Comirnaty CTD 3.2.S.2.3.1 Generation of Plasmids
A new EMA release of relevance
Comirnaty CTD 3.2.S.2.3.1 Generation of Plasmids
We kindly ask for your assistance by comments in unredacting this document with specific regard to the DNA-related aspects. Please consider supporting the appeal to the EMA by commenting on relevant scientific reasons or publications that demonstrate why residual DNA, its composition, quantification, or potential for integration constitutes a regulatory safety issue.
Scientific concerns regarding DNA impurities, especially in the context of novel mRNA-based therapies, are well documented. Residual host cell DNA, plasmid DNA fragments, or modified synthetic sequences can pose theoretical and potentially real risks including oncogenicity, immunogenicity, and genotoxicity. As such, both the ICH guidelines (such as ICH Q5D) and the Ph. Eur. provide specific thresholds and testing requirements for DNA impurities.
Given that these thresholds relate directly to public health, their transparent evaluation should not be withheld from public oversight. This strengthens the argument that the redacted sections concerning DNA are not merely commercial but form a core component of risk assessment and regulatory compliance, and thus fall under overriding public interest.
If you have any scientific advice, please comment below!
Thanks for your help!
I would like to see the Endotoxin Limit hidden on pages 11 and 18 because they lied about it to get EUA, later admitting they had no control.
https://geoffpain.substack.com/p/pfizer-lied-about-endotoxin-to-get
Endotoxin is required to activate Germline DNA transcription and Class Switch Recombination of the DNA contaminant.
https://geoffpain.substack.com/p/yin-yang-1-requires-endotoxin-to
Due to its properties, a person familiar with BioTech says that quantification of short contaminant DNA is not possible with the qPCR method.
Fluorometer + Oxford NanoPore reagent is said to be essential.
Everything related to numbers is important, and I think it is necessary to check how the numbers that came out came out.