Gone Rambling

Go a little off topic

Quick Addendum: 28 Jan 2023

Coronavirus Archive

Pfizer dropped a press release responding to the allegations about “directed evolution” as part of the SARS-CoV-2 research they have been doing for their vaccine, per their director of pipeline captured on video by Project Veritas suggesting this was happening. Before being confronted by Project Veritas more directly, and pretty much completely flipping out.

Regardless, you can find their press release here.

Since this story still has online legs, and got some reader inquiry before we went to “press” on Thursday, I figured I would disturb your weekend to update.

First, on the timing of the release. So part of the online commentary is “look how Pfizer waited days to announce this press release… they are obviously guilty…”

That actually misses the bigger tip off in the timing of this press release. This got dropped at 8 pm EST on a Friday (yesterday). That timing was absolutely deliberate. Pfizer is undoubtedly incredibly embarrassed by this whole debacle, as at best their new hire director of pipeline was just making up some incredibly conspiranoia ish to “impress a date.” The best case (and I would say on face, the most likely) is still not a great look. It’s gone viral, so Pfizer’s leadership know they have to do something. But if they make a big press release in the middle of the work week denying everything all they do is feed the viral fire. If they do nothing, make no press release and try to quietly ignore it, they will just draw even MORE attention via the Streisand Effect. So they’re damned when they do, and damned if they don’t.

The best middle ground, then, from Pfizer’s view, is to go ahead and prep your press release (at a company the size of Pfizer and for a marketed product especially, this will get a bazillion reviews by lawyers, so just the draft will take a minute). Then drop it late Friday night when no one is paying attention to the news because the weekend has started–even on the West Coast (5 pm local there!). They haven’t even posted it on the main site yet–I had to deliberately search for that release.

You may recognize this strategy from “every time the government has to cop to something embarrassing or revise something stupid they said/released or pretty much needs to say something, but doesn’t want anyone to really notice.”

Second, let’s parse what they actually say for a moment. They deny doing gain of function testing -or- directed evolution in their SARS-CoV-2 vaccine program.

THAT’S JUST WHAT A COMPANY DOING EVIL BOND VILLAIN GAIN OF FUNCTION OR DIRECTED EVOLUTION WOULD SAY! WE’VE SEEN THE VIDEO!” I hear you say, Hypothetical Default Cynicism Reader.

And yes, that is what a company doing something they know is illegal or dumb might say. I’m willing to trust but verify here. There are a number of regulatory agencies already with the power to knock on Pfizer’s door and demand to see the notebooks and labs to confirm this statement. Hopefully they do so, but they probably won’t announce it until it’s done.

Not that it will matter, because a certain portion of the internet, in the world in which we live, will assume that the relevant agencies are already captured, and the government is owned by Big Pharma, and will simply cover what is clearly GOF or directed evolution research going on.

I can’t persuade those people otherwise, and I’m not sure what will. “Unless I can touch the wounds” and all that, Thomas, I suppose.

But you can go back to Thursday’s update and re-read the section where I cover, in brief, how this is an incredibly stupid idea for a company, a conspiracy unlikely to be undiscovered if it were going on (arguably, already failed on the cover up), and slow and expensive at best. All of those are equally compelling incentives for this NOT to be going on, and Pfizer to be telling the truth here.

If you drag them before Congress, their story won’t change from what’s in that press release. But some politicians are unlikely to resist looking like they are being effective, so a hearing won’t surprise me. You want to really be effective, and ensure this isn’t happening, exercise the authority that already exists for an unannounced inspection. Go through the labs. Go through the notebooks.

Or if you want to be really sneaky and are concerned that the “directed evolution” is what they are doing, just go through lab animal shipments and purchases by Pfizer. All of that is tracked, especially for exotics like monkeys. Same for their food. If Pfizer is suddenly going through a lot of monkeys and a lot of monkey feed, and they would have to be for the method described in Project Veritas, yeah, someone should have some questions…

Pfizer then goes on to describe what they are actually doing. I will translate that into what will hopefully be more understandable.

Working with collaborators, we have conducted research where the original SARS-CoV-2 virus has been used to express the spike protein from new variants of concern. This work is undertaken once a new variant of concern has been identified by public health authorities. This research provides a way for us to rapidly assess the ability of an existing vaccine to induce antibodies that neutralize a newly identified variant of concern.

