Pfizer Docs Part 1: The Great Big Document Dump
Thanks to a FOIA request, we get to see the enormous pile of documents that a company files with the FDA and which the FDA probably doesn't read.
Due to a FOIA (Freedom of Information Act) request the FDA is releasing all of the documents filed by Pfizer with their Biologics License Application (BLA) for Comirnaty, their new mRNA vaccine for SARS-CoV-2.
Comirnaty is the marketing name for BNT162b2, which is the vaccine they have actually been sellling for COVID-19 under Emergency Use Authorization (EUA). If you are just getting up to speed on this, the EUA version carries no legal liability for Pfizer (the “authorized” vaccine) while the BLA version (the “approved” vaccine) does. These two products are legally distinct per the FDA, which might be why no one has seen vials of actual Comirnaty out in the world.
That’s a whole different topic and outside the intent of this discussion. We’re here to look at the big stack of documents from the Comirnaty BLA. Lots of people seem interested in combing through these documents but don’t really know how to start, so we’re going to take a first look at the files and start trying to understand it all.
I don’t work for some attorneys, or any organization that’s looking into this - I’m just a regular person who has some background in a related industry (medical devices). So what we’re following along with here is my own investigation, with suggestions on strategy and points of interest.
How to get the files
The first group of documents have been released to the public in 150 separate files and are available for download (https://phmpt.org/pfizer-16-plus-documents/). If you check all the boxes in the right hand column and then click on Download Selected Documents at the bottom, a zip file will be downloaded with all the files you checked.
Organize it first
In order to digest the large amount of information in this, and future, document dumps it’s best to try and understand the structure of the information first. To that end, I have started by generating a spreadsheet of the first 150 files. I’m not sure how to share that spreadsheet here on Substack so I’ll put it over on GitHub instead.
A quick note on GitHub and software:
GitHub is a site for software developers to archive and share code, and an Excel spreadsheet is just another piece of code. Programmers use the site to collaborate on projects, and to both share and find useful software1.
My spreadsheet is located here: https://github.com/JohnHowardRoark/Pfizer_doc_dump/blob/main/Index_of_files.xlsx
If you click on the button labeled “Download” it will bring up a dialog box to download the file. Easy peasy. You can click on the blue “Pfizer_doc_dump” to see the whole repository but there’s only this one file in it right now.
My GitHub account is very boring and mostly filled with junk. Feel free to look at all the public repositories if you wish - I’m a pretty useless programmer so you won’t find much of value.
Now let’s take a look at the spreadsheet
Not all the documents are of equal importance - in fact, many of them are not helpful at all. It’s best to group files based on purpose and review them together. For example, SAS software files should be reviewed by someone who uses the SAS programming language. The rest of us won’t understand any of it anyway. Some files are just Excel tables of data found in other files.
There are columns for the filenames, the FOIA page numbers and other interesting things. There is a column with the title from each document if it has one, or my best short description of the document or file. Hopefully this will help people zero in on the more interesting files.
Time for some quick background
These documents are coming from the FDA, not from Pfizer, and the FDA has sequentially numbered the documents. These numbers start with FDA-CBER-2021-5683-0000001 and end with FDA-CBER-2021-5683-0024281.
CBER stands for Center for Biologics Evaluation and Research, and is the parent organization of the group responsible for vaccine approvals, which is the Office of Vaccines Research and Review. From the bottom up it’s:
The Office of Vaccines Research and Review, which is part of:
The Center for Biologics Evaluation and Research (CBER), which is part of:
The Food and Drug Administration (FDA), which is part of:
The Department of Health and Human Services (HHS)
I really hope I got that all correct.
2021-5683 is the FOIA request number, filed by Aaron Siri (this can be found in the response letter from HHS, see file: signed-F21-5683-CBER-Dec-13-2021-Response-Letter.pdf).
The files contained in this doc dump have pages numbered from 1 to 24281. It looks like 1,294 pages are missing and these may have been withheld or redacted by the FDA. There are some gaps in the numbers, and the FDA missed at least two files when they assigned the FOIA numbers.
Since these are sequentially numbered pages we should expect future doc dumps to continue the same numbering system. The FDA can order these documents any way they wish so we probably can’t infer too much based on the order of the page numbering. Obviously we are all very suspicious of what might be in the missing pages, since they would be foolish to give us the worst stuff right up front (me editorializing, since I assume both Pfizer and the FDA have something to hide).
When you see BLA 125742, this is the number of the Biologics License Application filed by Pfizer for their vaccine (Comirnaty) and this number (125742) appears in the names of many files. Note that the EUA version (BNT162b2) does not have a BLA number - emergency authorization means the BLA process was bypassed to get the drug to market more quickly. This BLA is essentially the documentation needed to get actual approval for their vaccine (so it’s “approved” rather than “authorized”).
The Pfizer documents have a date printed vertically in the left margin. This is probably the date the document was officially approved (internally) at Pfizer. Regulated companies are required to have an internal system for document review and approval and these dates are probably related to that internal system.
