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
Remdesivir is under EUA as a covid treatment with NIH guidelines. WHO said in 10/2020 don't use it. It had miserable drug trials for hepatitis and ebola. (From all the experiment on the Third World normal Big Pharma system. This is our payback for never telling Pharma to leave the poor alone) Kills your kidneys. Needs serious monitoring of both kidneys and liver, yet now, they are prescribing as outpatient early treatment. "Covid killed 'Aunt Mary' and gave them kidney failure and organ failure".... Likely remdesivir did. Sadly clinicaltrial.gov shows enrolling even newborns. I guess if you deliver and the baby tests positive, they try and "save it" and enroll it in the drug trial. So criminal.
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".
GMO Epicyte Corn from 2008 or so was designed to reduce fertility. You can find articles with Bill Gates and others talking about that. Please tell any tortilla chip lovers. And sad that the Bernie type kids cheered on Gates. His GMO obsession is "progressive." Not a permaculture slow food future. But the collectivization of farmland, like the Russians did in their bolshevik revolution with the small farmers called kulaks. Gates is the largest US farmland person, isn't he?
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?
Don't know about the UK but in the US it seems pretty clear the intent was a bait and switch. You can't compel someone to take an experimental vaccine, the EUA legislation is quite clear on this. So the FDA approved Comirnaty as a legally-separate entity to get around this. It allowed them to put out press releases saying it was "approved" (i.e. no longer experimental) and gave government and businesses legal cover for mandates.
However, Comirnaty was not immediately distributed as Pfizer was allowed to use existing stocks of the EUA vaccine. It's now six months later and it still has not been distributed. Obviously the EUA stocks should be long gone. It seems pretty clear the plan was to always continue to use the EUA version to maintain liability immunity for Pfizer. It's a Catch-22: It can be mandated as Comirnaty, but you cannot sue if you actually got the EUA version.
I don't think they thought this was going to go on this long as they planned to ram it onto the CDC Childhood vax schedule. Once that happens, Pfizer gets liability immunity under the National Childhood Vaccine Injury Act of 1986 and no longer needs EUA immunity. Then they could distribute Comirnaty. However, huge numbers of parents balked at this, some at the CDC weren't willing to just rubber stamp it, lots of adverse reactions started to show up, and to top it off Omicron demonstrated how worthless the vaccine actually is.
So now they are stuck still making the EUA version without any good reason. They can't do this forever and only way out of this predicament is to get it on the CDC childhood schedule. Expect another huge push for this at the next wave.
boil down to money, had to many vials of EUA left, so rather than lose a lotof money, continued on til gone or given to other countries. I don't think Comirnalty is being used yet, but I really do not know. Crimes against humanity every level.
if you look here, they state pretty clearly that Pfizer has no intention of using cominarty, or Moderna spikevax, in the US (*until added to the childhood poison injection schedule giving them liability protection for the non-EUA product under the 1986 act)
The following vaccines and associated tradenames have been approved by the FDA under BLA License. They are listed separately because while they may represent the same formulations as the EUA authorized and labeled products listed above, the NDCs listed with the new BLA licensed tradenames in the FDA BLA approval or the FDA Structured Product Labels (SPL) are not currently being produced by the manufacturers while EUA product is available.
....
both cominarty and spikevax (the non-EUA mRNA pokies from Pfizer and Moderna respectively) in that table say they will not be produced for use in the US for an unspecified number of months.
the cominarty disclaimer (spikevax is basically the same.)
The following vaccines and associated tradenames have been approved by the FDA under BLA License. They are listed separately because while they may represent the same formulations as the EUA authorized and labeled products listed above, the NDCs listed with the new BLA licensed tradenames in the FDA BLA approval or the FDA Structured Product Labels (SPL) are not currently being produced by the manufacturers while EUA product is available.
