The other day we asked--tongue in cheek--why would anyone not trust their government. As if on cue, the government has provided a perfect, well, reminder of that basic fact of life. The FDA 'authorization' of a Covid 'vaccine' is another one of those now-you-see-it-now-you-don't government actions. One is left wondering, What does it mean? Fortunately, there are people who can explain it.
First the short version, via Twitter:
1/ So now that Come-Here-Naughty is approved (ish), the @moderna_tx @JNJNews lose their Emergency Use Authorizations, right? Because there's an approved alternative and you can't have an EUA when there are "adequate, approved, and available alternatives."— Alex Berenson (@AlexBerenson) August 25, 2021
2/ Or is this another reason @us_fda is going out of its way to say Comirnaty is not available?— Alex Berenson (@AlexBerenson) August 25, 2021
"although COMIRNATY (COVID-19 Vaccine, mRNA) is approved... there is not sufficient approved vaccine available for distribution to this population."https://t.co/XrqIORQZVt
3/ Whatever game(s) they are playing here, they're being too clever by half.— Alex Berenson (@AlexBerenson) August 25, 2021
SOURCE: Footnote 9https://t.co/sEU2YzOwfP
In other words, the vax that was 'approved' you can't have. What was the point? This looks like an attempt to extend the Emergency Use Authorizations, which provide full immunity. The FDA couldn't actually approve those EUA injections because they haven't completed the clinical trials--and won't, if ever, for quite some time. It boils down to a ploy to 'mandate' that people participate in the Great Experiment, under the assumption that people won't read the fine print. People will assume that these EUA injections are what were approved. But they're not. You can't have what was approved.
Think I'm wrong about people being fooled like that? Look what a savvy guy like Don Surber--who went and got himself shot up--wrote this morning [his typos, not mine:
"People will need to wear masks regardless of whether they are vaccinated."
If you still must wear masks, what was the point in vaccination?
It is as if they do not know what they are doing, not that any doubt wold stop them from doing what they are doing.
Actually, they really do know what they're doing and, of course, aren't about to stop doing it. But what about Surber? If a well informed guy like Surber clearly didn't bother getting informed about these 'vaccines' and still hasn't bothered, what's the likelihood that large numbers of others will also be fooled? Pretty high, I'd guess. That's your government at work. Surber thought he knew what a 'vaccine' is and didn't need to read about these gene based 'vaccines'. Trust the science, I suppose. Most people who got vaxxed thought 'vaccine' meant 'vaccine'--just like tetanus, or measles, mumps rubella, etc. That's what the government wanted them to think.
Now here's an article that gives you the longer version or explanation. It exposes the full cynicism of your government toward its subject population, and the equal cynicism and devil-may-care operating practices of Big Pharma. This is what Bannon and Malone were talking about yesterday, but in greater detail. BTW, the Zhou regime as well as your legislators and judges are fully aware of the legal distinctions involved. Who raised a voice when Zhou personally encouraged illegal mandates of experimental injections?
2 Things Mainstream Media Didn’t Tell You About FDA’s Approval of Pfizer Vaccine
Buried in the fine print of Monday’s approval by the U.S. Food and Drug Administration of the Pfizer Comirnaty COVID vaccine are two critical facts that affect whether the vaccine can be mandated, and whether Pfizer can be held liable for injuries.
But there are several bizarre aspects to the FDA approval that will prove confusing to those not familiar with the pervasiveness of the FDA’s regulatory capture, or the depths of the agency’s cynicism.
First, the FDA acknowledges that while Pfizer has “insufficient stocks” of the newly licensed Comirnaty vaccine available, there is “a significant amount” of the Pfizer-BioNTech COVID vaccine — produced under Emergency Use Authorization (EUA) — still available for use.
The FDA decrees that the Pfizer-BioNTech vaccine under the EUA should remain unlicensed but can be used “interchangeably” (page 2, footnote 8) with the newly licensed Comirnaty product.
Second, the FDA pointed out that the licensed Pfizer Comirnaty vaccine and the existing, EUA Pfizer vaccine are “legally distinct,” but proclaims that their differences do not “impact safety or effectiveness.”
There is a huge real-world difference between products approved under EUA compared with those the FDA has fully licensed.
EUA products are experimental under U.S. law. Both the Nuremberg Code and federal regulations provide that no one can force a human being to participate in this experiment. Under 21 U.S. Code Sec.360bbb-3(e)(1)(A)(ii)(III), “authorization for medical products for use in emergencies,” it is unlawful to deny someone a job or an education because they refuse to be an experimental subject. Instead, potential recipients have an absolute right to refuse EUA vaccines.
