Pfizer Docs Part 3: The even more boringer part
This part is just a bunch of legal documents. One of them states that Pfizer is aware any lies in the application constitute a federal crime, so there's that.
Welcome to Part 3 of reviewing the the first set of documents, released under FOIA, from Pfizer’s Biologics License Application (BLA) for their vaccine called Comirnaty.
This post will be short and simple - we’re going to quickly run through the Module 1 files to see if there’s anything useful, then likely not return to these files again. Module 1 contains all the legal forms filed with a BLA.
If you are new to this series, here’s a link to the previous post:
Or you can back to the beginning:
Let’s get started looking at these boring legal forms
125742_S1_M1_356h.pdf
This is the application form for the Biologics License Application (BLA) with the FDA. The applicant is BioNTech Manufacturing GmbH, located in Mainz, Germany. Their U.S. agent is Elisa Harkins, Global Regulatory Lead, Pfizer Global Regulatory Affairs - Vaccines.
The product’s proprietary name is Comirnaty, and its chemical name is COVID-19 Vaccine (BNT162b2, PF-07302048). The FDA is picky about these details because they don’t want a company to substitute one product for another by renaming the product.
We also learn the BLA number, which is 125742.
125742_S1_M1_userfee.pdf
There’s a fee for filing a BLA, in this case it’s $2,875,842. Quite a bit more than the cost to register a Toyota.
125742_S1_M1_3674.pdf
This is another legal document - the Certification of Compliance. Someone has to sign a form saying the company met all the legal requirements. This is the critical part:
In case that’s hard to read, here it is again:
The undersigned declares, to the best of her/his knowledge, that this is an accurate, true, and complete submission of information. I understand that the failure to submit the certification required by 42 U.S.C. § 282(j)(5)(B), section 402(j)(5)(B) of the Public Health Service Act, and the knowing submission of a false certification under such section are prohibited acts under 21 U.S.C. § 331, section 301 of the Federal Food, Drug, and Cosmetic Act.
Warning: A willfully and knowingly false statement is a criminal offense, U.S. Code, title 18, section 1001.
Note that warning - it’s a federal offense to knowingly submit false statements. This is signed by Elisa Harkins Tull and if anybody broke that law, she’s in a bit of trouble.
125742_S1_M1_cover.pdf
This letter is the official request for priority review, which is an option in the regulations. Here is their justification for the request:
It meets the criteria for Priority Review Designation, as outlined in the 2014 Guidance for Industry: Expedited Programs for Serious Conditions – Drugs and Biologics because BNT162b2 prevents a serious and life-threatening condition (COVID-19) and, if approved, would provide a significant improvement in safety and effectiveness because there are currently no vaccines licensed for the prevention of COVID-19 in the US.
[My editorial comment:
“... because there are no vaccines licensed for the prevention of COVID-19 in the U.S.” - and of course the NIH didn’t test other potential treatments like Hydroxychloroquine or Ivermectin.]
125742_S1_M1_trans-of-oblig.pdf
This lists the legal responsibilities being transferred from BioNTech to Pfizer for study number C4591001 (the clinical study in this application).
125742_S1_M1_debarment.pdf
This letter certifies that Pfizer didn’t employ anyone who is debarred from working on a BLA. Just like a store that keeps pictures of people who have bounced checks, the FDA keeps a list of people who aren’t allowed to work on a BLA.
125742_S1_M1_financial-cert-bias.pdf
This letter certifies that the study was conducted per Pfizer’s Standard Operating Procedures (SOPs) and followed ICH Good Clinical Practices. It lists a few bullet points of specific actions taken to minimize potential bias in the study.
[Update: In Part 7 we finally looked up who the ICH is. There is a brief explanation of the organization in that post.]
125742_S1_M1_financial-cert-3454.pdf
This is a certification that Pfizer has no financial relationship with any of the Clinical Investigators (the people running the testing centers) that would bias the testing results (like paying them more based on the results of the trial).
