30 Comments
User's avatar
Omicron's avatar

Why I choose not to engage in conversation with those who use the polio vaccine argument - apples to oranges. They then assume my refusal to accept as a vaccine is because it does not prevent covid.

Hopeful and determined, I’m willing to implement this very simple suggestion, “gene-therapy,” in hopes of getting past their thick skulls and remolding their play-doh.

Otherwise, see you in the “gene-therapy” free camps. Cheers!

Expand full comment
Ignasz Semmelweisz's avatar

Thanks for your comment and your engagement.

I understand attempts to vaccinate against polio have caused it to evolve into a more severe strain:

https://www.the-scientist.com/news-opinion/polio-vaccination-causes-more-infections-than-wild-virus-66778

"Nigeria, Democratic Republic of Congo, Central African Republic, and Angola have experienced nine new cases of polio caused by the live virus in oral polio vaccines that has mutated into an infectious form, according to statistics released last week (November 20) by the World Health Organization. That brings the global total of these types of infections to 157 for the year, and it means that more children are paralyzed as a result of such vaccine-derived infections than illnesses caused by the wildtype virus, which has affected 107 people this year."

"“It’s actually crazy because we’re vaccinating now against the vaccine in most parts of the world,” Vincent Racaniello, a virologist at Columbia University, tells NPR, “not against wild polio, which is confined to Pakistan and Afghanistan.”

Starting in April 2016, public health care workers around the world have made the transition from a trivalent vaccine with types 1, 2, and 3 to a bivalent version without type 2 to prevent such vaccine-derived cases."."

Sound familiar?

Polio vaccination may not be the sole determinant of polio disease reduction. There is, for example, a view that smallpox was not erradicated solely by vaccination. A historic dataset presented argues that smallpox cases were tracking down on a basically linear curve and the vaccine came into play halfway down that curve, with no (as I recall) impact on the curve's gradient. To even say this is largely blasphemy. I have not done the due diligence into this, I simply flag it here as food for thought.

Furthermore, medical science does not conclusively know how flu is transmitted. It is simply a means of linguistic presentation that people willingly choose to interpret as "certainty". Experiments into transmission that are too unethical to do today (extreme forms of challenge on prisoners) resulted in no knowledge of how it was spread. My understanding is that this is still, broadly, the case. If one researches Covid transmission, you get into the world of secondary attack rates in infected households that are as low as sub-20%. The cruise ships also demonstrate this, and they were all closed systems.

Expand full comment
DR's avatar

What is your definition of 'gene-therapy'.

Expand full comment
Ignasz Semmelweisz's avatar

Hi David, Thanks for your question.

I feel compelled to ask, why is my definition of gene therapy important or relevant?

Expand full comment
DR's avatar

If you state that mRNA is gene therapy and can't be a vaccine, then how does it fit the second definition?

Expand full comment
Ignasz Semmelweisz's avatar

Forgive my directness, but I think this is important to state the following.

You ask very specifically for my definition of the term. I asked, why mine? You haven't answered that very specific question.

You have then said that *I* stated:

- mRNA is gene therapy;

- It cannot be a vaccine.

Neither of these things is actually what the piece is about and I think it's overly simplistic to state what you have. *Moderna* itself stated that its products were classified by the FDA as gene therapy. *I* have pointed this out with reference to the source material from Moderna. Therefore, Moderna, in highlighting this in their SEC documentation and not, at that time, stating otherwise, were accepting the FDA's categorisation of "gene therapy". If Moderna and the FDA both described the products as gene therapy, it begs the question of why they were consciously reclassified as "vaccines".

In order for the FDA to make that categorisation of gene therapy to which Moderna referred, it must itself have or refer to a definition of gene therapy. It so happens, it does:

https://www.fda.gov/vaccines-blood-biologics/cellular-gene-therapy-products/what-gene-therapy

"Human gene therapy seeks to modify or manipulate the expression of a gene or to alter the biological properties of living cells for therapeutic use."

The FDA's very own definition of "gene therapy" encapsulates entirely the mechanism of mRNA/DNA treatment techology in use for Covid-19 today.

Thus, my own definition, were I to have my own, is utterly irrelevant.

The above is not "me" stating anything. It is me pointing out the above and relating that to another matter you allude to.

If one changes the definition of a word deliberately, things that did not meet the previous definition could, following the change, then meet the new definition i.e. mRNA/DNA tech *can* be a vaccine if you deliberately change the definition to allow them to meet it, which is exactly what has happened in this case, as shown by Moderna's docs combined with the FDA emails and dictionary definition comparisons. All of this evidence shows that the FDA and other sources of definition have done this after the fact, with massive downstream ramifications.

Expand full comment
DR's avatar

So I will be more specific - why do you claim that the change in the definition is not legitimate? Shouldn't we continue to correct the definition of things, as our understanding improves? Wouldn't it be narrow-minded to keep a definition to stay with an ill suiting definition?

