By now, everyone who has been documenting and shouting about the harms, deaths, contamination, and other dangerous production practices for YEARS now, only to be silenced, censored, smeared, and ignored per the standard Disinformation Playbook (https://www.ucsusa.org/resources/disinformation-playbook) is evidence enough that this is a criminal enterprise intent on achieving three aims:
1) Profit
2) Power
3) Democide
Five years into the COVID psyop and four years into the injection rollout, we have tens of thousands of pieces of evidence proving they caused injuries and deaths, and yet they're still on the market. That means these are desired effects.
I saw your post a few weeks ago:-) The gene therapy vaccines are regulated by the FDA and the authorizations state the manufactures must comply with cGMP. They can’t be adulterated or misbranded.
Hedley has mentioned many times the manufactures for the jabs are Catalent and Lonza for Moderna and Wyeth for the Pfizer vaccines. These manufactures are commercial not military. You can easily look this info up on Google. FDA inspectors have gone on site and issued 483s due to concerns regarding product safety!
Have you read the FDA federal register for the authorization of two biological products for Pfizer and Moderna? If you haven’t, I can follow up and include the link. The link will confirm that Hedley is correct and the vaccines are regulated by the FDA under section 564 of the FD&C Act. Once you look at the Federal Register you will see this not a military campaign to depopulate the world. This is what convinced me these jabs were FDA regulated.
I'm sorry but it is duplicitous. They were first issued under Emergency Use Authorization and not through the FDA. One of the last acts of the previous HHS Secretary was to renew the EUA for another 5 years, until after Trump has left the Whitehouse. This means they are under BOTH and EUA and the FDA. It is Diabolical. They can choose which rules to follow.
Thanks Maurice. Do you know that the EUA was only invoked in the US? No other country in the world claimed that it was safe to launch experimental drugs on a population that could kill far more than any 'manufactured' pandemic. In the EU and UK, the initial drug approval was known as a conditional marketing approval. It had strict requirements to follow good manufacturing and distribution practice, as well as a formal licensing process. I have all the evidence if you would like me to share? Just ask...
Thank you Hedley, and by the way I live in Swansea :-) . I would certainly be interested in seeing the evidence and understanding better, yes. (I'm a retired North Sea oil worker so right out of my field.) It was my impression, however, that something similar happened here throughout UK and Europe due to the EU Advance Purchasing Agreement which we still abided, even though it was after Brexit. Got that from TTE here: https://trusttheevidence.substack.com/p/the-oxford-astra-zeneca-az-advance which deals with both AZ and Pfizer, if I remember rightly. As we now live in a totalitarian world it felt reasonable that this had to be the case. (Bit slow to reply but been tied up all day. Thanks again.)
Actually (as the joint creator of the EUA), I would argue that rights to Life, Liberty and Property under a true “emergency” can be temporarily suspended under a “strict scrutiny” analysis. The question is what that national security “emergency” is now. Hopefully our new Secretary can clarify that soon…
Well said. Let's hope Becerra (or Fink maybe) can explain that to Kennedy. How can you have an "emergency" which lasts continuously for 10 years? What is emergent about that? If they cannot he should rescind it.
This is where you have the misunderstanding. You are referring to the Prep Act in the link which is different from the EUAs for Moderna and Pfizer. The link you sent is regarding Department of HHS Office of the Secretary 12th Amendment to the Public Readiness and Emergency Act for Medical Countermeasures or Prep. The Prep Act gives those that administer countermeasures in this case the vaccines a liability shield.
Hedley is referring to the EUAs. The EUAs are FDA regulated. There is no military involvement. See the link below. He is probably best at commenting but EUAs allows the FDA to fast track in this case a biologic through the drug approval process. I was conflating the two at first also and it is easy to do.
None of your statements is correct, though I don’t doubt you’re faithfully reproducing the falsehoods you’ve been told.
Please go to Katherine Watt’s and separately to Sasha Latypova’s Substack and in each case look for “Orientation for new readers”.
You’ll be shown all the relevant legislation that makes non regulation entirely legal and applicable to these injections (legally, “countermeasures”, whence liability for harms is entirely waived under a Public Health Emergency, which is still in force, provided the PREP Act is applicable & it is).
No pandemic.
Obviously no need for anything let alone rushed injections about which the world was deceived into believing were regulated, when nothing about them is. In these circumstances they’re even defined as non investigational and not capable of being deemed misbranded or adulterated.
My comments came directly from reading the FDA EUA Federal Register document.
Recommend everyone read the FDA EUA link posted above and come to their own conclusions.
Anyone advancing the military theory has either not read the FDA EUA link or has a conflict of interest in keeping the vaccines on the market$$$$$.
Pfizer made 80 billion in COVID vaccine sales and Moderna made approx 30 billion to date. I think Covid might be one of their most successful product launches $$$$$.
I’m sorry Alison, but once again, I’m imploring you to run this thought experiment. That is, that I’m correct and that covering up includes drafting all the customary regulatory submission documentation and signatures including contract manufacturers and FDA. Of course these documents are present. Imagine the horror if they weren’t!
Now, with that thought experiment parked, providing as it does an explanation for why this documentation exists, and yet does not show that the injections were regulated as we’d all have hoped they would be, please allow me to point you to the proof that they’re not even medical products and that FDA did not & is not regulating them.
