Great post! Man, you'd think every senator would want to sign their name to that letter.... hopefully those 10 senators will get things rolling and more will get on board.
It’s insane that they are drawing this out, but then again it will only prove what most of us have been saying all along. Fraud, corruption, lies, likely equaling the single largest crime against humanity that has ever taken place, and hopefully that ever will take place.
Is the dam about to burst? There are a lot of bodies and lives ruined by the DEATHVAX ☠️☠️☠️ More politicians may want to join us and distance big pharma $
Thanks for the reminder of the Comirnaty bait and switch. There are so many issues with this crime against humanity, but we must never forget that one.
The simple reason why the vaccines are still distributed under EUA is that the booster and children’s doses were never approved, and the formula is exactly the same for all doses. Simplifies packaging and distribution.
A vaccine distributed in a “Comirnaty” vial could never be used for children or for boosters in the US.
I would concede that the COVID-19 mRNA vaccines we have are FDA “approved” (FDA says EUA version is different only “legally” as in how it can be marketed, but it’s the same formula and just as safe as the licensed one) but only for adults and only for two “primary” doses.
For under 16 and for boosters the FDA has never declared these vaccines safe (which what “approval” or to be exact, “licensure” implies, that the formula has been proven safe and effective for the use indicated).
For these doses especially there should be no doubt that it’s “emergency use only” and “take at your own risk.”
The bait and switch is in how the FDA materials phrase things to make the casual reader think the vaccine has been approved for all uses for which it is merely “authorized.”
The web page and linked fact sheets for all doses lead with the statement that the vaccine was approved, and goes on to say how various uses are “authorized”. Most people reading this will not distinguish between “approved” and “authorized” and will not realize that the FDA never approved, so never declared the benefits to outweigh the risks, for either boosters or children’s doses.
I recall the FDA said Comirnaty was “substantially similar” to the EUA Pfizer product. Sen Johnson wrote and asked what that meant but unsure if he got a response. Also, didn't a military court rule that Comirnaty could not be used as a substitute for the EUA Pfizer product?
Sorry, there are so many problems I can’t keep them straight!
It is the same product. What was “approved” was a license application. The license allows marketing it under a brand name and when there is no EUA declaration in effect. The license only applies to the adult primary two doses. That’s all there is to it.
Do you have a reference for “substantially similar”? The word I’ve seen used in official FDA documents is “interchangeable” for example in this Q&A (scroll to bottom):
It’s a mess because I guess “legally” they can’t say they’re the same (“identical”). But that’s what they’re saying.
But this recently-updated page implies there is only one COVID-19 vaccine from Pfizer-BioNTech which now can optionally be marketed as Comirnaty for ages 16 and up, two dose series.
<<On August 23, 2021, FDA announced the first approval of a COVID-19 vaccine. The vaccine has been known as the Pfizer-BioNTech COVID-19 Vaccine, and will now be marketed as Comirnaty, for the prevention of COVID-19 in individuals 16 years of age and older.>>
Here is an article from Heavy on the subject, with one Pfizer representative giving clarification. Yes it’s the exact same formula. As was the case with Senator Johnson no response from the FDA, who would be the ones most qualified to speak on the exact “legal” differences as they are the ones whose job it is to consider them when granting a license or authorization.
<<Pfizer confirmed with Heavy that those differences do not involve vaccine ingredients or how the vaccines are made. Heavy asked for confirmation that the “certain differences” only involve labeling.
Pfizer responded and reiterated to Heavy that in terms of being “legally distinct with certain differences,” the FDA-approved Comirnaty vaccine and the EUA-authorized Pfizer-BioNTech COVID-19 vaccine have the same ingredients and are made using the same processes. Safety and effectiveness are the same, Pfizer noted.
The phrase “legally distinct with certain differences,” the [Pfizer] representative said, simply refers to differences in the documentation included in the separate regulatory submissions for emergency use authorization and full approval. For example, the submissions may have indicated different manufacturing locations or different approved materials suppliers.>>
Thanks! Great questions from the senator! Too bad no answers. But I still maintain the only differences are outside the vial as it were, labeling and distribution requirements. More later!
