Really good interactions with regulatory professionals. I agree that it’s senior management who are systematically criminal & that many, perhaps most, on the ground staff & inspectors are working sincerely.
What’s been uncovered through your FOIA requests damns the product.
I don’t know if you’re aware that, legally, the FDAs role in regulating biologicals, including vaccines, is in reality nothing like we thought when in industry?
I was shocked to learn quite recently that, though the inspectors may well be sincere in their work, senior management do not use such inspection results to regulate these products at all. It’s a charade & has been for many years.
As I understand it, those on the ground go about their work, totally unaware that senior management has no intention of responding and instead grant waivers, because these rules don’t apply to certain classes of products and never have.
The implications for human safety are breathtaking.
Thank you again for blowing up the fraudulent propaganda!
Hi Mike - great to have you comment here 😁. What I will say is that I will not roll over and let dangerous drugs be pushed onto global populations. The Food, Drug and Cosmetics Act, 1938 and 21 CFR are still legally enforceable in my opinion, and us insiders should be making a loud noise about that. These injections are defective medicinal products and I can prove it unequivocally. History will be in our side Mike. The FD&C Act was passed to stop drugs killing people - in 1938! We cannot let these criminals get away with it - does that make sense, or no? Cheers, Hedley
No mere law - and the rule of law itself can be understood to have effectively ended in 2020 - has ever stopped a government intent on murder from carrying out its purposes.
The 'Never Again' slogan in connection with the death camps and Dr Mengele's activities was always, and obviously, utterly, empty and naive. When they believe themselves strong enough to do it, in order to meet wider objectives, they will do so.
Not least because all the innocent little people down the line will comply and facilitate, believing they are doing good, as we have seen in all the Totalitarian murder programmes.
No doubt all the architects, engineers and construction workers building the new vaccine production facilities springing up everywhere are delighted to be contracted, but they are preparing their own doom.
Thank you for this in-depth report spotlighting the behind-the-scenes shenanigans in that Andover manufacturing site. I just wanted to point out something in your sub-headline: "Pfizer should never have been allowed to put its products into patient's bodies". Technically, a "patient" is some sort of sick person. Remember these injectables were foisted upon and administered to supposedly healthy individuals walking in off the street to roll up their sleeves so they could first and foremost "protect others". Some of those well-intentioned people keeled over and died shortly thereafter. This fact makes the situation even worse. They harmed otherwise healthy people with this scam of a "drug product" and let us not forget that it was by its very nature and experimental drug product.
Couldn’t agree more! I go back to the days before all this COVID stuff, when advanced therapy products were being injected into patients with rare blood cancers, known as CAR T therapies. The first was approved by FDA in August 2017, marketed by Novartis, at $475,000 per patient treatment. The latest advanced therapy steam rollered through by Peter Marks, against the advice of all his staff, is $4.25 million per patient treatment. Never in a million years did I think they would pump these in the global population - thanks for the comment 👍😁
You're welcome. Thanks for replying. Words matter now more than ever, so I think it's worth taking a few extra minutes to make sure we've put the right ones in the right places. I even think every mention of "covid", "covid-19", "coronavirus", "vaccine", "PCR test" and "pandemic" should always be put in quotes because there never was anything to back any of them up, except perhaps for invoices from PR agencies and other extraneous consultants who were paid handsomely to name things and direct the messaging based on personality profiles and types. [Hint: For that last one, look up SPI-B]
Even "cases" and "deaths" could or should get the quotation mark treatment because they too were distortions of the commonly understood definition because the definition was extended to "possible, probable or confirmed case of coronavirus" and "possible, probably or confirmed death due to coronavirus".
The person responsible at the FDA for approval of new medicines is a Peter Marks “Peter Marks, M.D., Ph.D. is the director of the Center for Biologics Evaluation and Research (CBER) at the Food and Drug Administration. The center is responsible for assuring the safety and effectiveness of biological products, including vaccines, allergenic products, blood and blood products, and cellular, tissue, and gene therapies”. I wrote to him during the C19 academic plandemic and blasted him for approving the vaccines for children without proper oversight which is one of the points you have raised. He is still in postion and needs to be questioned before a jury about the neglect of his duties to protect the public from what we now know were untested, fraudulent and deliberately dangerous materials.