That proof is absorbed rapidly, by reading “Orientation for new readers” in the Substack accounts of Katherine Watt and of Sasha Latypova.
Would you please honour me by doing that?
Many thanks
Mike
Ps: I’m not crazy, I’m not being paid to be persistent like this and I want only that more people realise quite how dangerous things really are in the world right now. Yes, pharma is corrupt here and I believe criminal. But no, they’re not the instigators of this unholy mess, that’s the Money and the Military machine.
Alison, may I ask you for the links you mention please? I'd like to go through them myself to double check what I think is going on.
Following Mike Yeadon's suggestion to read Watt or Latypova's "orientation for new readers" -which is a lot of reading- I've dug out what I think is Latypova's most succinct presentation why she believes the FDA approval to be false a representation of what is legally non-binding Guidance. It is an interview with Dutchman Willem Engel https://willdofreedom.com/videos/fda-flooded-the-market-with-illegal-drugs/ It is about 45 mins long.
She says there are 4 routes: FDA approval, investigational, Expanded access (compassionate approval), and EUA. The last having zero legal requirement for any regulation.
Essentially she says they knew the covid transfections were illegal so they made another law to stamp them legal. This is a gross over-simplification mind.
I love your curiosity Maurice! This is something may help:
Regulatory Authorities hold delegated authority for the safety, efficacy, and quality of drugs in a specific country or region. The general term for such bodies is competent authority, which is a legal entity with regulatory powers delegated by the government. Nearly every country in the world has an authority with the same mission.
In the United States (US) the regulatory authority is the Food and Drug Administration The regulations were originally laid down in the Federal Food, Drug, and Cosmetic Act (FD&C Act), 1938, and subsequently incorporated into the US Code of Federal Regulations (CFR), under Title 21.
In the European Union (EU), the regulatory authority is the European Medicines Agency (EMA). Regulations are laid down in EU Directive Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001, as amended.
The principles of regulation are the same, with some differences in methods. Most regulatory authorities across the world have websites that will expand on the details.
The two authorities above, along with the Pharmaceuticals and Medical Devices Agency (PDMA) in Japan , signed up to global harmonization of regulations under the facilitation of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use.
ICH was established in Switzerland in 1990. Their mission, published on its website, is to achieve greater harmonization worldwide to ensure that safe, effective and high-quality medicines are developed, and registered and maintained in the most resource efficient manner whilst meeting high standards.
This is the real story, Maurice. Even if the US had passed a law such as the PREP Act, the rest of the world would not have followed, as now such Acts were ever passed. The SARS-CoV-2 scam was about Gates infiltrating these authorities to turn them rogue. Feel free to ask more, this is what I do for a living...
"The SARS-CoV-2 scam was about Gates infiltrating these authorities to turn them rogue. Feel free to ask more, this is what I do for a living..."
I'm a lot more pessimistic. All the bastions of morality have been undermined - the academic institutions, the press ... you name it. When the Abstract of an article co-written by Chris Whitty in government and published by the Royal Society is belied by the Article itself and whole press trumpets the lie then what we have is the manifestation of a fait accompli. The whole world has already been taken over. Masks on! Masks off! And the world turned on the commands. 'They' were flexing their muscles.
And Rumour Control, or the TNI, is led by the BDC, the British Deceiving Corporation. You don't command the world without control of by far the largest broadcaster. Must go.
The article, link above, was published in 2015. This helped with greater insight on FDA mechanisms to accelerate drug approvals which include - A. Priority Review B. Accelerated Approval C. Fast Track Approval and D. Breakthrough Therapy Designation. (Scroll down to bottom of publication and you will see more detail regarding A, B, C and D.)
EUAs or Emergency Use Authorizations are another mechanism the FDA has now has at it's disposal to accelerate the drug approval process.
The link takes you to the Federal Register/A Notice by the Food and Drug Administration on 01/19/2021. The notice or Authorizations of Emergency Use for 2 Biological Products, Pfizer and Moderna, confirm the EUAs are regulated by the FDA under Section 564. Further confirmation that the EUAs are FDA regulated include FDA Letterhead to Pfizer stating the FDA has issued an EUA under Section 564 of the FD&C Acit. Similar confirmation for Moderna further down page. We also know the FDA will be regulating these biologics because the FDA has issued I. Criteria for Issuance of Authorization and III. Conditions of Authorization. Under III. Pfizer and Moderna must meet several conditions which include I. All manufacturing facilities will comply with cGMP requirements.
I. - This is where Hedley's experience comes in and pharmaceutical supply chains. The manufacturers Catalent, Lonza, Wyeth/Pfizer have not been meeting cGMP and FDA inspectors have been on site and issued 483s. The 483s and concerning inspection reports are grounds for removing the vaccines from the market.
The link to the FDA EUAs confirms the vaccines are FDA regulated. This is why I started following Hedley Rees's Substack because what he says lines up to the EUAs;-)!
The EUAs in the US were known as a conditional marketing authorisation (CMA) in EU/UK. The conditions were clearly articulated in the CMA, confirming that good manufacturing practice and good distribution practice had to be observed. I’ll look up the links.
