poor old MHRA; they never thought that TTE would have downloaded all the files as they were put up; so they have reviewed the changes; it all seems to be
"A comparison of the two sets of files shows 60 changes with three replacements, 17 insertions, and 40 deletions. What follows are the most significant parts of the old geezer’s views."
"Note that “batch” occurs 202 times in the redacted file and 243 times in the unredacted file. The primary purpose of these files was to remove any mention of the manufacturing process and the batch identification and content.
We welcome your thoughts on whether the information is commercially confidential or in the public interest of being made available so we can better understand the safety issues."
So presumably the bosses of the MHRA wanted all mentions of manufacturing process removed; well, if they pay 86% of their wages, they are entitled to do that, aren't they?
Tom Jefferson did another post soon after the above; where he tries to make sense of minutes being put up; then rapidly pulled down; they put up again; what were they trying to hide some suspicious minds mused?
Tom in this second piece echoes what Hedley has talked of extensively here; that folks need to know how stuff is made; and what is in it; that is potentially being injected into them
searching on the you know what foundation, the search engines yield the above; "Before joining the MHRA, Dr. Hudson held various senior roles at SmithKline Beecham, working for more than a decade in clinical research and development. " SKB would become GSK?
but as you say, "Dr. Hudson is currently serving as Senior Advisor, Integrated Development for the Bill and Melinda Gates Foundation, working in areas that include optimizing clinical studies and strengthening regulatory systems in low-resource regions, as well as providing regulatory input to teams working on malaria, polio, and COVID-19 drugs."
Not understanding U. S . Departments here in Oz. Will new HHS Secretary have any influence on FDA? I sure hope so. By the way our state capitals are building mRNA manufacturing sites at universities. Yes those awake here are disgusted by that....
If the FDA was doing its job in the beginning of the fake covid pandemic, none of these poison mRNA injections would have ever hit the beaches. And millions of people would still be alive and many millions more would not have suffered debilitating reactions. No excuse possible or accepted.
Sorry, too little too late and I couldn't care less if the FDA or CDC even survive another day.
Under EUA, the FDA has no door, no power, they were just smoke & mirrors for sell the whole sordid mess to the public. Since they didn’t point that out, they were complicit. They were essentially cut out of the process. The whole thing stinks to high heaven.
EUA bypasses all FDA regs & processes, IIRC per Sasha Latypova’s SubStack from several months to 1 year ago where she detailed her research into the bowels of the EUA process.
To confirm the EUAs are regulated by the FDA they do not bypass the FDA. Conditions for authorization of Moderna and Pfizer per FDA require the manufacturers comply with cGMP. This is why Marks wants to waive condition I. for cGMP. It’s stated at the bottom of the letter.
Did you get that from reading the EUA regs or from the nearby correspondence? From my recollection of Sasha’s write up & discussion lack of need to comply with cGMP is/was one of the problems & putative reasons for the observed variation in frequency and severity of side effects from batch to batch. My recollection may be wrong & they in the intervening couple years added cGMP to the requirements.
But I don’t think so. I’d be happy to be proven wrong.
Here is the link to the Federal Register for the authorizations of Pfizer and Moderna 1/19/21. A. The vaccines are definitely regulated by the FDA. Under Supplementary Information 1. Background - Section 564 of the FD&C Act allows FDA to authorize EUAs. So, the good news is they are definitely regulated by the FDA which means the FDA also has the authority to withdraw the vaccines from the market. B. Scroll down to page 6-Pfizer Inc. letter I. - you will see - All manufacturing facilities will comply with Current Good Manufacturing Practice. As Hedley has pointed out, Pfizer/Moderna are not complying with cGMP which means the FDA has the power to withdraw the jabs.
I think it always a good idea to read the official documents and not rely on someone else interpretation because sometimes people are wrong or have a conflict of interest.
The FDA is complicit in the crime along with all the vaccine manufacturers for not shutting down the rollout of these toxic jabs when it was established that none these companies withdrew their products after it was learnt that the cold chain by the wholesalers was not maintained.
Except, unless these products are no longer under EUA ‘non-licensure’ none of this applies. Read Sasha Latypova’s SubStack from months ago. Anything that is said about FDA regs & approval is all window dressing for us plebes. Under EUA all
FDA standards & regs don’t apply, it is just up to the judgment of some FDA bureaucrats (Secretary or undersecretary). It is just their judgment (or lack thereof).
over at TTE, (Trust the Evidence) with Carl Heneghan and Tom Jefferson; they are talking of how minutes put up by MHRA were rapidly pulled down; https://trusttheevidence.substack.com/p/the-mhra-papers-comparison-of-the
poor old MHRA; they never thought that TTE would have downloaded all the files as they were put up; so they have reviewed the changes; it all seems to be
"A comparison of the two sets of files shows 60 changes with three replacements, 17 insertions, and 40 deletions. What follows are the most significant parts of the old geezer’s views."
"Note that “batch” occurs 202 times in the redacted file and 243 times in the unredacted file. The primary purpose of these files was to remove any mention of the manufacturing process and the batch identification and content.
We welcome your thoughts on whether the information is commercially confidential or in the public interest of being made available so we can better understand the safety issues."
So presumably the bosses of the MHRA wanted all mentions of manufacturing process removed; well, if they pay 86% of their wages, they are entitled to do that, aren't they?
Tom Jefferson did another post soon after the above; where he tries to make sense of minutes being put up; then rapidly pulled down; they put up again; what were they trying to hide some suspicious minds mused?
