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.
The fraud expands and continues
“Spikevax” REALLY? They need a new marketing department.
Thanks for posting this.
[[Omicron, which accounts for 99.9% of current U.S. COVID cases]]
First I’ve heard of this. So covid 19 (the original virus/strength) hardly exists anymore? So now all we have is people with sniffles? Certainly the 1000’s of deaths supposedly still happening (don’t know if they are or not- but we are told they are) aren’t from omicron? I haven’t even heard of deaths from omicron lately.
Even though it does not work.
Criminals
The fraud, shell game will continue until they get them on child vaccine schedules..then they’re immune from injuries.
This is not about health, all about money.
Parents need to fight back hard.
IOW when the EUA buhzillions of ‘moo’derna doses(like pfizer) run out you MIGHT be able to get the fda approved vial. Since there is allegedly no difference in the fluid, why should it matter? Remain “NON GMO”.
And they wonder why everything they say is considered complete BS.
I think the wife has it. I’ve ordered some tests from China, so we should know in a month or two.
They don’t wonder.
They know.......................
It’s probably not really 99.9% but omicron is the vast majority of cases right now. Since this is an approval process dating back to 2019 there’s not disparity. The virus has moved on but that doesn’t mean these rna vaccines shouldn’t be approved
I guess my question is, if omicron isn’t causing deaths, or very few deaths according to reports about omicron from overseas, and supposeodly 1000’s are still dying per day innthe us alone, then what is killing them? If covid and delta are no longer around, then something is killing the 1000’s that are supposedly of a virus every day, because omicron isnt deadly.
" 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.”
This is information that you won't find on the label, or on the consent form.
Whenever you take a vaccine, you can safely assume that the Pharma manufacturer has no "legal liablity" for any damages.
Consider that for a moment or two ..
They removed monoclonal antibodies because they say they are not effective against omicron. However, this vax wasn’t even checked for its effectiveness against omicron.
Smh
FDA = Serial Liars
No wonder Deep State has a mad-on for substack...
It’s probably not really 99.9% but omicron is the vast majority of cases right now. Since this is an approval process dating back to 2019 there’s not disparity. The virus has moved on but that doesn’t mean these rna vaccines shouldn’t be approved
~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~
Why would it be prudent to approve them if they are causing adverse events and are not effective against Omicron?
Here's your answer
https://www.cell.com/action/showPdf?pii=S0092-8674%2821%2900706-6
The AB's produced from the vexxine are functionally different from the AB's from a natural infection. While the AB's titer is high with the vexxine the ratio is heavily skewed towards non-neutralizing AB's rather than sterilizing AB's plus is non durable. ie: the vexxine is leaky and non-sterilizing. That sets the recipient up for pathogenic priming.
Then there is this
https://www.medrxiv.org/content/10.1101/2021.03.07.21253098v2
Pay attention to this entry
“We also found a co-dominance of mAbs targeting the NTD and RBD of SARS-CoV-2 spike and an original antigenic-sin like backboost to seasonal human coronaviruses OC43 and HKU1.”
What you are describing is the early markers of OAS, most likely to OC43
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