Pfizer mRNA Batch Distribution

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Pfizer mRNA Batch Distribution

Postby drstrangelove » Tue Dec 07, 2021 4:03 am

The BMJ has reviewed the documents, which show that regulators had major concerns over unexpectedly low quantities of intact mRNA in batches of the vaccine developed for commercial production.

EMA scientists tasked with ensuring manufacturing quality—the chemistry, manufacturing, and control aspects of Pfizer’s submission to the EMA—worried about “truncated and modified mRNA species present in the finished product.” Among the many files leaked to The BMJ, an email dated 23 November by a high ranking EMA official outlined a raft of issues. In short, commercial manufacturing was not producing vaccines to the specifications expected, and regulators were unsure of the implications. EMA responded by filing two “major objections” with Pfizer, along with a host of other questions it wanted addressed.

The email identified “a significant difference in % RNA integrity/truncated species” between the clinical batches and proposed commercial batches—from around 78% to 55%. The root cause was unknown and the impact of this loss of RNA integrity on safety and efficacy of the vaccine was “yet to be defined,” the email said.

- https://www.bmj.com/content/372/bmj.n627

At 7:14 in this Dec 23 2020 interview, BioNTech CEO Ugur Sahin appears to state plans for the production of a completely seperate vaccine batch for his company and corporate associates, which he says would be distinct from the batches being used commercially.


Which brings me to this now deleted post by Karl Denninger at market watch, who claims to have discovered an uneven distribution in deaths and adverse events across vaccine lot numbers.

The outcome distribution isn't "sort of close" when most of the lots have a single-digit number of associated deaths.
Isn't it also interesting that when one removes the "dead" flag the same sort of correlation shows up? That is, there are plenty of lots with nearly nothing reported against them. For Moderna within the first page of results (~85 lots) there is more than a three times difference in total adverse events. The worst lot, 039K20A with 87 deaths, is not only worst for deaths; it also has more than 4,000 total adverse event reports against it. For context if you drill down a couple hundred entries in that report the number of total adverse events against another lot, 025C21A number 417 with five deaths.
Are you really going to try to tell me that a mass-produced and distributed jab has a roughly ten times adverse event rate between two lots and seventeen times the death rate between the same two, you can't explain it by "older people getting one lot and not the other" and this is not a screaming indication that something that cannot be explained as random chance has occurred?


- https://archive.md/Fc8w5#selection-899.0-899.9

This post also claims to refute the theory that adverse events are for the most part a result of not aspirating the needle before injection, a previous theory I found the most convincing.

Basically the inference here is that scaling the production process to commercial levels has made the vaccine batches produced at mass scale much more dangerous than the small batches used in clinical trials. If this were true, getting vaccinated with a lot number from a batch that wasn't produced at commercial scale would be much safer. And the CEO of BioNTech did state in that interview they planned on making a seperate batch for themselves and their associates, which would be a limited amount of people, thus they wouldn't be using the commercially scaled production equipment.

The next step would be finding out which production facilities were used for the trial batches, and see if they are still being used. Or finding out the specifics of the different production facilities currently being used, to find out if any are much smaller than the rest. Then ultimately figure out where the smaller batches were being sent.

According to this article the clinical trial batches were produced at BioNTech facilities in Mainz and Idar-Oberstein in Germany.
- https://www.biopharma-reporter.com/Arti ... production
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Re: Pfizer mRNA Batch Distribution

Postby drstrangelove » Tue Dec 07, 2021 4:12 am

In Australia at least, Pfizer employees have been receiving exclusive and distinct batches of the mRNA gene therapy solution for administration.

Not tested. OCABR Reviewed. Limited batch quantity allocated for use in Pfizer Australia employee vaccination program

- https://www.tga.gov.au/batch-release-as ... 9-vaccines

batches in question:
FF0884* 12/8/2021
FA4598* 30/7/2021
FE3064* 25/6/2021
FA7338* 22/6/2021
FA7812* 22/6/2021
FC8736* 22/6/2021
FC3558* 21/6/2021
FD0927* 7/6/2021

These batches are not tested at all in Australia by the regulatory agency that tests all the other batches.

Pathway one uses overseas certification as evidence that the batch has already undergone independent testing and assessment by a recognised National Control Laboratory, such as the Official Control Authority Batch Release (OCABR) process(link is external) in Europe.

The OCABR process involves assessment of manufacturing documentation (summary protocol review) and laboratory testing for potency, identity and appearance based on guidelines for specific COVID-19 vaccine types (e.g. RNA, viral vector, and inactivated vaccines).

When the Sponsor provides evidence that the batch supplied in Australia has passed OCABR testing, the vaccine can be released without the TGA conducting a manufacturing protocol assessment or (potentially) laboratory testing.

The Sponsor must still supply samples, batch details and evidence of the maintenance of adequate shipping conditions for the batch under this pathway.