What this says is when a new variant of concern has been identified, working with collaborators, they are taking the sequence of that spike protein and popping it into wild type (Wuhan strain, or original strain) SARS-CoV-2 in place of the original spike protein. This lets them duplicate the new variant without worrying about transporting live versions of the new variant to them from around the world, growing them up, verifying that the new variant survived and is growing etc. etc. This saves them several weeks to several months and is safer than transporting live new variant from a clinical sample. I have no issues with this. They’re not creating a new virus variant–they are duplicating, via lab methods, one that has already emerged in the wild to make sure antibodies from their vaccine still cover it. If they don’t, they can start to modify the vaccine to deal with this new threat.

This is NOT gain of function research or directed mutation. All good.

“In addition, to meet U.S. and global regulatory requirements for our oral treatment, PAXLOVID™, Pfizer undertakes in vitro work (e.g., in a laboratory culture dish) to identify potential resistance mutations to nirmatrelvir, one of PAXLOVID’s two components . . . Most of this work is conducted using computer simulations or mutations of the main protease–a non-infectious part of the virus. In a limited number of cases when a full virus does not contain any known gain of function mutations, such virus may be engineered to enable the assessment of antiviral activity in cells. In addition, in vitro resistance selection experiments are undertaken in cells incubated with SARS-CoV-2 and nirmatrelvir in our secure Biosafety level 3 (BSL3) laboratory to assess whether the main protease can mutate to yield resistant strains of the virus. It is important to note that these studies are required by U.S. and global regulators for all antiviral products and are carried out by many companies and academic institutions in the U.S. and around the world.”

This is the paragraph likely to create the most confusion and concern.

You need be neither confused nor concerned about this. Pfizer is actually going above and beyond the Project Veritas video here, to their credit, because this work to support Paxlovid and has nothing to do with the vaccines.

First, when Pfizer says what they are describing here is required by law, and is routinely done for “all anti-viral products” by “many companies and academic institutions in the US and around the world” they are 100% right. This is not only REQUIRED for anti-virals, it must be done for antibiotics and antifungals too.

So what are they doing?

Like Pfizer said, this is all petri dish work. What they are doing is taking cell cultures in which the virus can replicate and grow and treating them with the anti-viral part of Paxlovid. Because viruses/bacteria/fungus can mutate around treatments for them, we want to know how likely, and how quickly, those resistance mutations can occur to a potential new drug–and if we can overcome them with just more of the same new drug, or if we need a different drug entirely to kill the resistant strain. There is no point in releasing a new antibiotic, for example, if every bacteria it treats evolves to be completely resistant to it in a petri dish within a week. So this testing is required by law for the submission and post-market surveillance of antivirals/antibiotics/antifungals. If you know the active site of the new drug–in this case, Paxlovid targets a specific part of the SARS-CoV-2 protease (NOT the spike protein) which makes the protease work–you can try to model on a computer all the different mutations a virus might create at that part of the protein where the protein will still work, but your drug won’t. Resistance mutations, in other words. If the virus/bacteria/fungus does NOT mutate its way into those resistance mutations by itself, great! That means the chance it will do so in the wild is considerably less, and you have yourself a useful new drug against them. But, to anticipate what to do if the virus/bacteria/fungus gets “luckier” in the real world than it did in the lab, or to verify computer predictions that say a particular mutation MIGHT be resistant but not really clear, you can change the target protein to the resistance mutations. You then take this new possibly resistant strain in petri dishes and treat it with your new drug to see if the mutation does confer resistance as predicted. Pfizer is doing in this in sealed petri dishes in a BSL 3 lab–very reasonable precautions. As soon as the experiment is over, you also kill these resistance testing viruses with fire. They NEVER go through animal models, and are not selected to be more contagious/more dangerous. As soon as you’ve got the data, you no longer need the bug.

This is a far cry from developing a virus that will be MORE infectious or MORE clinically severe, which is gain of function or directed evolution (in practice, as was described in the Project Veritas video).

Pfizer said this twice; I will say it again. This resistance mutation prediction and testing is required by law and is so because it really is a good idea to know how quickly and how likely it is for the target virus/bacteria/fungus to mutate its way past your new drug. This is the only way to get that data. The chance that it will unleash one of these resistant strains on the world is, indeed, non-zero–but a lot less than gain of function testing which requires animal models, and thus a less controllable environment AND a selection pressure to continue to be able to infect animals. The only selection pressure here is a virus form that can resist -one specific- drug at a time (may well still be killable by MANY others), and then, only in a petri dish.

But that’s what is going on here. I see nothing suspicious in Pfizer’s statement. I see nothing wrong with “trust but verify” either, and checking Pfizer’s work (and bills for animals and animal feed). That’s a fair penance for hiring some guy willing to spout conspiracy, even if you’re not engaged in Bond villain work.

Anyways, just wanted to send the follow up context.

Happy weekend all.

<Paladin>