I think HHS may have legally nullified the principle of informed consent, through 2017/07/25 revisions to Common Rule on informed consent and IRBs, authorized by 2016 21st Century CURES Act, draft timeline below, more info available to anyone interested. Kgwatt@protonmail.com
They also mooted Nuremberg code, by redefining any product given EUA status as, by definition, not part of any “clinical investigation.”
1981/01/27 - FDA regulations on Institutional Review Boards - 21 CFR 56.101-56.124. Multiple revisions 1981-2016, FR citations logged
1981/01/27 - FDA regulations on Informed Consent of Human Subjects - 21 CFR 50.2 et seq. Human subject defined as recipient of test article or control. Multiple revisions through 1999, FR citations logged.
1982/12/31 - Termination date for Presidents Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research. 48 FR 34408.
1991 - Common Rule. Federal Policy for the Protection of Human Subjects. 45 CFR Part 46
1997/11/18 - 50 USC 1520a, restrictions on use of human subjects for testing of chemical or biological agents. Passed after anthrax vaxx/Gulf War Syndrome?
2004/07/21 - Project Bioshield Act, EUA provisions. As soon as a product (vaxx, mask, test) has EUA status, by legal definition, it’s under 21 USC 360bbb-3(k), the product cannot be considered part of any “clinical investigation.” “(k) Relation to other provisions - If a product is the subject of an authorization under this section, the use of such product within the scope of the authorization shall not be considered to constitute a clinical investigation for purposes of section 355(i), 360b(j), or 360j(g) of this title or any other provision of this chapter or section 351 of the Public Health Service Act [42 U.S.C. 262].”
2013/10/13 - Army Regulation AR 40-562, in effect 11/7/2013 - enumerates exemptions for vaxxes.
2016/12/13 - 21st Century Cures Act. Amended informed consent sections of FDA FDC Act of 1938 - Section 520(g)(3) and 505(i)(4) and parts of Public Health Service Act of 1944.
2017/01/19 - HHS revised 45 CFR 46.104 relating to “basic HHS policy for protection of human research subjects.” 82 FR 7259 and 82 FR 7273 The regulatory changes were made under authority of 5 USC 301, 42 USC 289(a) and 42 USC 300v-1(b). Human subject defined as someone about whom data is obtained, not to whom treatment is given. [suggests that VAERS, DMED other data collection failures deliberate. No data collection, no human subject, no clinical investigation, no informed consent rights.]
2017/01/19 - HHS changes to the 1991 Common Rule on waivers of informed consent and Institutional Review Boards. 82 FR 7149. Went into effect 1/19/18. I haven’t read the Federal Register entry in detail yet. I did find and skim a summary report about the changes.
2017/07/25 - HHS FDA IRB Guidance to Investigators (not published until 5/29/20?) HHS-0910-207-F-7422. Waiver of informed consent and IRB review for clinical investigation involving no more than minimal risk to human subject.
2018/06/19 - Another revision to 45 CFR 46.101-124. Need to track down. 83 FR 28518.
2018/07/19 - More HHS revisions to 45 CFR 46.116, regulations on informed consent under the Public Welfare laws. Need to find FR citation.
2021/07/06 Deputy AG Dawn Johnsen’s July 6, 2021 “slip opinion” about the lawfulness of public and private vaxx mandates.
Everyone seems to think that the Republicans are not supportive of the narrative but if they weren't, D. Kory revealed months ago that a significant number of congresspeople are taking Ivermectin and since the Dems have no problem saying they were vaxxed, it has to be members of the Republican congress. If they were supportive of non-vaxxed people and their right to reject the shots, they would revel they are taking IV. But instead, they have kept quiet, not revealing their vax or non-vax status. They would have verbally & publicly supported the IV positive studies and made some move to allow people in this country to access & use IV & HCQ, but they haven't. Some Republicans have quietly encouraged their constitutes to take the shot, but they aren't really saying it in the NYT. Republicans are playing it safe politically, waiting to see what the polls will say over the summer. They are not supportive of the right to choose but supportive of the right to not answer the questions. If Republicans wanted to change the situation, they would have supported Ron Paul amendment to defund the vaccine mandates. Many voted with the Dems and enough didn't bother to show up to vote which tanked it.
