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.
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.
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.
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.
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.
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?
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