In early November 2021 I was speculating about a tiny but publicly-traded Maryland vaccine company called Novavax (NASDAQ:NVAX) and what their entry in the Rona stakes might offer medico-immunologically. On January 31, 2022, the clinical study reports and final submission to FDA that they had promised since August 2021 was finally handed over for government review with a bow on top. Disclaimer: This isn’t a puff-piece for Novavax, I am not 100% sanguine about the need to do any “vaccination” for this bug but I seek social workarounds that will appease the communists for a time, I am not paid by Novavax or any other company, and I am not trading Novavax stock or options, indeed if I was, I would be shorting it.
Their CEO, Stanley Erck, has a small regulatory affairs team, possibly inexperienced but clearly more experienced now, who for a year faced strong headwinds from a Pfizer-captured FDA (the PFDA). I can imagine how the Agency slow-walked their pre-submission and nitpicked and henpecked them nearly to death with data and stats and presentation demands, and in the last half of 2021, with child age group and variant handling insistences. Though he was able to submit according to plan in the EU and across the Anglosphere, including fascist-occupied Australia, the regulatory nut here in the “Land of the Free” was uniquely harder to crack. He had been forced to kick the can for months saying the submission would be “by the end of the month” then “by the end of this quarter” then “by the end of the year” and finally “by the end of January.” With just minutes to spare, he received his receipt from PFDA that they will now be dutifully bureaucratizing their vaccine offering and weighing the risks against the benefits. With Novavax now coming in for review, there is a risk that most-favored son Pfizer will encounter competition and dilution of that sweet sweet EUA no-liability guaranteed-government-payday pie. I expect…trouble.
Novavax’ product is a traditional vaccine, aka tradvaccs. Their technology is different from all the other Rona injectibles (distinguished by vaxx) currently offered in the United States. There are two (2) key differences with Novavax: 1) they make their tradvaccs based solely on protein antigen and do not contemplate any genetic expression mechanism like mRNA or Adenovirus vectors; 2) the Spike protein they are including in their shot has been modified to remove the artificial Furin Cleavage Site (FCS) that EcoHealth Alliance described and funded and the Wuhan lab inserted. You may recall that when the universally-present Furin enzyme snips that synthetic viral Spike protein, the fragment that floats away is actually quite cytotoxic, and it kills cells that have ACE2 (and other) receptors on the surface. Every genejab1 includes full code for the FCS contained within the engineered O.G. 2019 Wuhan strain, the entire 29,000-base sequence kindly provided by our friends in Chy-nah, about 4,000 bases of which make up the vaxxen. Why they all uncritically accepted this genetic sequence without review, or upon discovery, rolled-back or updated their code to more of a wild-type virus is a giant mystery. It would amount to swapping fewer than 12 nucleotides to fix this. They apparently thought: Nahh….It’ll be fine. (h/t TheCriticalDrinker).
What Do I like About the Novavax Product?
With regard to safety profile, not forcing the body to make a modified (anchored) antigen protein is the correct approach, and it immediately limits the negative long-term consequences that even now we do not fully appreciate in genejabs.2 Critically, removal of that FCS sequence is very based science and should have been on everybody’s agenda by January 01, 2020, yet only Novavax got it nailed down. (Apparently they were not in Fauci’s email loop that was super eager to not talk about these 12 artificial nucleotides that he paid for.) Delivering 5 micrograms of protein twice is probably easily cleared from the blood, and yet it seems to do the basic trick of desired IgG immunostimulation. The only long term side effect I would watch for carefully would be IgE development, which directs the clearance process toward allergic pathways, which itself is not a big deal and may never happen; I would not anticipate anaphylaxis in the general population but I might watch hypersensitives a bit more. Though I have used a very closely related saponin-based adjuvant system contained in this product and had great lab results (sorry cannot share), I know only that a great long-lasting and highly differentiated B-cell response is the likeliest outcome. The high-temperature handling available to Novavax is a cool (ha) feature, but frankly as a non-investor, I don’t care much about this as it doesn’t bear on American safety.
