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Washed Up Pharmacist's avatar

Re the SV40 promoter.

There is no doubt this is intentional. The plasmid map was provided to the FDA for the monovalent without the SV40 promoter but shows a normal T7 promoter. This was then repeated for the bivalents. For the bivalents the plasmid map provided by Pfizer has been made public by the EMA, an unusual move since this would be considered proprietary information.

I suspect the EMA knows as does the FDA. Having read the EMA regulatory documents in detail for the past 2 years, they were upset in the original submission but for the bivalents it is even more obvious imho. For instance Moderna changed the sequence for the 3" UTR without letting the EMA reviewers know, they found out about it and raised a Major Objection. It was all smoothed over but when you read the justification, you are like the EMA accepted that? Including these details which would normally be considered proprietary in their public assessment reports is a big tell for me.

All these actions by the manufacturers are what I consider hard fraud, and that, is a line I have not yet seen a manufacturer cross. They exaggerate, give embellished answers, delay, reclassify things (like the novel lipids as inactive excipients instead of adjuvants say..) but deliberately hide or make up data out of whole cloth? Nope. That is a massive fine and they know it.

So my assessment is that the regulators are just fake approving (as Sasha says), and the manufacturers are sometimes following directions from someone/somewhere else and fake manufacturing.

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Kathleen Janoski's avatar

Not sure I would blame China entirely.

After all, it was the University of North Carolina Chapel Hill that weaponized the coronavirus. UNC Chapel Hill was working with the Bat Lady of Wuhan.

But the blame, at least 95%, should be on the US.

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