The EMA RNA integrity issue
info
2022-11-29
Several people have been investigating the contents of the pfizer vials over the course of last years. We'll be primarily taking a look at the RNA integrity.
You know, the trials with more than 1200 deaths have been made with the "clinical", high quality version of the experimental product.
Going live means large-scale manufacturing, so the processes change and so could the quality of the commercial product.
Why would this matter?
“The complete, intact mRNA molecule is essential to its potency as a vaccine, even a minor degradation reaction, anywhere along a mRNA strand, can severely slow or stop proper translation performance of that strand and thus result in the incomplete expression of the target antigen.”
Said this study
There has been a leak of EMA data, which showed that regulators had major concerns over unexpectedly low quantities of intact mRNA in batches. (old news)
The BMJ then asked Pfizer, Moderna, and CureVac, as well as several regulators, what percentage mRNA integrity they consider acceptable for vaccines against covid-19. None offered any specifics.
Reading the product information of the Paul Ehrlich Institute(PEI) does not give any more information on RNA integrity needed to pass the controls, which leaves one with the impression, that this was never a subject worth looking at.
Check out this page - I haven't found any related information.
For completionists, here the original EU Clinical Trials Register - Phase II/III Study COVID-19 Vaccine BioNTech from 09.09.2020 and the ONGOING trial protocol.
Try not to laugh now - the trial aims to show
PROTECTION AGAINST COVID-19
and PREVENTION OF INFECTION with the SARS-COV2 virus
Why do they even bother continuing this?
Searching for the product code PF-07302048 gives out this document, again, no information.
This document offers a very idealistic explanation about the supposed working mechanism of the mRNA product, still, no integrity question is being raised (in german).
Good to know all the batches passed in Australia.
Here a lady from the EU parliament, asking why the amount of “on the spot” mRNA has been lowered to 50%
Suppose this question is too technical and WILL BE BROUGHT TO PAPER.. waiting…
Joerg Al Pfizer: Weicht erst aus, und dann: Ich verstehe die Frage nicht (Gelächter im Saal).
Vorsitzende: Das ist zu technisch, wir bringen es zu Papier.
Would you buy an aspirin without knowing how much of the active substance you'll get from one tablet?
Yeah, thought so. Me neither.
Supposedly, there are some 55-78% of intact mRNA in the vials, we stay with 22-45% of unknown garbage mRNA (m1ψ) fragments. What are these doing in our bodies?
Did anybody take a look?
Why not?
Now, let's talk about Jonathan Weissman, formerly MIT.
This guy was trying to ask similar questions under FOI from November 2021 till now. Every one of his requests was refused or is pending:
This person's Freedom of Information requests
Host Cell Protein (HCP) Impurities in COVID-19 VaccinesResponse by Medicines and Healthcare Products Regulatory Agency to Jonathan Weissman on 21 November 2022.
Awaiting response.
Contamination, exact ingredients and WFI GMP for Pfizer's product BNT162b2Response by Medicines and Healthcare Products Regulatory Agency to Jonathan Weissman on 8 September 2022.
Awaiting classification.
RNA integrity of experimental modRNA COVID-19 drugs (Pfizer and Moderna)Request to Medicines and Healthcare Products Regulatory Agency by Jonathan Weissman. Annotated by Matt Cooper on 11 August 2022.
Refused.
Quality control of excipients in modRNA Pfizer and Moderna COVID-19 drugsResponse by Medicines and Healthcare Products Regulatory Agency to Jonathan Weissman on 1 July 2022.
Refused.
Lipid-related impurity issues for BNT162b2Response by Medicines and Healthcare Products Regulatory Agency to Jonathan Weissman on 11 April 2022.
Refused.
ALC-0159 purity and tetrahydrofuran contamination in Pfizer's BNT162b2Response by Medicines and Healthcare Products Regulatory Agency to Jonathan Weissman on 23 February 2022.
Long overdue.
Exact definitions of PF-07305885 and PF-07302048 in BNT162b2
Response by Medicines and Healthcare Products Regulatory Agency to Jonathan Weissman on 21 February 2022.
Long overdue.
NaOH and HCl Excipients in Pfizer’s SmPC for ComirnatyResponse by Medicines and Healthcare Products Regulatory Agency to Jonathan Weissman on 21 February 2022.
Long overdue.
Weight of water for injection in BNT162b2Response by Medicines and Healthcare Products Regulatory Agency to Jonathan Weissman on 21 February 2022.
Long overdue.
Important protocol deviations within 7 days after Dose 2 in BNT162b2 clinical trialResponse by Medicines and Healthcare Products Regulatory Agency to Jonathan Weissman on 19 February 2022.
Long overdue.
Exact quantity of Water for Injection pre and post dilution in BNT162b2Response by Medicines and Healthcare Products Regulatory Agency to Jonathan Weissman on 23 November 2021.
Refused.
I would love for us, the bubble, to start supporting people like this, to give them more exposure and back them up in their claims. We want to know, too..
Jonathan, if you are reading this, what can we do?