Skip to content

Global AE Surge, Bradford Hill and the RotaShield Precedent

Day 2 · 4:53:15 · Dr. Jessica Rose

  • 🌍 WHO/Uppsala reports jumped from under half a million (2016–2020, all vaccines) to almost 6 million in 2021—a 1,300%+ safety signal.
  • 📋 She lists Bradford Hill criteria and the short list of acknowledged causal links (myocarditis, TTS, GBS, anaphylaxis) that agencies already accept.
  • 🛑 RotaShield was suspended after only 15 intussusception VAERS reports in 1998–99; she asks why a far larger early COVID death signal brought no similar action.

How pharmacovigilance is supposed to work—and how it worked for RotaShield.

← Rose: V-Safe FOIA Data and a ~26× Underreporting Factor | U.S. CICP Rejection Rates and Canada’s Secret VISP Design →

Transcript

Dr. Jessica Rose · 4:53:15

I'll, I'll go quickly through this because it's an obvious slide. Prior to the COVID-19 injection rollout for the, for four years, 2016 to 2020, all the data combined gathered by the WHO and the Uppsala Monitoring Center, which is run by the WHO, have a total of less than a million, or half a million, less than half a million adverse event reports for all vaccines combined across the world. Come 2021, this rose, same people reporting this data, to almost 6 million. That's not a small discrepancy. That is a safety signal. 1,300% Or more increase in the number of Global reports. Now, whenever you're analyzing or investigating pharmacovigilance databases, you have to follow up. And if there is a safety signal detected therein, you have to do a causality assessment.

Dr. Jessica Rose · 4:54:19

These are the Bradford Hill criteria listed here. This is what the CDC, the FDA, and the WHO use. They've traditionally used in the past, and they have used these to make determinations of causal effects that you can see on the, the right. But this is a short list. So these are the ones that we all heard about: the myocarditis, pericarditis, thrombosis with thrombocytopenia syndrome, uh, deaths which were causally linked to the TTS, Guillain-Barré, which we heard about today, and anaphylaxis. Of course, there was a particular Moderna batch number that had to be withdrawn in the United States because the signal for anaphylaxis was so high. Temporality is the mandatory gatekeeper of these criteria. Of course, one thing has to come before the other in order for a causal effect to be there, and the shorter the time frame between those two things, the higher the likelihood. I've, I've heard a number of people here saying that they got their symptoms within hours of their shots, so that's the most important criteria, and it's satisfied.

Dr. Jessica Rose · 4:55:26

So these are acknowledged by all of these agencies here, ACIP, CDC, FDA, and EMA. So this is, this is not anecdotal. Like I said, pharmacovigilance, which is necessary when you're dealing with vaccines, includes follow-up, and it works. So back in 1998, there was a vaccine called the RotaShield vaccine, and within VAERS, the Vaccine Adverse Event Reporting System, There were 15, one-five, intussusception reports. Intussusception is when the bowel folds over on itself. It's very painful. This was in children. The CDC saw the signal, they looked it up, they suspended the vaccine because this was considered to be a strong enough safety signal to do an investigation. And lucky that they did, because follow-up had almost 100 confirmed cases and 60 within a week. So that's showing a temporal signal. Eventually, in 1999, the manufacturer themselves voluntarily withdrew the product because they saw that it was damaging kids.

Dr. Jessica Rose · 4:56:32

So the point of this, before I show you that, is that VAERS works. I'm absolutely sure everybody here has heard, well, you can't use VAERS to infer causation. It's like nobody saying that, but you need to have a detection system ongoing in order to detect the signals with proper signal maintenance like Senator Johnson was speaking about. And then you have to do follow-up, you have to do a causality assessment, which was not the case in the context of the COVID-19 quote-unquote vaccine. This is my data. I've been looking at theirs since, uh, The day one of the rollout, December 17th, uh, 2020, um, and there is a death signal on January 30th, 2021 that was not deniable. 634 Cases of death. Now last time I checked, you can't recover from death. This is, uh, clearly showing, um, that most of these deaths are occurring in our elders.

Dr. Jessica Rose · 4:57:35

This makes sense because they were targeted first. For the products. So my question is, why did the early death signal not prompt similar action in this COVID shot context? Because this is CDC data. VAERS is owned by HHS and its daughter agencies, FDA and CDC.