That is music to my ears! Yes, I’ve done lots of posts on him attending mRNA conferences in London. He is the man to take down. The house of cards will collapse then - can you tell us what you know please? 👍🙏
Hedley, I picked most up from Steve Kirsch’s brilliant efforts through his substack which I was following when the C19 fiasco was at its height. I don’t know much more except that the emails I wrote to Marks (where I had the pleasure of telling him that one day he would face punishment for what he was doing) were not responded to but I received some nasty backchannel feedback from what appeared to me to be someone in the intelligence community or someone with other technical infiltration abilities. Marks is a nasty piece of work and is surely on a number of lists for indictment for his irresponsible criminal behaviour. May I suggest that you contact Steve Kirsch whom I believe Mike Yeadon has come across in the past.
Thanks for the reference…yes Farrar is another who needs to be strung up by his gonads along with Marks, Fauci, Gates and the rest which I believe is currently work in progress. For those who are skeptical I do understand but there is a massive global covert operation to bring these people to task. We the people cannot do it on our own as some will suggest we must. The grip that the evil satanic cabal has on humanity developed over thousands of years is such that it requires a significant coordinated effort supported by a global military alliance which is currently in effect and led by its CIC wartime President DJT. Don’t take my word for it here is the evidence which explains it in detail. Go to: www.thedocuments.info where the whole matter is explained in detail supported by US Government documents. Also visit: www.whitehouse.gov and search for executive orders 13818 and 13848 in the search engine. These two EO’s are self evident and they have even been extended by the fake president Biden. Lastly watch the brilliant Nick Alvear film “The Greatest Show on Earth” on rumble. This film explains the global capitulation of world governments to CIC Trump when he visited each in turn. This is not a joke folks….look it up and see what is going on, something which people still fail to do even when presented with the evidence in B&W and then stare blankly in disbelief when it is explained to them.
Let's not forget the panel of 14 at the CDC, who although not regulators could have stopped the injections dead in their tracks, but who voted enthusiastically for repeated doses. People like Camille Kotton, for instance, who continued voting yes despite all the evidence of deaths and major harms. Ditto for the corrupt JCVI in the UK.
You’ve helped already Paul, by raising the topic of pushback - can you tell us what you are doing? That will help me understand how best you can put your shoulder behind this - is that OK?
At present workers in the NHS are seeing a lot of vaccine harms, especially after the seasonal campaigns.
But everyone is afraid of the GMC, and also those colleagues who are still true believers.
It is very helpful to pass on details of blogs, etc, giving good and accurate coverage of these issues to these people, so they can then circulate them among their colleagues, with the intention of fostering a successful resistance within the medical profession when they try this again with another 'pandemic'. Hopefully resulting in even more refusing to be injected (or take the planed oral pills) or administer and recommend them than occurred last time.
Dynamite- but a quibble. These are patients only in terms of the Latin origin of the word, suffering.(Google, with great insight says: "2/ Patient is derived from Latin word “patientia”, which means patience, suffering, endurance or forbearance. Those terms were perhaps applicable to type of care delivered centuries ago, when suffering was the rule, and waiting was often your best option.Jul 18, 2020") May I suggest to change the word in your heading to human beings, victims, subjects? I am not sure your reader will know the word's original meaning, and "Patient" also implies that the people who were injected had medical conditions they were being treated for, when in fact , many were healthy volunteers or under coercion.
