October 03, 2022 from Steve Kirsch's newsletter

Executive Summary

If you want objective proof of total ineptitude by the CDC and the medical community in monitoring the safety of the COVID vaccines, this is the article you’ve been waiting for. We use their numbers and their own algorithm and show that it should have triggered a safety signal for “death.” There is no way they can argue their way out of this one. There is no rock that is large enough for them to hide under.

We need look no further than the vaccine safety signal monitoring formula used by the CDC to prove our point.

Problems include:

  1. The formula the CDC uses for generating safety signals is fundamentally flawed; a “bad” vaccine with lots of adverse events will “mask” large numbers of important safety signals.

  2. The CDC refused to correct their algorithm when officially notified of the error in August 2021.

  3. Death is such a huge signal in the COVID vaccines that even the CDC’s flawed formula still shows a safety signal

  4. The CDC failed to notify the public that the death signal was triggered. That is unconscionable.

  5. The mainstream medical community didn’t notice anything was wrong and remained silent while hundreds of thousands of Americans were killed by the COVID vaccines. See this article or Dr. Naomi Wolf’s independent validation of my numbers.

  6. CDC management still isn’t aware of any of these problems (or if they are aware, they aren’t acknowledging or doing anything about them).

  7. It is doubtful that the mainstream media will ever hold the CDC accountable. Even Fox News won’t cover this.

Introduction

Very early on in my new professional career as a misinformation superspreader (which began on May 25, 2021 when I authored a 285-page article “Should you get vaccinated?” for Trial Site News), I discovered a document entitled Vaccine Adverse Event Reporting System (VAERS) Standard Operating Procedures for COVID-19 (Jan 29, 2021).

Note that FOUO stamped on each page means “For official use only” so please do not use this for other than official use or you could get in trouble. I clearly violated that warning and look at what happened to me.

It was immediately clear to me when I first read this document in early July 2021, that the formulas they used to trigger safety signals were flawed.

I tried to bring this to the attention of the CDC and the outside committee of the CDC. The CDC ignored me and the outside committee members refused to consider my emails and the two that replied said to submit it as a public comment which I did months later when they opened the window for public comments. See Comment tracking number: ksy-ckr3-73lv.

I also pointed the error out to Mathew Crawford. I didn’t have a substack at the time, but Mathew did.

Mathew memorialized it in a Substack article dated July 26, 2021 aptly titled Defining Away Vaccine Safety Signals. That was the first article in a three part series. Here are Part 2 and Part 3.

So there is a clear public record that we pointed this out in Mathew’s Substack article.

The medical community doesn’t seem to mind. No complaints from any of them. Even Vinay Prasad said nothing.

The flaws in the CDC safety signal detection algorithm

Let me summarize the key points for you in a nutshell:

  1. PRR is defined on page 16 in the CDC document as follows (and note they should have capitalized all the letters in the formula):

  2. A “safety signal” is defined on page 16 in the CDC document as a PRR of at least 2, chi-squared statistic of at least 4, and 3 or more cases of the AE following receipt of the specific vaccine of interest.  This is the famous “and clause.” Here it is from the document

  3. Only someone who is incompetent or is deliberately trying to make the vaccines look safe would use the word “and” in the definition of a safety signal. Using “and” means that if any one of the conditions isn’t satisfied, no safety signal will be generated. As noted below, the PRR will rarely trigger which virtually guarantees that most events generated by an unsafe vaccine will never get flagged.

  4. The PRR value for the COVID vaccines will rarely exceed 1 because there are so many adverse events from the COVID vaccine because it is so dangerous (i.e., B in the formula is a huge number) so the numerator is always near zero. Hence, the “safety signal” is rarely triggered because the vaccine is so dangerous.

Chronology of events

  1. The CDC publishes: Vaccine Adverse Event Reporting System (VAERS) Standard Operating Procedures for COVID-19 (Jan 29, 2021).

  2. I first learned of this paper in July after I couldn’t figure out why the CDC wasn’t warning anyone of the safety signals in plain sight.

  3. I read the paper. It was clear on my initial reading that the formula the CDC uses to trigger safety signals is seriously flawed: it will rarely fire if the vaccine under test is very dangerous because it relies on using PRR in an “and” clause (more about that below).

  4. On July 25, I notified Mathew Crawford and others of the error. Here’s the email I sent:

  5. Crawford cranks out an article (first in a series of 3 articles) just one day later on July 26, 2021: Defining Away Vaccine Safety Signals.

