer is responsible for the fact we won’t have good updated data going forward.

It destroyed the chance for longer-term results by offering the vaccine to people who had received the placebo in the trial only days after regulators authorized its use.

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In general, to provide useful data, a clinical trial needs two “arms” – people who have gotten a drug or vaccine, and people who haven’t. Only by comparing the arms can we see the differences the treatment has caused.

Pfizer’s trial now has only one arm. Going forward, we will have no way of knowing what we see in terms of infections and side effects – good or bad – comes from the vaccine, broader changes in the epidemic, or other factors.

So the July 28 paper is worth a close read.

The headlines about the update mostly focused on the fact that the vaccine’s protection fell from a peak of 96 percent in the first two months after people received the second dose, to an average of 84 percent four to six months later. (Note that using these average ranges overstates how well the vaccine is doing at the end of six months. Efficacy is higher at four months than six and drops over time.)

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Amazingly, the Washington Post called the results “robust,” as if anyone getting the vaccine this spring had expected its full protection to last weeks, rather than years. And the company and governments are now telling older people that they will need another shot soon. Israel, which had the earliest and most aggressive mass vaccination program of any country, is already giving third shots.

But those of us who have been paying close attention to the data coming out of the United Kingdom and Israel – which have been far more transparent than the United States – already knew the vaccines were failing. Cases, including serious cases, soared in Israel in July. Covid deaths are rising too. And most of them are among the vaccinated.

So I went looking for another piece of data in the six-month trial report, arguably the simplest and most important of all.

All-cause mortality.

All-cause mortality is exactly what it sounds like – the total number of people who received either the vaccine or the placebo who died for any reason. All-cause mortality inherently helps balance a treatment’s side effects and efficacy.

To take a crude example: a drug that saves 10 people from cancer but kills 20 from heart attacks is probably a bad bet.

Other statistics can be massaged or defined away. Drug companies are very good at convincing regulators that side effects are unrelated to their medicines. All-cause mortality cannot.

And deep in the paper, Pfizer reported the numbers. Fifteen people who received the vaccine died, compared to 14 who received placebo – not including another five who received the vaccine and died in the weeks after the trial blind was broken.

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You will note that Pfizer’s investigators concluded that the vaccine didn’t cause any of the deaths. Without knowing the specifics of the cases, it is impossible for anyone outside the trial to judge this statement. But the next sentence – claiming that the deaths did not show a pattern – is not quite true.

The causes of the 29 deaths were not listed in the report itself. Finding them means digging into the report’s appendix (in general, the most interesting information in clinical trial reports is often stuck in the appendixes).

They show that three vaccine recipients died of sepsis, while no one who received the placebo did. Given that the vaccine is known to cause transient drops in white blood counts, that gap might be worthy of follow-up.

Further, another nine vaccine recipients died of heart problems, compared to six who received placebo. Regulators have already acknowledged the vaccine can cause heart problems in young people, so that gap may also be notable. In contrast, the placebo arm included deaths from overdose and dementia, clearly unrelated to the vaccine, as well as two COVID deaths (the vaccine arm had one COVID death).

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None of this proves the vaccine increases mortality from heart problems or anything else. In the context of a trial where almost 22,000 people who received the vaccine and a similar number received the placebo, these are very small numbers.

But what we can say with certainty is that Pfizer did not prove the vaccine reduces mortality – either from the coronavirus or from all other causes – with this trial. It didn’t prove the vaccine reduced all-cause hospitalizations, either. It NEVER released those figures.

When I pointed this out on Twitter, the usual vaccine fanatics said I was being “misleading.” They didn’t say I was wrong, or that I had made up the numbers, or anything else. They said the trial hadn’t been designed to prove that the vaccine could reduce deaths from Covid or all-cause mortality.

And they’re right.

But the question we should be asking is, Why not?

Remember, only three people in both the placebo AND vaccine arms died of Covid out of the 44,000 enrolled in the trial over its entire six months – even though that included part of the winter wave. The reason is that Pfizer enrolled only a tiny handful of the older people most at risk from Covid in the trial (I explain this in greater detail in my Unreported Truths booklets).

Why didn’t regulators force Pfizer to enroll people at high enough risk from Covid to demonstrate the vaccines actually reduced mortality – either from Covid or, even better, from all-causes?

At this point, we don’t know. Perhaps we never will. But what we do know is that we have given hundreds of millions of healthy people a treatment that has not been demonstrated in a trial to save their lives. And we also know that many people who receive the vaccine have serious side effects. One in four people in the vaccine reported having side effects – four times as many as in the placebo arm.

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Other treatments regularly given as preventatives – like the cholesterol-lowering medicines called statins – have much stronger evidence they reduce deaths both from the diseases they are meant to treat (heart disease, in the case of statins) and all-cause mortality. They also have far milder side effect profiles.

Why haven’t we demanded similar evidence for the Covid vaccines – especially since it is now obvious whatever protection they offer against infection is only temporary?

I don’t know.

What I do know is that asking this question got me banned from Twitter for a week.

2 thoughts on “Surprise—Pfizer Untruthful—Berenson

  1. It is worse than that…with only 3 deaths attributed to COVID, the data do not support any conclusion but still illuminate a substantial risk concern. One death out of 77 in the vaccine group as compared to 2 deaths among the 850 controls with COVID, equates to a 5.6 times HIGHER risk of death in the vaccinated if infected with the virus (breakthrough). Sure would have been nice if the study could definitively clarify this issue.
    Additionally the six month report erroneously claims, in appendix Table S6, a viral efficacy of 96.7%. The logic is flawed as the denominators , n2d, should be the numbers of participants with COVID (77 and 850) and NOT the entire 22K cohort size. “Severe” is a subset of those with COVID. The true VE would be closer to 35%, less compelling evidence of protective effects of the vaccine against severe disease. Sure hope this gets cleaned up in peer-review…

    Like

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