"The shortcoming of the repeat dose toxicity study design should not preclude approval of the vaccine."
UPDATE: Thank you to this person on Twitter.
Well, well, well. This document that I will talk about today is not new, but it is hot. Where to start? Considering I’m not even sure what the quote that became the title of this article means, let’s start with the title of the Report:
Nonclinical Evaluation Report
BNT162b2 [mRNA] COVID-19 vaccine
Submission No: PM-2020-05461-1-2
Sponsor: Pfizer Australia Pty Ltd
The document begins with a summary of what they found in their own assessment of the safety of the COMIRNATY product made by Pfizer. The first thing that you should probably pay attention to is the comment about pharmacology and toxicity in the summary. But wait one second. Let’s set the stage here.
Say you want to buy a car. You have children and so you want a vehicle that has been tested rigorously for safety and durability for many years. The yearly death rate of people in traffic accidents today in the U.S. averages around 40,000, so you really do want a durable vehicle.1 You go shopping for cars and you find three that you like. They all look great! They’re all red and 4 wheel drives. The first one has an excellent safety rating: ‘The manufacturer has conducted thorough and lengthy studies on chassis stability and has been approved for market use following 10 years of testing. Insurance Institute for Highway Safety (IIHS) approved!” The second one also has a good safety rating too: “The manufacturer has conducted rigorous safety testing and the vehicle has been approved for market use. National Highway Traffic Safety Administration (NHTSA) approved!” The third one however, says this: “The manufacturer has generally conducted adequate studies regarding safety with limited testing conducted on the steering and the durability of the chassis. Manufacturer approved!” Which car would you not pick? I think 100% of people would not pick car #3, right? Now I take you back to our document. Check out the wording of the second point in the Summary on page 4.
The sponsor has generally conducted adequate studies on pharmacology and toxicity (GLP compliant repeat dose and developmental and reproductive toxicity studies) with BNT162b2 (V9). Limited pharmacokinetic studies were conducted with the LNP formulation and two novel lipid excipients (ALC-0159 and ALC-0315).
Later on the page, you’ll find this:
Question: What if that blacked out statement read like this:
“In the cases of partial recovery, where 95% of animals recovered only partially, the animals all died from liver failure. No data was collected post 3 weeks.”
The next thing I am going to pick on is on page 7 in the Pharmacology section. What could that redacted sentence have said? I leave that to my readers to have some fun in the comments section.
The next thing I am going to pick on can be found on page 16 where they decided to exclude everything pertaining to Preclinical safety data. They don’t need to include what they found since their statement on genotoxicity and carcinogenicity were ‘acceptable’. But wait, they didn’t do genotoxicity and carcinogenicity studies.
And we move onto page 17 where we are supposed to be able to see what the hell they are injecting into every goddamned person they can. Now this info has been revealed since this document was released but still. This is all about thinking about motives and the insanity of hiding such vital and relevant information from a public that is meant to simply comply.
It gets pretty funny from here on in. Check this out. It’s so… black. Why would they not just omit the page? Would that have been ‘illegal’?
And more blackness. Color our world blackened. Blackened.
And for the piece de resistance! This gorgeous work reveals localization of the BNT162b2-RNA in transfected cells, and the spike protein can also be seen localized in the nucleus of the cells. Wait. What? In the nucleus? Is that right?
ImmunoFluorescence (IF) staining is really cool and you can use it to detect and localize antigens in cells using fluorophore-conjugated specific antibodies. Hoechst dye is a blue fluorescent stain specific for DNA (i.e., nuclei of eukaryotic cells). Confocal microscopy is also really cool because you can essentially create optical cross-sectioning of stuff like cells and then reconstruct these ‘z-stacks’ into gorgeous 2D or 3D images. But I digress. You can show localization using IF as was done in the last panel below. Green glowing means spike protein = yes. See where the ‘yes’ is?
Here are some pink additions.
Ok. Just one last creepy point. Doesn’t the higher number in the BNT162b2 group (the Pfizer shit) mean that the rates of pre-implantation loss were higher in the Wistar Rats who got injected with the equivalent COMIRNATY product (the b2 version) than for placebo? Granted, there were only 22 female rats but the difference is still 1 versus 2 - so twice. It’s a 2X higher rate in a small study group. I feel it’s worth mentioning considering we are talking about the ability to reproduce and also considering what we are seeing in human subjects in the context of adverse event data for COVID-19.
So here’s to Pfizer. Thanks for being criminally insane and oh-so transparent and uncreepy.
Have a wonderful New Year’s Eve and party like there’s no tomorrow. Cuz, there might not be. Happy 2022.