  6. On August 29, 2021, I notified the CDC using their official notification channels of the flaw: see Comment tracking number: ksy-ckr3-73lv which was submitted prior to the August 30, 2021 ACIP meeting. See Attachment 1, page 1 and page 6 which documents the error as well as my attempts to bring the error to the attention of the ACIP committee (that part continues on to page 7). The other two attachments are also useful reading and proves that the CDC was notified and they chose to entirely ignore all the input that the vaccines are unsafe.

  7. The safety signal for death (and likely many more adverse events) is so extreme that even using their own flawed formula for detecting safety signals, the “death” safety signal should have triggered as I show below. Yet we heard nothing, not even in the FOIA requests. How is it possible that they missed the single most important safety signal for a vaccine? The deaths are off the charts; even their flawed safety signal was finally triggered, but they said absolutely nothing to the American people.

  8. The medical community has chosen to look the other way and ignore all of this: (a) the flawed formula, and (b) the failure of the CDC to use their own erroneous formula with the data in plain sight to notify the public of a potential problem.

  9. The mainstream media has refused to report on this.

  10. The only member of Congress that will talk to me about vaccine safety is Senator Ron Johnson. The others hang up or refer me to staffers who then ignore me.

An example using a fictitious dangerous vaccine

If you don’t see why dangerous vaccines will rarely generate a PRR signal, here’s an example.

Suppose we have the world’s most dangerous vaccine that causes adverse events in everyone who gets it and generates 25,000 different adverse events, and each adverse event has 1,000 instances. That means that the numerator is 1,000/25,000,000 which is just 40 events per million reported events.

Now let’s look at actuals for something like deaths.

For all other vaccines, there are 6,200 deaths and 1M adverse events total.

Since 40 per million is less than 6,200 deaths per million, we are not even close to generating a safety signal for deaths from our hypothetical vaccine which killed 1,000 people in a year (the MMR vaccine by comparison reports around 5 deaths per year in VAERS for 10M doses).

The point is that a dangerous vaccine can look very “safe” using the PRR formula.

PRR calculation for death for the COVID vaccine

Let’s do the PRR for death for the COVID vaccine.

For all other vaccines, there are 6,157 deaths and 918,717 adverse events total:

For the COVID vaccines, there were 31,214 deaths and 1.4M adverse events total.

PRR = (31214/1.4e6) / (6157/918717) = 3.32 which exceeds the required threshold of 2.

In other words, the COVID vaccine is so deadly, that even with all the adverse events generated by the vaccine, the death signal did not get drowned out!!!

But there is still the chi-square test.

Chi-square test results were 18,549 for “death” which greatly exceeds the required threshold of 4

The CDC chi-square test is clearly satisfied for the COVID vaccine.

I did a very rough calculation making simplifying assumptions since it was obvious that the value would be quite high. I assumed the number of vaccinations was the same in every year (which is approximately true) and that in 2021, the number of vaccinations went up by a factor of 5X normal.

The estimated chi-square statistic of 18,549 exceeded the threshold of 4 using the symptom of death.

Death should have triggered a safety signal. Why didn’t it?

Because the death signal is so huge, it even survived the PRR test.

This means that even using the CDCs own erroneous “safety signal” formula, all three criteria were satisfied:

  1. PRR>2: It was 3.32

  2. Chi-square>2: It was 18,549

  3. 3 or more reports: There were over 31,214 death reports received by VAERS so far which is more than 3.

A safety signal should have been generated but wasn’t. Why not?

Why does the CDC ignore me?

Does anyone care? Hundreds of thousands of American lives have been lost due to the inability of the CDC to deploy their own flawed safety signal analysis.

Could there be a Simpson’s paradox here where the overall numbers trigger the signal, but each age range does not?

No, not in this case.

Here’s a partial analysis by Mike Deskevich.

As Mathew Crawford notes:

  1. Essentially, if a safety signal is present in the aggregate, it must be present in at least one demographic group. This can be proved using Jensen's Inequality and viewing the aggregate as an average (which doesn't change PRR numbers).

  2. Due to convexity of the function, the PRR on the aggregate is between the maximum and minimum of the PRRs of the subgroups for any given AE.

You can have Simpson's paradoxes with fractions, but the PRR functions are more complex than simple fractions, and the math to get there is a bit more difficult.

Here is one of Mathew’s early articles with a Simpson's paradox in fractions/proportions:

In plain English, the fact that the overall aggregate PRR number is bad (as calculated above) is sufficient to trigger the safety signal since it guarantees that at least one of the age cohorts would trigger the signal.

So you can’t argue that I’m doing it wrong and it is age confounded and I have to do the calculation by age cohorts.

Furthermore, even if there was a Simpson’s paradox (which there isn’t), any cohort definition that shows a signal should be investigated.

