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U.S.—After an intense period of testing on 200 million guinea pigs throughout the U.S. and some very fancy lobster dinners with Pfizer executives, the Food and Drug Administration finally approved the Pfizer vaccine, and then knocked on some nearby wood just in case.
"I dunno, I guess we can just approve it now," said FDA researchers... Besides, can you imagine what would happen if we suddenly told millions of people who have already taken it that it was unsafe? Yikes! I guess we can just approve this puppy!"
"Hopefully nothing terrible will happen! Knock on wood! Haha!"
The FDA then got out the very official ceremonial rubber stamp that they only use on very special occasions, dipped it in official red ink, and then stamped the little paper that said "Pfizer COVID-19 Vaccine" on the top of it to prove to the world that the vaccine was very very safe and there was nothing to worry about.
"With lady luck on our side, everything will be ok!" said the FDA Commissioner as everyone chuckled nervously. ...
The American people report feeling very relieved that the vaccine is approved and expressed the desire to wait until the other two vaccines are approved before they make a decision.
FDA Pfizer authorization (Comirnaty): Key points to consider and discuss.
These points are an aggregate of many minds, including Dr. Robert Malone.
23 Aug 2021
General talking points
• Why mandates if herd immunity isn't possible?
• What happens 8 months after boosters?
• What's the plan for the next variant?
• Why we're messing with vaccine injury liability if the vaccines are safe and effective?
There are now TWO LEGALLY distinct (Pfizer vs. BionTech), but otherwise identical products,
based on two FDA letters, as well as a press release. The analysis of these FDA products
below is preliminary and subject to change.
Letter to Pfizer
https://www.fda.gov/media/150386/download
• DOES NOT GIVE FULL APPROVAL
• Extends EUA to allow supply of current Pfizer under EUA because limited supply of
BioNTech version.
• “The products are legally distinct with certain differences that do not impact safety or
effectiveness. (page 2, Pfizer letter)
o here FDA quietly admits that the licensed Pfizer vaccine and the authorized
Pfizer vaccine are identical with regard to safety/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."
o page 12 AA (Conditions with Respect to Use of Licensed Product). 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 and
will continue to be used.
o 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.
o Along with the license comes liability for the manufacturer. (While all EUA
products were given a liability shield.)
o Unfortunately, our federal governments would prefer us to be without
recourse if we are injured, rather than have Pfizer defend its product in court.
So, the feds want us to THINK the vaccine we are receiving is licensed, which will
make people submit because they think it can now be mandated, but instead we
are almost certain to receive the EUA vials instead, to save Pfizer's behind. Yes, a
stingy CICP injury program exists, but it has not paid out for a single COVID
vaccine injury yet.
• Warning about myocarditis and pericarditis
Letter to BioNTech (COMIRNATY): (signed by Mary Malarkey) – MARKET AUTHORIZES BLA
(APPROVAL)
https://www.fda.gov/media/151710/download
• For “active immunization to prevent coronavirus disease 2019 (COVID-19) caused by
severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 16 years of
age and older.”
• Analysis of […] adverse events reported […] not be sufficient to assess known serious
risks of myocarditis and pericarditis and identify an unexpected serious risk of subclinical
myocarditis.
• 13 Post marketing studies required
o Pediatric (3 studies) < 6m to <15 y
o Myocarditis and pericarditis (6 studies), with UP TO 5 years follow up
o Pregnancy – teratology (1 study)
o Dose levels, VA, effectiveness in Kaiser system (3 studies)
• The FDA bypassed/disregarded the normal advisory committee and public comment
process for this license. See p2 “We did not refer your application to the Vaccines and
Related Biological Products Advisory Committee because our review of information
submitted in your BLA, including the clinical study design and trial results, did not raise
concerns or controversial issues that would have benefited from an advisory
committee discussion.”
@RC2006 does she know that kids are more likely to die in the car ride to school than from Fauci Flu?
You could point out that the vaxx makes them more likely to die, not less.
And you could point out all the myocarditis cases in the young.
Robert W Malone, MD
@RWMaloneMD
11h
What is Pfizer so afraid of if these vaccines are perfectly safe?
Tallystick
@tallystick
11h
Replying to @RWMaloneMD
That is telling to me. Corporations or government have no standing to mandate any medicine that it has not recourse attached to it. I see a bright shiny line coming into view.
Gary Wiggin
@GaryWiggin
11h
Replying to @RWMaloneMD
Why is Pfizer not mandating their employees get vaccinated?
6:11 PM · Aug 24, 2021
Barbara Martin
@BMartin0318
5h
Replying to @GaryWiggin @RWMaloneMD
Is that true... Pfizer not mandating their employees to get their vax?
Gary Wiggin
@GaryWiggin
4h
Yes. Watch the CEO interview with Lester Holt.
Alex Berenson
@AlexBerenson
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."
2/ Or is this another reason @us_fda is going out of its way to say Comirnaty is not available?
"although COMIRNATY (COVID-19 Vaccine, mRNA) is approved... there is not sufficient approved vaccine available for distribution to this population."
3/ Whatever game(s) they are playing here, they're being too clever by half.
SOURCE: Footnote 9
Ah, now I get it:
original link
I'll put this in the OP.
The existing Pfizer jab was not approved by the FDA.
The FDA approved a different Pfizer jab which does not exist yet.
I'm concerned about what is happening at the higher levels and what is trying to be hidden at this point.
The FDA approved a different Pfizer jab which does not exist yet.
https://childrenshealthdefense.org/defender/mainstream-media-fda-approval-pfizer-vaccine/
Interesting article about approved vaccine
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.
Ok, so I have it on authority that the FDA approved the clot shot for everyone 16+. The 12-15 ages are still under the EUA, which is part of what triggered the confusion.
Ok, so I have it on authority that the FDA approved the clot shot for everyone 16+. The 12-15 ages are still under the EUA, which is part of what triggered the confusion.
No one has mentioned MIS-C, which is a more likely outcome than death for COVID-19 in minors. I think that is the main factor you're balancing again myo- and pericarditis in when you're thinking about vaccinating the 12 and up crowd.
But Pfizer has liability for “Comirnaty”, for now,
the Pfizer jab having a 1 in 9 chance of SAE, that's still a 100 fold risk of getting maimed by the jab.
mell saysthe Pfizer jab having a 1 in 9 chance of SAE, that's still a 100 fold risk of getting maimed by the jab.
Still trying to figure out what you're referring to mell. Is it this, or something else? If something else, a link would be helpful.
Severe adverse reactions (grade ≥3, defined as interfering with daily activity) occurred more commonly with the vaccine (10.7%) compared with placebo (1.9%). The most common grade 3 symptoms reported by vaccine recipients were fatigue (3.5%), fever (3.0%), headache (2.7%), chills (2.1%), and injection site pain (1.5%). Generally, grade ≥3 reactions were more commonly reported after the second dose than after the first dose.
Adverse events classified as serious† were reported in more recipients of vaccine than...
No it's here:
The entire government is corrupt. The Law doesn't mean shit. At. All.
So start doing whatever the fuck you want.
There's still that little issue with arbitrary and selective enforcement
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