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