As for Ron Johnson, when he began his meetings with people who have been harmed or died from the shot, he was not running for re-election so he basically had nothing to lose. Now that he has all this publicity within the pro-choice, anti-vax community he suddenly decide to run again. Dr. Malone & Steve Kirsch are even soliciting donations for him. Sounds like a replay of Trump telling the pro-choice, anti-vax community he would set up a commission headed by RKJ to look into vaccine safety, development etc. But even before the election he had flipped the script demonstrated by in an interview with Sharyl Attkisson.
Even after that interview people still said he would change the vax situation. Once in office all it took was a meeting with Bill Gates to blow up any thoughts of a commission:
Don't you love it when he says somebody named Robert Kennedy Jr as if he's never heard of him because he's has been a torn in his side for decades. But the video says it all.
Johnson will get no where because he has no clout which is why he wasn't running for office again. Will Posey's letter get any attention, probably not. Posey has been at odds with the CDC, FDA, NIH for decades because he has an autistic grandson. He may have been instrumental at forcing the CDC to release the transcript of a secret illegal meeting government & vaccine manufactures held at a retreat at Simpsonwood Methodist retreat and conference center in Norcross, Georgia in June 2000 to discuss mercury & autism but hasn't done much since than. He did read the CDC's whistleblowers statement into the congressional record when he refused to go public with his findings. His record shows he's not very effective.
Keep in mind: Pharma owns the hill. This is a statement made by Dick Durbin back in early 2020.
Actually, RFK said he didn't think Bill Gates' comment was enough to kill the commission. Instead, he thinks it was a huge donation from Pfizer, which was promptly followed the appointment of a Pfizer exec to a key decision-making position.
If I can find the video link again, I'll share it.
Think like Trump. Bill Gates is a BILLIONAIRE. Bill Gates COMMANDS overwhelming fidelity from people in positions of power from around the world. Gates is not a MD BUT he commands the respect and the attention around the world as if he was. Gates facilitates invitation only conferences for scientist & doctors without holding medical degree and they all bow down to him. His influence in the scientific community is paramount. RKJ, although influential and a premiere litigator & researcher, he is not as well respected and received by the scientific community who calls him a conspiracy theorist. Trump has a need to be liked, especially by wealthy & influential people. If his tanking the commission puts him in a good light with these people, he will do it. RKJ IMHO is being naive if he thinks Gates comment about RKJ heading a commission was a bad idea, didn't have anything to do why that commission didn't happen.
I just retweeted Posey's tweet to my congress critter (Rep. Nydia Velázquez) saying "Why aren't you on this list? Is partisanship more important than your constituents' lives?"
Great post! Man, you'd think every senator would want to sign their name to that letter.... hopefully those 10 senators will get things rolling and more will get on board.
No kidding! It boggles the mind. And makes one weep... and wish to exit this existence...
https://youtu.be/00CUaIoO5w4
Wonderful news. Glad I signed up for this substack!! It’s the first I’ve seen this story.
Thank you! Glad you're here.
It’s insane that they are drawing this out, but then again it will only prove what most of us have been saying all along. Fraud, corruption, lies, likely equaling the single largest crime against humanity that has ever taken place, and hopefully that ever will take place.
Is the dam about to burst? There are a lot of bodies and lives ruined by the DEATHVAX ☠️☠️☠️ More politicians may want to join us and distance big pharma $
We are in a WAR….Do Not Comply!!!
Thanks to the 10 members of Congress!!
Thanks for the reminder of the Comirnaty bait and switch. There are so many issues with this crime against humanity, but we must never forget that one.
Regarding bait and switch.
The simple reason why the vaccines are still distributed under EUA is that the booster and children’s doses were never approved, and the formula is exactly the same for all doses. Simplifies packaging and distribution.
A vaccine distributed in a “Comirnaty” vial could never be used for children or for boosters in the US.
I would concede that the COVID-19 mRNA vaccines we have are FDA “approved” (FDA says EUA version is different only “legally” as in how it can be marketed, but it’s the same formula and just as safe as the licensed one) but only for adults and only for two “primary” doses.