What Am I Disappointed In Regarding the Novavax Product?
Like everybody else, Novavax are also deeply swept up in the “Spike-only Regime” that has dominated thought in this area. Yes, Spike is the microscopic outer shell of virus protein that meets the world. Yes, it has a lot of immunogenic traits predicted by “computer models.” Yes, when convalescent plasma is harvested and the IgGs are looked at, they like Spike in large part. Overwhelming every virum in the body with enough IgG to bind every spike and halt all cellular entry of virus amounts to impossible amounts of the stuff to achieve body-wide COVID-Zero. Not gonna happen. IgG tagging of virums for macrophage and neutrophil removal isn’t the whole immunological story at all, that is mostly the cleanup phase. I wish there was a business path for Novavax to have resisted this urge to hug the Spike and shown the world they have the smarts to anticipate and stop variants since they can only happen in limited ways and still remain effective at cell entry, but that bullet is downrange.
I cannot be disappointed in Novavax for being unable to do what all who came before them also could not do: engineer a method to cause CD8+ memory phenotype cytotoxic T-cells (MP-CTLs) to develop, select, expand, and ramp-up avidity for the most invariant sequences in Rona, particularly, the Nucleocapsid (N) protein. This is the Holy Grail of strong immunity to Rona variants. Nobody has done this MP-CTL trick as a therapeutic injection ever in any circumstance. Genejabs are a limp-wristed attempt to make it happen, but it winds up being just a giant sCiEnCe experiment on the entire planet, sequences that recombine and make mutants with live virus and select for their immune escape. What I can be disappointed in is that Novavax didn’t even seem to try to go after N protein, that we know of, even for just antibody/IgG claims. Perhaps Novavax tried N protein antigen and it didn’t meet acceptable clinical endpoints for PFDA, or perhaps they found that it didn’t add anything. But if I was in marketing/bizdev, I would be asking for distinguishing features like that on Day One.
We now know with pretty good certainty that the current best and so far only way to generate a proper T-cell based immunity is via voll viral infection, with the entire complement of the uncountable biochemical steps needed to do it comprehensively. That means having a fully adaptive immune system on tap, not one that has been painted into a corner with Original Antigenic Sin (OAS) from jabbed antiquated viral code that was actually decrepit in October 2019. Cut a corner here and there, and you leave yourself vulnerable.
Sympathy for the Novel
A lot of digital ink has been spilled over the simple weirdness of the source of the Novavax protein. Let’s get that out of the way. Spike isn’t a small protein, as proteins go, and the company needs literal tons of it for a jab-thristy planet. The best known expression systems for high concentrations and high volumes of protein include bacteria like E. coli to start, mammal cells like hybridomas that make monoclonal antibodies in bioreactors (not the same as axlotl tanks, btw), some yeast systems are fast at scaling up bigger proteins, tobacco plants surprisingly can be forced to make IgG, and the Big Daddy of them all in routine production is called the Sf9 cell system. They make a lot of protein in giant cells, to high concentration and post-processing is even available if needed. Here’s the quirk: Sf9 cells are from caterpillars. That is all you need to know really. I shrug. I say so what. E. coli comes from shit, to be frank, so guess where your insulin and other BLAs have come from…
Also, there is a soapy-yet-greasy molecule that they discovered/licensed that functionally irritates the immune system on a tiny scale. That is the goal. It acts like a primer by turning on white blood cells to anticipate immunological action. It is called an adjuvant, and such things have been in common use since 1942 (see Freund’s adjuvant). The Novavax adjuvant comes from the bark of a South American tree. It works remarkably well.
I have started to see organic or paid shade-casters out on the socials trying to sow FUD. They are already out in force with “WTAF? Tree sap and bug cells?!?!?!” and the like. So if you encounter such, fire off the link to this space.