Excellent point! I fully agree 👍🙏 am I getting the point over that these dangerous therapies are still being manufactured and marketed for people with rare diseases and Peter Marks is waving them through? That is something that we should be able to stop, now? 🤔
Another cracking post! You may like to take a look at the presentation of mine titled: Brought to you by the British Government and GlaxoSmithKline (GSK)—The SARS-CoV-2 Injections Fraud https://www.dropbox.com/s/nnorff3vrjst9z2/The%20SARS-CoV-2%20Injections%20Fraud.mp4?dl=0 It doesn't mention Marks specifically, but Marks is obviously enjoying the power, prestige and backhanders by being a part of the scam. Hopefully the link will work and you could comment as before? Best, Hedley
Oops, my bad! Even manufacture date means nothing according to Section 564B
“Products Held for Emergency Use
PAHPRA established new FFDCA §564B, which allows government entities and their agents to preposition or stockpile an unapproved medical product intended for emergency use, provided the product is held and not used until it is approved, cleared, or licensed; authorized for investigational use; or authorized for use under an EUA.”
IMHO HC, this shouldn't be blindly accepted - it should be called out as another scam. Even if it stood for the EUA, Pfizer's COMIRNATY® (Tozinameran) was fully approved and allowed into interstate commerce in the US. Same in the rest of the world - it has been fully approved for administation into unsuspecting people. People must put their critical thinking heads on. I'm repeating this then: https://open.substack.com/pub/hedleyrees/p/rock-solid-evidence-that-pfizers?r=xoehy&utm_campaign=post&utm_medium=web Military involvement (DOD) is zero, zilch, zippo. Wyeth Biopharma in Andover made the initial drug substance (DS) batches that were way out of compliance and certain to kill and maim people. The DS was then shipped thousands of miles to Pfizer in Belgium (Puurs), supposedly at -20 degrees C the whole time, but that's very unlikely. The Pfizer Belgium plant was never inspected by FDA for compliance with biologics regulations as THEY REFUSED! Some other, unknown agency in the EU did it. Whoever is pushing this US-centric version of events needs to stop, IMHO. Thanks HC!
Well, it wasn't like that in EU/UK. The conditional marketing authorisations (not EUAs) stipulated that cGMP should be followed as if it were a full approval. I have all the evidence. I think you guys in the US have been conned and we should look at this from the global perspective - all big pharma companies work globally...what do you think?
Here is my question that needs more investigation:
The manufacture date of the vaccine? We saw the massive volume of vaccine poured into the field. Those were made Prior EUA or after EUA? That would be the key to determining the liability of such government actions.
Hedley,
Really good interactions with regulatory professionals. I agree that it’s senior management who are systematically criminal & that many, perhaps most, on the ground staff & inspectors are working sincerely.
What’s been uncovered through your FOIA requests damns the product.
I don’t know if you’re aware that, legally, the FDAs role in regulating biologicals, including vaccines, is in reality nothing like we thought when in industry?
I was shocked to learn quite recently that, though the inspectors may well be sincere in their work, senior management do not use such inspection results to regulate these products at all. It’s a charade & has been for many years.
https://open.substack.com/pub/bailiwicknews/p/on-fda-guidance-for-industry-documents
This takes some absorbing.
As I understand it, those on the ground go about their work, totally unaware that senior management has no intention of responding and instead grant waivers, because these rules don’t apply to certain classes of products and never have.
The implications for human safety are breathtaking.
Thank you again for blowing up the fraudulent propaganda!
Best wishes
Mike
Hi Mike - great to have you comment here 😁. What I will say is that I will not roll over and let dangerous drugs be pushed onto global populations. The Food, Drug and Cosmetics Act, 1938 and 21 CFR are still legally enforceable in my opinion, and us insiders should be making a loud noise about that. These injections are defective medicinal products and I can prove it unequivocally. History will be in our side Mike. The FD&C Act was passed to stop drugs killing people - in 1938! We cannot let these criminals get away with it - does that make sense, or no? Cheers, Hedley
No mere law - and the rule of law itself can be understood to have effectively ended in 2020 - has ever stopped a government intent on murder from carrying out its purposes.
The 'Never Again' slogan in connection with the death camps and Dr Mengele's activities was always, and obviously, utterly, empty and naive. When they believe themselves strong enough to do it, in order to meet wider objectives, they will do so.
