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 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.
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.
Wonderful news. Glad I signed up for this substack!! It’s the first I’ve seen this story.
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.
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?
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?"