Week #12: Earth-Shattering Event in the Science World! Hard Evidence that mRNA Vaccines are Out of Specs (OOS)
Hard evidence of DNA Contaminants in Pfizer and Moderna's "vaccines"
Well, an Earth Pfizer-shattering event just happened in the last few weeks in the science world, and many of us missed it because it was too sciencey! So what just happened?
Some years ago, when I was working in Pharma, I was called into an urgent meeting. My boss told me to clear my schedule and attend an emergency meeting with our colleagues from Headquarters. In the meeting, we had the medical head, regulatory head, our legal team and my boss (the country manager). I was the commercial head during that time.
During the meeting, our colleagues from HQ explained to us that several manufacturing batches of one of our drugs were found to be “Out of Specs” during some quality audits.
So what does “out of specs” mean? Well, when you sell a product, you have a list of all the ingredients within the product in the package insert.
Here is the package insert for Pfizer’s mRNA experiment.
(By the way, I am aware of some viral videos showing that the package inserts are empty. They have been updated since mid-2022).
Anyway, when a product is "Out of Specs", it means some ingredients are not supposed to be there (or in the wrong quantity).
During the meeting, HQ instructed us to investigate our country's "out of specs" implications. You see, every country has their own set of regulations (but most of them follow the FDA or EMA). Therefore, we were asked to conduct a risk-benefit analysis to see if a voluntary product recall was warranted (or just keep really quiet until the product is wholly sold off / used up in the market).
Being "out of specs" is a grey area - i.e. lower concentration of active ingredient on a small number of batches. Regulatory agencies may close an eye if the overall implications are insignificant because they do not want to cause panic. It looks terrible on them because patients who took the product might bring lawsuits to the government (for not doing their due diligence).
However, when "out of specs" goes entirely OUT OF SPECS, the shit hits the fan. That's when a product recall is warranted.
Pharmaceutical products are generally recalled for two reasons. The first reason is manufacturing-related (quality issue), and the second is safety/efficacy related. So far, Pfizer and governments have navigated the safety/efficacy angle by muddying the waters (i.e. fudging data, buying off scientists, paying medical journals to publish flawed studies etc.).
OK, So what's the Earth Pfizer shattering event?
This is where it gets to sciencey, and only a few caught on to the news. I caught the news when I saw Jessica Rose's interview with Kevin McKernan. Jessica was really animated, so I thought there must be something there, so I dug deeper into it.
I will try to explain the gist of it.
Kevin McKernan published his deep sequencing findings on the Moderna and Pfizer bivalent vaccines a few weeks ago.
What does it mean?
Kevin found that there were DNA contaminants in the vaccines. This is important because Pfizer and Regulatory Agencies with the fake news media have repeatedly asserted that vaccines do not alter DNAs. After all, “it is only using a fragment of mRNA”. Here’s an example from the Aussie Govt.
If you want to read the sciencey stuff, Jessica Rose wrote an excellent follow-up on DNA contamination here.
TLDR Version: There are trillions of DNA molecules per dose of vaccines. Here’s Jessica’s Take Home Message:
On top of his findings, Kevin McKennan also published his entire methodology for other independent labs to replicate his results by using a minimal amount of vaccine and some cheap test kits.
Kevin’s finding is so profound that it caught the attention of someone who has frequently clashed with Kevin (“Writing this piece is not easy…” lol!!)
[SOURCE]
But it is refreshing to see scientists from opposing sides discuss the results rather than calling people names like this Yale “Professor”.
In Summary
This DNA contamination is significant because it ultimately pushes the COVID vaccines into the “Out of Specs” category.
This is a PRODUCT RECALL situation.
Independent labs can now replicate the findings (with hard evidence) easily. We are not discussing an insignificant “out of specs” situation here. Trillions of DNA molecules that can potentially integrate into the human genome are not insignificant.
Based on FDA’s regulation, it is an OOS situation.
FDA regulation (§ 211.192)
All drug product production and control records, including those for packaging and labeling, shall be reviewed and approved by the quality control unit to determine compliance with all established, approved written procedures before a batch is released or distributed. Any unexplained discrepancy (including a percentage of theoretical yield exceeding the maximum or minimum percentages established in master production and control records) or the failure of a batch or any of its components to meet any of its specifications shall be thoroughly investigated, whether or not the batch has already been distributed. The investigation shall extend to other batches of the same drug product and other drug products that may have been associated with the specific failure or discrepancy. A written record of the investigation shall be made and shall include the conclusions and followup.
Governments and Pfizer need to recall the product voluntarily now. Otherwise, it is just plain criminal negligence. If something like this happened pre-covid, the vaccine would have been recalled immediately.
But I won’t be surprised if governments double down since they are already in deep shit after injecting millions of citizens with a potentially harmful DNA-altering product.
Let me repeat this, Pfizer is Pfucked, and the elephant baby T-Rex in the room grew into a troubled teenager!!
Signing off for now!!
-Aussie17
Terrific substack! Thanks for the detailed explanation!
Going the "out of Spec" is probably the best way to get this product out of circulation, and lawsuites started.