Thanks Hedley for explaining how the supply chain works. You make this so clear.
It’s interesting because I still follow some of the medical freedom folks regarding Covid from time to time to see if anything has advanced. Unfortunately, while their efforts seem to be well intentioned, they are still analyzing clinical data like the data from a Czech study for example. But as you’ve stated multiple times the key issue is the broken supply chain which occurred because critical steps were skipped from preclinical to Phase III. Once this is understood along with the FDA 483s it’s clear the products would never work and be harmful.
There’s still lots of focus on Fauci and gain of function viruses with little to no focus on the fact that most of the injuries and deaths were the result of a contaminated biologic that did not follow GMP. It seems so simple and straightforward yet we seem to want to focus on analyzing more clinical data, Fauci and G of F.
This is the 80 page FDA inspection report of the manufacturer of the Pfizer injections, Wyeth Biopharma, carried out to 'approve' Comirnaty in 2021, given me by FDA under a FOIA request:
Thanks Hedley for explaining how the supply chain works. You make this so clear.
It’s interesting because I still follow some of the medical freedom folks regarding Covid from time to time to see if anything has advanced. Unfortunately, while their efforts seem to be well intentioned, they are still analyzing clinical data like the data from a Czech study for example. But as you’ve stated multiple times the key issue is the broken supply chain which occurred because critical steps were skipped from preclinical to Phase III. Once this is understood along with the FDA 483s it’s clear the products would never work and be harmful.
There’s still lots of focus on Fauci and gain of function viruses with little to no focus on the fact that most of the injuries and deaths were the result of a contaminated biologic that did not follow GMP. It seems so simple and straightforward yet we seem to want to focus on analyzing more clinical data, Fauci and G of F.
The inspection observations begin on Page 60
Complete sense, as ever Alison!
This is the 80 page FDA inspection report of the manufacturer of the Pfizer injections, Wyeth Biopharma, carried out to 'approve' Comirnaty in 2021, given me by FDA under a FOIA request:
https://www.dropbox.com/scl/fi/so7ahasc461qazjpslu2k/116_BLA-125742-0_08-21-2021_Inspection-Related_Establi.pdf?rlkey=ymc1tswf0df3exxbuxsdlc8zd&dl=0
12 observation showing contamination, lack of standard operation procedures, failed quality control, etc, etc.