Official documents reveal enormous gap between what FDA and Pfizer would attest to, compared to what the public was told about the Pfizer COVID vaccine
Official documents reveal enormous gap between what FDA and Pfizer would attest to, compared to what the public was told about the Pfizer COVID vaccine
The label for COMIRNATY is a legal document updated on 12/20/21: 1. CDC made the false claim on its website that anaphylactic reactions occur at rates approximately the same after COVID vaccines as other vaccines. I just looked for the citation and see the claim has recently been removed. Now, CDC
(And now they do it again with Paxlovid and Molnupiravir .. officially saying there's not enough evidence to assess, yet pushing it and telling pharmacies to give it if people test positive. And, guess what turns out to be a horse medicine? "Molnupiravir began as a possible therapy for Venezuelan equine encephalitis virus at Emory University’s non-profit company DRIVE (Drug Innovation Ventures at Emory) in Atlanta. But in 2015, DRIVE’s chief executive George Painter offered it to a collaborator, virologist Mark Denison at Vanderbilt University in Nashville, Tennessee, to test against coronaviruses...." https://www.nature.com/articles/d41586-021-02783-1
The label also neglects to let people know it was not studied for drug interactions (including getting the flu vaccine at the same time). I guess this is standard practice with vaccines, but still, there is "biological plausibility" that it could interact with prescription medication.
Finally, I noticed this: "COMIRNATY has not been evaluated for the potential to cause ... impairment of male fertility."
This one bugs me because the Santa Clara County (California) Public Health department has been weirdly warning men that they should get vaccinated because if they catch Covid their sperm count can be lower and they could have erectile dysfunction. The lack of evaluation of the vaccine's impact allows them to give a biased view to men i.e. "there's no evidence it impacts fertility".
There's more... WATCH the FDA vax and biological products advisory meetings on FDA Youtube channel. 10/22/20, 2:33:40 Slide 17. 9/17/21 booster video where they voted 16-2 AGAINST approving. The 5-11yo where the whole 8 hours they presented great reasons to not approve, but did anyway. Safety for those poor kids was based on TWO weeks of data after the second dose.
Geriatric for Moderna booster-- 38 folks 65+ studied. Safety based on ZERO. Effectiveness ZERO.
Geriatric Pfizer booster--65 years old & older had 4,294 participants, (n=4,294).
'The safety of a booster dose of Pfizer... in individuals 65 years of age and older is based on safety data in 12 booster dose recipients..." TWELVE! (But better than none for Moderna)
Gets better---also, like Moderna, showed NO effectiveness for 65 years old +.
"The effectiveness of a booster dose of Pfizer...65 years of age and older is based on effectiveness data in 306 booster dose recipients 18 through 55 years."
Like the 5-11 year old study, they used other ages to determine safety. Print out those Fact Sheets. Take a different color highlighter for each age. Look at study numbers AND placebo numbers. Then go throw up.
Especially knowing the way the trials were set up nobody could report Level 3 or 4 adverse events. Folks were given an app with only benign things to "click" if they had, like fever, rash, fatigue. No "Other" space to fill in: blood clots, myocarditis, endless menstrual cycle, neurological issues causing uncontrollable shaking.
CRIMINAL! Media are the worst. And the NIH and CDC.
I think they need the 0-17 to add to the childhood schedule. With trials not going well in 2-4 group I think they'll need to rethink the whole covid shots for kids. But of course they'll push as hard as they can (CDC ACIP included).
Is Comirnaty actually being used yet or still the EUA version? I still can't get to the bottom of why this is still the case (In the UK anyway), although I've read the rumours. Any ideas?
I would really like numbers on how many have actually received "Comrinaty". Because all the documentation and legal frameworks are based on "Comrinaty". All around the world.
Yet every bit of info from Pfizer advises that "it will distribute Comrinaty, AFTER existing EUA stores are used for each country that have purchased/licenced Comrinaty."
However, my understanding is that if Comrinaty is given, then as a licenced product Pfizer is liable, under licencing laws for any injuries. Unless its on the childhood scheme- hence the push for 5-11yrs.
Yet, no compensation has been given as such, because the shots are under EUA, and therefore Pfizer and co arnt liable unless it's proven that they knowingly falsified data on the original clinical trials....
So I guess my point is, there still seems to be confusion as to the actual shots available. Has anyone, anywhere in the world compared the vials of what's actually being given, to a vial of Comrinaty? As in seen 2 different vials with, the two different formulations?
Because what I am seeing is pharmaceutical legalese double speak going on. Shots that are EUA are being given out to people who think that they are receiving the licenced Comrinaty, complete with modified formulation and storage requirements. Yet ADE/ADRs are occurring and no compensation is been given, as per EUAs. And still government's and bureaucrats are advertising, actively marketing and mandating as though these shots are licenced. Has Pfizer even bothered to produce any of the "Comrinaty" formulation?
Am I just being simple? Did I mis something in all the stress of the pandemic?