Bill Gates is a notorious eugenicist, as was his father who founded the eugenic foundation, which was banned. Now again they are out in the open. "CLIMATE CHANGE"
Save the planet - kill yourself. or we can help you...
Wonder which type of eugenics it is, or which group it is supposed to favour. In the early stages of this, non Hispanic blacks in America and BAME people in the UK supposedly had higher mortality rates. Somewhere around 2022, it looks like the mortality rates changed. White Americans had the highest crude mortality rate for most 2023, with Indigenous Americans experiencing a slightly higher rate in May.
2024: The data is still being collected and analyzed, but early indications suggest that White Americans continue to have high mortality rates per WHO COVID dashboard and CDC. Similar data from UK’s ONS, but good luck getting it all compiled in one place.
I don't think it needs to be either or it can be both. The Club of Rome originally pushed the too many humans message ( Limits to Growth) which has been repeated by 'Mr Vaccines' - Bill Gates. It just so happens that the COVID 19 vaccines are not the first ones to result in 'fertility issues' and why not make money whilst reducing the global population if you believe the future for humanity is yours to design and rule over - which they do.
Money, power, control, obviously, but hard not to conclude some inevitable depopulation intended too. But overall , ‘Covid’ has been used as a necessary vehicle to push society towards the end goals set out in Agenda 2030 , to usher in ‘The Great Reset’, and ultimately a one world government solution.
Agree to that, only the way to stop it is to get judges to accept that fraud was committed by known individuals in the pharmaceutical industry - remember Donald Trump was advised by a 30 year GSK main board member Moncef slaoui on operation Warp speed:: https://en.wikipedia.org/wiki/Moncef_Slaoui and in the UK GSKs Sir Richard Sykes Chaired the vaccines Task Force: https://en.wikipedia.org/wiki/Richard_Sykes_(microbiologist) - they benefitted massively from the fraud…
Yes, I think the clear fraud element of it all is what has to be focussed on sharply, from a cold legal perspective. Crimes have been committed and there is evidence of that. The motivation question? - open to speculation, debate…but in some ways a distraction and probably not helpful to get sidetracked by it at the moment.
Absolutely spot on Andrew - the voice of clear thinking in the face of so much complexity and confusion. It begins with dismantling Gates’ global, pharmaceutical cartel that he engineered over 25 years. We know his team - Trevor Mindel, former Novartis, Ian Hudson, former CEO, MHRA, Sir Richard Sykes, former CEO GlaxoSmithKline and Chairman, GSK, Jeremy FARRAR, former Wellcome Trust, now Chief Scientist at the WHO, ET AL. That’s the beginning of the fall of the house of cards #NurembergII
As you know the DOD was heavily involved. Which begs the question as to who was running the DOD? We also know fauci and friends were captured by the pharma companies. Have you ever conversed with Kathryn Austin Fitts? Shash Latypova? Or the other researchers who have delved into the massive corruption of the program via the prep act and other government entities. This cesspool is very deep and has an “iron dome” over it protecting the malefactors.
Dennis Meadows who co-authored the Limits to Growth report for the Club of Rome is on video saying "we are at 7 billion and we need to get down to one". In their own words, it is a depopulation event.
Maurice Strong, past Secretary General of the UN said there is a duty of those in power to collapse modern society to bring about equity.
Yes that is true. Interestingly a new report from the Club of Rome predicts that the world's population will peak at 8.6 billion in the middle of the century before declining by nearly 2 billion before the century's end. Of course, as we all, know modelling is simply a hoax in that what they put in determines what they get out - what a surprise! Interesting though that they are adapting their projections presumably due to global fertility rates declining to 2.3.
It doesn't mean they haven't started... I don't think we've seen the worst of the fall-out from the mRNA jabs yet, with more to come no doubt, although I hope not.
If the video of Pfizer CEO Albert Bourla is not a fake, then we must accept that the motive is depopulation: "At last our dream of halving the world population will have come true by 2025".
Had you considered that the big pharma cartel purposefully created the depopulation narrative, Lynette?
Same for bioweapons being manufactured in Ukraine laboratories? Then the military involvement? How could military source cell lines, drug substance, drug product, glass vials, aluminum seals etc, etc? Then, one single Act of Congress, known as the PREP Act, negates pharmaceutical law under the Food. Drugs and Cosmetics Act, 1938 and the Code of Federal Regulations, Title 21. Those law have not been repealed, so should we, at least, ask the question as to why CFR Title 21 was ignored? What do you think Lynette? Regards, Hedley
Of course there is always behind the scene a money-making scheme. However I think there is also an hidden agenda of depopulation. Why? Because the "names we know" are neo-malthusian enthusiasts and also had the opportunity and the means to advance their agenda. The motivation comes from their beliefs, namely in neo-malthusian theories, fulfilling the needed trilogy: motivation, opportunity and means.
I’d like to give a more accurate answer to this question.
The Golden Rule is universal to human morality, humanist and spiritual or religious. “Do unto others as you wish them to do unto you.” The second commandment uttered by Christ Himself was “Love thy neighbour as thyself.” Because, “Whatsoever ye do unto others ye also do unto me.”