U.S. laws, however, permit employers and schools to require students and workers to take licensed vaccines.
EUA-approved COVID vaccines have an extraordinary liability shield under the 2005 Public Readiness and Preparedness Act. Vaccine manufacturers, distributors, providers and government planners are immune from liability. The only way an injured party can sue is if he or she can prove willful misconduct, and if the U.S. government has also brought an enforcement action against the party for willful misconduct. No such lawsuit has ever succeeded.
At least for the moment, the Pfizer Comirnaty vaccine has no liability shield. Vials of the branded product, which say “Comirnaty” on the label, are subject to the same product liability laws as other U.S. products.
Pfizer is therefore unlikely to allow any American to take a Comirnaty vaccine until it can somehow arrange immunity for this product.
Given this background, the FDA’s acknowledgement in its approval letter that there are insufficient stocks of the licensed Comirnaty, but an abundant supply of the EUA Pfizer BioNTech jab, exposes the “approval” as a cynical scheme to encourage businesses and schools to impose illegal jab mandates.
The FDA’s clear motivation is to enable Pfizer to quickly unload inventories of a vaccine that science and the Vaccine Adverse Events Reporting System have exposed as unreasonably dangerous, and that the Delta variant has rendered obsolete.
Americans, told that the Pfizer COVID vaccine is now licensed, will understandably assume COVID vaccine mandates are lawful. But only EUA-authorized vaccines, for which no one has any real liability, will be available during the next few weeks when many school mandate deadlines occur.
The FDA appears to be purposefully tricking American citizens into giving up their right to refuse an experimental product.
While the media has trumpeted that the FDA has approved COVID vaccines, the FDA has not approved the Pfizer BioNTech vaccines, nor any COVID vaccines for the 12- to 15-year age group, nor any booster doses for anyone.
And the FDA has not licensed any Moderna vaccine, nor any vaccine from Johnson & Johnson — so the vast majority, if not all, of vaccines available in the U.S. remain unlicensed EUA products.
Here’s what you need to know when somebody orders you to get the vaccine: Ask to see the vial. If it says “Comirnaty,” it’s a licensed product.
If it says “Pfizer-BioNTech,” it’s an experimental product, and under 21 U.S. Code 360bbb, you have the right to refuse.
If it comes from Moderna or Johnson & Johnson (marketed as Janssen), you have the right to refuse.
The FDA is playing bait and switch with the American public — but we don’t have to play along. If it doesn’t say Comirnaty, you have not been offered an approved vaccine.
UPDATE: Better late than never. This should have been in the Bring On The Variants post:
Dangerous New Freedom Variant Causing People To Ignore Government And Live Their Lives https://t.co/RBdrrM2CNx— The Babylon Bee (@TheBabylonBee) August 24, 2021
I had just got done reading that article by RFK jr. and glad you have it posted. What a dirty trick brought to you by the same group of folks that muffed the Afghan pullout. Makes it clear why RFK jr is on the Ministry of Information's attack list.ReplyDelete
Dr. Bob does post some really good and useful stuff lately. The study on "Pathogenic antibodies induced by spike proteins of COVID-19 and SARS-CoV viruses" was long read but gets at the reason for the cytokine storms as well as long covid being a result of pathogenic antibodies creating a feedback loop by in essence "attacking self", causing inflammation, more response to inflammation, wash/rinse/repeat. Wondering if this is why inflammation attenuation strategies like early IVM (believed to suppress NLRP3) are able to quiesce the runaway train process before you have what they might call a bad outcome?
Mikey, please clarify "why inflammation attenuation strategies like early IVM (believed to suppress NLRP3) are able to quiesce the runaway train process".ReplyDelete
Is this about early IVM, after getting this particular jab?
The speculation which they of course refuse to test is the IVM reduces inflammation in addition to being a good anti-parasite. Lots of anecdotal info that people taking it are claiming reduced arthritis issues. This is different from HCQ which is theorized to halt Covid cellular replication when used with Zinc. The evidence for IVM is in India where they are not heavily vaxed all over and all but one province are using IVM aggressively. The one province, Utar Pradesh stopped IVM and have higher cases and deaths than the others however no where near the US, Israel, UK where vaxes are widely in use.Delete
Judging by the aggressive moves by the CDC to dissuade use of IVM and I just read that they are seizing imported IVM that folks are trying to get overseas, seems to indicate that it has value.
