Project Scope

The primary source material is available here: https://phmpt.org/pfizers-documents/.

The purpose of this site is to review the trove of documents released by Pfizer pursuant to a Freedom of Information Act court order. The FDA wanted to seal these documents for 75 years. After you spend some time with these documents you will see why.

My initial effort is directed at the primary source documents from Pfizer as a means to lay a foundation upon which to later use for further analysis and commentary. The focus early on will be documents from 2020 and 2021 but heavily weighted toward the Phase 1 (animal studies), Phase 2 (human trials) and Phase 3 (expanded human trials).

BNT162b2 is a novel drug product best considered a transfection agent rather than a vaccine and terms including injection, inoculation or administration will be used although by habit the term vaccine may slip through.

From https://www.drugs.com/fda-approval-process.html

I have adopted a methodlogy simliar to that I use in my peer review work, specifically taking notes from the Confidential documents and offering my Comments and Questions, which is what would be submitted to the Editors.

The editors then take two or three peer revewer’s comments and questions and decide whether to publish the paper as is, send it back to the authors for revision or reject the work outright.

Subsequent work will look at these foundational papers in the context of subsequent research illustrating consequences of the compressed time frame for development of BNT162b2 in terms of safety, efficacy and effectiveness.

Finally, topics such as Informed Consent, Pfizer Methodology, Time Line and other subject matter will follow. This is very much a work in progress that will be updated from time to time.

R.W. Chandler, MD, MBA