For under 16 and for boosters the FDA has never declared these vaccines safe (which what “approval” or to be exact, “licensure” implies, that the formula has been proven safe and effective for the use indicated).
For these doses especially there should be no doubt that it’s “emergency use only” and “take at your own risk.”
The bait and switch is in how the FDA materials phrase things to make the casual reader think the vaccine has been approved for all uses for which it is merely “authorized.”
https://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/comirnaty-and-pfizer-biontech-covid-19-vaccine
The web page and linked fact sheets for all doses lead with the statement that the vaccine was approved, and goes on to say how various uses are “authorized”. Most people reading this will not distinguish between “approved” and “authorized” and will not realize that the FDA never approved, so never declared the benefits to outweigh the risks, for either boosters or children’s doses.
I recall the FDA said Comirnaty was “substantially similar” to the EUA Pfizer product. Sen Johnson wrote and asked what that meant but unsure if he got a response. Also, didn't a military court rule that Comirnaty could not be used as a substitute for the EUA Pfizer product?
Sorry, there are so many problems I can’t keep them straight!
As far as I'm aware, Sen Johnson has not yet received a response. His letter can be found here: https://www.ronjohnson.senate.gov/2022/2/sen-johnson-to-secretary-austin-has-dod-seen-an-increase-in-medical-diagnoses-among-military-personnel
It is the same product. What was “approved” was a license application. The license allows marketing it under a brand name and when there is no EUA declaration in effect. The license only applies to the adult primary two doses. That’s all there is to it.
The bait & switch also keeps the products under the EAU and maintains the blanket liability for the gene-based therapy shots.
I’m curious why, then, the FDA stated the two versions are “substantially similar’? Why didn’t it say they were identical?
Do you have a reference for “substantially similar”? The word I’ve seen used in official FDA documents is “interchangeable” for example in this Q&A (scroll to bottom):
https://www.fda.gov/vaccines-blood-biologics/qa-comirnaty-covid-19-vaccine-mrna
It’s a mess because I guess “legally” they can’t say they’re the same (“identical”). But that’s what they’re saying.
But this recently-updated page implies there is only one COVID-19 vaccine from Pfizer-BioNTech which now can optionally be marketed as Comirnaty for ages 16 and up, two dose series.
https://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/comirnaty-and-pfizer-biontech-covid-19-vaccine
<<On August 23, 2021, FDA announced the first approval of a COVID-19 vaccine. The vaccine has been known as the Pfizer-BioNTech COVID-19 Vaccine, and will now be marketed as Comirnaty, for the prevention of COVID-19 in individuals 16 years of age and older.>>
It seems I remembered the words wrong. It’s “certain differences” and “legally distinct” that were questioned by Sen Johnson, among other questions:
https://www.ronjohnson.senate.gov/services/files/50503B93-EB6A-49C3-ADAA-4B93200D32D5
Hope this helps!
Here is an article from Heavy on the subject, with one Pfizer representative giving clarification. Yes it’s the exact same formula. As was the case with Senator Johnson no response from the FDA, who would be the ones most qualified to speak on the exact “legal” differences as they are the ones whose job it is to consider them when granting a license or authorization.
https://heavy.com/news/comirnaty-vs-pfizer-vaccine-legally-distinct/
<<Pfizer confirmed with Heavy that those differences do not involve vaccine ingredients or how the vaccines are made. Heavy asked for confirmation that the “certain differences” only involve labeling.
Pfizer responded and reiterated to Heavy that in terms of being “legally distinct with certain differences,” the FDA-approved Comirnaty vaccine and the EUA-authorized Pfizer-BioNTech COVID-19 vaccine have the same ingredients and are made using the same processes. Safety and effectiveness are the same, Pfizer noted.
The phrase “legally distinct with certain differences,” the [Pfizer] representative said, simply refers to differences in the documentation included in the separate regulatory submissions for emergency use authorization and full approval. For example, the submissions may have indicated different manufacturing locations or different approved materials suppliers.>>
Thanks! Great questions from the senator! Too bad no answers. But I still maintain the only differences are outside the vial as it were, labeling and distribution requirements. More later!
