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The shell game continues: Moderna’s 'FDA approved' vax is not available to Americans, and it's not scrutinized for Omicron...Omicron accounts for 99.9% of sequenced cases
https://dossier.substack.com ^ | February 01, 2022 | Jordan Schachtel

Posted on 02/01/2022 8:27:10 AM PST by Red Badger

Two FDA “approvals,” two shell games.

On Monday, the FDA “approved” Moderna’s Spikevax COVID-19 vaccine for all US customers. Just like the Pfizer “approval” episode, this vaccine will not be able for anyone for an indefinite period of time. And according to the FDA, the shot was approved without being tested for Omicron, which accounts for 99.9% of current U.S. COVID cases.

“Today, the U.S. Food and Drug Administration approved a second COVID-19 vaccine. The vaccine has been known as the Moderna COVID-19 Vaccine; the approved vaccine will be marketed as Spikevax for the prevention of COVID-19 in individuals 18 years of age and older,” the FDA said in a widely-celebrated press release Monday.

The FDA noted in the small print of its approval letter that Spikevax and Moderna’s emergency use authorization shot are “legally distinct” products, adding that there are “certain differences that do not impact safety or effectiveness.” The same disclaimer was made when the FDA approved Pfizer’s Comirnaty, which has never seen the light of day in the United States.

Moreover, the FDA said that Spikevax will not be available for an indefinite period of time.

The FDA stated:

“Although SPIKEVAX (COVID-19 Vaccine, mRNA) and Comirnaty (COVID-19 Vaccine, mRNA) are approved to prevent COVID-19 in certain individuals within the scope of the Moderna COVID-19 Vaccine authorization, there is not sufficient approved vaccine available for distribution to this population in its entirety at the time of reissuance of this EUA.”

And recent history tells us that the best guess for Spikevax’s availability is… probably never.

As of this writing, it has been 161 days since the FDA approved the Pfizer shot Comirnaty. When Comirnaty was approved, government health authorities and Pfizer claimed that Comirnaty was not available due to emergency use authorization shots still being in stock at pharmacies and doctor’s offices.

Since then, nothing has changed.

Almost six months after its “full approval,” the CDC website continues to state that Comirnaty “is not orderable at this time” in the United States.

Now back to Moderna’s Spikevax for a moment.

The FDA makes it clear that Spikevax has not been approved or tested for the Omicron variant, and that it was approved for former mutations that no longer exist in circulation. This extension also applies to the EUA version of the Moderna shot.

So not only is the FDA approving what amounts to a ghost shot, they’re acknowledging that this injection may only stand to allegedly combat a strain that no longer exists. According to the most recent data, Omicron now accounts for 99.9% of sequenced cases.

CDC variant tracker website

Paradoxically, the FDA just last week cited Omicron as a reason to pull its emergency use authorization for monoclonal antibody products. With mounting evidence that the shots seemingly have zero ability to prevent COVID-19 in the Omicron era, the FDA seems to have decided to carve out a special place for Moderna and Pfizer in its regulatory scrutiny processes.

So why aren’t these FDA approved shots making their way to US customers. The answer may lie in the legal status of the shots. As I explained in The Dossier last month:

“Due to a law passed during the Reagan Administration, in order for drug makers to be granted more robust legal liability protection for their vaccines, they must first secure full approval for the children’s version of their shot.

The National Childhood Vaccine Injury Act (NCVIA), which was passed into law in 1986, provides a legal liability shield to drug manufacturers if they receive full authorization for all ages.”

Are Pfizer and Moderna waiting for full authorization for children’s shots to distribute Comirnaty and Spikevax to the masses? There’s plenty of litigators who have suggested that this is exactly what is going on in Big Pharma world.


TOPICS: Business/Economy; Crime/Corruption; Culture/Society; Government
KEYWORDS: baitandswitch; clickbait; comirnaty; fraud; legalliability; liability; moderna; pfizer; spikevax; substackdollars; substackgrifters; unavailable
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To: Polynikes

I’m afraid you posted stuff over my head- Not sure what you mean? I’m not familiar with the abbreviations you posted either-


21 posted on 02/01/2022 9:03:35 PM PST by Bob434
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To: Bob434
Ok. I'll try to para phrase.

AB's = Antibodies

The AB's produced by the Pfizer injection are of a high level but within that level there are 2 types of antibodies

1. Non-neutralizing or some times referred to as binding antibodies. They out number the sterilizing antibodies by 5 to 6 times. This is bad. Binding antibodies either will do nothing to stop further infections or make new infections worse by helping the virus.

The antibodies produced by both Pfizer and Moderna shots are to the spike protein (Spike) only. That's how they are designed. The bodies cells are stimulated to produce the spike but the spike by itself is dangerous and does not stay at the injection site. It migrates and lodges in various systems such as the lining of your blood vessels and causes unwanted effects such as strokes and clots.