Transfection has been used in the lab for over 30 years. Every transfected animal has always been sacrificed because of the increasing harm caused by the transfection itself. Therefore it was known that transfecting human beings was certain to cause increasing harm and death. Therefore transfection is directly contrary to the Golden Rule.
It has also been known since 2012 that LNPs tend to gather in the liver and reproductive organs. Taking these facts together I am certain that depopulation is a purposeful intent.
and Dr Paul Alexander an epidemiologist who worked as a senior policy adviser for the COVID response at HHS (until they chucked him out) said the whole thing was controlled by the military.
Indeed, but the crucial difference is that one road leads to acceptance of a fate over which we have no control; the other route leads to real people who can be identified as specific individuals to join the line for Nuremberg II. Which do you choose? Thanks for the comment Tea42!
It is clear that these people in power do not care much about human lives. If they do not care about human lives, then what do they really care about?
It could be money/ profits, to help them buy luxury or power or sex. It could be to create their own utopia, with less people and/or more obedient people. It could be control over money and/or all economy. Maybe some believe they need to save earth from CO2 (plant food) or too many humans.
The choices towards anti-human decisions may not even be clear to themselves, as they are stuck in their group-think and in global corruption. But as a group the choices are obvious.
Definitely attack on population with Big Pharma and others benefiting on the side. As Henry Kissinger said “they will demand the vax, unwittingly participating in their demise and all you here will benefit”
Thanks Anne - can you explain your reasoning please? That would be very helpful. For example, is over $100 billion in a single year "Big Pharma and others benefiting on the side.?" Also, you are right, WHO/WEF/Globalists demanded the vax (following the words of Henry Kissinger), but that was achieved by mass global propaganda campaigns paid for, in large part, by big pharma companies - what do you think Anne?
I believe that the globalist elite eugenicists want a reduced population to be easily enslaved and controlled ( smart cities, ruining farmers, forcing people into their designated places, use of carbon credits, digital ID and currencies etc) thus reducing the world population by any means necessary ie: manufactured wars, gainer function diseases, bioterrorism via deadly medical practices, euthanasia , weather manipulation and of course fake vaccines. Pharma were losing money fast and were desperate to get the RNA based vaccines through and were unsuccessful until the fake emergency, they now have free reign to put it into absolutely everything, thus fulfilling the PLAN and lining their pockets. Win win. Just my opinion, not sure what you want really. Anne
Thanks for taking the time to reply Anne! If I can quote you here: "Pharma were losing money fast and were desperate to get the RNA based vaccines through and were unsuccessful until the fake emergency" That can be proven as a fact, see my post of patent expiries looming in 2025: https://open.substack.com/pub/hedleyrees/p/key-drugs-losing-patent-protection?r=xoehy&utm_campaign=post&utm_medium=web&showWelcomeOnShare=false I completely agree with you there :). Also, I agree with you about the globalist elites planning all the stuff you mention - in my town they've spent a fortune on building cycle tracks, bus shelters, etc ready for 15 minute cities. But no one has used them because people want to get out of their town, not stay locked in. It's been a complete flop. Again, wars are profitable for armament suppliers etc. Don't think too much thought is given to population reduction. In fact, if the jabs were about depopulation, they did a pretty poor job of it, when the target is supposed to be 8 billion down to 1 billion! All I'm saying it that there are real people in the pharmaceutical industry that are doing this. They can be stopped if folk realise they don't have special powers - they can be put in jail, and I know most of them either personally or p[professionally. Thanks again Anne. Hedlley
It is more of a sinister approach to create a new stream/pipeline of blockbusters via fast track discovery/development and quick return on investment. Circumventing the conventional product lifecycle.
The inconvenient truth is giving life to a once failed gene manipulation therapy.
See the extensive evidence I compiled for my Corona Investigative Committee presentation in July 2022 (I was on right after you, Hedley :-)
• "A Mostly Peaceful Depopulation": https://margaretannaalice.substack.com/p/a-mostly-peaceful-depopulation
Mistakes Were NOT Made:
• https://margaretannaalice.substack.com/p/mistakes-were-not-made-an-anthem
By now, everyone who has been documenting and shouting about the harms, deaths, contamination, and other dangerous production practices for YEARS now, only to be silenced, censored, smeared, and ignored per the standard Disinformation Playbook (https://www.ucsusa.org/resources/disinformation-playbook) is evidence enough that this is a criminal enterprise intent on achieving three aims:
1) Profit
2) Power
3) Democide
Five years into the COVID psyop and four years into the injection rollout, we have tens of thousands of pieces of evidence proving they caused injuries and deaths, and yet they're still on the market. That means these are desired effects.
I saw your post a few weeks ago:-) The gene therapy vaccines are regulated by the FDA and the authorizations state the manufactures must comply with cGMP. They can’t be adulterated or misbranded.
Hedley has mentioned many times the manufactures for the jabs are Catalent and Lonza for Moderna and Wyeth for the Pfizer vaccines. These manufactures are commercial not military. You can easily look this info up on Google. FDA inspectors have gone on site and issued 483s due to concerns regarding product safety!
Have you read the FDA federal register for the authorization of two biological products for Pfizer and Moderna? If you haven’t, I can follow up and include the link. The link will confirm that Hedley is correct and the vaccines are regulated by the FDA under section 564 of the FD&C Act. Once you look at the Federal Register you will see this not a military campaign to depopulate the world. This is what convinced me these jabs were FDA regulated.
