200 billion pieces of DNA contaminating Pfizer vaccines - manufacturing problem exactly as the EMA said there was in late-2020?
Well it was in the EMA's original Public Assessment report that was written prior to the EUA being approved.
I’m sure that being the inquisitive type, questioning and sceptical like I am (hence why you read my ramblings) you will have read about the recent lab findings that there is DNA contamination in the Pfizer vaccine vials.
If you’ve not seen them here’s some articles so you know what I am on about:
https://www.researchgate.net/publication/369967228_Sequencing_of_bivalent_Moderna_and_Pfizer_mRNA_vaccines_reveals_nanogram_to_microgram_quantities_of_expression_vector_dsDNA_per_dose
I did post comments about the manufacturing issues and so on in various places but no notice was taken of it.
Maybe now more in-depth analysis of the EMA’s PARs will be done by those more expert than me.
Here is the Pfizer one:
Relevant section is 2.2 starting on pg 14. Very vague comments about what steps were taken to stop the manufacturing issues that were highlighted. Comments include:
The applicant will provide clarification on the mechanism of action for BNT162b2.
During the procedure, a number of issues were highlighted relating to the GMP status of the manufacture of the active substance and of the testing sites of the finished product for the purpose of batch release. These issues were classified as a Major Objection (MO).
After further information was obtained from the sites and inspectors, the MO was considered resolved. (My comment - but no explanation fo what these were)
The BNT162b2 active substance is manufactured by in vitro transcription using a linear DNA template, produced via plasmid DNA from transformed Escherichia coli cells. The linear DNA template is not part of the final product but defines the sequence of the mRNA product and therefore it is fundamental to ensure the adequate control of the active substance to the manufacturing process of the linear DNA template (e.g. change to plasmid host cell) may result in a different impurity profile in the active substance.
a decrease in RNA integrity was observed for the initial Process 2 batches compared to Process 1 batches
The robustness of the DNase digestion step is not considered comprehensively demonstrated. It has been confirmed that studies to enhance the robustness of this step are ongoing some differences between Process 1 and 2 were also noted. It can therefore not be concluded that identical species are obtained by the processes. It is likely that the fragmented species will not result in expressed proteins, due to their expected poor stability and poor translational efficiency
lack of experimental data on the truncated RNA and expressed proteins does not permit a definitive conclusion and needs further characterisation. Therefore, additional characterisation data remain to be provided as a specific obligation
this argument alone cannot fully confirm the comparability of Process 2 versus Process 1, and further characterisation data and justification of specifications were requested
the results indicating a substantial proportion of shorter/truncated mRNA with both cap and poly(A)tail are not in agreement with this statement
most fragments would arise from premature termination in the IVT reaction
It is recommended that the applicant should comprehensively describe the capability of a specific analytical method to detect lower amounts of product related impurity in the presence of the correct form in the active substance
It is noted that not all process parameters are listed
The sole product-related impurity addressed is double-stranded RNA, derived from the in-vitrotranscription reaction.
The Applicant should provide additional data to further characterise the truncated and modified mRNA species present in the finished product
The rationale used to establish the acceptance criteria is described in detail and based on a limited data set representative of BNT162b2 active substance manufactured at the intended commercial scale and process
Need I go on?
Plus DNA, albeit non-human, is used in the manufacturing process. Is this the DNA contamination being found in the vials?
But these are the plants, especially the one at Andover Massachusets, that FDA inspectors had inspected and found many issues with and in teh past requested them to be shut down but the FDA management refused. A trawl of the internet will eventually lead you to the FDA reports.
https://www.thedailybeast.com/pfizers-newest-vaccine-plant-has-persistent-mold-issues-and-a-history-of-recalls
To help those who want to delve into the murky approval documents here are previous substack’s about the original PARs:
https://awkwardgit.substack.com/p/the-4-official-ema-public-assessment
https://awkwardgit.substack.com/p/mhra-ema-and-the-chmp
https://awkwardgit.substack.com/p/3-simple-easy-to-answer-questions
Plus there is this comment which started my journey of discovery into the ingredients and the initial FOIs to the MHRA detailed above:
The functional lipid excipients ALC-0315 and ALC-0159, are classified as novel excipients.
They couldn’t/wouldn’t answer so until they do I’m not having the chemical concoction injected into my body.
Simples.
I will not have any chemical concoction injected into my body be it a vaccine or anything else unless it is a life or death situation and even then it would have to be independently verified! How can anyone trust the manufacturing process when there are no checks and balances and our regulatory bodies appear to be bought and paid for by the pharmaceutical industry.
Please read Jessica Rose Substack on this too. You are cross referenced there by some readers.
https://open.substack.com/pub/jessicar/p/remember-that-4chan-post-from-2020?r=c8vqx&utm_campaign=post&utm_medium=web&comments=true