I did a lot of reading on the NLRP3 inflammasome and how Covid triggers it in the lungs to create inflammation which if not checked can escalate to cytokine storm.
Interestingly, someone on Denninger pointed me to another well known substance that has supporting studies showing it suppresses the inflammation mechanism of NLRP3 which is Curcumin.
What would be interesting would be to see if it has a benefit against SC2? One question to find out would be if one is on high dose Turmeric as prophylactic, would you gain any benefit. I'm guessing Toady the gnome would try to misdirect us in finding out since he's already poo poed IVM.
"I just read that they are seizing imported IVM"Delete
Where did you read that?
I got some imported a week ago just fine. And CVS is filling prescriptions locally as well as of last week. The USA mailorder place I used worked fine. We're stocked for a two years now.Delete
Its disgusting that they would rather see people die then to use the treatment protocols. I'll hold a doctor at gunpoint if I have to for treatment.
Anecdotal complaints of folks not getting their Indian IVM due to customs. I should've have looked for a link to support if, but I don't see one. 1 fake news strike for me. dohDelete
By the way, I tried to get some from India too and MC blocked my payment. I have ordered meds via Canada in the past and both Visa and MC won't let you do that anymore. Nice guys eh.
Yes, looks legit. If you read to the bottom of the notice, it says the shipment lacks adequate instructions for use, can be obtained in the US, and THEREFORE is "not permitted for personal importation." IOW, you can get it through Frontline Doctors.Delete
It's possible the size of that shipment--300 tablets--attracted attention. Whoever that was was probably obtaining it for multiple people or for resale.Delete
Same dirty trick they used when approving Boeing 737 MAX.ReplyDelete
"... but this is the same already approved Boeing 737, no need for tests. Just approve it and sell."
Hundreds were killed and the planes are still grounded.
"Hundreds were killed"Delete
In this case they're admitting 12k deaths, and there are credible estimates that it actually runs into the tens of thousands.
Kirk, a small correction. The Max is now flying paying passengers. They changed the computer program that over rode the pilot inputs, made the optional second Angle of Attack indicator mandatory with a warning if there were any differences between the two and changed the training in the Sim to cover the differences between it and the other 737 versions. It is a safe plane to fly now. Still outdated, but safe.ReplyDelete
Greenwald today, on "The Bizarre Refusal to Apply Cost-Benefit Analysis to COVID Debates:ReplyDelete
Are those who oppose a ban on cars, or a radical reduction in speed limits sociopaths, given the huge number of people they are knowingly consigning to death or maiming?...
... what is unacceptable — *sociopathic*, really — is the insistence on assigning severe costs to just one side of the ledger (harms from COVID itself), while categorically *refusing* to recognize, let alone value, the costs on the other side of the ledger (from severe, enduring anti-COVID disruptions...).
Given the *reflexive* rage, that is produced when one tries to make this argument — what immediately emerges are *accusations* that one is indifferent to COVID deaths — I wanted to walk through the evidence and rationale, demonstrating why this approach is reckless, *immoral* and irrational...."
His substack page then has a 30-minute video he produced for Rumble.
I'm really confused about the apparent subterfuge in the new FDA authorization/license. They make clear that the vaccine with the "new" name (Comirnaty) is covered by the license, but they don't have enough supply, so they will continue using the "old" vaccine, which still falls under the Emergency Use Authorization. They claim that both vaccines have pretty much the same ingredients, so why the distinction for the purposes of FDA approval? But moreover, it appears that the use of the name Comirnaty has been in use pretty much from the beginning, and is the name they use in the European market. Obviously, FDA approval only covers use in the U.S., but how can they say they have insufficient supplies of the "approved" vaccine if they have been selling it under that name in a large market for months. Here's the description from Wikipedia:ReplyDelete
BNT162b2 was the code name during development and testing, tozinameran is the recommended international nonproprietary name (INN), and Comirnaty is the brand name. According to BioNTech, the name Comirnaty "represents a combination of the terms COVID‑19, mRNA, community, and immunity".
The vaccine also may be distributed in packaging with the name "Pfizer–BioNTech COVID‑19 Vaccine" in the United States.