Manufacturer FDA Authorization
(BLA, EUA, Pre-EUA) Sale Proprietary Name Product Description Unit of Sale NDC10 (UOS) UoS Package Unit of Use NDC10 (UOU) UoU Presentation
Pfizer-BioNTech BLA-licensed for ages 16+ COMIRNATY 30 mcg/0.3 mL for adult 16+ (original formula) 0069-1000-02 CARTON, 195 MULTI-DOSE VIALS 0069-1000-01 VIAL, 2 mL, MULTI-DOSE VIAL COMINARTY products are not orderable at this time. NDCs are listed per FDA Structured Product Label (SPL) document for the BLA licensed product. These codes are not included in CDC Vaccine Code Set files at this time. Pfizer has provided the following statement regarding the COMINARTY branded NDCs and labels:
“Pfizer received FDA BLA license on 8/23/2021 for its COVID-19 vaccine for use in individuals 16 and older (COMIRNATY). At that time, the FDA published a BLA package insert that included the approved new COVID-19 vaccine tradename COMIRNATY and listed 2 new NDCs (0069-1000-03, 0069-1000-02) and images of labels with the new tradename.
Pfizer subsequently received approval to amend its FDA BLA License on December 16, 2021 to include its tris-sucrose formulation COVID-19 vaccine for use in individuals 16 and older (COMIRNATY). At that time, the FDA published a BLA package insert that included the approved new COVID-19 vaccine tradename COMIRNATY and listed 3 new NDCs (0069-2025-10, 0069-2025-25, 0069-2025-01) and images of labels with the new tradename.
At present, Pfizer does not plan to produce any product with these new NDCs and labels over the next few months while EUA authorized product is still available and being made available for U.S. distribution. As such, the CDC, AMA, and drug compendia may not publish these new codes until Pfizer has determined when the product will be produced with the BLA labels.”
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?
While everyone we speak to has been offered only the EUA vaccine, Pfizer did get codes needed for brand-name Comirnaty sales and distribution in the US on Feb 14, for a few lots. Whether they are being used is unknown.
Jordan Schachtel looked into this in detail about a month ago and could not find any evidence that Comirnaty has actually been distributed (at least in the US). It's all been the EUA version, not Comirnaty.
My comment replying to Naked Emperor below explains the shell game going on. Key point is that Comirnaty and the EUA version are legally distinct products.
Exactly, that's why they never distributed Comirnaty. The plan was to quickly get it added to the CDC childhood schedule. Once that happened they would have liability immunity under the Nat'l Childhood Vax Injury Act of 1986 and no longer need EUA immunity. Then they would distribute Comirnaty and also lobby for it to be mandated (an EUA vax cannot be legally mandated).
That's the reason for the insane push to to vaccinate all children, they were attempting to build momentum to get it rubberstamped and added to the CDC schedule. Thank God so many parents resisted as it muddled up their plans.
Unfortunately my wife and I learned this lesson the hard way over a decade ago when out son had a serious AE after MMR, DTaP, polio, and flu all in one "well toddler" visit to the pediatrician. We trusted them out of naivete, they harmed our son, then denied it. Never again.
You are correct, there is no law, but people are lawlessly losing their jobs if they refuse to accept an experimental product, which according to the law should not happen. What do you do when the government breaks the law?
Mar 14, 2022·edited Mar 14, 2022Liked by Meryl Nass
The reason people were forced to take the poisons is because there was - and still is - no critical mass of opposition. If half the people in critical sectors said "no", they could not have proceeded.
There was no law nor necessity for people to pack stadiums or watched sports which enforced the v-mandate. Or go to concerts, etc.
See? It was us individually and collectively who allowed that to happen.
Bingo! Now WHO plans to put the world's population under their medical control. Total tyranny! None of the international giant organizations can be trusted--at all! (e.g WEF WHO, UN, World Bank, IMF . . .)
"What do you do when the government breaks the law?" Put secession (without raising an army) on the table for consideration, The colonies seceded from England in 1776. Maine seceded from Massachusetts, West Virginia from Virginia, Crimea from Ukraine, South Sudan from Sudan, Pakistan from India, and so on.
If you are disabled from the poisonous injections, you won't be able to work at the job anyway. So, the obvious choice to make is putting your health first, over your job. You can always get another job. You can't get another body (as far as I know...)
Suing the government might be difficult. But suing an employer who forces you take a drug you don't want... seems like a cakewalk to me. We'll see. I have a feeling...
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
It was admitted by Dr. Jansen of Pfizer at that meeting that in primates the vaccine had failed to prevent transmission, and it had not been studied in humans. I would love for you to point out where someone said a criterion for authorization was successful prevention of transmission, as I do not recall hearing that. Did I miss it?
