It's a mixed blessing having these editing skills. As it turned out, I was an excellent auditor and no one could trick me when I rose to become a CFO. Now, I learn things that I never had time for...who knew I would be reading stuff like this. I can't begin to express my appreciation for you and so many others. In future, I'll use the DM feature. I'll delete this comments shortly.
The producers Moderna, BioNTech/Pfizer and Curevac REFUSED to agree an acceptance criteria:
"Because specific details of bulk and drug product production processes vary between manufacturers, and much of this information is currently kept confidential, the final criteria for regulatory approvals were left to be decided by each of the individual national regulatory authorities. For example, the criteria and acceptance ranges for specific manufacturing steps are not accessible in the public domain and companies often decline to respond in public to such inquires.48 Although the United States Pharmacopeia (USP) has recently released a Draft Chapter on Analytical Procedures for mRNA Vaccine Quality with methods to support the testing of quality attributes for mRNA-based vaccines, the document does not include any acceptance criteria. "
"However, they deliberately avoided discussion of acceptance criteria: “Like those of any API, acceptance criteria for oligonucleotide APIs are based on preclinical and clinical data, manufacturing process variability, and analytical control strategies. However, these factors are likely to vary dramatically among oligonucleotide APIs, rendering it impossible to provide even general suggestions on acceptance criteria”
Dr. Malone talked about how the EUA allows manufacturers to "fine tune" the vaccine formula. I really wonder how much fine tuning was going on during the rollout - words like that give a lot of leeway. Were they testing various formulas on people? I doubt they went back for regulatory review after each change.
Two typos: accommodate, equipment.
There are several methods for many of these to accomadate differences in testing equipement
Excellent content...Dr Wiseman is a hero alongside of you. Thank you, as always.
Blame my editing/spelling on the nuns (also my penmanship, multiplication table)!
Thanks!
I reread but don't catch these typos. My dry eyes don't help either.
It's a mixed blessing having these editing skills. As it turned out, I was an excellent auditor and no one could trick me when I rose to become a CFO. Now, I learn things that I never had time for...who knew I would be reading stuff like this. I can't begin to express my appreciation for you and so many others. In future, I'll use the DM feature. I'll delete this comments shortly.
You don't have to. I am glad there is only 2 typos. I usually have a LOT MORE. LOL.
Brilliant summation, thank you for all the hard work, saving this as a reference!
The producers Moderna, BioNTech/Pfizer and Curevac REFUSED to agree an acceptance criteria:
"Because specific details of bulk and drug product production processes vary between manufacturers, and much of this information is currently kept confidential, the final criteria for regulatory approvals were left to be decided by each of the individual national regulatory authorities. For example, the criteria and acceptance ranges for specific manufacturing steps are not accessible in the public domain and companies often decline to respond in public to such inquires.48 Although the United States Pharmacopeia (USP) has recently released a Draft Chapter on Analytical Procedures for mRNA Vaccine Quality with methods to support the testing of quality attributes for mRNA-based vaccines, the document does not include any acceptance criteria. "
"However, they deliberately avoided discussion of acceptance criteria: “Like those of any API, acceptance criteria for oligonucleotide APIs are based on preclinical and clinical data, manufacturing process variability, and analytical control strategies. However, these factors are likely to vary dramatically among oligonucleotide APIs, rendering it impossible to provide even general suggestions on acceptance criteria”
https://drbine.substack.com/p/es-gibt-fur-die-modrna-produkte-keinerlei and https://jpharmsci.org/article/S0022-3549(22)00514-7/fulltext
How convenient, they cause cancer because they desperately wanted to test a therapy that they thought might cure cancer.
Dr. Malone talked about how the EUA allows manufacturers to "fine tune" the vaccine formula. I really wonder how much fine tuning was going on during the rollout - words like that give a lot of leeway. Were they testing various formulas on people? I doubt they went back for regulatory review after each change.
https://youtu.be/prGAsGgByA4?t=2935
Hmmmm I think he’s referring to process 1 and 2 lots. Maybe? It’s very vague