FDA did not grant Full Approval
The mandates are coming, but if you look at the actual release of the guidance on the Pfizer vaccine, it’s been branded with a marketable name, but it’s still only available for emergency use. Go through the actual document and point out that it’s still only approved under something called “Emergency use authorization” (EUA). Print a copy of the source document and use it to fight the mandates with your HR department.
Here’s the document from the FDA
Here’s the document from the FDA
This product has not been approved or licensed by FDA, but has been
authorized for emergency use by FDA, under an EUA to prevent Coronavirus
Disease 2019 (COVID-19) for use in individuals 12 years of age and older; and
• The emergency use of this product is only authorized for the duration of the
declaration that circumstances exist justifying the authorization of emergency
use of the medical product under Section 564(b)(1) of the FD&C Act unless the
declaration is terminated or authorization revoked sooner.
My interpretation of this is that the 12-15 is under the extended EUA along with the existing vials.
Going forward the comirnaty vials, if you can find them, are approved for 16+.
I’d snap a picture of the vial if I were forced to take this. My guess is anyone vaxxed with the old vials under the EUA will have no legal recourse anywhere whereas those who have the FDA approved version might. So step one will be to prove you got the comirnaty not the old vial.
Monday, August 23, 2021
I explain my theory of the COMIRNATY “license” scam by referring to passages in the FDA approval letter
Read the FDA approval letter please. This is how they scam you, by making it nearly impenetrable. Below, I identify the two most relevant passages. The rest of the letter is repetitive blather to keep your head spinning.
page 2 last line, footnote: here FDA quietly admits that the licened Pfizer vaccine and the authorized Pfizer vaccine are identical w.r.t. safety and efficacy, but they are “legally distinct.” That’s code for one has manufacturer liability, while the other doesn’t. It is also code for “we don’t want to impose a mandate on the EUA product ’cause it is illegal, but we can probably get away with a mandate on the licensed product.”
page 12 AA. This tells you that yes, we licensed the vaccine, but…there is a lot of the old vaccine out there, actually “a significant amount” and this amount will be considered an EUA vaccine and will continue to be used. Maybe for a very long time.
Now, why would they do that? Why specify that identical versions of the product will be legally different? Because they need the license to impose the mandates. But they need the EUA to evade liability.
Along with the license comes liability for the manufacturer. (But all EUA products were given a liability shield.)
Unfortunately, our federal overlords would prefer us to be without recourse if we are injured, rather than have Pfizer risk defending its product in court.
So, my inference is that the feds want the public to THINK the vaccine they are receiving is licensed, which will make people submit because they believe it can now be mandated, but instead the public is almost certain to receive the EUA vials instead, to save Pfizer’s behind.
* You will be able to tell the difference when you see the vaccine vial. The letter explains that the COMIRNATY-labelled vials will be the licensed ones, and the others (under EUA) will say something like Pfizer BioNTech Covid-19 Vaccine without the brand name COMIRNATY.
Yes, a stingy CICP injury program exists, which I have previously written about, but it has not paid out for a single Covid vaccine injury, last time I checked.
How did I figure this out? Because I have read other FDA approval letters, and this one had significant weasel wording. And I have seen other FDA tricks. So it just took me awhile to identify what was being hidden. I could be wrong. But then we would need another explanation for the language in the approval letter. I’m happy to entertain other interpretations.
P.S. Pfizer made $33 billion so far this year on its mRNA vaccine.
That profit would be a net negative by about 1000% if they just paid the medical bills of the adverse events. Or just 100k to each person that died. Or just 10k to each person that has permanent heart damage, or suffered a blood clot, or bells palsy , guillian barre, seizures, paralysis or other neurological issues.
Is it fair for a company to make so much $$$ while actually costing us and the economy , and wasting valuable resources such as medical beds and staff.
No more liability indemnity for vaccine manufacturers – ever.
On a side note – My understand is to be granted the EUA, the vaccine must have an efficacy of 50% or greater. It may not have this against delta – and certainly doesnt against any after 6 mos. So, I see that the EUA should be pulled.
I would like to add a thought here, why would Pfizer even leave the protection of the EUA? They have nothing to loose if they remain under the EUA but if they put their label on it they are at legal risk. We all know the FDA and the deep state know all the problems with the “vaccine”. So which way will Pfizer lean in this development?
My prediction is eventually all these “vaccine” manufacturers are going to be found out and brought down. Eventually, one doctor or group will stand up and speak out in boldness.
Pfizer has no liability for the innoculations whether the vials fall under the EUA or whether they fall under full FDA approval. When the vials fall under the EUA protection, Pfizer is shielded by one federal mechanism and when the vials fall under full FDA approval because they have the “Comirnaty” brand name on them, Pfizer is shielded by another mechanism.
https://www.hrsa.gov/vaccine-compensation/index.html describes the National Vaccine Injury Compensation program, which is the liability protection which will apply to the “Comirnaty” shots. When you follow that link, you will see a link to another webpage, https://www.hrsa.gov/cicp , where the liability protection for the EUA is described.
Either way Pfizer is protected from liability and the U.S. citizenry is not.
The NVIC program page has a specific list of vaccines covered. According to Meryl Nass, these are all vaccines that are for pediatric use, or during pregnancy. So she’s sticking with her story, that the FDA approved, licensed version of the Pfizer vax will not have federal liability protection.
These are two very different government programs.
We do not even know if Comirnaty will be provided with any specific protections of the NVIC program.
In any case, an FDA approved drug…not given any special dispensation…is going to be treated exactly like any other FDA approved drug. Therefore, any criminal, or fraudulent act, or withholding of information, or failure to properly inform, on the part of Pfizer, pierces the protective screens guarding them.
Further, the FDA can retract their approval at any time, even in the absence of any wrongdoing.
Once the un-approved stock of Pfizer’s mRNA serum has been depleted…and the target percentage of the inoculated has been reached…the FDA simply revokes their “approval” preventing Pfizer from using “Comirnaty”…as they simply point to the accumulated harm the same technology caused to several thousands of its victims…and done.
The FDA “approval” of “Comirnaty,” having had its desired effect to enhance the numbers of people subject to inoculation, who were then injected with EUA mRNA stock (Same Stuff, Right?), the approval is revoked.
But, since the FDA approved “Comirnaty” never was actually injected into anyone…and no one could possibly claim being harmed by it…
Well, you get the picture….