Not least because all the innocent little people down the line will comply and facilitate, believing they are doing good, as we have seen in all the Totalitarian murder programmes.
No doubt all the architects, engineers and construction workers building the new vaccine production facilities springing up everywhere are delighted to be contracted, but they are preparing their own doom.
Thank you very much for this, Hedley. My reaction: no words.
No words indeed…but it can be stopped if we understand that this is gross malfeasance in the SUPPLY CHAIN. There are US Regulations in place since 2013 demanding controls in the supply chain that are being ignored: https://www.fda.gov/regulatory-information/selected-amendments-fdc-act/food-and-drug-administration-safety-and-innovation-act-fdasia Title IV speaks to supply chain. If an Act is not repealed, then it is before KE, IMHO!
Thank you for this in-depth report spotlighting the behind-the-scenes shenanigans in that Andover manufacturing site. I just wanted to point out something in your sub-headline: "Pfizer should never have been allowed to put its products into patient's bodies". Technically, a "patient" is some sort of sick person. Remember these injectables were foisted upon and administered to supposedly healthy individuals walking in off the street to roll up their sleeves so they could first and foremost "protect others". Some of those well-intentioned people keeled over and died shortly thereafter. This fact makes the situation even worse. They harmed otherwise healthy people with this scam of a "drug product" and let us not forget that it was by its very nature and experimental drug product.
Couldn’t agree more! I go back to the days before all this COVID stuff, when advanced therapy products were being injected into patients with rare blood cancers, known as CAR T therapies. The first was approved by FDA in August 2017, marketed by Novartis, at $475,000 per patient treatment. The latest advanced therapy steam rollered through by Peter Marks, against the advice of all his staff, is $4.25 million per patient treatment. Never in a million years did I think they would pump these in the global population - thanks for the comment 👍😁
You're welcome. Thanks for replying. Words matter now more than ever, so I think it's worth taking a few extra minutes to make sure we've put the right ones in the right places. I even think every mention of "covid", "covid-19", "coronavirus", "vaccine", "PCR test" and "pandemic" should always be put in quotes because there never was anything to back any of them up, except perhaps for invoices from PR agencies and other extraneous consultants who were paid handsomely to name things and direct the messaging based on personality profiles and types. [Hint: For that last one, look up SPI-B]
Even "cases" and "deaths" could or should get the quotation mark treatment because they too were distortions of the commonly understood definition because the definition was extended to "possible, probable or confirmed case of coronavirus" and "possible, probably or confirmed death due to coronavirus".
The person responsible at the FDA for approval of new medicines is a Peter Marks “Peter Marks, M.D., Ph.D. is the director of the Center for Biologics Evaluation and Research (CBER) at the Food and Drug Administration. The center is responsible for assuring the safety and effectiveness of biological products, including vaccines, allergenic products, blood and blood products, and cellular, tissue, and gene therapies”. I wrote to him during the C19 academic plandemic and blasted him for approving the vaccines for children without proper oversight which is one of the points you have raised. He is still in postion and needs to be questioned before a jury about the neglect of his duties to protect the public from what we now know were untested, fraudulent and deliberately dangerous materials.
See: https://hedleyrees.substack.com/p/fdas-peter-marks-should-be-getting
That is music to my ears! Yes, I’ve done lots of posts on him attending mRNA conferences in London. He is the man to take down. The house of cards will collapse then - can you tell us what you know please? 👍🙏
Hedley, I picked most up from Steve Kirsch’s brilliant efforts through his substack which I was following when the C19 fiasco was at its height. I don’t know much more except that the emails I wrote to Marks (where I had the pleasure of telling him that one day he would face punishment for what he was doing) were not responded to but I received some nasty backchannel feedback from what appeared to me to be someone in the intelligence community or someone with other technical infiltration abilities. Marks is a nasty piece of work and is surely on a number of lists for indictment for his irresponsible criminal behaviour. May I suggest that you contact Steve Kirsch whom I believe Mike Yeadon has come across in the past.