The FDA meeting held on Dec. 10th, 2020: the document appear to actually state that preventing transmission was the basis of Pfizer qualifying for EAU. ANd the same document suggests that Pfizer provided NO DATA on preventing transmission/reaching herd immunity(not just limited data):
p. 342:
"DR. PATRICK MOORE: Hi, yes. One question
that addresses these two discussion items, I find is
really, really central, and important, is that FDA did
not ask in its guidance and Pfizer has presented NO EVIDENCE in its data today that the vaccine has any
effect on VIRUS CARRIAGE OR SHEDDING which is the
fundamental basis for herd immunity. And so even
though the individual efficacy of this vaccine is very,
very, very high, we really, as of right now, do not
have any evidence that it will have an impact, socialwide, on the epidemic."
P. 44
DR. DORAN FINK: Right. I think what you’re
getting at is the fourth criterion for issuance of an
EUA, which says that there must not be any adequate
approved and available alternative therapy.
5 DR. JEANNETTE LEE: Yes. Correct.
P 29. There are special considerations for a COVID19 vaccine anticipated for widespread deployment to millions of individuals, and these will be discussed on
my next slides. The final criterion is that there
should be no adequate approved and available alternative to the product for diagnosing, preventing or treating the disease or condition. (bye bye Ivermectin)
p. 30
At this time, the only FDA approved product
for COVID-19 is remdesivir. This is an anti-viral
agent that is approved for treatment of COVID-19, not
prevention. Additional products have been issued under
emergency use authorization but have not been FDA
approved. And none of these products is authorized for
use to PREVENT COVID-19. Thus, at this time, there is
no adequate approved and available alternative to a
COVID-19 vaccine for PREVENTING COVID-19 caused by
Nevermind. Now I see the whole thread talking about the bait and switch. I figured it Comirnaty had been given to people, we'd be seeing a ton of lawsuits pop up
I didn't think Comirnaty was commercially available in the US. I thought the fact sheet gave administers the authority to switch the Comirnaty vaccine with the unapproved EUA Pfizer-BioNTech COVID-19 Vaccine.
They probably needed 5 to 11 yr old approval to get on the childhood schedule. Shockingly, they have not rubber stamped that yet. The results must be appallingly bad. Its only a matter of time before they settle on some rationale for approval though. After all, a lot of money is at stake.
(And now they do it again with Paxlovid and Molnupiravir .. officially saying there's not enough evidence to assess, yet pushing it and telling pharmacies to give it if people test positive. And, guess what turns out to be a horse medicine? "Molnupiravir began as a possible therapy for Venezuelan equine encephalitis virus at Emory University’s non-profit company DRIVE (Drug Innovation Ventures at Emory) in Atlanta. But in 2015, DRIVE’s chief executive George Painter offered it to a collaborator, virologist Mark Denison at Vanderbilt University in Nashville, Tennessee, to test against coronaviruses...." https://www.nature.com/articles/d41586-021-02783-1
Wow, thanks for all this information!! I just found your Substack through Ed Dowd's twitter feed- subbed.
I wrote this about the confusion surrounding the EUA/Approval for Pfizer BioNTech Covid-19 vacccine/ Comirnaty. Would love to hear your thoughts.
https://etana.substack.com/p/bait-and-switch?s=w
Another contrast: we hear "safe and effective" all the time, including for kids 12-15 and 5-11, but in the label we get this--
8.4 Pediatric Use
. . . .
"The safety and effectiveness of COMIRNATY in individuals younger than 16 years of age have not been established."
The label says this: "It is not known whether COMIRNATY is excreted in human milk."
This is a pre-print so I guess doesn't count, but they found the vaccine in breast milk: https://www.medrxiv.org/content/10.1101/2021.04.27.21256151v1
The label also neglects to let people know it was not studied for drug interactions (including getting the flu vaccine at the same time). I guess this is standard practice with vaccines, but still, there is "biological plausibility" that it could interact with prescription medication.
Finally, I noticed this: "COMIRNATY has not been evaluated for the potential to cause ... impairment of male fertility."
This one bugs me because the Santa Clara County (California) Public Health department has been weirdly warning men that they should get vaccinated because if they catch Covid their sperm count can be lower and they could have erectile dysfunction. The lack of evaluation of the vaccine's impact allows them to give a biased view to men i.e. "there's no evidence it impacts fertility".
https://twitter.com/HealthySCC/status/1489705542075523075
https://twitter.com/HealthySCC/status/1499852399384883200
There's more... WATCH the FDA vax and biological products advisory meetings on FDA Youtube channel. 10/22/20, 2:33:40 Slide 17. 9/17/21 booster video where they voted 16-2 AGAINST approving. The 5-11yo where the whole 8 hours they presented great reasons to not approve, but did anyway. Safety for those poor kids was based on TWO weeks of data after the second dose.
Geriatric for Moderna booster-- 38 folks 65+ studied. Safety based on ZERO. Effectiveness ZERO.
Geriatric Pfizer booster--65 years old & older had 4,294 participants, (n=4,294).
'The safety of a booster dose of Pfizer... in individuals 65 years of age and older is based on safety data in 12 booster dose recipients..." TWELVE! (But better than none for Moderna)
Gets better---also, like Moderna, showed NO effectiveness for 65 years old +.
