How did regulators miss this?
Brilliant analysis! Everyone involved in this debacle deserves hard time.
one assumption we're making is that the placebo group actually got saline. What if they didn't? What if they got lipid nanoparticles without the mRNA? What if they were injected with everything that's in the "vaccine" except the mRNA? At this point there is evidence that the lipid nanoparticles themselves are toxic even without the mRNA. If the placebo group did not get saline and instead got the vaccine concoction sans mRNA, then that would explain the serious reactions in the placebo group in the first couple of weeks.
First off, my guess is word cloud 1 for the vaccine group, given the size of "acute myocardial infarction" there and the size of "pneumonia" in the other cloud.
Second, thanks for this analysis. I've heard it tossed around that the original Pfizer trial had more SAEs of all types (including COVID) in the treatment group than the control group. I had also heard about the whistleblower from the Pfizer trial but hadn't see anyone dig in to the differences in the SAEs of the two groups and what they may reveal about the possibility of Dx tampering to "nudge" the trial in the treatment's favor.
Third, to steel man the regulators' position about the SAE rates: when someone says "not enough to draw conclusions from", there's a possible technical meaning to that phrase - "small enough to have occurred by chance" AKA "statistically insignificant". I'm not saying anyone actually did this calculation, and based on the prose in the paper it certainly seems plausible that doing so was purposely omitted. Essentially we're trying to estimate the parameter of a Bernoulli random variable. When I do that in a principled way with these numbers (Wilson interval for proportions), I get 95% confidence intervals that are significantly overlapping:
Vaccine: 0.00488, 0.00692
Placebo: 0.00425 - 0.00616
Those intervals are significantly overlapping, and so most statisticians would say therefore that the difference doesn't rise to the level of significance.
I read the original Pf study protocol and related article, and I found only one point where the placebo was actually declared: one mention of the word "saline" in the article. Is that credible enough to accept that saline was actually used (e.g. as opposed to the AZ trials that used a meningitis vaccine to inflate control-group AEs)? I know - what else are we going to go on? But the control-group AEs seem remarkably high to me.
Thank you for your thorough work. If you want to talk Python data analysis, please feel free to get in touch.
Thank you for doing this work and your analysis.
In addition to pima’s comment, I would say the explanation for the distiribution of complications in the placebo group is as follows:
1. The placebo contained an active ingredient
2. The simple act of getting an injection (whatever the injectate) causes a reaction (maybe something akin to the surgical stress response) which results in complications
3. The complications were reported in a biased and/or fraudulent fashion
Maybe I’m not understanding something here but I would expect the SAE’s in the placebo group to be evenly distributed throughout the reporting period. In other words, if there were 111 SAE’s over a 10 week period then there should be roughly 11 per week.
By the way, a skewed distribution of SAE’s clustered around the first few weeks is actually ok if noted, discussed, explained and accounted for.
It certainly is bizarre but if an explanation is given the perhaps it is permissible.
I am presuming no such discussion is present in the paper
I may be wrong but I read somewhere that the placebo was thought to be an MMR vaccine because it is known to have some side effects and therefore assists in blinding the trial . Like others commenting here I very much doubt the placebo was saline.
Does anyone know why the adverse events reported in the MHRA report differs in many numbers from the adverse events reported by the article "Six Month Safety and Efficacy of the BNT162b2 mRNA COVID-19 Vaccine" (https://www.medrxiv.org/content/10.1101/2021.07.28.21261159v1.supplementary-material)? MHRA e.g.:reported 4 SAE and the 6 months study only 3 ?
IMO, unless there has been a previous study of saline injection vs a mixture of the adjuvants, lipid nano particles, PEG, etc., it does not make sense to use the adjuvants, lipids, etc as the PLACEBO. By definition, isn’t the placebo supposed to be inert, innocuous, “of no physiological effect”?? If we don’t know that PEG plus lipid nanoparticles plus adjuvants are harmless and of no physiological effect, it does not make sense to use that mixture as the placebo in a drug trial. Suppose that mixture alone harms people? Then how can you say anything about the safety of that plus the nRNA and further, approve the mRNA produce when you have no idea if the “carrier mixture” for the mRNA is safe or not? In addition, haven’t we already learned that the LNP (lipid nanoparticles) do collect excessively in certain body parts like the ovaries? IMO, only saline makes sense for a placebo and a separate study (previously done or concurrently run) would be needed to determine the safety of the carrier mixture if not already known.