Many thanks Chali's Food for Thought - I will give Steve Kirsh a go, although when I last looked him up you have to pay for his time. On the topic of nassty pieces of work, this is something you may find interesting: https://open.substack.com/pub/hedleyrees/p/dynamite-cast-iron-evidence-that?r=xoehy&utm_campaign=post&utm_medium=web Britain and GSK are up to their neck it it! (I think the paywall is off, if not let me know)
Thanks for the reference…yes Farrar is another who needs to be strung up by his gonads along with Marks, Fauci, Gates and the rest which I believe is currently work in progress. For those who are skeptical I do understand but there is a massive global covert operation to bring these people to task. We the people cannot do it on our own as some will suggest we must. The grip that the evil satanic cabal has on humanity developed over thousands of years is such that it requires a significant coordinated effort supported by a global military alliance which is currently in effect and led by its CIC wartime President DJT. Don’t take my word for it here is the evidence which explains it in detail. Go to: www.thedocuments.info where the whole matter is explained in detail supported by US Government documents. Also visit: www.whitehouse.gov and search for executive orders 13818 and 13848 in the search engine. These two EO’s are self evident and they have even been extended by the fake president Biden. Lastly watch the brilliant Nick Alvear film “The Greatest Show on Earth” on rumble. This film explains the global capitulation of world governments to CIC Trump when he visited each in turn. This is not a joke folks….look it up and see what is going on, something which people still fail to do even when presented with the evidence in B&W and then stare blankly in disbelief when it is explained to them.
You speak such perfect sense...will check out your links and get back to you :O)
You can reach me by email: chartcom@ymail.com There is much to be hopeful for…
Let's not forget the panel of 14 at the CDC, who although not regulators could have stopped the injections dead in their tracks, but who voted enthusiastically for repeated doses. People like Camille Kotton, for instance, who continued voting yes despite all the evidence of deaths and major harms. Ditto for the corrupt JCVI in the UK.
I love you all that help push back against this totalitarian agenda and all moves that flow with it.
Keep going, I’m doing my bit too.
If I can help in anyway then please just ask
You’ve helped already Paul, by raising the topic of pushback - can you tell us what you are doing? That will help me understand how best you can put your shoulder behind this - is that OK?
Absolutely, I own a barbershop with 9 barbers in there.
I speak openly about the Covid lies and all the other agendas and reference Mike Yeadon, Sasha latypova and yourself regularly.
Perhaps to the detriment of losing customers.
And oppositely gaining even more respect possibly.
I know Matt Letissier and have met him recently in the midlands before an evening he hosted in Northampton. He is also a truth speaker.
I have studied NLP (neuro linguistic programming) and have a solid understanding of the language and approach the media use to influence the masses.
This helped me spot quite early on that we were being lied to and it was blatant.
If I can help in any way then let me know.
I’m happy to give you my phone number for a chat to see how I can help etc and even if it is just menial tasks then I’m with you my friend
At present workers in the NHS are seeing a lot of vaccine harms, especially after the seasonal campaigns.
But everyone is afraid of the GMC, and also those colleagues who are still true believers.
It is very helpful to pass on details of blogs, etc, giving good and accurate coverage of these issues to these people, so they can then circulate them among their colleagues, with the intention of fostering a successful resistance within the medical profession when they try this again with another 'pandemic'. Hopefully resulting in even more refusing to be injected (or take the planed oral pills) or administer and recommend them than occurred last time.
Dynamite- but a quibble. These are patients only in terms of the Latin origin of the word, suffering.(Google, with great insight says: "2/ Patient is derived from Latin word “patientia”, which means patience, suffering, endurance or forbearance. Those terms were perhaps applicable to type of care delivered centuries ago, when suffering was the rule, and waiting was often your best option.Jul 18, 2020") May I suggest to change the word in your heading to human beings, victims, subjects? I am not sure your reader will know the word's original meaning, and "Patient" also implies that the people who were injected had medical conditions they were being treated for, when in fact , many were healthy volunteers or under coercion.