I'm sorry but it is duplicitous. They were first issued under Emergency Use Authorization and not through the FDA. One of the last acts of the previous HHS Secretary was to renew the EUA for another 5 years, until after Trump has left the Whitehouse. This means they are under BOTH and EUA and the FDA. It is Diabolical. They can choose which rules to follow.
Thanks Maurice. Do you know that the EUA was only invoked in the US? No other country in the world claimed that it was safe to launch experimental drugs on a population that could kill far more than any 'manufactured' pandemic. In the EU and UK, the initial drug approval was known as a conditional marketing approval. It had strict requirements to follow good manufacturing and distribution practice, as well as a formal licensing process. I have all the evidence if you would like me to share? Just ask...
Thank you Hedley, and by the way I live in Swansea :-) . I would certainly be interested in seeing the evidence and understanding better, yes. (I'm a retired North Sea oil worker so right out of my field.) It was my impression, however, that something similar happened here throughout UK and Europe due to the EU Advance Purchasing Agreement which we still abided, even though it was after Brexit. Got that from TTE here: https://trusttheevidence.substack.com/p/the-oxford-astra-zeneca-az-advance which deals with both AZ and Pfizer, if I remember rightly. As we now live in a totalitarian world it felt reasonable that this had to be the case. (Bit slow to reply but been tied up all day. Thanks again.)
Blimey Maurice - I was born in Swansea :-), lived in Neath, now in Bridgend…
Hahaha, yes I read you were a Swansea man somewhere. I’m Saes myself, an immigrant but I had my naturalisation papers for 50 years residence :-)
It has just occurred to me that we may have a similar duplicity between the European APA and the UK CMA.
https://www.govinfo.gov/content/pkg/FR-2024-12-11/pdf/2024-29108.pdf Extends the covid-19 EUA until 29 Dec 2029. See the bottom of page 1.
An EUA essentially annuls the US Constitution.
Actually (as the joint creator of the EUA), I would argue that rights to Life, Liberty and Property under a true “emergency” can be temporarily suspended under a “strict scrutiny” analysis. The question is what that national security “emergency” is now. Hopefully our new Secretary can clarify that soon…
Well said. Let's hope Becerra (or Fink maybe) can explain that to Kennedy. How can you have an "emergency" which lasts continuously for 10 years? What is emergent about that? If they cannot he should rescind it.
This is where you have the misunderstanding. You are referring to the Prep Act in the link which is different from the EUAs for Moderna and Pfizer. The link you sent is regarding Department of HHS Office of the Secretary 12th Amendment to the Public Readiness and Emergency Act for Medical Countermeasures or Prep. The Prep Act gives those that administer countermeasures in this case the vaccines a liability shield.
Hedley is referring to the EUAs. The EUAs are FDA regulated. There is no military involvement. See the link below. He is probably best at commenting but EUAs allows the FDA to fast track in this case a biologic through the drug approval process. I was conflating the two at first also and it is easy to do.
https://www.federalregister.gov/documents/2021/01/19/2021-01022/authorizations-of-emergency-use-of-two-biological-products-during-the-covid-19-pandemic-availability
Thank you I ll have a rethink.
It’s quite simple. They are lying.
None of your statements is correct, though I don’t doubt you’re faithfully reproducing the falsehoods you’ve been told.
Please go to Katherine Watt’s and separately to Sasha Latypova’s Substack and in each case look for “Orientation for new readers”.
You’ll be shown all the relevant legislation that makes non regulation entirely legal and applicable to these injections (legally, “countermeasures”, whence liability for harms is entirely waived under a Public Health Emergency, which is still in force, provided the PREP Act is applicable & it is).
No pandemic.
Obviously no need for anything let alone rushed injections about which the world was deceived into believing were regulated, when nothing about them is. In these circumstances they’re even defined as non investigational and not capable of being deemed misbranded or adulterated.
My comments came directly from reading the FDA EUA Federal Register document.
Recommend everyone read the FDA EUA link posted above and come to their own conclusions.
Anyone advancing the military theory has either not read the FDA EUA link or has a conflict of interest in keeping the vaccines on the market$$$$$.
Pfizer made 80 billion in COVID vaccine sales and Moderna made approx 30 billion to date. I think Covid might be one of their most successful product launches $$$$$.
Can’t argue with that.!!
I’m sorry Alison, but once again, I’m imploring you to run this thought experiment. That is, that I’m correct and that covering up includes drafting all the customary regulatory submission documentation and signatures including contract manufacturers and FDA. Of course these documents are present. Imagine the horror if they weren’t!
Now, with that thought experiment parked, providing as it does an explanation for why this documentation exists, and yet does not show that the injections were regulated as we’d all have hoped they would be, please allow me to point you to the proof that they’re not even medical products and that FDA did not & is not regulating them.
That proof is absorbed rapidly, by reading “Orientation for new readers” in the Substack accounts of Katherine Watt and of Sasha Latypova.
Would you please honour me by doing that?
