Comirnaty Specific Obligation 1 (SO#1)
The European Medicines Agency has been sued before the European Court for releasing these three documents with extensive redactions due to CCI concerns, which obscure important safety information
These documents were obtained in 2022 from the European Medicines Agency (EMA) under Regulation 1049/01. However, under BioNTech’s supervision, the EMA refuses to release critical safety information about the vaccine, referring to Confidential Commercial Information (CCI).
This refusal violates transparency laws. By invoking CCI, the EMA not only obscures its own regulatory shortcomings but also conceals quality defects in the Comirnaty vaccine.
As a result, a case has been filed against EMA and is pending before the European Court regarding the CCI exemption to transparency. Hearings on the alleged misapplication of transparency laws will begin in short in Luxembourg in the first week of March 2025.
Help us to win the case for transparent vaccine information! If you are aware of any sources that have disclosed these redacted Pfizer/BioNTech data, please share them in the comments!
This case aims to set a European precedent ensuring that critical vaccine information is not withheld behind blacked-out sections but is made transparent as a standard operating procedure by EMA. The public has a right to know detailed safety data, including RNA integrity levels, dsRNA content, residual DNA levels, RNA sequence identity, RNA concentration, bioburdens, pH balance, 5’-CAP structure, and Poly(A) tail composition.
Specific Obligation#1 - Answer by Biontech July 2021
Specific Obligation#1 - Answer by Biontech November 2021
3.2.S.3.1 Elucidation of Structure and Other Characteristics
Hi Sylvia
Regarding SO1, Pfizer actually PUBLISHED some of these results in a peer reviewed journal.
see here. https://jpharmsci.org/article/S0022-3549(23)00009-6/fulltext
However, some of the information in the release is NOT included in the article by Patel, specifically Figure 9. Also note a few admissions from these Pfizer scientists in the second last paragraph.
1. a hidden gene (which Kevin McKernan and others have found)
2. poly (A) tail design ie the segmented poly A tail which may be translated....
For the release for SO1 November 2021, note BioNTech used an engineering run for the analysis. This engineering run, 1071509, is I believe, manufactured in March 2020 and is a Process 1 batch. As a result, the 5' cap and poly A tail quality and quantity will be much different. I also believe the residual DNA in this batch is very high but the dsRNA is very low based on data on the leaked Rolling Review.
Oligonucleotide Mapping via LC-UV-MS/MS to Enable Comprehensive Primary Structure Characterization of mRNA Drug Substance (by Pfizer) PDF
https://mamconsortium.org/wp-content/uploads/2023/10/2023Sep28_MAMConsortium_OligoMapping_GAUB.pdf