The larger point still remains: the CDC doesn’t seem to care whether there is anything wrong with the vaccines. That’s the big problem.

Now that this problem is out in the public domain, and they are notified of this, they will do nothing, as usual.

Plain common sense says something is wrong

As you can see from the death numbers in previous years, the number of deaths never exceed 300 in any single year.

For the COVID vaccines, over 31,214 death reports have been received to date.

Do you see a problem here? Why are there 100X times more death reports being filed.

Busting the “it’s just overreporting” argument

The CDC likes to “claim” it is because people are more aware of VAERS, but I haven’t found a single physician who is now “suddenly” aware of VAERS and making VAERS reports. Furthermore, I know a physician who is under reporting events this year by 1,000X. In previous years, it was 1X. So when you actually talk to the doctors, the picture of reporting becomes clear: there are so many reports because there are so many events. This isn’t a reporting artifact.

To further address the hand-waving claim of “over reporting,” why would this new “awareness of VAERS” not translate into reporting of deaths for any other vaccines? As you can clearly see from this chart, the death reporting for all other vaccines has remained flat. It is only the deaths from the COVID vaccines that are “off the charts.”

How could the CDC not see a safety signal in plain sight like this?

Only the COVID deaths are elevated. There is no elevation for any other vaccine.

Some people claim, “oh, look unrelated events are up such as ingrown toenails. That proves it is just over reporting!” The problem with this argument is that because there are so many people who are injured there will be more reports. Assuming that ingrown toenails are not caused by the vaccine, the reporting rate for ingrown toenails will increase by 30X or more solely because there are more people reporting serious adverse events.

I point out many more reasons that it is not just over reporting in this paper (see pages 8 through 17).

Here are a few more observations that are not consistent with a safe vaccine:

  1. The Social Security death master file showed a 60% increase in all-cause mortality 5 months after the peak of the initial vaccine delivery.

  2. Embalmers reported odd clots in up to 93% of cases

  3. The “Died Suddenly” group was adding 20,000 new people per day before Facebook shut it down

  4. Insurance company are reporting 12 sigma increases in deaths of people under 60 and they aren’t due to COVID

  5. My neurologist reported 0 events to VAERS in the last 11 years. For these vaccines, she has 1,000 reports to file. My other doctor friends in smaller practices are reporting statistics like 0 in 25 years, now 26.

  6. User surveys done by outside firms show the vaccines are killing more people than COVID.

  7. Independent experts in their field such as Paul Marik, Peter McCullough, and Aseem Malhotra all went from blue pill to red pill when they stopped trusting the experts and started looking at the data.

  8. Millions of people are estimated to be vaccine injured. I just heard today about one group of 100 people at Netflix who were all vaccinated and 30% suffered injuries.

  9. Troubling anecdotes such as Wayne Root’s wedding where it was the vaccinated who were being injured and dying. I did a follow up survey with 600 people and found similar numbers.

Does the CDC want to see any safety data at all?

Clearly, the CDC isn’t bothering to check its own safety signals.

Martha Sharan claims the CDC does investigate deaths after vaccination though.

I wonder how many times the CDC has requested that the proper staining be done to the tissue samples to find a link to the COVID vaccines.

A good guess would be zero.

After all, it’s safe and effective so why bother to look for evidence of harm, right?

Why am I bringing this up again now, more than a year later?

Because the Epoch Times just published an article today about newly disclosed emails about the CDC safety monitoring debacle where first they were doing it and then they weren’t and then they were and then they weren’t. It’s so confusing.

So I thought this would be a good time to bring to light the huge problem that they have a flawed safety signal definition and even with their flawed definition, the safety signals still trigger for “death” but the CDC remains silent. This is the big story that has not been reported.

There are at least 7 articles in The Epoch Times recently about the CDC safety monitoring disaster:

The most recent article reveals that the two people who appear to be most responsible for this failure are John Su and Tom Shimabukuro.

Also special mention goes to Martha Sharan who makes sure that people like me cannot talk to the principal players. Martha is nice enough to ignore all attempts at communication so that John and Tom are never held accountable for their mistakes.

None of them will respond to any emails I’ve sent them.

Maybe you will have better luck than I have had getting their attention.

Here are their emails:

  1. John Su, the CDC VAERS expert. I’ve written many articles about John. My very first Substack article was about John and I didn’t mince words: It's time for John Su to go (Oct 30, 2021).