Many thanks
Mike
Ps: I’m not crazy, I’m not being paid to be persistent like this and I want only that more people realise quite how dangerous things really are in the world right now. Yes, pharma is corrupt here and I believe criminal. But no, they’re not the instigators of this unholy mess, that’s the Money and the Military machine.
Alison, may I ask you for the links you mention please? I'd like to go through them myself to double check what I think is going on.
Following Mike Yeadon's suggestion to read Watt or Latypova's "orientation for new readers" -which is a lot of reading- I've dug out what I think is Latypova's most succinct presentation why she believes the FDA approval to be false a representation of what is legally non-binding Guidance. It is an interview with Dutchman Willem Engel https://willdofreedom.com/videos/fda-flooded-the-market-with-illegal-drugs/ It is about 45 mins long.
She says there are 4 routes: FDA approval, investigational, Expanded access (compassionate approval), and EUA. The last having zero legal requirement for any regulation.
Essentially she says they knew the covid transfections were illegal so they made another law to stamp them legal. This is a gross over-simplification mind.
I love your curiosity Maurice! This is something may help:
Regulatory Authorities hold delegated authority for the safety, efficacy, and quality of drugs in a specific country or region. The general term for such bodies is competent authority, which is a legal entity with regulatory powers delegated by the government. Nearly every country in the world has an authority with the same mission.
In the United States (US) the regulatory authority is the Food and Drug Administration The regulations were originally laid down in the Federal Food, Drug, and Cosmetic Act (FD&C Act), 1938, and subsequently incorporated into the US Code of Federal Regulations (CFR), under Title 21.
In the European Union (EU), the regulatory authority is the European Medicines Agency (EMA). Regulations are laid down in EU Directive Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001, as amended.
The principles of regulation are the same, with some differences in methods. Most regulatory authorities across the world have websites that will expand on the details.
The two authorities above, along with the Pharmaceuticals and Medical Devices Agency (PDMA) in Japan , signed up to global harmonization of regulations under the facilitation of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use.
ICH was established in Switzerland in 1990. Their mission, published on its website, is to achieve greater harmonization worldwide to ensure that safe, effective and high-quality medicines are developed, and registered and maintained in the most resource efficient manner whilst meeting high standards.
This is the real story, Maurice. Even if the US had passed a law such as the PREP Act, the rest of the world would not have followed, as now such Acts were ever passed. The SARS-CoV-2 scam was about Gates infiltrating these authorities to turn them rogue. Feel free to ask more, this is what I do for a living...
"The SARS-CoV-2 scam was about Gates infiltrating these authorities to turn them rogue. Feel free to ask more, this is what I do for a living..."
I'm a lot more pessimistic. All the bastions of morality have been undermined - the academic institutions, the press ... you name it. When the Abstract of an article co-written by Chris Whitty in government and published by the Royal Society is belied by the Article itself and whole press trumpets the lie then what we have is the manifestation of a fait accompli. The whole world has already been taken over. Masks on! Masks off! And the world turned on the commands. 'They' were flexing their muscles.
And Rumour Control, or the TNI, is led by the BDC, the British Deceiving Corporation. You don't command the world without control of by far the largest broadcaster. Must go.
No reason to be pessimistic Maurice now that you know the deception - enjoy helping bring the house of cards down!
Maurice, I just read your reply as well as Hedley's! Here are 2 links I used to confirm the EUAs are FDA regulated.
First link - FDA Expedited Drug Approvals
https://pmc.ncbi.nlm.nih.gov/articles/PMC4326266/
The article, link above, was published in 2015. This helped with greater insight on FDA mechanisms to accelerate drug approvals which include - A. Priority Review B. Accelerated Approval C. Fast Track Approval and D. Breakthrough Therapy Designation. (Scroll down to bottom of publication and you will see more detail regarding A, B, C and D.)
EUAs or Emergency Use Authorizations are another mechanism the FDA has now has at it's disposal to accelerate the drug approval process.
https://www.federalregister.gov/documents/2021/01/19/2021-01022/authorizations-of-emergency-use-of-two-biological-products-during-the-covid-19-pandemic-availability
The link takes you to the Federal Register/A Notice by the Food and Drug Administration on 01/19/2021. The notice or Authorizations of Emergency Use for 2 Biological Products, Pfizer and Moderna, confirm the EUAs are regulated by the FDA under Section 564. Further confirmation that the EUAs are FDA regulated include FDA Letterhead to Pfizer stating the FDA has issued an EUA under Section 564 of the FD&C Acit. Similar confirmation for Moderna further down page. We also know the FDA will be regulating these biologics because the FDA has issued I. Criteria for Issuance of Authorization and III. Conditions of Authorization. Under III. Pfizer and Moderna must meet several conditions which include I. All manufacturing facilities will comply with cGMP requirements.
I. - This is where Hedley's experience comes in and pharmaceutical supply chains. The manufacturers Catalent, Lonza, Wyeth/Pfizer have not been meeting cGMP and FDA inspectors have been on site and issued 483s. The 483s and concerning inspection reports are grounds for removing the vaccines from the market.
The link to the FDA EUAs confirms the vaccines are FDA regulated. This is why I started following Hedley Rees's Substack because what he says lines up to the EUAs;-)!