Boy...and Fauci just 4 days later said we could probably reach herd immunity by the following spring/summer.
I apologize-I misinterpreted the language from the meeting when I said transmission prevention was a criteria for authorization. My bad!
Just fyi...I grew up in North Yarmouth/Cumberland ME and still have extended family there. I sent them the story regarding your license...trying to get them to see what is happening with medicine. Not sure it got through...most of them appear to be in a trance. It was interesting to me that it appeared they suspended your license the day you testified to the state of ME regarding the vaccines(if I pieced that together correctly?). What has happened to you(and I know you're not alone) is absolutely frightening. I'm sorry you have had to go through this. I'm curious how you're doing, the status of your license and lastly...please tell me you managed to fight the psy. evaluation they were demanding! I still cannot believe this is actually happening in this country.
Thanks for all you do Meryl. If I still lived in Maine-I'd want you as my primary! You're a rare breed.
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.
This is all completely gobsmacking! I've only just discovered Meryl's brilliant substack. Here in Australia our TGA (Therapeutic Goods Admin - our version of CDC I guess) have been advertising the Comirnaty for months as being provided via Pfizer but I am unsure of the legal situation viz a vis the US legal wranglings though we are a mere client state of the US and seemingly incapable of saying no to any 'initiative' US powers throw our way - we are just building a Moderna mRNA plant in Melbourne to ensure we have the 'very best' of genetic engineering in our bodies from now on! Good on your Meryl and your learned correspondents. I will raise these legal matters with our CHD group here. Froggie
(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
Haha! What a good find!... horse medicine. It's a good thing you knew what 'equine' means... I didn't. Somebody has to tell Joe Rogan this.
Yep - heard Ryan Cole say the horse medicine connection and looked it up.
Remdesivir is under EUA as a covid treatment with NIH guidelines. WHO said in 10/2020 don't use it. It had miserable drug trials for hepatitis and ebola. (From all the experiment on the Third World normal Big Pharma system. This is our payback for never telling Pharma to leave the poor alone) Kills your kidneys. Needs serious monitoring of both kidneys and liver, yet now, they are prescribing as outpatient early treatment. "Covid killed 'Aunt Mary' and gave them kidney failure and organ failure".... Likely remdesivir did. Sadly clinicaltrial.gov shows enrolling even newborns. I guess if you deliver and the baby tests positive, they try and "save it" and enroll it in the drug trial. So criminal.
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
GMO Epicyte Corn from 2008 or so was designed to reduce fertility. You can find articles with Bill Gates and others talking about that. Please tell any tortilla chip lovers. And sad that the Bernie type kids cheered on Gates. His GMO obsession is "progressive." Not a permaculture slow food future. But the collectivization of farmland, like the Russians did in their bolshevik revolution with the small farmers called kulaks. Gates is the largest US farmland person, isn't he?
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?"
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).
Apparently if they add to the schedule, rumor is it removes liability for Big Pharma. Why they are pushing it.
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?
Don't know about the UK but in the US it seems pretty clear the intent was a bait and switch. You can't compel someone to take an experimental vaccine, the EUA legislation is quite clear on this. So the FDA approved Comirnaty as a legally-separate entity to get around this. It allowed them to put out press releases saying it was "approved" (i.e. no longer experimental) and gave government and businesses legal cover for mandates.
However, Comirnaty was not immediately distributed as Pfizer was allowed to use existing stocks of the EUA vaccine. It's now six months later and it still has not been distributed. Obviously the EUA stocks should be long gone. It seems pretty clear the plan was to always continue to use the EUA version to maintain liability immunity for Pfizer. It's a Catch-22: It can be mandated as Comirnaty, but you cannot sue if you actually got the EUA version.
I don't think they thought this was going to go on this long as they planned to ram it onto the CDC Childhood vax schedule. Once that happens, Pfizer gets liability immunity under the National Childhood Vaccine Injury Act of 1986 and no longer needs EUA immunity. Then they could distribute Comirnaty. However, huge numbers of parents balked at this, some at the CDC weren't willing to just rubber stamp it, lots of adverse reactions started to show up, and to top it off Omicron demonstrated how worthless the vaccine actually is.