"The effectiveness of a booster dose of Pfizer...65 years of age and older is based on effectiveness data in 306 booster dose recipients 18 through 55 years."
Like the 5-11 year old study, they used other ages to determine safety. Print out those Fact Sheets. Take a different color highlighter for each age. Look at study numbers AND placebo numbers. Then go throw up.
Especially knowing the way the trials were set up nobody could report Level 3 or 4 adverse events. Folks were given an app with only benign things to "click" if they had, like fever, rash, fatigue. No "Other" space to fill in: blood clots, myocarditis, endless menstrual cycle, neurological issues causing uncontrollable shaking.
CRIMINAL! Media are the worst. And the NIH and CDC.
In other words (Pfizer) We don't know very much, so we'll just assume everything is OK. And this is called "trust the science?"
It's just incredible. Pure fraud.
I think they need the 0-17 to add to the childhood schedule. With trials not going well in 2-4 group I think they'll need to rethink the whole covid shots for kids. But of course they'll push as hard as they can (CDC ACIP included).
Is Comirnaty actually being used yet or still the EUA version? I still can't get to the bottom of why this is still the case (In the UK anyway), although I've read the rumours. Any ideas?
I would really like numbers on how many have actually received "Comrinaty". Because all the documentation and legal frameworks are based on "Comrinaty". All around the world.
Yet every bit of info from Pfizer advises that "it will distribute Comrinaty, AFTER existing EUA stores are used for each country that have purchased/licenced Comrinaty."
However, my understanding is that if Comrinaty is given, then as a licenced product Pfizer is liable, under licencing laws for any injuries. Unless its on the childhood scheme- hence the push for 5-11yrs.
Yet, no compensation has been given as such, because the shots are under EUA, and therefore Pfizer and co arnt liable unless it's proven that they knowingly falsified data on the original clinical trials....
So I guess my point is, there still seems to be confusion as to the actual shots available. Has anyone, anywhere in the world compared the vials of what's actually being given, to a vial of Comrinaty? As in seen 2 different vials with, the two different formulations?
Because what I am seeing is pharmaceutical legalese double speak going on. Shots that are EUA are being given out to people who think that they are receiving the licenced Comrinaty, complete with modified formulation and storage requirements. Yet ADE/ADRs are occurring and no compensation is been given, as per EUAs. And still government's and bureaucrats are advertising, actively marketing and mandating as though these shots are licenced. Has Pfizer even bothered to produce any of the "Comrinaty" formulation?
Am I just being simple? Did I mis something in all the stress of the pandemic?
Remember, there is no law forcing people to listen to the corrupt CDC and FDA. They need to "shop around".
Thanks for this Meryl,
Regarding transmission and herd immunity:
The FDA meeting held on Dec. 10th, 2020: the document appear to actually state that preventing transmission was the basis of Pfizer qualifying for EAU. ANd the same document suggests that Pfizer provided NO DATA on preventing transmission/reaching herd immunity(not just limited data):
p. 342:
"DR. PATRICK MOORE: Hi, yes. One question
that addresses these two discussion items, I find is
really, really central, and important, is that FDA did
not ask in its guidance and Pfizer has presented NO EVIDENCE in its data today that the vaccine has any
effect on VIRUS CARRIAGE OR SHEDDING which is the
fundamental basis for herd immunity. And so even
though the individual efficacy of this vaccine is very,
very, very high, we really, as of right now, do not
have any evidence that it will have an impact, socialwide, on the epidemic."
P. 44
DR. DORAN FINK: Right. I think what you’re
getting at is the fourth criterion for issuance of an
EUA, which says that there must not be any adequate
approved and available alternative therapy.
5 DR. JEANNETTE LEE: Yes. Correct.
P 29. There are special considerations for a COVID19 vaccine anticipated for widespread deployment to millions of individuals, and these will be discussed on
my next slides. The final criterion is that there
should be no adequate approved and available alternative to the product for diagnosing, preventing or treating the disease or condition. (bye bye Ivermectin)
p. 30
At this time, the only FDA approved product
for COVID-19 is remdesivir. This is an anti-viral
agent that is approved for treatment of COVID-19, not
prevention. Additional products have been issued under
emergency use authorization but have not been FDA
approved. And none of these products is authorized for
use to PREVENT COVID-19. Thus, at this time, there is
no adequate approved and available alternative to a
COVID-19 vaccine for PREVENTING COVID-19 caused by
SARS-coronavirus-2.
Nevermind. Now I see the whole thread talking about the bait and switch. I figured it Comirnaty had been given to people, we'd be seeing a ton of lawsuits pop up
I didn't think Comirnaty was commercially available in the US. I thought the fact sheet gave administers the authority to switch the Comirnaty vaccine with the unapproved EUA Pfizer-BioNTech COVID-19 Vaccine.
You are providing an invaluable service with your articles, thank you!
They probably needed 5 to 11 yr old approval to get on the childhood schedule. Shockingly, they have not rubber stamped that yet. The results must be appallingly bad. Its only a matter of time before they settle on some rationale for approval though. After all, a lot of money is at stake.