The EUAs in the US were known as a conditional marketing authorisation (CMA) in EU/UK. The conditions were clearly articulated in the CMA, confirming that good manufacturing practice and good distribution practice had to be observed. I’ll look up the links.
Thank you. Got the documents. I'll try to digest them now.
Here is the EMA link to the Pfizer/BioNTech CMA: https://www.ema.europa.eu/en/news/ema-receives-application-conditional-marketing-authorisation-covid-19-mrna-vaccine-bnt162b2
Here are the conditions for the Pfizer approval: https://www.gov.uk/government/publications/regulatory-approval-of-pfizer-biontech-vaccine-for-covid-19/conditions-of-authorisation-for-pfizerbiontech-covid-19-vaccine
Where is Reiner?
Still in Jail in Germany, so I've been told Thomas...
Depopulate while making profit.
Bill Gates is a notorious eugenicist, as was his father who founded the eugenic foundation, which was banned. Now again they are out in the open. "CLIMATE CHANGE"
Save the planet - kill yourself. or we can help you...
Wonder which type of eugenics it is, or which group it is supposed to favour. In the early stages of this, non Hispanic blacks in America and BAME people in the UK supposedly had higher mortality rates. Somewhere around 2022, it looks like the mortality rates changed. White Americans had the highest crude mortality rate for most 2023, with Indigenous Americans experiencing a slightly higher rate in May.
2024: The data is still being collected and analyzed, but early indications suggest that White Americans continue to have high mortality rates per WHO COVID dashboard and CDC. Similar data from UK’s ONS, but good luck getting it all compiled in one place.
I don't think it needs to be either or it can be both. The Club of Rome originally pushed the too many humans message ( Limits to Growth) which has been repeated by 'Mr Vaccines' - Bill Gates. It just so happens that the COVID 19 vaccines are not the first ones to result in 'fertility issues' and why not make money whilst reducing the global population if you believe the future for humanity is yours to design and rule over - which they do.
Money, power, control, obviously, but hard not to conclude some inevitable depopulation intended too. But overall , ‘Covid’ has been used as a necessary vehicle to push society towards the end goals set out in Agenda 2030 , to usher in ‘The Great Reset’, and ultimately a one world government solution.
I agree with this
Agree to that, only the way to stop it is to get judges to accept that fraud was committed by known individuals in the pharmaceutical industry - remember Donald Trump was advised by a 30 year GSK main board member Moncef slaoui on operation Warp speed:: https://en.wikipedia.org/wiki/Moncef_Slaoui and in the UK GSKs Sir Richard Sykes Chaired the vaccines Task Force: https://en.wikipedia.org/wiki/Richard_Sykes_(microbiologist) - they benefitted massively from the fraud…
Yes, I think the clear fraud element of it all is what has to be focussed on sharply, from a cold legal perspective. Crimes have been committed and there is evidence of that. The motivation question? - open to speculation, debate…but in some ways a distraction and probably not helpful to get sidetracked by it at the moment.
Absolutely spot on Andrew - the voice of clear thinking in the face of so much complexity and confusion. It begins with dismantling Gates’ global, pharmaceutical cartel that he engineered over 25 years. We know his team - Trevor Mindel, former Novartis, Ian Hudson, former CEO, MHRA, Sir Richard Sykes, former CEO GlaxoSmithKline and Chairman, GSK, Jeremy FARRAR, former Wellcome Trust, now Chief Scientist at the WHO, ET AL. That’s the beginning of the fall of the house of cards #NurembergII
As you know the DOD was heavily involved. Which begs the question as to who was running the DOD? We also know fauci and friends were captured by the pharma companies. Have you ever conversed with Kathryn Austin Fitts? Shash Latypova? Or the other researchers who have delved into the massive corruption of the program via the prep act and other government entities. This cesspool is very deep and has an “iron dome” over it protecting the malefactors.
Dennis Meadows who co-authored the Limits to Growth report for the Club of Rome is on video saying "we are at 7 billion and we need to get down to one". In their own words, it is a depopulation event.
Maurice Strong, past Secretary General of the UN said there is a duty of those in power to collapse modern society to bring about equity.
Yes that is true. Interestingly a new report from the Club of Rome predicts that the world's population will peak at 8.6 billion in the middle of the century before declining by nearly 2 billion before the century's end. Of course, as we all, know modelling is simply a hoax in that what they put in determines what they get out - what a surprise! Interesting though that they are adapting their projections presumably due to global fertility rates declining to 2.3.
This will take them a while without help of antagonistic space aliens....
It doesn't mean they haven't started... I don't think we've seen the worst of the fall-out from the mRNA jabs yet, with more to come no doubt, although I hope not.
I like this take on the subject https://celiafarber.substack.com/p/covid-is-not-an-epidemiological-story
That's a great catch Sandra!
If the video of Pfizer CEO Albert Bourla is not a fake, then we must accept that the motive is depopulation: "At last our dream of halving the world population will have come true by 2025".
Had you considered that the big pharma cartel purposefully created the depopulation narrative, Lynette?