So now they are stuck still making the EUA version without any good reason. They can't do this forever and only way out of this predicament is to get it on the CDC childhood schedule. Expect another huge push for this at the next wave.
Interesting thanks!
Here in the US some batches of Comirnaty were given codes required for sales on Feb 14, but no one has told me thaey have seen a bottle of it yet.
boil down to money, had to many vials of EUA left, so rather than lose a lotof money, continued on til gone or given to other countries. I don't think Comirnalty is being used yet, but I really do not know. Crimes against humanity every level.
if you look here, they state pretty clearly that Pfizer has no intention of using cominarty, or Moderna spikevax, in the US (*until added to the childhood poison injection schedule giving them liability protection for the non-EUA product under the 1986 act)
https://www.cdc.gov/vaccines/programs/iis/COVID-19-related-codes.html
the table below this text:
The following vaccines and associated tradenames have been approved by the FDA under BLA License. They are listed separately because while they may represent the same formulations as the EUA authorized and labeled products listed above, the NDCs listed with the new BLA licensed tradenames in the FDA BLA approval or the FDA Structured Product Labels (SPL) are not currently being produced by the manufacturers while EUA product is available.
....
both cominarty and spikevax (the non-EUA mRNA pokies from Pfizer and Moderna respectively) in that table say they will not be produced for use in the US for an unspecified number of months.
the cominarty disclaimer (spikevax is basically the same.)
The following vaccines and associated tradenames have been approved by the FDA under BLA License. They are listed separately because while they may represent the same formulations as the EUA authorized and labeled products listed above, the NDCs listed with the new BLA licensed tradenames in the FDA BLA approval or the FDA Structured Product Labels (SPL) are not currently being produced by the manufacturers while EUA product is available.
Manufacturer FDA Authorization
(BLA, EUA, Pre-EUA) Sale Proprietary Name Product Description Unit of Sale NDC10 (UOS) UoS Package Unit of Use NDC10 (UOU) UoU Presentation
Pfizer-BioNTech BLA-licensed for ages 16+ COMIRNATY 30 mcg/0.3 mL for adult 16+ (original formula) 0069-1000-02 CARTON, 195 MULTI-DOSE VIALS 0069-1000-01 VIAL, 2 mL, MULTI-DOSE VIAL COMINARTY products are not orderable at this time. NDCs are listed per FDA Structured Product Label (SPL) document for the BLA licensed product. These codes are not included in CDC Vaccine Code Set files at this time. Pfizer has provided the following statement regarding the COMINARTY branded NDCs and labels:
“Pfizer received FDA BLA license on 8/23/2021 for its COVID-19 vaccine for use in individuals 16 and older (COMIRNATY). At that time, the FDA published a BLA package insert that included the approved new COVID-19 vaccine tradename COMIRNATY and listed 2 new NDCs (0069-1000-03, 0069-1000-02) and images of labels with the new tradename.
Pfizer subsequently received approval to amend its FDA BLA License on December 16, 2021 to include its tris-sucrose formulation COVID-19 vaccine for use in individuals 16 and older (COMIRNATY). At that time, the FDA published a BLA package insert that included the approved new COVID-19 vaccine tradename COMIRNATY and listed 3 new NDCs (0069-2025-10, 0069-2025-25, 0069-2025-01) and images of labels with the new tradename.
At present, Pfizer does not plan to produce any product with these new NDCs and labels over the next few months while EUA authorized product is still available and being made available for U.S. distribution. As such, the CDC, AMA, and drug compendia may not publish these new codes until Pfizer has determined when the product will be produced with the BLA labels.”
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?
While everyone we speak to has been offered only the EUA vaccine, Pfizer did get codes needed for brand-name Comirnaty sales and distribution in the US on Feb 14, for a few lots. Whether they are being used is unknown.
Jordan Schachtel looked into this in detail about a month ago and could not find any evidence that Comirnaty has actually been distributed (at least in the US). It's all been the EUA version, not Comirnaty.
My comment replying to Naked Emperor below explains the shell game going on. Key point is that Comirnaty and the EUA version are legally distinct products.