Those antibodies from the shot do not last and start to drop off at 4-5 months.

That's how Pfizer gamed its trials, they were only 3 mos long otherwise if they were longer they would have shown the effectiveness faded.

That's why you need “boosters” every 5 to 6 months. With each new jab you roll the dice by getting a new stimulation to produce the spike and risk the side effects again. During the time the booster is working to stimulate your cells to produce new spikes your immune system gets weakened. That's why some people get boosted and promptly get the virus.

Because the antibodies eventually drop off it is also is why there are breakthrough infections.

2. The sterilizing antibodies, which is the gold standard, work like they are supposed to and actually protect you but since the levels are lower and as time passes they drop off you end up with mainly binding or non-sterilizing antibodies allowing you to be reinfected and when infected you get really sick because the antibodies you have help the virus.

This is somewhat simplified but maybe it can help you understand how the jab works and why the jab won't stop you from getting the virus nor spreading it. Pfizer and Moderna are selling a defective and dangerous product.

Now to the issue of whats possibly killing even though the Alpha strain is gone and Delta is mostly gone. The antibodies have a place called the RBD or reverse binding domain. Thats where the spike from the virus tries to latch on. With sterilizing antibodies you are protected and the virus is resisted and neutralized. With binding antibodies the virus is helped ie: enhanced and you usually get really sick. This is ADE (Antibody-dependent enhancement). That's where the original virus or one of its variants (Omicron?) gets you. Without the jab Omicron is usually mild but with the jab its nasty but not necessarily fatal.

The second study I cited found some interesting things
What was found was the antibodies from the Jab also enhance 2 other corona viruses OC43 and HKU1 by a factor of 2-3 times by their reverse binding domain.

This is OAS or original antigenetic sin. That's when you get jabbed for one type of virus but another one gets you.

OC43 is a known historical killer. Under normal circumstances OC43 just causes a bad cold or flu like conditions. When it is enhanced by the Jab's antibodies you get sick with corona like symptoms but test negative. Depending how healthy you are to begin with you get admitted and sometimes also get covid most likely from the vaccinated staff.

Now the “approved” protocols kick in. Remdesevir, ventilator etc. If you have other problems like diabetes,obesity, high blood pressure you are likely hosed.

The medical system has been so corrupted by the likes of the CDC and NIH that for decades anyone with a white coat will be viewed with suspicion and distrust. The hospital collects $$$ from .Gov to the tune of 100K via the Prep act when the dust settles.

What you are seeing is the end result of multiple factors in play.

22 posted on 02/02/2022 2:43:18 AM PST by Polynikes (Nicht geimpft Mensch 2nd Klasse)
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To: Polynikes

Thank you very much for taking the time to explain.
I’m trying gto go through your post, but am suffering from a flu or something and my mind is just not thinking well. Brain fog big time, but i think iS more clear now.

[[The hospital collects $$$ from .Gov to the tune of 100K via the Prep act when the dust settles.]]

Yeah, that shocked me. Until,the virus, I didn’t realize just how corrupt it was, then we learned that hospitals were getting fed money for every covid patient, and it dawned o. Folks thst they didn’t want people,getting better with off label drugs because hospitals wouldn’t profit as much. That blew my mind. What Cuomo and ilk did with the nursing homes was unconscionable.

I’m trying gto go through your post, but am suffering from a flu or something and my mind is just not thinking well. Brain fog big time.

One question about the spike proteins, doesn’t covid itself cause spike proteins? Or am I understanding that wrong? If so, wouldn’t the spike from covid coupled with the deleterious effects of covid (ie deep lung issues, organ issues) be worse than spike proteins from vaccines which “apparently” don’t cause deep lung issues?

[[Those antibodies from the shot do not last and start to drop off at 4-5 months.]]

Oh I thought it was a lot sooner? Like hardly effective at even 3 months (something like only 20% effective at 3 months)? I see a report out today where natural,resistance after getting covid lasts for like 8 months (or 18, can’t remember which now)

[[With each new jab you roll the dice by getting a new stimulation to produce the spike and risk the side effects again. ]]

Yeah, that is the bummer, it’s like playing Russian roulette every time, only there are more than one bullet In The gun.

[[Pfizer and Moderna are selling a defective and dangerous product]]

Agreed. It “could be” more effective IF they gave it to the sickly and elderly who wanted it, along with other measures to make sure they don’t get reexposed, (because as You said,,it opens them up to worse infections later, but they are the most vulnerable, and should,at the very least be offered the right to try off label meds, and maybe take the vaccines IF they are really,high risk) and left everyone else alone. But I see now they are really pushing for kids as young as 5 to be vaccinated- kids who have a mere 0.0002% chance of dying from the virus according to a report I heard.