OCABR certificates are unlikely to be available for all COVID-19 vaccine batches as their availability depends on many factors, including the final global distribution of a batch.
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Re: Pfizer mRNA Batch Distribution

Postby drstrangelove » Tue Dec 07, 2021 5:51 am

Some guy actually audited the Australian Pfizer batches:
- http://craigduncan.com.au/index.php/cov ... ply-audit/
- http://craigduncan.com.au/index.php/cov ... und-notes/
- https://docs.google.com/spreadsheets/d/ ... 2028058027

He found some interesting irregularities concerning batch FA4598, which was marked for Pfizer employees.

Pfizer Australia employees receive special July release

Several batches of Pfizer vaccine, manufactured in June 2021, was delivered to Australia no later than 5 July and passed by the TGA without testing. The TGA web site noted these as batches for “Pfizer Australia employee vaccination program”. If these were released at that time, then it was ahead of some other in-progress batches that had been disclosed by the TGA as at end June 2021.


Batch FA4598 at first gets entered into the system marked as a Pfizer employee batch that hasn't been tested with a completion date of 22 June 2021.

Then on the 12th of August this audit claims that another entry was made into the system for Batch FA4598, but without being marked for Pfizer Employees and rather just being "Untested" and with a completion date of 30 June 2021.

The TGA information update on 11 August 2021 included a shipment from batch FA4598, which had previously been part of a Pfizer Employee delivery on or about 22 June 2021.


So as of the 12th of August there are now two entries for Batch FA4598 in the database:
- 22 June 2021, Marked for Pfizer Employees.
- 30 June 2021, Untested.

The TGA updated its batch release web page overnight 19 August 2021, changing the status of all batches to ‘passed’. It also made several changes to the data, which are most easily seen by a comparison between the previous day’s list and the next day’s list:


Then on the 19th of August the database updates once more

This latest update has removed two of the previous batch entries (FA4598 and FF8871, the latter being included as recently as last week). FA4598 (22 June) was originally described as a Pfizer Employee batch but those details are no longer included on the TGA web page.


According to this guys audit, the FA4598 batch entry marked for Pfizer employees(22 June 2021) has been removed, leaving only the one which had been marked "Untested"(30 June 2021), but now all the status of all batches have been changed to 'Passed'.

So as of the 19th of August there is now one entry for Batch FA4598 in the database:
30 June 2021, Passed.

Yet if I go to the TGA records as they currently stand now, Batch FA4598 has a single entry which is:
30 June 2021, Marked for Pfizer Employees(Untested)


So if the audit is correct, then the following has happened in summary:

July-August:
Batch FA4598 - 22 June 2021, Marked for Pfizer Employees.
- https://archive.md/62l9z

August 12th:
Batch FA4598 - 22 June 2021, Marked for Pfizer Employees.
Batch FA4598 - 30 June 2021, Untested.

August 19th:
Batch FA4598 - 30 June 2021, Untested.
-https://web.archive.org/web/20210819062504/https://www.tga.gov.au/batch-release-assessment-covid-19-vaccines
Dec 7th:
Batch FA4598 - 30 June 2021, Marked for Pfizer Employees.


I can't verify the claims of this audit yet, but it was done in relation to delays in the australian vaccine rollout not to any other investigative ends.

Federal politicians vaccinated ahead of possible 'super-spreader' federal parliament sitting
JULY 28 2021 - All senior federal politicians bar five younger MPs have been vaccinated against COVID-19 just days ahead of a sitting of Federal Parliament widely feared could become a "super-spreader" event.

https://archive.md/CnqSM
Last edited by drstrangelove on Tue Dec 07, 2021 8:15 am, edited 2 times in total.
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Re: Pfizer mRNA Batch Distribution

Postby drstrangelove » Tue Dec 07, 2021 6:05 am

Running theory: Pfizer Employee batches are safer than mass produced batches. Possibly these batches are being used in government and industry to lower the risk for what have been determined VIPs.
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Re: Pfizer mRNA Batch Distribution

Postby drstrangelove » Tue Dec 07, 2021 9:22 am

Manufacturing process development
Process development changes were adequately summarised. Two active substance processes have been used during the development history; Process 1 (clinical trial material) and Process 2 (commercial process). Details about process differences, justification for making changes, and results from a comparability study are provided. The major changes between active substance process versions were described in the dossier.
Batch analysis results showing comparability between non-clinical and clinical batches are provided. Additional characterization of product-related species and their relation to final product specifications will be provided as a specific obligation.
Electropherograms were presented demonstrating similarities in the peak pattern of RNA species, but 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 (see below). However, the 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 (SO1).


Efficacy, safety and immunogenicity was demonstrated using clinical batches of vaccine from Process 1. The commercial batches are produced using a different process (Process 2), and the comparability of these processes relies on demonstration of comparable biological, chemical and physical characteristics of the active substance and finished product.


Data demonstrate the presence of significant amounts of truncated/modified forms of mRNA at somewhat higher levels in the batches manufactured with the commercial process as compared to material used in clinical trials. These forms are poorly characterised, and the limited data provided for protein expression do not fully address the uncertainties relating to the risk of translating proteins/peptides other than the intended spike protein.

- https://www.ema.europa.eu/en/documents/ ... ort_en.pdf
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