Pfizer Docs Part 8: Doc Dump 2
The FDA has released 16 more documents, including a new, unredacted copy of a document they released previously.
The FDA has released another sixteen Pfizer documents under FOIA, and just like with the first dump we’re going to start by looking at what’s there.
If you want to go back and start at Part 1 click here:
How many pages are we up to?
The latest dump was only 16 files and they contain 11,098 pages. Two documents are in the page range of the first doc dump; one is a re-issue of something that was in the previous dump, and the other was supposed to be in the first dump but they accidentally sent the wrong file (so this file is filling in some missing page numbers).
The new pages continue the previous numbering scheme, and begin at FDA-CBER-2021-5683-0024282. Here’s the total pages from both dumps so far, by FOIA page numbers:
The previously missing document filled in 17 of our missing pages, so the new total is 1,277 missing or redacted pages. That missing document was part of Module 1, so we probably now have all the Module 1 documents. The remaining documents are all part of Module 5.
Based on the order of the pages, the missing pages from 0006621-0007338 and 0020398-0020649 are probably participant Case Report Forms. Since this is 970 pages it might only be four participants (based on the average of 250 pages per participant) of the 44,000 total.
This doc dump includes a few very useful items such as the study randomization (so we know who received vaccine vs. placebo), the participant demographic data, and the informed consent templates.
The informed consent templates in 125742_S1_M5_5351_c4591001-fa-interim-iec-irb-consent-form.pdf might contain the most useful explanation of the study for the average person.
If you know absolutely nothing about these types of clinical studies, reading a few pages of this document (such as pages 63 through 72) will answer a lot of questions.
We’ll get to that one later, but first let’s deal with those two docs from the earlier page range. Remember this is just an overview, so there’s only a small amount of discussion on each particular file.
reissue_5.3.6-postmarketing-experience.pdf
This is the exact same document as the first dump, but without the redactions on page 6. The FDA had redacted the number of employees Pfizer added to handle the increase in adverse events to investigate, and the total number of vaccine doses shipped during the reporting period.
We now know they were planning on 1,800 total new employees:
To date, Pfizer has onboarded approximately 600 additional full-
time employees (FTEs). More are joining each month with an expected total of more than 1,800 additional resources by the end of June 2021. (reissue_5.3.6-postmarketing-experience.pdf, page 6)
And they shipped about 126 million doses:
It is estimated that approximately 126,212,580 doses of BNT162b2 were shipped worldwide from the receipt of the first temporary authorisation for emergency supply on 01 December 2020 through 28 February 2021. (reissue_5.3.6-postmarketing-experience.pdf, page 6)
Remember this is a two-dose vaccine, and we don’t know how many people received both during the reporting period. So this could represent anywhere from about 60 million to 120 million people.
The re-issuing of this particular document is probably meaningful. A lot of people on social media have been making excited posts about the 1,223 deaths listed in this report, and without context many assume these are all from the clinical study. I suspect the FDA felt they had to remove the redactions in response to those posts.
Some quick calculations for perspective
According to the CDC1, there were 3,383,729 all cause deaths in the U.S. in 2020, out of a population of 329,484,123. This is about 9,270 deaths per day total, or about 28 deaths per million per day.
Over a 90-day period this is 2,532 people per million. If we assume the low end number of 60 million vaccinated people, then we should expect all cause death among those 60 million to be a total of 151,936.
The Postmarketing Experience report lists 1,223 deaths post vaccination. These are deaths reported to various databases, and the cause of death is not known. We also don’t know how many deaths after vaccination don’t get reported at all.
But the point is: the number of 1,223 deaths in the report is not a big smoking gun about vaccine deaths - this report covers tens of millions of people at a minimum.
You can read the rest of my discussion of the report here:
125742_S1_M1_priority-review-request-1.pdf
The document with this title in the first dump was a redlined copy of a summary of reactions among the test participants, so it was clearly not the document described by its title. Its inclusion was almost certainly an error and this was the intended document.
The remaining fourteen documents extend the FOIA page range out to 35,324 (with some pages missing). First, some boring paperwork.
Various declarations (5 files)
125742_S1_M5_5351_c4591001-fa-interim-invest-signature.pdf
125742_S1_M5_5351_c4591001-interim-mth6-invest-signature.pdf
125742_S1_M5_5351_c4591001-fa-interim-sponsor-signature.pdf
125742_S1_M5_5351_c4591001-fa-interim-audit-certificates.pdf
125742_S1_M5_5351_c4591001-interim-mth6-audit-certificates.pdf
These are all signed declarations. Three are the signatures of investigators, certifying the study test report is accurate. The other two are certifications that all the required quality system audits were conducted.
