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.
- 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.
- The CDC refused to correct their algorithm when officially notified of the error in August 2021.
- Death is such a huge signal in the COVID vaccines that even the CDC’s flawed formula still shows a safety signal
- The CDC failed to notify the public that the death signal was triggered. That is unconscionable.
- 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.
- 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).
- It is doubtful that the mainstream media will ever hold the CDC accountable. Even Fox News won’t cover this.
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:
- 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. “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
- The CDC publishes: Vaccine Adverse Event Reporting System (VAERS) Standard Operating Procedures for COVID-19 (Jan 29, 2021).
- 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.
- 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).
- 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.