It lists all the investigators at all testing centers by name. The centers are mostly listed in order but there are gaps in the numbers so manual review would be required to determine the total number of centers listed.
Curiously, when we looked at the site list in Part 2 the last site was 270 (so numbered 1270) but this document has four pages tacked on at the end adding centers 276-01, 276-02, 276-03, 276-04, and 276-05, all of which are located in Germany. Presumably these are last-minute additions, but they’re not included in the Comprehensive List of All Clinical Sites in Module 5.
We’re assuming for now that testing centers and testing sites are the same thing.
Of note, Form FDA 3455 is not included in the BLA. Where 3454 lists all the investigators who DON’T have a financial interest in the outcome of the study, 3455 is the form to submit if any investigators DO have a financial interest. Presumably there were no such investigators and therefore no need to use the form.
125742_S1_M1_exclusivity-claim.pdf
Exactly what one would expect, it states this is the first licensure of this vaccine and is exclusive to BioNTech. This part is interesting:
Pursuant to Section 351(k)(7)(A), no approval of an application submitted under Section 351(k) for which Pfizer-BioNTech- COVID-19 is the reference product can be made effective until 12 years after the date of licensure of Pfizer-BioNTech-COVID-19.
Apparently the exclusivity lasts for 12 years (so less than a patent)?
125742_S1_M1_us-agent-authorization.pdf
This letter just tells us the names of the people at Pfizer who are authorized agents of BioNTech for the purpose of this BLA.
125742_S1_M1_fast-track-designation.pdf
FDA letter granting fast track designation. Not shocking, since this was part of Operation Warp Speed Into a Brick Wall.
125742_S1_M1_ipsp-agreed-letter.pdf
FDA letter stating they agree with the planned deferral of an assessment of the vaccine in the pediatric population (defined here as 0 to < 16 years old).
125742_S1_M1_waiver-req-designated-suffix.pdf
This is a request to waive the FDA requirement for the assignment of a suffix to the product name to aid in tracking of issues. The FDA has a guidance document for this, Nonproprietary Naming of Biological Products Guidance for Industry1.
FDA’s naming convention for biological products licensed under the PHS Act will be a proper name consisting of a core name and an FDA-designated suffix. Proper names designated by FDA for originator biological products, related biological products, and biosimilar products will include a combination of a core name and a distinguishing suffix.
The suffix is for cases where more than one version of a product with the same core name exists, to make it easier to distinguish the two. Pfizer is arguing that existing systems for monitoring vaccines are adequate therefore the suffix is not required.
The FDA already has a draft document2 that suggests they may drop the requirement of suffixes for vaccines. Per that document:
FDA is also reconsidering whether vaccines should be within the scope of the naming convention.
So the request is consistent with the new guidance.
A brief summary
That’s it - all the documents in Module 1 (at least, the ones included in this document dump). Checking this against Pfizer’s Supplemental-Index-12-22-21.pdf, almost everything is there.
Only one document from the Pediatric Administrative Information is included, which is the letter of agreement from the FDA to defer the pediatric studies. The remaining pediatric study documents might be irrelevant since they’re deferring the pediatric study.
We don’t know if the missing documents were even part of the original FOIA request so we may also see them in a later doc dump.
That’s it for now - we reviewed the simple stuff and next time we’ll look for something more interesting to review.
FDA guidance on suffixes:
https://www.fda.gov/media/93218/download
Archived copy:
https://web.archive.org/web/20220308164456/https://www.fda.gov/media/93218/download
FDA draft guidance:
https://www.fda.gov/media/121316/download
Archived copy:
https://web.archive.org/web/20210310010140/https://www.fda.gov/media/121316/download
WRT 125742_S1_M1_cover.pdf, “… because BNT162b2 prevents a serious and life-threatening condition (COVID-19)…” seems to be a fraudulent statement if the data I’ve seen shows that Pfizer knew it did not -prevent- COVID-19. One might argue it helped -reduce- the seriousness (that is debatable), but it does -prevent- COVID-19. Thank you for what you are doing here!