In other words - If the mRNA vaccines didn't comply with the previous definition, why don't you think that the definition should be changed?

Another issue is why do you characterize the mRNA vaccine as a treatment? Do you think that it 'alter the biological properties of living cells for therapeutic use'? I agree that this raises interesting questions regarding mRNA-based immunotherapies (such as cancer treatment).

I guess that you think the same for Viral vector vaccines.

Expand full comment
Ignasz Semmelweisz's avatar

If legitimacy of an action stems from the reason it was taken, one must understand why the FDA recategorised products from GTs to vaccines. This explanation is absent, even though it is obviously fundamentally in the public interest to know.

No one in mainstream spheres has asked this question of any regulatory body. That too, should be questioned.

There is a big difference between making something that fits a definition and making a definition fit something.

Further, what is the meaning of "definition"?

https://www.collinsdictionary.com/dictionary/english/definition

So, creating a definition then, as you say, "fixing it" at whim without justification means what? The subversion of language, amongst other things. One navigates from and via reference points. If you move those points or make them unrecognisable, one's navigation is degraded. This is a political technique. If you constantly shift the means by which people make sense of the world in terms of truth - language being fundamental to this - then their ability to determine, label and communicate about reality becomes warped (see Curtis' Hypernormalisation for a take on this).

If something doesn't fit definition A or B or any existing definition, then consider a whole new label and definition. The definition of vaccine has existed before Malone invented mRNA tech. Its invention and the understanding of their relevance gave rise to a new label and definition of "gene therapy".

There are two reference definitions in play here: "gene therapy" and "vaccine".

Documentary evidence shows that the Covid-19 treatments fitted and still fit the gene therapy definition. They did not fit the vaccine definition at any time, up until the definition was changed after they existed. This was likely done for political and business ends i.e. to skip much more stringent and longer regulatory pathways applied to drugs or gene therapies, where the pathway for gene therapy didn't exist. This is evident in the regulatory documentation.

Even now, mechanistically, based on their proven outcomes, it can be argued they are still not vaccines. They confer no immunity, prevent no illness, hospitalisation or death, per the UK and other government's own figures. The claim that "it would have been worse" has little to no experimental evidential basis. I have yet to encounter a solid justification for that claim, but I welcome anything to consider in this regard. If one looks at the manufacturer's own claims about Phase 3 trial efficacy, the claims are weak in how the results were arrived at in what sized cohort. Also, no narrative is referencing Absolute Risk Reduction. Go down that road with Pfizer's own data and you get efficacy ARR rates of sub 2%.

If you look at the mechanism of Covid-19 gene therapies, they do what that definition describes. DNA viral vectors transfect foreign (synthetic) DNA into the cell nucleus, causing it to express RNA into the cytoplasm to be translated by the ribosome in to spike protein, which the cell then expresses on its outer surface, making the cell look foreign and triggering an autoimmune response. mRNA LNPs puts the synthetic mRNA into the cytoplasm and the same happens from there.

Malone expressly states that these mRNA technologies (that he invented) are gene therapies at best turned to the purpose of vaccination, but are clearly not understood, flawed and dangerous. That DNA viral vectors work further upstream in the nucleus is further support of his position.

Expand full comment
DR's avatar

So you're going for a definition based on the biological effect? I guess that we can start with that. Is a vaccine designed for a virus from a previous season still a vaccine? What about 5 years ago? Seems a simplistic look at things.

How do you differentiate between the different SARS-COV-2 vaccines (mRNA, Protein etc.) or all they all the same in your eyes? Will you take the Sinovac 'vaccine'?

Expand full comment
DR's avatar

By the way, your line 'mechanistically, based on their proven outcomes' is perfect - you can't be both, you have to choose one or the other.

Expand full comment
Ignasz Semmelweisz's avatar

Per the article, the mechanism of mRNA/DNA GT is not the same as the pre-existing definition of vaccine.

Also, the outcomes of these GTs does not meet the pre-existing definition as they confer no immunity to disease. The only claim is that they *may* reduce severity of it. That's absolutely not the same thing and I await solid evidence for that claim.

Expand full comment
Ignasz Semmelweisz's avatar

I haven't provided my definition. I have referenced other definitions.

Some C19 vaccines fit the pre-existing definition in that they are supposedly attenuated/inactivated virus. Valneva have one in Phase 3 trial. Bharat's is in use but apparently hit a QC issue when the Brazilians found out it contained live virus and was therefore dangerous, according to reports and a statement issued by a Brazilian government agency IIRC.

I have been specific in this article about mRNA/DNA tech with regards to gene therapy vs vaccine.

Expand full comment
DR's avatar

Did you read your article?

As I see it, the main issue is the evolution of the definition. Shouldn't the definitions evolve with the times and the science?

Expand full comment