In Pfizer's combined Phase 2/3 study, they didn't do any of the many standard procedures required for first-in-class drugs (or any IND). The Schedule of Activities in the protocol shows what procedures are required for every trial participant at each visit. Other than immunogenicity, no labs of any kind were done.
Typically, you would do a huge series of pre-drug administration labs, and then repeat those labs post-drug administration. These would include serial PK/PD labs, basic safety labs (chemistry, hematology, etc.), specialty labs like d-dimer, cardiac enzymes, inflammatory biomarkers and so on. None of these were done. Nor did they do any pre/post drug ECGs, vitals or physical exams which are also standard procedures.
Without knowing what the drug does in the body as seen by lab work and procedures (ECGs/Vitals), there is no way, no way at all to say "Safe" or say "no causality". How can they? They have no real safety data. It's really unbelievable. I'd love to cross examine any health care official: "and when you say "safe", what actual safety tests are you referring to?" "When you say "rigorous" testing was done, what exact testing are you referring to?" Go to jail, go directly to jail.
Thank you very much SQ for expanding so eloquently on the numerous and deadly shortcuts that the pharmaceutical companies and regulators have taken.
It is not by chance that until COVID-19 pandemic most trials on mRNA and DNA technology equivalent to the COVID-19 vaccines which led to FDA approval have been conducted with people with the following diseases with short prognosis, incurable and progressive debilitating diseases, or diseases with high rate of mortality postinfection, namely: melanoma, leukaemia, lymphoma, cholera, dengue, Ebola, spinal muscular atrophy, retinitis pigmentosa, multiple myeloma.
To think that the vast majority of vaccinated people are healthy people with minimal risk of death or serious adverse events from the COVID-19 disease, it is, as you say, unbelievable that less testing has been done for COVID-19 vaccines than for preceding gene therapy trials.
We are back to the early 60s pharmaceutical companies' modus operandi. And we give them standing ovations.
Back in late 202 Pfizer's website had a natty little video on it - now changed and original gone - that showed the mRNA jab editing the DNA and inserting a new sequence in the DNA.
Crawling with WaybackMachine I can see Pfizer science page has changed significantly since 2020.
However, the only reference to gene editing I can see in the good old pre-lethal-injection days are in relation to GT for genetic diseases.
At least by what Pfizer/BioNTech have always declared, Comirnaty is a straightforward mRNA vaccines with a LNP vector. No gene editing there.
In reality, the mechanism of harms is perhaps related to the LNP and perhaps S1, rather than anything related to host DNA changes. Also, as Cominarty is designed to fight against the host natural mechanism to eliminate exogenous mRNA, in some individual the production of the antigen might go on longer than expected and safe.
Confident statements like "it stays in the body for a few days" should be instead prefixed by 'hopefully'
As I said in the post, absolute statements in non-exact sciences are dangerous.
If you see a figure without its confidence interval, question it.
Interestingly, the start of the COVID-19 vaccination campaign marked the 50th anniversary of the dissolution of the Central Dogma of molecular biology, when it was shown that RNA could reverse transcribed into DNA. Perhaps we will soon witness the dissolution of current vaccine dogmas.
9. Conclusion – Are existing methodologies to assess the potential human health and environmental risks associated with products of nanotechnology appropriate?
To conclude, the SCENIHR (Scientific Committee on Emerging and Newly Identified Health Risks) of the European Commission expressed the following opinions:
Although the existing methods are appropriate to assess many of the hazards associated with the products and processes involving nanoparticles, they may not be sufficient to address all the hazards. Also, the existing methods used for environmental exposure assessment are not necessarily appropriate. Therefore, the current risk assessment procedures need to be modified for nanoparticles.
Existing methodologies need to be modified or new ones developed to be able to better determine the physical and chemical properties of nanoparticles, measure exposure to them, assess their potential hazard, and detect their movement inside living systems, be it in human tissues or in the environment.
In general, and in spite of a rapidly increasing number of scientific publications dealing with nanoscience and nanotechnology, there is insufficient knowledge and data concerning the characteristics of nanoparticles, their detection and measurement, their behaviour in living systems, and all aspects of their harmful potential in humans and in the environment, to allow for satisfactory risk assessments for humans and ecosystems to be performed.