Now some more interesting files.
Participant randomization (2 files, 4,427 pages)
125742_S1_M5_5351_c4591001-fa-interim-randomization.pdf
This file contains the randomization of the Phase 1 participants, by number. It shows who received the vaccine and placebo, and for the vaccine groups what each dosage was.
125742_S1_M5_5351_c4591001-fa-interim-randomization-sensitive.pdf
This file contains the randomization of the Phase 2/3 participants by number, and shows who received the vaccine and placebo.
If you read the post about the participant Case Report Forms, you already know how to search for deaths. In the file CRFs-for-site-1081.pdf we find that participant 10811194 died from a myocardial infarction. This was the only death among the 52 participant records released in the first document dump.
We can easily search this new document for that participant number, and we find this participant was in the placebo group:
We can also search for this participant in the demographic data.
Demographic data (2 files, 6,090 pages)
125742_S1_M5_5351_c4591001-fa-interim-demographics.pdf
125742_S1_M5_5351_c4591001-interim-mth6-demographics.pdf
These two files contain the demographic data of all study participants. Using the same example above, we can search for participant 10811194:
This participant was a 51 year old white, non-hispanic female, 5’ 6” tall, weighing about 211 pounds.
125742_S1_M5_5351_c4591001-fa-interim-sample-crf.pdf
This file is also very interesting. It’s the template for the Case Report Forms used for all participants in the study. With this template, we can now see all the possible responses to each Form question - on the filled out CRFs we only see the response that was chosen.
For example, here is the Form for demography, and we can read the ethnicity and race options that were available:
This file also contains the instructions for using the TrialMax App (starting on page 102) which is the e-diary phone app used by study participants to record reactions to the vaccine.
Anyone who is curious about what reactions were being recorded can read all the screenshots in this manual and learn exactly what the participants were asked. For example:
125742_S1_M5_5351_c4591001-fa-interim-iec-irb-consent-form.pdf
This file contains templates for the informed consent forms given to the study participants. It contains some very simple explanations of elements of the study, such as this one:
These vaccines do not contain the whole virus, or the parts of the virus that can make you ill, instead the vaccines are made up of part of the virus’s genetic code, surrounded by fatty particles called lipids. They use your own cells’ protein making machinery to produce some, or all, of the spike protein seen on the outside of the virus. This spike protein, made by your own body, may help your body to produce antibodies to fight against COVID-19. We will check how many antibodies you make by taking blood
samples and testing them. (125742_S1_M5_5351_c4591001-fa-interim-iec-irb-consent-form.pdf, page 63)
This file contains templates for adults and for children. Each is twenty or so pages long and there are multiple copies - closer review will be needed to determine the differences between them.
125742_S1_M5_5351_c4591001-interim-mth6-adverse-events-sensitive.pdf
This sounds very interesting but isn’t. It’s only 3 pages, and includes Listing of Severe and Grade 4 Local Reactions, Listing of Severe and Grade 4 Systemic Events, Listing of Adverse Events. There is only one event listed, which is a subject with anxiety.
125742_S1_M5_5351_c4591001-fa-interim-protocol-deviations.pdf
This is the Listing of Important Protocol Deviations and only lists five subjects, all of whom met the same study exclusion criterion.
Inclusion/Exclusion Participant met exclusion criterion #19 ( Phase 1 only: any screening hematology and/or blood chemistry laboratory value that meets the definition of a >=grade 1 abnormality)
125742_S1_M5_5351_c4591001-fa-interim-publications.pdf
And finally, a reprinting of two publications (in scientific journals) that were based on this study.
Mulligan MJ, Lyke KE, Kitchin N, et al. Phase 1/2 study of COVID-19 RNA vaccine BNT162b1 in adults. Nature. 2020;10.1038/s41586-020-2639-4.
Walsh EE, Frenck FW, Falsey AR, et al. Safety and immunogenicity of two RNA-based Covid-19 vaccine candidates. N Engl J Med 2020; DOI: 10.1056/NEJMoa2027906.
And that’s it
The bit about the Postmarketing Experience is important because a lot of people keep misrepresenting the contents. If you want to share this post with one of those folks try this button, which I have never used before:
I hop it’s not actually a self-destruct button in disguise.
Besides the unredacted copy of the Postmarketing Experience this dump also included documents that are useful to people doing research, like the randomization and demographics of the participants, but not much more.
To go to part 9 click here:
CDC FastStats on mortality:
https://www.cdc.gov/nchs/fastats/deaths.htm
CDC Mortality database (this will redirect to the request page first):
https://wonder.cdc.gov/controller/datarequest/D76;jsessionid=A8210C07B57993CB2DB5EC078A07