In the mind-numbingly stupid new mandate world that has been pulled over our lives by thousands of proto-commie M.P.H.s and teachers’ union leaders, the one thing that seems to remain constant is their mantra of “muh science” followed by their insistence upon compliance “in accordance with the Public Health Order…” One day the public health order will be too much for anybody to take anymore. Today it is looking like they will reach to demand proof of vaccine for your children to attend school. In order to secure your rights to an education that you have paid for all your life, then Novavax may be a logical and relatively safe method of tossing them (temporarily) off your and your kids’ backs. They don’t care about you and they absolutely don’t care about the science. If they did, they would have never gone all-in on eternal boost mode for a known toxic jab that sets them up for variant-exposed immunological failure. If they truly cared about kids, they wouldn’t hold the vaxxharm gun to their heads.
Incisive mind of great repute Eugyppius just today wrote “It is hard to imagine a worse strategy than universal vaccination against a single, obsolete virus protein.” He’s not wrong. The only nuance I could think to add to that solid take on worst strategy is: unreviewed, repeated, relentless re-injection with obsolete virus protein code that puts the immune system to sleep on many levels3 and is plainly toxic on others. Novavax isn’t that.
The neologism “genejab” refers to the genetic material injections (“jabs,” tyvm England) of quasi-biological modified-RNA offered by Pfizer/BioNTech and Moderna, and Adenovirus vectors from J&J/Janssen (also from AstraZeneca who are as-yet on hold in the U.S.) All of these agents enter cells of the body and trick the cellular machinery into exclusively making “the Spike protein,” in conditions they hoped would enhance immunity. They failed to do so on a number of fronts.
Children and normal healthies like soccer star Kun Agüero are suddenly succumbing to really nasty cardiovascular insults in concert with mandated genejabs. There is no more need to be “scientifically cautious” in this claim, the data is obvious now. Novavax cannot get online fast enough to protect the kids from the senseless sacrifices bloodthirsty administrators and teachers’ unions will demand.
There have been no studies (that I am aware of) that examine the long-term effects of using persistent N1-methylpseudouridine (m1Ψ) on the RIG-1 and MDA5 viral nucleotide pattern recognition systems inside cells (Pfizer, Moderna). The m1Ψ was chosen specifically to hamper detection by these systems, a key step in the overall natural immune process of handling viruses. (They couldn’t have the cells simply clearing their vaxx-viral template instructions before they could do their thing; it also hampers RNAse degradation a bit.) What an off-balance, non-viral-but-transmembrane exposure does to T-helper cells in generating a proper B-cell response is anybody’s guess. Vaxxed cells create Spike antigens and wave them around, but they don’t “present” antigens. And they don’t call in airstrikes for clearing these antigens. This klunky arrangement is out-of-step, weird, and confusing to immune systems that operated a very different way around viral infected cells for oh, about 60 million years. What we do know is that the immunoglobulin response to genejabs is fleeting and decays to uselessness with each subsequent jab. What other elements may come into play in altering a person’s immunological landscape (anergy, T-regulatory “suppression”) with jabs are being reviewed, but the epidemiological data suggests strongly that somehow, genejabs both make variants and make people into variants’ favorite food.
By the way I want to second Stochastic's appreciation of this article. Thank you for this and your other posts which have been hugely informative as well as witty. That you quoted The Critical Drinker just made it that much better! Haha!
If being jabbed did not exacerbate the vaccine passport problem, I would heartily endorse Novavax and others of their ilk, assuming sufficient testing in sufficiently broad cohorts.
Alas, the internal to country vaccine passport is only perpetuated by being jabbed and then one is placed on the booster roller coaster. The requirement to present a passport to buy a fucking cup of coffee can go and get fucked.
Thus my attitude to submission to being jabbed remains a resolute fuck no.
I do appreciate your learned exposition, however, and thank you sincerely for sharing it.