"mRNA technology is a good fit for gene editing. We want to make these editing proteins for just a short period of time to modify the genome. And producing the editing enzymes transiently helps to reduce the potential for off-target effects"
Yours is a very good dissection of the machinations of authorities concerning the definition of "gene therapy". But their machinations may yet be proven to be insufficient. Consider:
1. In the case of the EMA's machinations, they carve out use as a "vaccine". HOWEVER, we must then turn our attention to the definition of 'vaccine'. Specifically, what characteristic is it that differentiates a "vaccine" from any other drug? Answer: the unique characteristic of a "vaccine" is that it meaningfully reduces (ideally prevents) the spread of a disease (e.g. it functions as a prophylactic). But it is now amply evident and even admitted by Pfizer that prophylactic/spread reduction was not the intent of the product. Unsurprisingly, there is no evidence of prophylaxis in the jabbed population (in fact the opposite appears to be the case). Further, Pfizer and the authorities central message these days is that these products "reduce severity of disease", which is an admission (despite their continuing use of the term "vaccines) that they principally provide *therapeutic* (not prophylactic) effect, no? So in actual fact the EMA's carve-out for gene therapies used as "vaccines" is ineffective in this case, yes?
2. In the case of the FDA's definition of gene-therapy, there appears to be no need to justify the question any further - these products are gene-therapies by the FDA definition and remain so, regardless of the tricks played by fact-checkers.
1. Very good and incontrovertible point. Back in the pre-tyrannical-medicine age, if you got flu after vaccination, that was called vaccination failure. Now is "but you could have died, and instead you only coughed, splattered, and had fever for three weeks off work at home".
2. Absolutely yes. I hope this transpires from the post. However, I was shocked to see biochemists and molecular biologists on Twitter firm on the opposite stance, calling me a quack. The latter label, by the way, never used on me before, I shall be wearing as a badge of honour from now on.
All of which are being ignored for covid vaccines.
Section 1.1 states:
"1.1 Adverse Drug Reaction (ADR) In the pre-approval clinical experience with a new medicinal product or its new usages, particularly as the therapeutic dose(s) may not be established: all noxious and unintended responses to a medicinal product related to any dose should be considered adverse drug reactions (my highlighting) . The phrase responses to a medicinal product means that a causal relationship between a medicinal product and an adverse event is at least a reasonable possibility, i.e., the relationship cannot be ruled out (my highlighting). Regarding marketed medicinal products: a response to a drug which is noxious and unintended and which occurs at doses normally used in man for prophylaxis, diagnosis, or therapy of diseases or for modification of physiological function (see the ICH Guideline for Clinical Safety Data Management: Definitions and Standards for Expedited Reporting).”
So in other words - with experimental medicines err on the side of caution and assume the problem was caused by the drug unless or until proven otherwise.
MHRA and other regulators are not doing this but the complete opposite.
Why?
Then there is this, the ICH have been trying to agree trials standards (since mid-2021) for gene therapies:
So no agreed requirement on what biodistribution studies are required for gene therapies, which the Pfizer and other mRNA jabs and treatments are, so that is why in the EMA’s public assessment report it states “not required” or something similar.
In Pfizer's combined Phase 2/3 study, they didn't do any of the many standard procedures required for first-in-class drugs (or any IND). The Schedule of Activities in the protocol shows what procedures are required for every trial participant at each visit. Other than immunogenicity, no labs of any kind were done.
Typically, you would do a huge series of pre-drug administration labs, and then repeat those labs post-drug administration. These would include serial PK/PD labs, basic safety labs (chemistry, hematology, etc.), specialty labs like d-dimer, cardiac enzymes, inflammatory biomarkers and so on. None of these were done. Nor did they do any pre/post drug ECGs, vitals or physical exams which are also standard procedures.
Without knowing what the drug does in the body as seen by lab work and procedures (ECGs/Vitals), there is no way, no way at all to say "Safe" or say "no causality". How can they? They have no real safety data. It's really unbelievable. I'd love to cross examine any health care official: "and when you say "safe", what actual safety tests are you referring to?" "When you say "rigorous" testing was done, what exact testing are you referring to?" Go to jail, go directly to jail.
Thank you very much SQ for expanding so eloquently on the numerous and deadly shortcuts that the pharmaceutical companies and regulators have taken.
It is not by chance that until COVID-19 pandemic most trials on mRNA and DNA technology equivalent to the COVID-19 vaccines which led to FDA approval have been conducted with people with the following diseases with short prognosis, incurable and progressive debilitating diseases, or diseases with high rate of mortality postinfection, namely: melanoma, leukaemia, lymphoma, cholera, dengue, Ebola, spinal muscular atrophy, retinitis pigmentosa, multiple myeloma.
