Does The FDA Even Bother To Look At The Data?
Their Guidance On The Next COVID Inoculation Formulation Makes NO Sense
Let’s get the obvious point out of the way first: the mRNA inoculations are toxic, dangerous, deadly, and of no practical benefit whatsoever. The data has proven that in abundance.
However, the jabs are still out there and the FDA is still lying about them, so we really do not have the luxury of ignoring them completely—if the Pandemic Panic Narrative tries to rise again like the undead zombies from Resident Evil, self preservation demands we be equipped with the facts and the data to politely (or impolitely) tell all the jab-happy Karens out there where to go.
Thus we come to an absolutely absurd bit of news: the FDA is telling the mRNA inoculation vendors how to prepare their next batch of poison inoculations.
The next round of COVID-19 vaccines will target one of the latest versions of the coronavirus, the Food and Drug Administration said Friday.
FDA’s decision came one day after an agency panel of outside advisers supported the recipe change. The agency told vaccine makers to provide protection against just one omicron strain, known as XBB.1.5.
Thank goodness we have the FDA keeping Pfizer and Moderna up to date on which strains of the (non-dangerous, non-deadly) Pandemic Panic inducing virus to use!
Oh, wait…I promised you absurdity, didn’t I? Well, absurdity we shall have.
We start with this depiction of the strain selected as “one of the latest” variants.
Yes, XBB.1.5 is of recent origin, if you consider a variant that’s been around for six months to as “one of the latest.” As readers may recall, the (non-)dangers of XBB.1.5 was a topic here right after the New Year.
Certainly, to hear the corporate media tell the tale, XBB.1.5 is cause for alarm, as where it is dominant COVID hospitalizations have risen.
Or have they?
The CDC hospitalization data leaves plenty of room for doubt. Consider the case of New York—in particular, the population epicenter of New York City, Kings County.
Per the CDC, hospitalizations have indeed been rising of late, but since mid-December new hospital admissions have been declining in Kings County.
That was at the beginning of January. One only needs consider all the stories about the horrors of XBB.1.5 that corporate media did not run since then to grasp the degree to which this particular variant is not a threat of anything.
The absurdity of the FDA worrying about this particular strain is amplified even more when we recall that XBB.1.5 was the variant that some snarky researcher with way too much time on a Friday night dubbed “Kraken”.
The corporate media seriously hoped that they could gaslight the public into believing that XBB.1.5 was a terrifying new variant (hence my suggestion that it be called “Ingrid”, in honor of Ingrid Bergman’s star turn in the movie that gifted us the term “Gaslight”). Instead, XBB.1.5 was a bigger non-event than last winter’s cold and flu season.
Another fun twist in the tale: the FDA is also backtracking on “bivalent” boosters.
For the 2023-2024 formulation of the COVID-19 vaccines for use in the U.S. beginning in the fall of 2023, the committee unanimously voted that the vaccine composition be updated to a monovalent COVID-19 vaccine with an XBB-lineage of the Omicron variant. Following discussion of the evidence, the committee expressed a preference for XBB.1.5.
During this meeting, the advisory committee was informed of the manufacturing timelines, they reviewed the available data on the circulation of SARS-CoV-2 virus variants, current vaccine effectiveness, human immunogenicity data of current vaccines against recently circulating virus variants, the antigenic characterization of circulating virus variants, animal immunogenicity data generated by new candidate vaccines expressing or containing updated spike components, and preliminary human immunogenicity data generated by one XBB.1.5 candidate vaccine.
This just two months after telling Pfizer and Moderna that the old monovalent jabs were no longer Emergency Use Authorized, and that only the bivalent booster was permissible to shoot into people’s arms.
Which means that the FDA will have to issue fresh EUAs for the new formulations. The bivalent EUAs won’t cover a monovalent formulation, and the old monovalent EUAs have been rescinded. Very soon we will get the first Emergency Use Authorization issued outside of a declared Public Health Emergency.
Xavier Becerra’s end run around the PHE declaration protocols is about to pay dividends to Pfizer stockholders.
All this for an inoculation which research has shown to be less effective than natural immunity from a mild case of COVID.
Yet the story gets even more comical. XBB.1.5 has been the dominant variant in the US since sometime in February.
Yet if you look closely, you see that XBB.1.5 only accounts for 39.9% of Nowcast estimated cases in the US. Meanwhile, XBB.1.16, XBB.1.16.1, XBB.1.9.1 and XBB.1.9.2 collectively account for 47.5% of cases in the US.
Even at that, we’ve heard of XBB.1.16 before. XBB.1.16 is the “Arcturus” variant that began to be noticed two months ago.
Side note: if you haven’t already you absolutely must check out Stephanie Brail’s AI-generated images for “Arcturus”—they’re far more interesting than the actual virus.
To put it simply, the FDA has decided that the strain named after a mythical Greek sea monster is a greater worry than the strain named after a red giant star in the constellation Betelgeuse. This even thought Arcturus is gaining ground and will, if current trends hold true, by the end of next month displace Kraken as the dominant COVID strain. By the time Pfizer gets its mRNA inoculation updated, Kraken will be on the way out as a variant of concern.
Why the FDA is ignoring Arcturus despite the obvious reality that it is gaining ground on XBB.1.5 is a mystery. What is not a mystery is that a preparation of the mRNA inoculation is not likely to have much impact on COVID cases. XBB.1.16 (Arcturus), as XBB.1.16 is a parallel offshoot of SARS-CoV-2 from the original XBB variant.
Don’t forget, the FDA is committed to science-based medicine. They even say so in their mission statement:
FDA is responsible for advancing the public health by helping to speed innovations that make medical products more effective, safer, and more affordable and by helping the public get the accurate, science-based information they need to use medical products and foods to maintain and improve their health.
Ignoring the data and current trends for an infectious respiratory pathogen is how “The Science™” is done these days, apparently!
Of course, all of this worry and concern over COVID is taking place against a backdrop of declining COVID cases being diagnosed from ED visits.
Not to mention declining test positivity overall—people are getting less and less COVID even with Kraken swimming around and Arcturus rising like a blood red moon (yes, that sounds cheesy, but the alternative is to be serious…that ain’t happening!).
Even when people do get COVID, they are hospitalized less and less.
They’re going to the morgue even less frequently.
Whether Kraken, Arcturus, or some variant to be named later, COVID variants are simply not an healthcare concern in the US.
The FDA is supposed to be looking at the data, weighing the evidence, and making its decisions accordingly—the way actual scientists do. Instead, they’re proving to be about as data dependent as the Federal Reserve (i.e., not at all). Instead of looking at how the SARS-CoV-2 virus is changing among the strains already in the wild, they’re constantly stuck two steps behind the virus.
Under the FDA directives, the new mRNA inoculations will be ready to go just after the strain they’re supposed to target, XBB.1.5, has already left the stage.
It’s just as well that the mRNA inoculations are useless, and that the latest variants of the SARS-CoV-2 virus pose no real public health concern. If COVID was something other than “just the flu”, the level of competency being shown by the FDA, would be an healthcare threat all its own.
Lordy. I feel like I’m “tripping” in a painting of melting clocks and trapped by an ornate frame.
There must be something in their lattes or bagels while they sit around a polished table planning this dangerous crap. Or do they zoom these days? I was under the impression the FDA does no testing themselves but as being also gaslit by big PHarma just passes the pharma hat around or plucks from cards like a monopoly game--XXB-WTF--You get to go directly to a big job at Pfizer. This monopoly game has no “Go to jail” card.