## Wednesday, July 28, 2021

### Defining Away Vaccine Safety Signals

roundingtheearth |  What if it turns out that vaccines are killing and crippling millions of people around the world, but that those harmed are just well enough spread out that almost nobody saw sufficient signals to build an intuition about the problem? And what if the agency most responsible for examining safety signals defines their algorithm using a nonsensical mathematical formula that hides nearly all serious problems?

Last night I tried to go to sleep early in order to shift my exercise routine to a morning schedule. But I'd received a late phone call from a friend whom I work with researching vaccine safety/danger, just as I was brushing my teeth. He remains anonymous for now due to fear of job loss or reprisal. I let the phone call go, but I couldn't just let it go. I needed to know why he would call me that late, so after spending an hour in bed not sleeping, I checked my email. I understood immediately.

Definitions

To a mathematician, everything depends on definitions. Whatever we state mathematically, the definitions of the terms we use should be traceable back to the axioms of the field we're working in. Mathematics is an artfully woven tapestry of axiomatic structure, lit brightly by definitions. Often, we create new definitions for the task at hand, but make sure that these relate clearly to the pyramid of definitions that come before it---generally as standard as possible to language common within the field. This becomes both a habit and also a part of the self-reinforcing social structure of the mathematics community. We talk definitions that sound boring to untrained ears, but we recognize that definitions are our palettes. We port definitions to applied fields, and we create new ones to use where needed. No mathematician or statistician with a soul forgets the well from which they draw energy and meaning.

During the past few months, many people (including myself) have learned for the first time about the Vaccine Adverse Event Reporting System (VAERS) where health care workers and patients can submit adverse events (AEs) suffered post-vaccination. While the VAERS database is understood to record an often small subset of the AEs, the information can still be used for purposes of establishing safety signals. A new influenza vaccine can be compared to other influenza vaccines, for instance. If the old ones were safe enough, and the reported AEs of a new one are in line or better than for past vaccines, then the risk-benefit analysis for the new vaccine (assuming sufficient efficacy) either remains the same or improves.

As with a great deal of health care regulation during the declared pandemic, changes were made to the VAERS system and also to safety signal analysis leading up to the experimental mass vaccination program officially targeting COVID-19. Without much fanfare, the CDC published a document on January 29, 2021 entitled Vaccine Adverse Event Reporting System (VAERS) Standard Operating Procedures for COVID-19. There is a lot to talk about in this document, but let us focus on Section 2.2, which begins on page 14. Here, the CDC states that, "A series of tables will be generated using the VAERS automated data," and that these, "will be refreshed daily for internal use," but "not for public release". One might wonder why the CDC would not want additional outside eyeballs on such data---particularly since it took them two full months to figure out that myocarditis was an issue with the vaccines despite Israel warning about it two full months before the CDCs scheduled, delayed, and finally held meeting in late June. Maybe the CDC should hire somebody to read the pertinent news?

We get to section 2.3, and this is where things get really crazy. This is where signals (for assessing safety/danger of the vaccines) get defined. Subsection 2.3.1 begins (emphasis mine),

CDC will perform PRR data mining on a weekly basis or as needed. PRRs compare the proportion of a specific AE following a specific vaccine versus the proportion of the same AE following receipt of another vaccine (see equation below Table 4). A safety signal is defined 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.

Only a real dork would emphasize the word 'and', right? A logic dork, mind you, but we'll get to that...