[[This is ADE (Antibody-dependent enhancement). That’s where the original virus or one of its variants (Omicron?) gets you. ]]

Ok, that makes sense for the rising cases of omicron and its possible deadlier or more severe outcomes.

[[The second study I cited found some interesting things
What was found was the antibodies from the Jab also enhance 2 other corona viruses OC43 and HKU1 by a factor of 2-3 times by their reverse binding domain]]

Swell! I wonder though how long it lasts (how long the antibodies fromjab make new infections worse?) Does that effect wear off over time?

It is just mind boggling that scientists and medical professionals who know all,this stuff aren’t warning the public about it. Instead, they are attacking folks like,Joe Rogan, Dr zelenko and others, who are trying to warn folks about the negative effects of the vaccines.


23 posted on 02/02/2022 8:27:50 AM PST by Bob434
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To: Bob434
“doesn't covid itself cause spike proteins? If so, wouldn't the spike from covid coupled with the deleterious effects of covid (ie deep lung issues, organ issues) be worse than spike proteins from vaccines which “apparently” don't cause deep lung issues?”

Yeah it could be but remember “natural” CV-19 enters through the Naso-Pharyngeal (Nose & Mouth) and there are various defense mechanisms as in mucousal layers etc. That gives you time to intervene with medications/treatments of your choice depending how you want to proceed. Hospitalization with ventilation/Remdesivir or Vitamin I.

Originally only about 20% of the population was vulnerable. The Diamond Princess incident proved that. If the spread is enhanced by exposing the most vulnerable ( think Nursing homes) then the process gets more coverage. Panic ensues and people line up for hours for a dangerous Jab that will hose your immune system. Then you are hooked into a process that will eventually damage you beyond repair.

The Jab is introduced directly into your body (IM) injection along with the problems the migrating spikes introduces.

With the Jab the formulation has not changed markedly since they were introduced. The Jab is for the Alpha variant which is gone. Since CV19 is a corona virus it mutates rapidly and each mutation selects to avoid any protection. That's why you never Jab into a active pandemic especially a corona virus, it's suicidal.

The jab turns your immune system into a one trick pony for a variant that isn't there anymore.

Think of it this way. Your immune system is now one inch wide and a mile deep. It needs to be one inch deep and a mile wide.

I used to think that the jab might be useful for the very vulnerable but it was shown CV19 could be managed with out a Jab. Look at the Spanish nursing home incident.

https://www.sciencedirect.com/science/article/pii/S1094553921000018?via%3Dihub.

“I thought it was a lot sooner? Like hardly effective at even 3 months (something like only 20% effective at 3 months)?”

Sounds like you are referencing the Boosters. Look at Israel. They are on their 4th shot with ever decreasing effectiveness.

You are right about naturally acquired immunity. The reason being is because you acquire N-protein (nucleocapside) antibodies. The N-protein is in the virus itself and governs replication it also gives you T-cell and I believe B-cell (long term memory) response.

The Israelis found this out. There are studies now surfacing that imply that the Jab does the same thing but frankly I don't believe them anymore because we have been lied to again and again. You can make your own choice.

“I wonder though how long it lasts (how long the antibodies fromjab make new infections worse?) Does that effect wear off over time?”

That I can't say. I prefer to make myself less vulnerable ie: loose weight, reverse any Type 2 diabetes (its possible),keep D3 levels up etc.

All this is somewhat simplified. There are other factors that influence this whole affair.

24 posted on 02/02/2022 11:07:25 AM PST by Polynikes (Nicht geimpft Mensch 2nd Klasse)
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To: Polynikes

[[Yeah it could be but remember “natural” CV-19 enters through the Naso-Pharyngeal (Nose & Mouth) and there are various defense mechanisms as in mucousal layers etc. That gives you time to intervene with medications/treatments of your choice]]

We use colgate total with cetylpyridinium chloride which neutralizes covid and other viruses completely for a few hours- we use it right before going into a store-

[[The jab turns your immune system into a one trick pony for a variant that isn’t there anymore.]]

Yep that’s why we avoided it

[[I used to think that the jab might be useful for the very vulnerable but it was shown CV19 could be managed with out a Jab.]]

I thought that too- thanks for the link- I’ll check that out for sure-

[[frankly I don’t believe them anymore because we have been lied to again and again.]]

Agreed- the lying is blatant too- studies all over are showing ivermectin helps fight it quite well, yet they lie and say it’s ineffective- I personally think 100’s of 1000’s could have been saved had they had access to ivermectin AND later to conventional drugs currently used to fight covid- there was no reason to ban it- the message should have been “Use it BUT seek medical care as well, as the two can work very well together without issues- If Ivermectin works, great, if it fails to work, oh well, at least it was tried against a deadly virus for some vulnerable folks without any ill effects”


25 posted on 02/02/2022 11:30:21 AM PST by Bob434
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