Maybe next we can challenge the "proof" that viruses cause disease
https://drsambailey.com/2022/01/05/why-nobody-can-find-a-virus/
Even Dr Malone recently said in a Tucker interview that sanitation, not vaccines reduced diseases.
But forget about clean water, because we need to make pharma money.
Forget about clean water, because companies lose money if they can't dump waste.
But let's all cry about CO2 and global warming, ignoring the elephants in the room.
Did you see that th FDA authorized a Covid-19 "Breathalyzer?"
Supposedly works in 3 minutes.
The "Deep State" (actually "The State") will be coming for us all!
I think HHS may have legally nullified the principle of informed consent, through 2017/07/25 revisions to Common Rule on informed consent and IRBs, authorized by 2016 21st Century CURES Act, draft timeline below, more info available to anyone interested. Kgwatt@protonmail.com
They also mooted Nuremberg code, by redefining any product given EUA status as, by definition, not part of any “clinical investigation.”
https://bailiwicknews.substack.com/p/2004-project-bioshield-act-amendments?s=w
1981/01/27 - FDA regulations on Institutional Review Boards - 21 CFR 56.101-56.124. Multiple revisions 1981-2016, FR citations logged
1981/01/27 - FDA regulations on Informed Consent of Human Subjects - 21 CFR 50.2 et seq. Human subject defined as recipient of test article or control. Multiple revisions through 1999, FR citations logged.
1982/12/31 - Termination date for Presidents Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research. 48 FR 34408.
1991 - Common Rule. Federal Policy for the Protection of Human Subjects. 45 CFR Part 46
1997/11/18 - 50 USC 1520a, restrictions on use of human subjects for testing of chemical or biological agents. Passed after anthrax vaxx/Gulf War Syndrome?
2004/07/21 - Project Bioshield Act, EUA provisions. As soon as a product (vaxx, mask, test) has EUA status, by legal definition, it’s under 21 USC 360bbb-3(k), the product cannot be considered part of any “clinical investigation.” “(k) Relation to other provisions - If a product is the subject of an authorization under this section, the use of such product within the scope of the authorization shall not be considered to constitute a clinical investigation for purposes of section 355(i), 360b(j), or 360j(g) of this title or any other provision of this chapter or section 351 of the Public Health Service Act [42 U.S.C. 262].”
2013/10/13 - Army Regulation AR 40-562, in effect 11/7/2013 - enumerates exemptions for vaxxes.
2016/12/13 - 21st Century Cures Act. Amended informed consent sections of FDA FDC Act of 1938 - Section 520(g)(3) and 505(i)(4) and parts of Public Health Service Act of 1944.
2017/01/19 - HHS revised 45 CFR 46.104 relating to “basic HHS policy for protection of human research subjects.” 82 FR 7259 and 82 FR 7273 The regulatory changes were made under authority of 5 USC 301, 42 USC 289(a) and 42 USC 300v-1(b). Human subject defined as someone about whom data is obtained, not to whom treatment is given. [suggests that VAERS, DMED other data collection failures deliberate. No data collection, no human subject, no clinical investigation, no informed consent rights.]
2017/01/19 - HHS changes to the 1991 Common Rule on waivers of informed consent and Institutional Review Boards. 82 FR 7149. Went into effect 1/19/18. I haven’t read the Federal Register entry in detail yet. I did find and skim a summary report about the changes.
2017/07/25 - HHS FDA IRB Guidance to Investigators (not published until 5/29/20?) HHS-0910-207-F-7422. Waiver of informed consent and IRB review for clinical investigation involving no more than minimal risk to human subject.
2018/06/19 - Another revision to 45 CFR 46.101-124. Need to track down. 83 FR 28518.
2018/07/19 - More HHS revisions to 45 CFR 46.116, regulations on informed consent under the Public Welfare laws. Need to find FR citation.
2021/07/06 Deputy AG Dawn Johnsen’s July 6, 2021 “slip opinion” about the lawfulness of public and private vaxx mandates.
Thank you for this. Where is the so-called Republican leadership on this, Kevin McCarthy? Too busy counting your Pharma donations?
