biological activity, cytotoxicity, mRNA-based vaccines, Robert Malone, Spike protein, the "active drug substance", the adenovirus-based (J&J), transfering foreign genetic material into the cells of the person receiving the vaccine
Source: Robert Malone
RW Malone MD, LLC: Consultancy and Analytics in the Biosector50m
Q: Why do you call the adenovirus-based (J&J) and mRNA-based vaccines gene therapy-based vaccines? And why is that important? Are you just trying to scare people? Are you an anti-vaxxer?
A: I have spent my whole career seeking to develop fundamental enabling vaccine technologies, developing vaccines, designing and managing vaccine studies etc. Vaccines are my business. I am not an anti-vaxxer. I am a pro-truth, pro-safety, pro-bioethics vaccine developer. Vaccines save lives. They are often (but not always) our best hope for reducing the death and disease associated with many pathogens, and offer hope for treating cancer and other diseases.
So, why are these gene therapy-based vaccines? Because both of these types of vaccines employ technologies that involve transfering foreign genetic material into the cells of the person receiving the vaccine, and making those cells essentially become miniature vaccine antigen manufacturing factories – inside the body.
Why does this matter? Because, from my point of view as the person who first came up with the idea to use “gene therapy” and “mRNA delivery” for vaccination, the “active drug substance” is not the gene therapy vector, it is the protein that is manufactured in your cells. So, from an FDA/regulatory point of view, these products need to be reviewed using the regulations applied to “gene therapy” products as well as those which apply to “vaccines”. These are NOT traditional vaccines. Therefore, the FDA should have insisted that the levels and duration of production of the transgene-encoded active drug product (spike protein) should have been well characterized. Make sense? How much spike is being made, in the body of people receiving the vaccine, for how long. Simple stuff. Pretty important.
But the FDA did not think this way, or just did not think. They treated these products like any other vaccine. They have check lists. And to their way of thinking (or not), the formulated mRNA and the adenoviral vector are the active drug product, and they did not need to insist that the product developers characterize how much and for how long the “antigen” (spike) would be produced in your body.
They were wrong..
For example, recombinant adenoviral vectored-vaccines expressing a variety of antigens have been investigated in human clinical studies for years. I am not aware of prior problems with coagulation triggered by those vaccines. So it is reasonable to conclude that the difference is the antigen. Spike. Adenoviral vectors are designed to make lots of protein for a long period of time. So FDA should have had the developer(s) determine how much Spike is being made, and for how long. Simple stuff, right? And the developers should have had to prove that the spike protein produced is not biologically active, that that level is safe, does not bind ACE2, does not open the blood brain barrier, is not cytotoxic etc.
Does that make sense?
Same logic applies to the mRNA vaccines.