If Pharma Did Not Have to Follow GMP Procedures...

Why did Moderna think the lipid adducts were SO important? Some observations and speculation

This is a very short substack entry and just really some speculation.

Based on the lipid adduct issue and the particulate issues of both Moderna and Pfizer that I wrote about in my last 2 substacks, we find a very. inconsistent picture of what’s considered important for Pharma with respect to the quality of these jabs.

Lipid Adducts

Particulates in Pfizer

Moderna's Issues with Particulates

Moderna

It is extremely unlikely that Moderna did not know of the stainless steel contamination as soon as the visual inspection noted it. But they did not voluntarily undertake a voluntary recall as is required. Japan’s regulator recalled 1.6 million doses in Sept 2021. I am not sure any regulator in the West would have done this.

The lots with black specks in the bivalents formulation was specifically approved (even if they didn’t know what it was, could have been asbestos, arsenic etc) and Moderna threatened the FDA with their waiver that allowed it to escape GMP standards.

Meanwhile, Moderna scientists were seriously concerned with this lipid adduct issue as I outlined in my previous substacks. Lipid Adducts represented only 3-5% on average for Pfizer of the total impurities, maybe a bit greater with Moderna. Those fragmented and truncated mRNA were in much greater quantities. Why didn’t Moderna concentrate on improving this particular critical quality attribute? And would a 5% difference in intact mRNA make ANY difference in the quantity of antibodies produced? Does anyone believe this? Compared to say a 15-20% increase in the intact mRNA?

I found the transcript from the head of chemistry at Moderna and his presentation is instructive.

Here is Dr Phil White at Moderna Science Day 2022

He’s worried about a critical quality attribute. Like for real??? That’s good, but I guess other attributes like particles are not?

Something never seen before that is interfering with expressing the intended protein. And Moderna had that SM102 and Tris buffer since about 2017 so 3 years already. And they JUST find out for the Covid vax??? No wonder they’re freaking out. Studied for years and years. PFFFFT. Thats why you do lots of testing over years to get drug products right. There are ALWAYS surprises.

Whoa. Those lipids are pretty reactive since they can be oxidized just with storage. That means avoiding air and oxygen as well as light. It is stored in ethanol to prevent this. It also means they have to be extremely pure, which is sure to be expensive and very difficult to obtain.

So what is NOT being said? He doesn’t talk about the aldehydes themselves. A chemist not talking about chemicals. That these amino lipids (the ionizable ones) are very reactive, get oxidized very easily, form aldehydes and then adducts with RNA and DNA. Which is mutagenic. Well we have quite a bit of oxygen in our blood. Hmmmmm. I think this Moderna chemist knows what this means.

That study be Packer was very detailed and very thorough. It must of cost them $$$ and time yet at the same time, no effort was made to determine these black particles, recall stainless steel particles or remove the small fragments of DNA. The total copy number of residual DNA fragments is actually higher than that of Pfizer BTW, they are just much smaller fragments. Meets FDA guidelines though. And Moderna knew that the residual DNA was an issue. They knew, because they have a patent on better ways to purify residual DNA from mRNA (though did they use these techniques?)

From their patent as posted by Kevin McKernan on twitter.

The EMA’s Take

The lipid adduct issue was identified as part of Specific Obligation 2, but soon after had its own specific obligation and separate regulatory monitoring. Both Modern and Pfizer were diligent in meeting EMA’s request for data on the purity of the lipids and its manufacturing and on these adducts, and did not hand wave it away, as they did with OTHER critical quality attributes. Very strange.

Speculation

Therefore I am thinking that transfecting people was the most important objective. I think I presented data that supports this position from the companies themselves and through deductive reasoning. I think getting the full intact mRNA into people to make spike protein was NOT the PRIMARY goal because they would have worked on decreasing the percent of fragmented and truncated mRNA to a greater degree and worked on residual DNA. They just needed enough to make a few antibodies and it is my theory that many patients made very little actual neutralizing antibodies with this jab. The particles and residual DNA contamination, SV40 etc and other issues were considered irrelevant so that these products are adulterated and dangerous purposefully, to perhaps muddy the waters ? The lipid adduct issue may have more to do with the LNPs and what they are doing in the cell than the loss of mRNA per se. There is also the possibility that Moderna knows the lipids will destroy both the mRNA and any DNA in the LNPs if storage requirements are not met. Similarly, how much would be destroyed in vivo before the LNPs can transfect and release the mRNA? Is that possible?

What do you all think?