  2. Tom Shimabukuro, a prominent member of the Vaccine Safety Team of the CDC COVID-19 Vaccine Task Force. Tom is also the first author of the NEJM paper on pregnancy and the vaccines, but there was never a follow-up paper showing what happened to women who got the shot early in their pregnancy. Why weren’t the final results ever published? He’s avoided answering this question and the press apparently doesn’t want to know the answer for some reason. How can the CDC promote the vaccine as safe and effective for pregnant women without publishing the result of the study? I don’t understand that.

  3. Martha Sharan, the press gatekeeper who makes sure nobody gets to John and Tom. Martha and I have never talked, not even by email. She’s ignored every form of communication from me. Nice lady.

Reporting odds ratio

It’s been known since at least 2004 that using reporting odds ratio (ROR) is a better estimate of relative risk than PRR. I don’t know why the CDC doesn’t use it.

They don’t seem very receptive to input from the public, do they?

Comment from the ACIP committee members?

I’ve emailed the ACIP committee members for comment. I will post here if I hear anything.

Comment from the CDC?

I’ve reached to Martha Sharan of the CDC for comment since she is the press person there. I’ll update the story if I hear back. Don’t hold your breath.

Comment from David Gorski?

I’ve also reached out to David Gorski for comment. David long ago realized he can’t beat me on the science, so he requested I never contact him again. I don’t expect to hear from him, but I emailed him just to leave no stone unturned.

Comment from UPenn Professor Jeffrey Morris?

I’ve emailed Professor Jeffrey Morris for comment. He calls himself a “truthseeker” but I haven’t seen any evidence of that.

Do you think he will call for an investigation? I don’t.

I was right. No call for an investigation. He replied to me with two points:

  1. He thinks the doctors could be reporting the COVID vaccines more and that accounts for the increase in the number of reports.

  2. He has nothing to do with creating the CDC’s criteria for safety signals

In other words, it appears he believe that doctors are around 40 times more likely to report deaths from the COVID vaccine than other vaccines. I’ve asked him for the data supporting that claim.

More importantly, the reporting rate is a red herring. The fact is that the PRR formula is immune to differential reporting rates of vaccines because it computes a ratio for each vaccine.

The key point of my article is that the CDC is ignoring their own safety signals and not informing the public. He avoided commenting on this massive failure affecting the lives of hundreds of thousands of people.

Comment from the medical community?

Why isn’t anyone from the medical community saying this is wrong?

Comment from fact checker organizations

No fact checker will touch this story. It’s too damaging for the narrative. Their job is to create fear, uncertainty, and doubt. This one is impossible to obfuscate. All the numbers and the formulas are in plain sight.

Plus, the graph of death reports compared to other vaccines… that one is hard to explain no matter how hard you try.

So none of the fact checkers will try. I guarantee it.

What you can do about it

  1. Make a donation to re-elect Senator Ron Johnson. This is the single best way to hold these people accountable.

  2. Ask your member of Congress to explain why they aren’t calling for an investigation into the safety monitoring at the CDC.

  3. Write a letter to your local newspaper asking why they aren’t calling for an investigation

  4. Ask on Twitter why nobody is calling for an investigation: the media, the medical community, members of Congress, honest employees at the CDC, …

  5. If you are a member of the press, ask President Biden why he isn’t calling for an investigation. You simply cannot have a safety agency not be able to monitor safety. Or maybe that’s OK with Joe and all the democrats in Congress?

Summary

The Proportional Reporting Ratio (PRR) is a measure used to assess safety signals in spontaneous reporting databases such as VAERS where people voluntarily report adverse events.

Using PRR alone is a very unreliable way to identify safety signals for a vaccine, especially vaccines which are extremely dangerous.

For the COVID vaccines, the PRR signal will rarely fire because there are so many adverse events so the numerator is always small so that the threshold (PRR>1) is only met for extremely serious events.

By making PRR a required element to detect a safety signal (the “and” clause described in the text above), the very dangerous COVID vaccines appear to be safe.

I was the very first person in the world to point out this error to the CDC in August 2021.

Nobody in the world except me and my misinformation spreader colleagues have questioned the clearly flawed safety signal formula used by the CDC.

The medical community looks the other way. Not a single member of the medical community has ever pointed out this error in the CDC formula.

The fact that no mainstream media, like the NY Times, Washington Post, CNN, and 60 Minutes will report on this even today shows you how captured the media is as well.

This is objective, unassailable proof of how deeply flawed and corrupt the medical system is. We pointed out the error publicly and everyone ignored it.

So important adverse events like death go unreported.

It simply doesn’t get any more clear than this that the people responsible for safety monitoring at the CDC are either incompetent, corrupt, or both.

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https://stevekirsch.substack.com/p/unassailable-proof-of-incompetence
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