Why no meaningful biodistribution studies done on Pfizer covid jab and other mRNA gene therapy treatments
Now you know why they are not a requirement
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:
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: