Robert Malone’s role in the invention of mRNA vaccines — an analysis

“Zero to one” or 0.5 to 0.51?

How It All Began

An Inventor is (Not) Born

So What Did Malone Invent?

Naked DNA and RNA Delivery

The experiment was so elementary, and the results so surprising, that researchers working with San Diego’s Vical Inc. couldn’t really believe what they were seeing. It all seemed too simple.

They had been injecting submicroscopic fatty globules containing DNA or RNA into mice to see what would happen. The idea was that the fat globules, called liposomes, would be taken up by cells. The cells would use the genetic material inside to make proteins they couldn’t otherwise make.

The researchers found moderate success with that, but the rigors of science demanded that the experiment have a “control” portion — injecting the raw DNA or RNA into the mice to show that the liposomes themselves were making it possible for the new genes to be incorporated into the cell’s processes.

It turned out the cells like the raw material even better and began making the new proteins for as long as six months.

“This was a big surprise, and that’s really what you’re looking for in this area,” said Philip L. Felgner, director of product development at Vical. Felgner worked on the experiment with Dr. Jon Wolff and others at the University of Wisconsin at Madison.

Vical hopes that the results of this checking and double-checking, reported in today’s issue of the journal Science, will convert the company from a bare-bones start-up to a major player in the ranks of San Diego’s biotechnology community.

In fact, what Felgner and Wolf originally thought was a laboratory error turned out to be a seminal observation — one that may lead to a revolutionary new type of vaccine — the naked DNA vaccine.

Only a small amount of protein was produced after DNA injection, but Felgner and Wolf immediately realised that it might be enough to generate an immune response to an antigenic protein. They tested this idea by injecting a plasmid containing the gene for the HIV envelope protein gp120 and found that they induced both antibody and cytotoxic immune responses in mice.

In our initial experiments, it was discovered serendipitously that naked DNA, without the liposome delivery system, gave better expression in the muscle than the DNA encapsulated in a liposome. I wrote a letter — I still have it — in 1988, to the CEO of the company, saying this was a major discovery and it could have very interesting applications in immunology. … I realized that injecting naked DNA with a vector simply mimicked what a virus did.

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Preventing death is my life’s mission. I am a drug developer currently working on a rejuvenating gene therapy using the approach of partial reprogramming.

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Yuri Deigin

Preventing death is my life’s mission. I am a drug developer currently working on a rejuvenating gene therapy using the approach of partial reprogramming.