Everyone seems to think that the Republicans are not supportive of the narrative but if they weren't, D. Kory revealed months ago that a significant number of congresspeople are taking Ivermectin and since the Dems have no problem saying they were vaxxed, it has to be members of the Republican congress. If they were supportive of non-vaxxed people and their right to reject the shots, they would revel they are taking IV. But instead, they have kept quiet, not revealing their vax or non-vax status. They would have verbally & publicly supported the IV positive studies and made some move to allow people in this country to access & use IV & HCQ, but they haven't. Some Republicans have quietly encouraged their constitutes to take the shot, but they aren't really saying it in the NYT. Republicans are playing it safe politically, waiting to see what the polls will say over the summer. They are not supportive of the right to choose but supportive of the right to not answer the questions. If Republicans wanted to change the situation, they would have supported Ron Paul amendment to defund the vaccine mandates. Many voted with the Dems and enough didn't bother to show up to vote which tanked it.
As for Ron Johnson, when he began his meetings with people who have been harmed or died from the shot, he was not running for re-election so he basically had nothing to lose. Now that he has all this publicity within the pro-choice, anti-vax community he suddenly decide to run again. Dr. Malone & Steve Kirsch are even soliciting donations for him. Sounds like a replay of Trump telling the pro-choice, anti-vax community he would set up a commission headed by RKJ to look into vaccine safety, development etc. But even before the election he had flipped the script demonstrated by in an interview with Sharyl Attkisson.
Even after that interview people still said he would change the vax situation. Once in office all it took was a meeting with Bill Gates to blow up any thoughts of a commission:
https://twitter.com/Storiesofinjury/status/1503211128255516672
Don't you love it when he says somebody named Robert Kennedy Jr as if he's never heard of him because he's has been a torn in his side for decades. But the video says it all.
Johnson will get no where because he has no clout which is why he wasn't running for office again. Will Posey's letter get any attention, probably not. Posey has been at odds with the CDC, FDA, NIH for decades because he has an autistic grandson. He may have been instrumental at forcing the CDC to release the transcript of a secret illegal meeting government & vaccine manufactures held at a retreat at Simpsonwood Methodist retreat and conference center in Norcross, Georgia in June 2000 to discuss mercury & autism but hasn't done much since than. He did read the CDC's whistleblowers statement into the congressional record when he refused to go public with his findings. His record shows he's not very effective.
Keep in mind: Pharma owns the hill. This is a statement made by Dick Durbin back in early 2020.
It’s clear we have a uni-party when it comes to Pharma. It’s all so frustrating.
Actually, RFK said he didn't think Bill Gates' comment was enough to kill the commission. Instead, he thinks it was a huge donation from Pfizer, which was promptly followed the appointment of a Pfizer exec to a key decision-making position.
If I can find the video link again, I'll share it.
Think like Trump. Bill Gates is a BILLIONAIRE. Bill Gates COMMANDS overwhelming fidelity from people in positions of power from around the world. Gates is not a MD BUT he commands the respect and the attention around the world as if he was. Gates facilitates invitation only conferences for scientist & doctors without holding medical degree and they all bow down to him. His influence in the scientific community is paramount. RKJ, although influential and a premiere litigator & researcher, he is not as well respected and received by the scientific community who calls him a conspiracy theorist. Trump has a need to be liked, especially by wealthy & influential people. If his tanking the commission puts him in a good light with these people, he will do it. RKJ IMHO is being naive if he thinks Gates comment about RKJ heading a commission was a bad idea, didn't have anything to do why that commission didn't happen.
I don't think RFK was saying Gates' comment didn't have any *anything* to do with the decision. (Notice I used the word "enough".)
Rather, I think Bobby was simply being realistic by recognizing, and publicly acknowledging, that money talks.
I get what you're saying, though, about Gates being a BILLIONARE. Certainly, the admonition that "money talks" applies here, as well. :-)
Off topic but -- this can circumvent paywalls - and f789 the MSM out of revenue...
Share it widely https://12ft.io/
I just retweeted Posey's tweet to my congress critter (Rep. Nydia Velázquez) saying "Why aren't you on this list? Is partisanship more important than your constituents' lives?"