Dr. Malone was also cautious. Calling the SV40 sequence fragments “small and residual,” he said the implications of the contaminants, while unknown, might not be as dire as some predict. “This is not full SV40; it’s DNA fragments,” he said, of certain key sequences involved in DNA replication and gen…
Dr. Malone was also cautious. Calling the SV40 sequence fragments “small and residual,” he said the implications of the contaminants, while unknown, might not be as dire as some predict. “This is not full SV40; it’s DNA fragments,” he said, of certain key sequences involved in DNA replication and gene expression. “SV40 is associated with tumors…(but) this isn’t that. In my mind the risk is not acute; I’m not hyper-alarmed about this.”
In an interview after his remarks to the audience, Malone told me, “In my opinion, it is a smoking gun, demonstrating the failure of the FDA to follow its own internal guidance and policies and international norms in regulating vaccines. It is the most egregious example I’ve ever seen. In a normal world, I would expect it [the vaccine] would be pulled.”
The new research, he said, shows “the clear presence of both contaminating DNA fragments at significant levels, and the use of a manufacturing material–this plasmid–that was not disclosed.” That, he said, “is absolutely an example of adulteration and cause for withdrawal from the market.”
There has been information reported regarding differences in the production of the product, possibly done deliberately. Not to mention "quality control". This should also be factored in. More SV40 in some series/vials than others?
By Mary Beth Pfeiffer, Trial Site News
Dr. Malone was also cautious. Calling the SV40 sequence fragments “small and residual,” he said the implications of the contaminants, while unknown, might not be as dire as some predict. “This is not full SV40; it’s DNA fragments,” he said, of certain key sequences involved in DNA replication and gene expression. “SV40 is associated with tumors…(but) this isn’t that. In my mind the risk is not acute; I’m not hyper-alarmed about this.”
In an interview after his remarks to the audience, Malone told me, “In my opinion, it is a smoking gun, demonstrating the failure of the FDA to follow its own internal guidance and policies and international norms in regulating vaccines. It is the most egregious example I’ve ever seen. In a normal world, I would expect it [the vaccine] would be pulled.”
The new research, he said, shows “the clear presence of both contaminating DNA fragments at significant levels, and the use of a manufacturing material–this plasmid–that was not disclosed.” That, he said, “is absolutely an example of adulteration and cause for withdrawal from the market.”
Yup: all good stuff.
There has been information reported regarding differences in the production of the product, possibly done deliberately. Not to mention "quality control". This should also be factored in. More SV40 in some series/vials than others?