Excellent point! I fully agree 👍🙏 am I getting the point over that these dangerous therapies are still being manufactured and marketed for people with rare diseases and Peter Marks is waving them through? That is something that we should be able to stop, now? 🤔
"Did it land on the desk of Peter Marks M.D., PhD., Director - Center for Biologics Evaluation and Research (CBER)."
Peter Marks appeared at an mRNA lobbyist conference in Europe (no doubt on the take, in my strong opinion):
https://thedailybeagle.substack.com/i/141635624/digging-out-the-lobbyists
If you search for 'Peter Marks' you'll find his grinning ugly mugshot on the right hand side of the image.
Great post! Yes, Marks have been virtually and in person at this conference with the next one in 2025: https://www.terrapinn.com/congress/advanced-therapies/index.stm. Sadly, I didn't take a screen shot of the three he attended in person, and he doesn't appear on the speaking panel for this one. One thing is for sure The Underdog, he is the one that needs to be exposed - he's even ignoring the adice of his staff in approving gene therpaies, see: https://hedleyrees.substack.com/p/top-fda-official-peter-marks-overruled
He's also implicated in the EMA leaks where he permitted direct lobbying from Albert Bourla (see 8:50 of this video which includes screenshots from the documents: https://www.brighteon.com/f038068d-862b-41ae-81fe-96bcd52c4cb7).
Perhaps I need some clarification, but isn't direct lobbying by pharmaceutical CEOs like this prohibited in some capacity?
Another cracking post! You may like to take a look at the presentation of mine titled: Brought to you by the British Government and GlaxoSmithKline (GSK)—The SARS-CoV-2 Injections Fraud https://www.dropbox.com/s/nnorff3vrjst9z2/The%20SARS-CoV-2%20Injections%20Fraud.mp4?dl=0 It doesn't mention Marks specifically, but Marks is obviously enjoying the power, prestige and backhanders by being a part of the scam. Hopefully the link will work and you could comment as before? Best, Hedley
Oops, my bad! Even manufacture date means nothing according to Section 564B
“Products Held for Emergency Use
PAHPRA established new FFDCA §564B, which allows government entities and their agents to preposition or stockpile an unapproved medical product intended for emergency use, provided the product is held and not used until it is approved, cleared, or licensed; authorized for investigational use; or authorized for use under an EUA.”
IMHO HC, this shouldn't be blindly accepted - it should be called out as another scam. Even if it stood for the EUA, Pfizer's COMIRNATY® (Tozinameran) was fully approved and allowed into interstate commerce in the US. Same in the rest of the world - it has been fully approved for administation into unsuspecting people. People must put their critical thinking heads on. I'm repeating this then: https://open.substack.com/pub/hedleyrees/p/rock-solid-evidence-that-pfizers?r=xoehy&utm_campaign=post&utm_medium=web Military involvement (DOD) is zero, zilch, zippo. Wyeth Biopharma in Andover made the initial drug substance (DS) batches that were way out of compliance and certain to kill and maim people. The DS was then shipped thousands of miles to Pfizer in Belgium (Puurs), supposedly at -20 degrees C the whole time, but that's very unlikely. The Pfizer Belgium plant was never inspected by FDA for compliance with biologics regulations as THEY REFUSED! Some other, unknown agency in the EU did it. Whoever is pushing this US-centric version of events needs to stop, IMHO. Thanks HC!
Trump EO plus EUA liability plus this, enough reason to say NO for any EUA medicines.
EUA - “Section 564A authorizes FDA to:
….
Allow deviations from GMP requirements to accommodate emergency response needs;”
https://crsreports.congress.gov/product/pdf/IF/IF10745
Well, it wasn't like that in EU/UK. The conditional marketing authorisations (not EUAs) stipulated that cGMP should be followed as if it were a full approval. I have all the evidence. I think you guys in the US have been conned and we should look at this from the global perspective - all big pharma companies work globally...what do you think?
Here is my question that needs more investigation:
The manufacture date of the vaccine? We saw the massive volume of vaccine poured into the field. Those were made Prior EUA or after EUA? That would be the key to determining the liability of such government actions.