FOIA request overview
Including EUA/Comirnaty/Cominarty updates and FDA activity
In light of my first FOIA request having been partially granted, I thought I’d start writing about the info I’m asking for. These are all directed at the Paul-Ehrlich-Institute, Germany’s pharmaceutical regulator.
From oldest to newest:
Communication with BioNTech on 16.4.2020
Sent: 20.10.2022
Lawsuit filed: 27.03.2023
Partially granted: 21.4.2023, documents still waiting on final release by BioNTech
Scientific advisory meetings with BioNTech Feb. March and June 2020
Sent: 14.11.2022
Lawsuit filed: 27.03.2023
Batch control of the bivalent Pfizer-BioNTech vaccine
Sent: 16.2.2023, can sue after three months
Sent: 19.3.2023
Sent: 20.3.2023
Non-clinical studies on BNT162c1/BNT162c2
Sent: 21.4.20223
Sent: 22.4.2023
The first two are requests for all documents concerning the scientific advisory meetings and communications between PEI and BioNTech as described in the clinical trial protocols. I outline PEI’s role in BioNTech’s vaccine development in this article (English translation link at the top): Das Spiel mit den Varianten.
The batch control request was made after Kevin McKernan’s sequencing data of the bivalent vaccines revealed high levels of plasmid contamination and SV40 promoters.
The next two requests are for three studies conducted by BioNTech during vaccine development. All three are briefly summarized in the TGA evaluation of the vaccine, yet are auspiciously unreferenced throughout the documentation made available so far. R-20-0054 is “Assessment of vaccine immunogenicity” of BNT162b2v8 in BALB/c mice, R-20-0360 is “In vitro expression of mRNA constructs encoding the SARS-CoV-2 Spike protein variants V8 and V9”, and R-20-0357 is “In vitro study of cytokine/ chemokine secretion” of BNT162b2v9 with human peripheral blood
mononuclear cells.
In other news, I have updated my EUA/Comirnaty article with a closer inventory of the NZ authorizations and some very bizarre findings concerning the vaccine in South Africa, where the vaccine has received the propietary name “Cominarty”, not “Comirnaty”.
I’m also going through the latest PHMPT document release from mid-April in twitter threads.
Last but not least, the latest FDA EUA shenanigans have been surprising to put it mildly, and I have yet another article in the works on V8/V9.
Excellent work. Have you received any new information on actual Endotoxin levels in any batches or lots?