Same for bioweapons being manufactured in Ukraine laboratories? Then the military involvement? How could military source cell lines, drug substance, drug product, glass vials, aluminum seals etc, etc? Then, one single Act of Congress, known as the PREP Act, negates pharmaceutical law under the Food. Drugs and Cosmetics Act, 1938 and the Code of Federal Regulations, Title 21. Those law have not been repealed, so should we, at least, ask the question as to why CFR Title 21 was ignored? What do you think Lynette? Regards, Hedley
It’s a “Win/Win/Win” for the Cabal. We are just test subjects with money.
Of course there is always behind the scene a money-making scheme. However I think there is also an hidden agenda of depopulation. Why? Because the "names we know" are neo-malthusian enthusiasts and also had the opportunity and the means to advance their agenda. The motivation comes from their beliefs, namely in neo-malthusian theories, fulfilling the needed trilogy: motivation, opportunity and means.
I’d like to give a more accurate answer to this question.
The Golden Rule is universal to human morality, humanist and spiritual or religious. “Do unto others as you wish them to do unto you.” The second commandment uttered by Christ Himself was “Love thy neighbour as thyself.” Because, “Whatsoever ye do unto others ye also do unto me.”
Transfection has been used in the lab for over 30 years. Every transfected animal has always been sacrificed because of the increasing harm caused by the transfection itself. Therefore it was known that transfecting human beings was certain to cause increasing harm and death. Therefore transfection is directly contrary to the Golden Rule.
It has also been known since 2012 that LNPs tend to gather in the liver and reproductive organs. Taking these facts together I am certain that depopulation is a purposeful intent.
Hedley a couple of additonal points on it being a military operation:
In October the New Dutch Health minister admitted in the Dutch parliament
“We must follow NATO, US and NCTV orders Covid is a military operation”
https://outraged.substack.com/p/new-dutch-health-minister-fleur-agema
and Dr Paul Alexander an epidemiologist who worked as a senior policy adviser for the COVID response at HHS (until they chucked him out) said the whole thing was controlled by the military.
Those motivations are not mutually exclusionary
Thanks Eric. The point I am making is that in any crime, the motive of the perpetrator is secondary to examining the evidence…
How about it’s a twofer? Gates of Hell said hey, we can get both, what a deal!
Indeed, but the crucial difference is that one road leads to acceptance of a fate over which we have no control; the other route leads to real people who can be identified as specific individuals to join the line for Nuremberg II. Which do you choose? Thanks for the comment Tea42!
It is clear that these people in power do not care much about human lives. If they do not care about human lives, then what do they really care about?
It could be money/ profits, to help them buy luxury or power or sex. It could be to create their own utopia, with less people and/or more obedient people. It could be control over money and/or all economy. Maybe some believe they need to save earth from CO2 (plant food) or too many humans.
The choices towards anti-human decisions may not even be clear to themselves, as they are stuck in their group-think and in global corruption. But as a group the choices are obvious.
Definitely attack on population with Big Pharma and others benefiting on the side. As Henry Kissinger said “they will demand the vax, unwittingly participating in their demise and all you here will benefit”
Thanks Anne - can you explain your reasoning please? That would be very helpful. For example, is over $100 billion in a single year "Big Pharma and others benefiting on the side.?" Also, you are right, WHO/WEF/Globalists demanded the vax (following the words of Henry Kissinger), but that was achieved by mass global propaganda campaigns paid for, in large part, by big pharma companies - what do you think Anne?
I believe that the globalist elite eugenicists want a reduced population to be easily enslaved and controlled ( smart cities, ruining farmers, forcing people into their designated places, use of carbon credits, digital ID and currencies etc) thus reducing the world population by any means necessary ie: manufactured wars, gainer function diseases, bioterrorism via deadly medical practices, euthanasia , weather manipulation and of course fake vaccines. Pharma were losing money fast and were desperate to get the RNA based vaccines through and were unsuccessful until the fake emergency, they now have free reign to put it into absolutely everything, thus fulfilling the PLAN and lining their pockets. Win win. Just my opinion, not sure what you want really. Anne
Thanks for taking the time to reply Anne! If I can quote you here: "Pharma were losing money fast and were desperate to get the RNA based vaccines through and were unsuccessful until the fake emergency" That can be proven as a fact, see my post of patent expiries looming in 2025: https://open.substack.com/pub/hedleyrees/p/key-drugs-losing-patent-protection?r=xoehy&utm_campaign=post&utm_medium=web&showWelcomeOnShare=false I completely agree with you there :). Also, I agree with you about the globalist elites planning all the stuff you mention - in my town they've spent a fortune on building cycle tracks, bus shelters, etc ready for 15 minute cities. But no one has used them because people want to get out of their town, not stay locked in. It's been a complete flop. Again, wars are profitable for armament suppliers etc. Don't think too much thought is given to population reduction. In fact, if the jabs were about depopulation, they did a pretty poor job of it, when the target is supposed to be 8 billion down to 1 billion! All I'm saying it that there are real people in the pharmaceutical industry that are doing this. They can be stopped if folk realise they don't have special powers - they can be put in jail, and I know most of them either personally or p[professionally. Thanks again Anne. Hedlley
Summary of the comments" "the power of 'and'. "
It is more of a sinister approach to create a new stream/pipeline of blockbusters via fast track discovery/development and quick return on investment. Circumventing the conventional product lifecycle.
The inconvenient truth is giving life to a once failed gene manipulation therapy.
Spot one Kannan - welcome back!