OK, so I got through the letter from FDA to Pfizer linked in Berenson's tweet#3 (fda.gov/media/150386/download), and it sure does seem precisely as advertised in Mark's post above.ReplyDelete
A few quick notes:
1) The shot that received approval is made by BioNTech, (or at least that's who filed for the approval license) and has the trade name COMIRNATY. The shot not approved is what they call “the Pfizer-BioNTech COVID-19 vaccine” and which the public has always just called “the Pfizer vaccine.” It is crystal clear these are not the same drug. They also refer to the unapproved Pfizer shot as the “authorized” vaccine, by which they really mean “not approved but emergency-authorized.” Pretty slippery lingo, but oh well.
2) There is no meaningful supply of Comirnaty nor any mention of any plans to ever produce any.
3) But there’s plenty of Pfizer, the unapproved shot, and they assure us the unapproved shot is just as wonderful and fabulous as the approved one. So everyone involved should treat the unapproved one just as if it were the approved one (and don't worry your pretty little heads about the liability differences between the two).
4) Comirnaty is approved only for 16 years of age and up and lacks the liability waiver for that age cohort. Still, it is being given emergency use authorization for ages 12-15 and of course enjoys the full liability waiver for use in that cohort. (Can you imagine if they ever got around to producing some Comirnaty but then only used it for its unapproved use in 12-15-year-olds?)
5) There’s a mention of updated language regarding expiration dates of the Pfizer shot (pushing the expiration dates farther out?) and of its connection to myocarditis and pericarditis, but no link to any details. What a surprise.
6) Keep all this in mind each time you read or hear that "the Pfizer shot is FDA approved." Just like you've seen on this site and elsewhere, it isn't, and all who say it is are lying, ignorant or, more likely, both.
Anyway, here’s what I saw at first glance as some of the most relevant parts:
Dear Ms. Harkins:
On August 23, 2021, FDA approved the biologics license application (BLA) submitted by BioNTech Manufacturing GmbH for COMIRNATY (COVID-19 Vaccine, mRNA) for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 16 years of age and older.
…FDA is reissuing the August 12, 2021 letter of authorization in its entirety with revisions incorporated to clarify that the EUA will remain in place for the Pfizer-BioNTech COVID-19 vaccine for the previously-authorized indication and uses, and to authorize use of COMIRNATY (COVID-19 Vaccine, mRNA) under this EUA for certain uses that are not included in the approved BLA. [i.e., liability-free use for 12-15-year-olds] In addition, the Fact Sheet for Healthcare Providers Administering Vaccine (Vaccination Providers) was revised to provide updates on expiration dating of the authorized Pfizer-BioNTech COVID-19 Vaccine and to update language regarding warnings and precautions related to myocarditis and pericarditis. The…Vaccine Information Fact Sheet for Recipients and Caregivers…comprises the Fact Sheet for the authorized Pfizer-BioNTech COVID-19 Vaccine and information about the FDA-licensed vaccine, COMIRNATY (COVID-19 Vaccine, mRNA).
Additionally, as specified in subsection III.BB, I am authorizing use of COMIRNATY (COVID-19 Vaccine, mRNA) under this EUA when used to provide a two-dose regimen for individuals aged 12 through 15 years…
Y. All descriptive printed matter, advertising, and promotional material relating to the use of the Pfizer-BioNTech COVID‑19 Vaccine clearly and conspicuously shall state that:
• 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...
2 questions that I keep wondering about.Delete
1. Why doesn't this cancel the EUA for Pfizer, Moderna, and others per the EUA that it only stands if there are no other treatments available?
2. How would this affect our military that Secdef is trying to kneecap with untested and potential issues highlighted by folks like Dr. Malone?
Mikeyinfl: Comirnaty isn't actually available, that's why. There's no physical product in hand or even soon to be so. Even if it begins to come available (which it won't unless it can somehow avoid the liability), the operating assumption is that there's no time to wait, so the unapproved shots will retain their EUAs unless an approved one is immediately available for everyone.Delete
Which ain't gonna happen.
Probably worth repeating the last part of the snippets I pasted in the above comment, so here goes:ReplyDelete
"All descriptive printed matter, advertising, and promotional material relating to the use of the Pfizer-BioNTech COVID‑19 Vaccine clearly and conspicuously shall state that:
• This product has not been approved or licensed by FDA."
So on the exact day all the world announces the Pfizer-BioNTech shot has received FDA approval, the FDA releases a letter saying that exact shot must "clearly and conspicuously state" it has not been approved.
Yep. Sounds about right.