To think that the vast majority of vaccinated people are healthy people with minimal risk of death or serious adverse events from the COVID-19 disease, it is, as you say, unbelievable that less testing has been done for COVID-19 vaccines than for preceding gene therapy trials.
We are back to the early 60s pharmaceutical companies' modus operandi. And we give them standing ovations.
Back in late 202 Pfizer's website had a natty little video on it - now changed and original gone - that showed the mRNA jab editing the DNA and inserting a new sequence in the DNA.
It openly stated "gene editing technology".
Strange how it's now gone from their website.
Could you please send me the link to the current one?
Here's Pfizer's latest mRNA page - they have changed their website a lot in the past few years:
https://www.pfizer.com/science/innovation/mrna-technology
Pity I didn't archive the original video - hindsight is great isn't it?
Thank you.
Crawling with WaybackMachine I can see Pfizer science page has changed significantly since 2020.
However, the only reference to gene editing I can see in the good old pre-lethal-injection days are in relation to GT for genetic diseases.
At least by what Pfizer/BioNTech have always declared, Comirnaty is a straightforward mRNA vaccines with a LNP vector. No gene editing there.
In reality, the mechanism of harms is perhaps related to the LNP and perhaps S1, rather than anything related to host DNA changes. Also, as Cominarty is designed to fight against the host natural mechanism to eliminate exogenous mRNA, in some individual the production of the antigen might go on longer than expected and safe.
Confident statements like "it stays in the body for a few days" should be instead prefixed by 'hopefully'
As I said in the post, absolute statements in non-exact sciences are dangerous.
If you see a figure without its confidence interval, question it.
Interestingly, the start of the COVID-19 vaccination campaign marked the 50th anniversary of the dissolution of the Central Dogma of molecular biology, when it was shown that RNA could reverse transcribed into DNA. Perhaps we will soon witness the dissolution of current vaccine dogmas.
How about this coincidence for lipid nanoparticle injections:
https://spayvac.com/about-spayvac
- wild horse and mammals humane sterilisation system that is lipid based could be used for covid
https://spayvac.com/f/covid-19-on-everyones-mind
subsequently licensed to Pfizer who’s boss is a vet who would have known all about this:
https://pharmaceutical-business-review.com/news/immunovaccine_seals_worldwide_license_agreement_with_pfizer_animal_health_091123-2/
Who then supply a lipid based mRNA vaccine against covid.
And subsequently a drop in pregnancy rates and births is observed.
This is a good primer on nanoparticles and what health problems they cause, it's just a bit awkward working through the levels to get all the info:
https://ec.europa.eu/health/scientific_committees/opinions_layman/en/nanotechnologies/index.htm#1
Here's part of the conclusion:
9. Conclusion – Are existing methodologies to assess the potential human health and environmental risks associated with products of nanotechnology appropriate?
To conclude, the SCENIHR (Scientific Committee on Emerging and Newly Identified Health Risks) of the European Commission expressed the following opinions:
Although the existing methods are appropriate to assess many of the hazards associated with the products and processes involving nanoparticles, they may not be sufficient to address all the hazards. Also, the existing methods used for environmental exposure assessment are not necessarily appropriate. Therefore, the current risk assessment procedures need to be modified for nanoparticles.
Existing methodologies need to be modified or new ones developed to be able to better determine the physical and chemical properties of nanoparticles, measure exposure to them, assess their potential hazard, and detect their movement inside living systems, be it in human tissues or in the environment.
In general, and in spite of a rapidly increasing number of scientific publications dealing with nanoscience and nanotechnology, there is insufficient knowledge and data concerning the characteristics of nanoparticles, their detection and measurement, their behaviour in living systems, and all aspects of their harmful potential in humans and in the environment, to allow for satisfactory risk assessments for humans and ecosystems to be performed.
Have you researched CRISPR technology?
Very interesting especially with regards to mRNA gene editing - which is what CRISPR is.
https://www.newscientist.com/definition/what-is-crispr/
On this page:
https://www.pfizer.com/news/behind-the-science/unlocking-power-our-bodys-protein-factory
"mRNA technology is a good fit for gene editing. We want to make these editing proteins for just a short period of time to modify the genome. And producing the editing enzymes transiently helps to reduce the potential for off-target effects"
Yours is a very good dissection of the machinations of authorities concerning the definition of "gene therapy". But their machinations may yet be proven to be insufficient. Consider:
1. In the case of the EMA's machinations, they carve out use as a "vaccine". HOWEVER, we must then turn our attention to the definition of 'vaccine'. Specifically, what characteristic is it that differentiates a "vaccine" from any other drug? Answer: the unique characteristic of a "vaccine" is that it meaningfully reduces (ideally prevents) the spread of a disease (e.g. it functions as a prophylactic). But it is now amply evident and even admitted by Pfizer that prophylactic/spread reduction was not the intent of the product. Unsurprisingly, there is no evidence of prophylaxis in the jabbed population (in fact the opposite appears to be the case). Further, Pfizer and the authorities central message these days is that these products "reduce severity of disease", which is an admission (despite their continuing use of the term "vaccines) that they principally provide *therapeutic* (not prophylactic) effect, no? So in actual fact the EMA's carve-out for gene therapies used as "vaccines" is ineffective in this case, yes?
