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Pfizer Trial Data: Risks Outweigh Benefits

Day 3 · 0:24:26 · Deanna McLeod

  • 📉 Six-month Pfizer data showed only a 4% absolute drop in COVID cases against an 18% rise in unsolicited side effects and five-fold more severe adverse events.
  • ❤️ Nine cardiovascular deaths occurred in the healthy vaccine arm, higher than placebo, yet were overlooked in “safe and effective” claims.
  • 🤒 Reactogenicity produced COVID-like illness (fever, fatigue, headache) that increased with the second dose.

Highest-level trial evidence is re-examined and found net-negative for participants.

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Transcript

Deanna McLeod · 0:24:26

But let's just get into some of the data. So whenever you're doing an evidence-based evaluation, what you do is you start with the highest level of evidence. The highest level of evidence produced for the mRNA product, which has also been marketed as a vaccine, is the Pfizer 6-month data. So this is called Level 1 evidence, and if I actually took the New England Journal of Medicine publication and summarized it in these slides, and if you actually were to read the paper in full, including the supplements, which is where they bury a lot of the safety data, what you'll find out is that in terms of the 6 months of evaluation for the COVID-19 vaccine, I'm looking at the Pfizer paper here, the COVID-19 cases were fewer in the vaccine arm than the placebo arm. But if you actually looked at the absolute change, it was -4%. So they were actually able to reduce the number of COVID cases by -4%. If you looked at the product side effects during that same period, and when I talk about product side effects, these were unsolicited side effects, meaning that the patient had to report them.

Deanna McLeod · 0:25:31

During the, the trial period. And just so that you know, a normal randomized controlled trial, you have a clinician that's monitoring the patient, you do lab work, you, you know, do symptom profiling. This was mediated through a phone app, and there was no lab work done at all. So the physicians and the clinicians had no idea what was actually happening in the bodies of the patients when they were running these trials. They were just looking at the symptoms. But interestingly enough, you have -4% of cases but +18% in side effects. And that's just patient-reported side effects. In terms of severe COVID-19, it was a -0.1% reduction in severe COVID cases but an increase of 0.5% in severe side effects. So what we're looking at here is 5 times the number of side effects for any benefit of reduction in COVID cases in the first 6 months. And they called this an incredible win.

Deanna McLeod · 0:26:31

But if you looked at the risk-benefit profile, it's actually a loss for each of the patients that are— for the patients as a whole who are in this trial. The other thing that's really interesting is that if you actually looked at cardiovascular-related deaths, and they did record these, we're looking at a population of healthy volunteers that participated in this trial. And yet there were 9 cardiovascular deaths in the 6-month period. After receiving the COVID-19 vaccine, and that was higher than the placebo arm. So to me, that would have been an immediate signal right away that this is going to have— this is cardio— this is going to have an impact on cardiovascular system, uh, and yet it was completely overlooked whenever they were presenting the results. We were told that this is safe and effective, but what this looks to me is that the risks outweigh the benefits. I just want to highlight another thing is one of the, the ways the primary endpoint that they used for this paper was confirmed COVID case, which is confirmed with a PCR test.

Deanna McLeod · 0:27:33

And they didn't actually look at clinical symptoms.

Speaker G · 0:27:36

They—.

Deanna McLeod · 0:27:36

This is basically a chart of reactogenicity, and reactogenicity is a fancy word for saying what happens immediately after you get your vaccine. And if you actually note here, a lot of the things that people were experiencing— fever, fatigue, headache, muscle pain, joint pain— remind you of COVID It's a COVID-like illness. So what they're actually reporting here is that 36— let's just take headache for instance, uh, after your first dose, 36% of the patients in the vaccine arm had, uh, headaches and 28% of the placebo. But that's a plus 8%. So what we're looking at is that we're actually getting increases in COVID-like illness with each dose. If you look to the second dose, you can see that those numbers go up even further. So you have plus 37% in fatigue, you have plus 29% in, in headache. And these are over and above what I mentioned earlier, which is the plus 18% in side effects. So what we're seeing here is this is having a major impact on people.

Deanna McLeod · 0:28:38

And curiously enough, when we looked at this, we're like, it looks like it's causing COVID. We can't say it's causing COVID, but it looks like it's causing COVID-like illness. So it's very interesting that we're trying to reduce COVID and then we're giving somebody something that actually produces COVID-like illness. If COVID-like illness was so bad, why are we inducing it with this product? But I guess we were told that it works.