Under FDA regulations for biological products, the manufacturing processes need not be validated by FDA before biologics license application (BLA), "approval," production and distribution, and can be changed by the manufacturer at will, after any BLA "approvals" have been granted.
Example: July 1997 FDA Guidance for Industry: Changes to an Approved Application for Specified Biotechnology and Specified Synthetic Biological Products
I've been tracking back to the 1973 FDA biological product manufacturing regulations and guidance documents, and somewhat further back, and then forward past 1973 through rule changes made throughout the 1980s and 1990s and to the present.
One finding is that the only "general safety" studies required for a manufacturer to claim a product was safe, per the 1973 regulations at 21 CFR 610.11, were injection into two mice and two guinea pigs, and if the two mice and two guinea pigs didn't get "significant symptoms" or die within seven days, "the product meets the requirements for general safety."
Other "safety" requirements had to do with FDA suggesting manufacturers try not to have a lot of flies and vermin in the live vaccine work areas, and maybe not use diseased monkeys and horses, or monkeys used previously for experiments, to generate the blood or kidney tissue that would be incorporated into the vaccine vials. But then again, at other sections, FDA says manufacturers can still use sick animals, if they seem recovered from their illnesses. For example, 21 CFR 600.11(f)(7).
I'm having a hard time figuring out how to write about the centuries-old non-regulation of biological products, because -- as others including Eleonor McBean had well-documented by the late 1950s (Poisoned Needle), citing dozens of doctors' observations throughout the 1700s, 1800s and early 1900s -- vaccines have always been nothing more than toxic compounds introduced into healthy people and animals for the purpose of making them weaker and sicker and dead, while the people injecting them lied about what they were doing and why.
So the things that FDA has demonstrably done since 1973, (through rule changes and guidance documents) to remove itself even more from the manufacturing processes, are acts to eliminate pretend-regulation authority over intentional poisons, not acts to eliminate actual regulation authority over medicines.
Vaccines have never been beneficial, and FDA and its precursor agencies have never regulated manufacturing processes used to make vaccines.
Not exactly. You order a rolls Royce same color and model. Only the paint was applied in circular strokes instead of up and down at 3am instead of 2 pm and that affects the speed and acceleration of the car.
What are the four proteins besides the spike protein thay Pfizer admits is being produced? Is there an article or references to review? Would like to know the sequence of those proteins.
Under FDA regulations for biological products, the manufacturing processes need not be validated by FDA before biologics license application (BLA), "approval," production and distribution, and can be changed by the manufacturer at will, after any BLA "approvals" have been granted.
Example: July 1997 FDA Guidance for Industry: Changes to an Approved Application for Specified Biotechnology and Specified Synthetic Biological Products
https://www.fda.gov/media/75318/download
I've been tracking back to the 1973 FDA biological product manufacturing regulations and guidance documents, and somewhat further back, and then forward past 1973 through rule changes made throughout the 1980s and 1990s and to the present.
This is the 1973 version:
https://bailiwicknewsarchives.files.wordpress.com/2024/03/1973.11.20-38-fr-32048-fda-biological-product-regulation-baseline-21-cfr-600-to-680-42-usc-262.pdf
One finding is that the only "general safety" studies required for a manufacturer to claim a product was safe, per the 1973 regulations at 21 CFR 610.11, were injection into two mice and two guinea pigs, and if the two mice and two guinea pigs didn't get "significant symptoms" or die within seven days, "the product meets the requirements for general safety."
Other "safety" requirements had to do with FDA suggesting manufacturers try not to have a lot of flies and vermin in the live vaccine work areas, and maybe not use diseased monkeys and horses, or monkeys used previously for experiments, to generate the blood or kidney tissue that would be incorporated into the vaccine vials. But then again, at other sections, FDA says manufacturers can still use sick animals, if they seem recovered from their illnesses. For example, 21 CFR 600.11(f)(7).
I'm having a hard time figuring out how to write about the centuries-old non-regulation of biological products, because -- as others including Eleonor McBean had well-documented by the late 1950s (Poisoned Needle), citing dozens of doctors' observations throughout the 1700s, 1800s and early 1900s -- vaccines have always been nothing more than toxic compounds introduced into healthy people and animals for the purpose of making them weaker and sicker and dead, while the people injecting them lied about what they were doing and why.
So the things that FDA has demonstrably done since 1973, (through rule changes and guidance documents) to remove itself even more from the manufacturing processes, are acts to eliminate pretend-regulation authority over intentional poisons, not acts to eliminate actual regulation authority over medicines.
Vaccines have never been beneficial, and FDA and its precursor agencies have never regulated manufacturing processes used to make vaccines.
If you buy a Rolls Royce and Del Boys' Robin Reliant arrives I think that is breach of contract? Obviously not in the pharmaceutical industry then?
Not exactly. You order a rolls Royce same color and model. Only the paint was applied in circular strokes instead of up and down at 3am instead of 2 pm and that affects the speed and acceleration of the car.
And the first time you go for a spin it blows up and kills you?
Very clear article for us laymen thanks!
What are the four proteins besides the spike protein thay Pfizer admits is being produced? Is there an article or references to review? Would like to know the sequence of those proteins.