2. In the case of the FDA's definition of gene-therapy, there appears to be no need to justify the question any further - these products are gene-therapies by the FDA definition and remain so, regardless of the tricks played by fact-checkers.
Your thoughts?
Thank you level323.
1. Very good and incontrovertible point. Back in the pre-tyrannical-medicine age, if you got flu after vaccination, that was called vaccination failure. Now is "but you could have died, and instead you only coughed, splattered, and had fever for three weeks off work at home".
2. Absolutely yes. I hope this transpires from the post. However, I was shocked to see biochemists and molecular biologists on Twitter firm on the opposite stance, calling me a quack. The latter label, by the way, never used on me before, I shall be wearing as a badge of honour from now on.
Why were no meaningful biodistribution studies done on Pfizer covid jab and other mRNA gene therapy treatments?
https://awkwardgit.substack.com/p/why-no-meaningful-biodistribution
On here is listed those organisations who agree to follow the guidelines on drug trails:
https://www.ich.org/page/members-observers
https://database.ich.org/sites/default/files/E6_R2_Addendum.pdf
Bill and Melinda Gates Foundation are on the list.
There also a lot of in-depth documents on how to run trials:
https://www.ich.org/page/search-index-ich-guidelines
All of which are being ignored for covid vaccines.
Section 1.1 states:
"1.1 Adverse Drug Reaction (ADR) In the pre-approval clinical experience with a new medicinal product or its new usages, particularly as the therapeutic dose(s) may not be established: all noxious and unintended responses to a medicinal product related to any dose should be considered adverse drug reactions (my highlighting) . The phrase responses to a medicinal product means that a causal relationship between a medicinal product and an adverse event is at least a reasonable possibility, i.e., the relationship cannot be ruled out (my highlighting). Regarding marketed medicinal products: a response to a drug which is noxious and unintended and which occurs at doses normally used in man for prophylaxis, diagnosis, or therapy of diseases or for modification of physiological function (see the ICH Guideline for Clinical Safety Data Management: Definitions and Standards for Expedited Reporting).”
So in other words - with experimental medicines err on the side of caution and assume the problem was caused by the drug unless or until proven otherwise.
MHRA and other regulators are not doing this but the complete opposite.
Why?
Then there is this, the ICH have been trying to agree trials standards (since mid-2021) for gene therapies:
https://database.ich.org/sites/default/files/S12_Step2_Presentation_2021_0618_0.pdf
https://database.ich.org/sites/default/files/S12_FinalConceptPaper_2019_1118.pdf
Which is part of following on from this in 2018:
https://www.iprp.global/working-group/gene-therapy
And 2015:
https://admin.iprp.global/sites/default/files/2018-09/IPRF_Gene_Therapy_WG__Meeting_Summary_May_2015_0.pdf
So no agreed requirement on what biodistribution studies are required for gene therapies, which the Pfizer and other mRNA jabs and treatments are, so that is why in the EMA’s public assessment report it states “not required” or something similar.
https://www.ema.europa.eu/en/documents/assessment-report/comirnaty-epar-public-assessment-report_en.pdf
Notice also that the MHRA is not on the list of participants.
Why?
Because the EMA is and under CHMP if they say “all’s good, approve it” then the MHRA just says “OK will do” and rubberstamps it.
Admitted to in a FOI to me.
And just to give you all the EMA PARs used to issue the EUAs in the EU and UK here are the other 3:
https://ema.europa.eu/en/documents/assessment-report/spikevax-previously-covid-19-vaccine-moderna-epar-public-assessment-report_en.pdf
https://ema.europa.eu/en/documents/assessment-report/vaxzevria-previously-covid-19-vaccine-astrazeneca-epar-public-assessment-report_en.pdf
https://ema.europa.eu/en/documents/assessment-report/covid-19-vaccine-janssen-epar-public-assessment-report_en.pdf
A lot to ponder. Thank you again.