FOIA update May 24th
FOIA update May 24th
Document release of BNT162-01 critical issue list by German regulator PEI, April 2020
Half past seven on Monday evening, the Paul-Ehrlich-Institute answered the first of my FOIA requests.
The documents in question are a one-page German-language letter and a four-page list of critical issues identified in the trial protocol of BNT162-01, the “first-in-human” study conducted in Germany, both dated April 16 2020, sent by the Paul-Ehrlich-Institute to BioNTech.
Link to the FOIA request on FragdenStaat
The cover letter
This is the official “Mängelschreiben”(list of critical flaws) in response to the clinical trial protocol submitted on April 9. It says the submitted document is flawed and the sponsor, BioNTech, is allowed one single resubmission addressing the identified issues in the next 90 days. Seeing how the trial was approved four days later on April 20, we know how that bit went.
The issue list
It starts off with a single issue under the “general” part; a request to specify which “MedDRA version, level, term and classification code” will be used. This was an entry in the clinical trial protocol they just didnt populate with data. MedDRA is “a rich and highly specific standardised medical terminology to facilitate sharing of regulatory information internationally for medical products used by humans”, so essentially a standardized form of medical terminology. Considering the lengths the trial sponsors went to in order to hide and intentionally misdiagnose adverse events, this is a bit like the police stopping a driver who’s falling down drunk and making sure he’s wearing his seatbelt before sending him on his way.
Then comes an entirely redacted “quality” part.
I’m currently weighing my options about maybe contesting these redactions, and have already asked whether specific terms are mentioned.
This brings us to the “clinical” part, where the PEI lists flaws it identified in the protocol.
Relatively straightforward criticism, and exemplary of the sleight-of-hand commonly used; lack of a “lower-bound” indicative of sero-negativity allows them to fiddle with the scaling until the product is very good at seroconversion (hypothetically).
Another rather common sense complaint by PEI; as far as I understand it, this is asking BioNTech to check for prior infection via serum antibodies or active infection via PCR not just once before dosing, but periodically for infection-specific markers in order to distinguish vaccination from vaccination+infection. Wouldn’t want any natural immunity tipping any scales, would we now?
Next up are some cohort shenanigans. The first seems to be BioNTech holding the option open of not listing a participant’s phone number; that data can only be entered when the participant is available is kind of useless as a statement, and then it would be phrased so as to apply to all the categories listed.
The second is quite interesting when looked at a little closer. PEI is criticizing that BioNTech “kept open” two dosing groups without further specification on dose, timing etc., and are asking them to fix it. BNT162b1 had 1,3,10,20,30,50,60,10 older, 20 older, 30 older = 10 cohorts = 120 people, BNT162b2 had the same minus 50 and 60, making 8 Cohorts = 96 people. We know from the PSUR that 30 people were exposed to BNT162a1, 411 to BNT162b1, and 96 for BNT162c2 and b3 each. Will update this section. Anyway, here BNT162c1 is still mentioned. The change to c2 occurred on the 17.4 when Biontech submitted the amended version.
The next bit is probably my favorite. The Paul-Ehrlich-Institute was pointedly vocal about Part B being a mandatory placebo-controlled randomized trial! No more “open-blind” nonsense, thank you very much!
It just so happens that in the course of proceedings being as they were, Part B of BNT162-01 was.. simply scrapped. Yeah, they just said “yeah we’re not doing that yucky RCT stuff more than we absolutely have to, thank you very much”. Instead, they just added 3 “expansion cohorts” to Part A, comprising another 150 patients receiving only BNT162b2. These 150 patients’ data I have not yet seen anywhere, only the base 216 b1 and b2 patients.
Next, PEI bullies BioNTech into including ADE risk warnings in the informed consent sheets and the protocol language. They were so concerned about this, they put in three separate headings!
Seeing as the sponsors were extremly scrupulous about not relaying a single byte of BNT162-01 safety data after 23 October 2020, and the government agencies were simultaneously unconcerned about this, it can be assumed they actually meant vaccine-enhanced disease in close temporal proximity to vaccination. The absolutely detrimental effect of vaccination on infection rates obvious ever since and the fact that the only Covid-19 death in the C4591001 trial had received both doses seem to be entirely unremarkable in this regard. Maybe that’s why they were so adamant about disclaiming it from the start?
Just let that settle for a moment. No stopping criteria defined in a first-in-human study of an entirely novel platform (up until R-20-0072 as far as I can tell, BioNTech was using liposomes (RNA-LPX, DOTMA/DOPE), not Acuitas LNPs).
And the last comment before a standardized notice is the following:
If Part B never began, the trial never progressed from Part A. Was Part B perhaps not simply “scrapped”, but not allowed to commence “based on sound analysis of immunogenicity and safety data gathered during part A”?
I have sued PEI for inactivity in this case and another concerning further meetings/communications with BioNTech February, March and June 2020. The judge will be viewing the files on May 29, and I’m going to try and get him on the phone beforehand. While I would get money back for withdrawing my lawsuit, I want to use the opportunity to challenge the redaction of the quality part, at least in part. The blanket redaction is an affront, because the document is 100% written by German government employees.
There has been a bunch of activity amounting to nothing in my other requests, but at least there has been an appreciable increase in urgency ever since I’ve started writing letters to the ombudsman how outrageous it is I’m being forced to sue to get this agency to comply with its legal obligations.
Seven months in, first set of documents.
Hot off the press: posted this article and realized the individual issues are numerically listed. 17/26 flaws identified by PEI are in the “Quality” part and redacted. Quite heavy-handed for a text written by a government agency, it’s absolutely impossible the entire block is BioNTech’s intellectual property, and even then they could show the individual mentions of the product names; BioNTech’s IP would not be infringed upon by revealing how often which product candidate was mentioned by Paul-Ehrlich-Institute. And I see that as the bare minimum, because the text is an official response by a German government agency, so entirely taxpayer-funded, about approval of a first-in-human experiment with a product developed by a company that had thus far consumed millions of taxpayer funds without bringing anything to market, a product governments the world over were poised to spend hilarious amounts of money on. I’m contesting the redactions for sure!
Fantastic detective work as usual, congrats !