Why would Pfizer distribute a vax for which they have liability when they have none for the EUA? They would have to be insane. https://childrenshealthdefense.org/defender/mainstream-media-fda-approval-pfizer-vaccine/
Exactly, that's why they never distributed Comirnaty. The plan was to quickly get it added to the CDC childhood schedule. Once that happened they would have liability immunity under the Nat'l Childhood Vax Injury Act of 1986 and no longer need EUA immunity. Then they would distribute Comirnaty and also lobby for it to be mandated (an EUA vax cannot be legally mandated).
That's the reason for the insane push to to vaccinate all children, they were attempting to build momentum to get it rubberstamped and added to the CDC schedule. Thank God so many parents resisted as it muddled up their plans.
Unfortunately my wife and I learned this lesson the hard way over a decade ago when out son had a serious AE after MMR, DTaP, polio, and flu all in one "well toddler" visit to the pediatrician. We trusted them out of naivete, they harmed our son, then denied it. Never again.
Remember, there is no law forcing people to listen to the corrupt CDC and FDA. They need to "shop around".
You are correct, there is no law, but people are lawlessly losing their jobs if they refuse to accept an experimental product, which according to the law should not happen. What do you do when the government breaks the law?
The reason people were forced to take the poisons is because there was - and still is - no critical mass of opposition. If half the people in critical sectors said "no", they could not have proceeded.
There was no law nor necessity for people to pack stadiums or watched sports which enforced the v-mandate. Or go to concerts, etc.
See? It was us individually and collectively who allowed that to happen.
Yes.
I've asked this question of a variety of people, authorities and others - and none could answer me:
Why would govts need to force people, directly and via proxy, to do or take something if they can prove it is safe, effective, and necessary???
I've come to the view that most governments are actually our enemies! And democracy is a con.
Bingo! Now WHO plans to put the world's population under their medical control. Total tyranny! None of the international giant organizations can be trusted--at all! (e.g WEF WHO, UN, World Bank, IMF . . .)
"What do you do when the government breaks the law?" Put secession (without raising an army) on the table for consideration, The colonies seceded from England in 1776. Maine seceded from Massachusetts, West Virginia from Virginia, Crimea from Ukraine, South Sudan from Sudan, Pakistan from India, and so on.
At least Mexico is planning to secede from USA any time soon, though.
If you are disabled from the poisonous injections, you won't be able to work at the job anyway. So, the obvious choice to make is putting your health first, over your job. You can always get another job. You can't get another body (as far as I know...)
Suing the government might be difficult. But suing an employer who forces you take a drug you don't want... seems like a cakewalk to me. We'll see. I have a feeling...
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.
It was admitted by Dr. Jansen of Pfizer at that meeting that in primates the vaccine had failed to prevent transmission, and it had not been studied in humans. I would love for you to point out where someone said a criterion for authorization was successful prevention of transmission, as I do not recall hearing that. Did I miss it?
Boy...and Fauci just 4 days later said we could probably reach herd immunity by the following spring/summer.
I apologize-I misinterpreted the language from the meeting when I said transmission prevention was a criteria for authorization. My bad!
Just fyi...I grew up in North Yarmouth/Cumberland ME and still have extended family there. I sent them the story regarding your license...trying to get them to see what is happening with medicine. Not sure it got through...most of them appear to be in a trance. It was interesting to me that it appeared they suspended your license the day you testified to the state of ME regarding the vaccines(if I pieced that together correctly?). What has happened to you(and I know you're not alone) is absolutely frightening. I'm sorry you have had to go through this. I'm curious how you're doing, the status of your license and lastly...please tell me you managed to fight the psy. evaluation they were demanding! I still cannot believe this is actually happening in this country.
Thanks for all you do Meryl. If I still lived in Maine-I'd want you as my primary! You're a rare breed.
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.
This is all completely gobsmacking! I've only just discovered Meryl's brilliant substack. Here in Australia our TGA (Therapeutic Goods Admin - our version of CDC I guess) have been advertising the Comirnaty for months as being provided via Pfizer but I am unsure of the legal situation viz a vis the US legal wranglings though we are a mere client state of the US and seemingly incapable of saying no to any 'initiative' US powers throw our way - we are just building a Moderna mRNA plant in Melbourne to ensure we have the 'very best' of genetic engineering in our bodies from now on! Good on your Meryl and your learned correspondents. I will raise these legal matters with our CHD group here. Froggie