"Shortcoming of the repeat dose toxicity study design should not preclude approval of the vaccine"

Revealing analysis of an Australian Government document by Dr Jessica Rose: a Canadian researcher with a Bachelor's Degree in Applied Mathematics and a Master's degree in Immunology from Memorial University of Newfoundland.

Dr Rose also holds a PhD in Computational Biology from Bar Ilan University and 2 Post Doctoral degrees: one in Molecular Biology from the Hebrew University of Jerusalem and one in Biochemistry from the Technion Institute of Technology. She was also accepted for a 2-month program as a senior researcher at the Weizmann Institute prior to completion of her latest post doctoral degree at the Technion. Her more recent research efforts are aimed at descriptive analysis of the Vaccine Adverse Event Reporting System (VAERS) data in efforts to make this data accessible to the public.

TGA Document: Nonclinical Evaluation Report BNT162b2 [mRNA] COVID-19 vaccine (COMIRNATY™) Submission No: PM-2020-05461-1-2 Sponsor: Pfizer Australia Pty Ltd January 2021

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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:

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).