I mention this because a few people online have been getting very excited about footer dates on documents - some of the dates are prior to COVID. But these appear to be the dates the templates for those documents were created, not the release date of each particular document. The document templates might not be specific to this project, but may instead be standard templates they use for every vaccine development project.
Here are a few notes from a cursory review of the files
file: signed-F21-5683-CBER-Dec-13-2021-Response-Letter.pdf
Fans of the movie The Princess Bride know Vizzini always says that when a job goes wrong, you go back to the beginning. This file is essentially the beginning.
It’s the FDA response to the FOIA (Freedom of Information Act) request submitted by Aaron Siri and his law firm. The letter states there are 2,890 pages of records, and I have not yet reconciled this number with the approximately 23,000 pages in this doc dump. Maybe I’m misunderstanding this, or maybe there’s another letter somewhere that clarifies this.
The letter states that some pages have been withheld to protect trade secrets, financial information, or personal privacy. This is not surprising - I’ve already found some redactions of names and addresses of personnel at testing sites.
The letter also states that (per Aaron Siri’s request) samples of SAS files have been provided, but not all SAS files. SAS is a computer language used for statistical analysis. They also included samples of xpt files, which are the output files from SAS.
file: 125742_S1_M1_cover.pdf
This is Pfizer’s letter to Marion Gruber, the Director of the Office of Vaccines Research and Review, requesting priority review of their application. This letter is useful because it contains a table listing everything Pfizer was submitting in their BLA. I haven’t had time to check all of these but some of them are definitely included in this first document dump from the FDA.
By the way, Marion Gruber is one of the two FDA people who resigned in protest2 over the politicization of the review process (the other person being Phil Krause, the Deputy Director of the same office). So the people Pfizer was sending their submission for approval, later quit.
The previously mentioned FOIA numbers from the FDA are a good way to keep track of how much has been released, but this letter contains a table of contents provided by Pfizer as a road map of the filing, and may be useful for understanding the whole submission.
Note that the filing fee for this BLA was $2,875,842 - I don’t know if this is the only fee they pay. Some people think it’s great that the government charges them for the BLA (saving tax dollars) but this is really just a barrier to entry for small companies that can’t easily pay these fees (my editorial comment).
file: 125742_S1_M1_priority-review-request.pdf
This document is a redlined copy but without explanation or FOIA page numbers, so it’s inclusion may be an error. There may be another document with the same info but in final form.
Redlines are common practice in regulated industries. When someone is updating a document, they create a redlined copy showing the original text and the changes. These are created for internal review of the changes before the updated document is published to make the task of reviewing those changes easier, and to keep a record of the changes.
Personally I find it a bit surprising to see a redlined document in this submission but its inclusion may be an error. Mistakes happens when people are assembling hundreds of documents comprising thousands of pages.
file: 5.3.6-postmarketing-experience.pdf
Lots of people are already going crazy with this one since it lists adverse events. One quick note of warning: the nine page list at the end isn’t a list of all adverse events they have seen. This WHO document explains the list:
It's a list of what they call adverse events of special interest (AESIs). Pfizer is required to make a list, prior to releasing the vaccine, of any adverse event that could possibly be related to the vaccination. This gives monitoring agencies a series of search terms to check for.
From the WHO document:
Operational definition of an AESI: An AESI is a pre-specified medically-significant event that has the potential to be causally associated with a vaccine product that needs to be carefully monitored and confirmed by further special studies.
Shortlisting pre-specified adverse events of special interest (AESIs) before COVID-19 vaccine introduction will enable countries and regions to define events, ensure the availability of suitable tools, provide training for relevant staff and identify disease codes and estimate background rates.
So it's a laundry list of everything they could think of that the vaccine could be associated with.
So that’s a quick review of the files, what the names mean, and a brief look at a small bit of the information contained in these files.
The spreadsheet is a lot of work, but it’s really just the electronic equivalent of printing out everything and laying it all out on a series of tables (the old school way).
This enables us to see the structure of the documents, identify missing items, group things for review, and find files quickly - since we now have an index of the file names.
That was the easy (although time consuming) part. Next, we need start actually reading them.
I have provided a wholly inadequate explanation of GitHub but wanted to keep it short. GitHub is a massive site, filled with programmers collaborating on exciting projects, interesting software you can access for free, and all sorts of other goodies for the professional programmer. Even if you’re a newbie it’s worth checking out. And for anyone considering a career in programming, actively using the site will teach you the basics of version control - which is a vital tool in any organization.
Gruber and Krause resign:
https://nypost.com/2021/09/01/two-senior-fda-officials-resign-over-biden-administration-booster-shot-plan/
Archived copy:
https://web.archive.org/web/20210901182431/https://nypost.com/2021/09/01/two-senior-fda-officials-resign-over-biden-administration-booster-shot-plan/