Tom in this second piece echoes what Hedley has talked of extensively here; that folks need to know how stuff is made; and what is in it; that is potentially being injected into them
https://trusttheevidence.substack.com/p/commercial-in-confidence-screen-or
When you know MHRA's CEO until 2019, Ian Hudson, worked for the gates foundation from mid 2019 until 9 months ago, James, there's your answer!
many thanks Hedley for this; June 18, 2021 https://talent4boards.com/sensyne-health-announces-dr-ian-hudson-to-its-board-as-independent-director/
searching on the you know what foundation, the search engines yield the above; "Before joining the MHRA, Dr. Hudson held various senior roles at SmithKline Beecham, working for more than a decade in clinical research and development. " SKB would become GSK?
but as you say, "Dr. Hudson is currently serving as Senior Advisor, Integrated Development for the Bill and Melinda Gates Foundation, working in areas that include optimizing clinical studies and strengthening regulatory systems in low-resource regions, as well as providing regulatory input to teams working on malaria, polio, and COVID-19 drugs."
and Hudson was replaced by the sparkling June Raine; who lives that post in a few months.
Not understanding U. S . Departments here in Oz. Will new HHS Secretary have any influence on FDA? I sure hope so. By the way our state capitals are building mRNA manufacturing sites at universities. Yes those awake here are disgusted by that....
mRNA is about to become a massive white elephant, Luise. Once Peter Marks, the mRNA czar at FDA is fired, it's all over. None of his staff support him, see: https://arstechnica.com/science/2024/06/top-fda-official-overrules-staff-to-approve-gene-therapy-that-failed-trial/ It has all been a massive scam, by replacing key people at the top of governments, regulatory authorities et al. RFK Jr will make Marks his number 1 target, me thinks...
That is great news thank you Hedley. 🙏
If the FDA was doing its job in the beginning of the fake covid pandemic, none of these poison mRNA injections would have ever hit the beaches. And millions of people would still be alive and many millions more would not have suffered debilitating reactions. No excuse possible or accepted.
Sorry, too little too late and I couldn't care less if the FDA or CDC even survive another day.
I have been sharing FDA inspections that went ahead for 3 years! Peter Marks was parachuted in to wave the jabs through - take your anger out on him: https://hedleyrees.substack.com/p/76013ed1-9777-4e5c-9510-a20d8df106ca
Under EUA, the FDA has no door, no power, they were just smoke & mirrors for sell the whole sordid mess to the public. Since they didn’t point that out, they were complicit. They were essentially cut out of the process. The whole thing stinks to high heaven.
One of Hedley's readers posted the link below a few weeks ago. It's a letter from Marks to FDA to waive cGMP for Moderna/Catalent batches.
https://www.fda.gov/media/161738/download
EUA bypasses all FDA regs & processes, IIRC per Sasha Latypova’s SubStack from several months to 1 year ago where she detailed her research into the bowels of the EUA process.
To confirm the EUAs are regulated by the FDA they do not bypass the FDA. Conditions for authorization of Moderna and Pfizer per FDA require the manufacturers comply with cGMP. This is why Marks wants to waive condition I. for cGMP. It’s stated at the bottom of the letter.
Did you get that from reading the EUA regs or from the nearby correspondence? From my recollection of Sasha’s write up & discussion lack of need to comply with cGMP is/was one of the problems & putative reasons for the observed variation in frequency and severity of side effects from batch to batch. My recollection may be wrong & they in the intervening couple years added cGMP to the requirements.
But I don’t think so. I’d be happy to be proven wrong.
https://www.federalregister.gov/documents/2021/01/19/2021-01022/authorizations-of-emergency-use-of-two-biological-products-during-the-covid-19-pandemic-availability
Here is the link to the Federal Register for the authorizations of Pfizer and Moderna 1/19/21. A. The vaccines are definitely regulated by the FDA. Under Supplementary Information 1. Background - Section 564 of the FD&C Act allows FDA to authorize EUAs. So, the good news is they are definitely regulated by the FDA which means the FDA also has the authority to withdraw the vaccines from the market. B. Scroll down to page 6-Pfizer Inc. letter I. - you will see - All manufacturing facilities will comply with Current Good Manufacturing Practice. As Hedley has pointed out, Pfizer/Moderna are not complying with cGMP which means the FDA has the power to withdraw the jabs.
I think it always a good idea to read the official documents and not rely on someone else interpretation because sometimes people are wrong or have a conflict of interest.
Thanks.
Sounds like having them do a recall is like asking an infant to change its own diaper. Incompetence does not mix well with vaccines.
The FDA is complicit in the crime along with all the vaccine manufacturers for not shutting down the rollout of these toxic jabs when it was established that none these companies withdrew their products after it was learnt that the cold chain by the wholesalers was not maintained.
Except, unless these products are no longer under EUA ‘non-licensure’ none of this applies. Read Sasha Latypova’s SubStack from months ago. Anything that is said about FDA regs & approval is all window dressing for us plebes. Under EUA all
FDA standards & regs don’t apply, it is just up to the judgment of some FDA bureaucrats (Secretary or undersecretary). It is just their judgment (or lack thereof).
Now, granted , there’s a new sheriff in town….
The fact that there are batch variations makes the entire process null and void.
I love the US FDA Act section 704(b) referenced on the last page of the Catalent 483 report.
Use of words Filth and Putrid warms my heart.
Aldevron.