[justsee]

mRNA vaccines are a gene therapy, and a gene therapy does not mean "must irreversibly change the genome".

Take for instance Moderna's own SEC filing discussing mRNA [1], which summarised the regulatory situation:

"Currently, mRNA is considered a gene therapy product by the FDA. Unlike certain gene therapies that irreversibly alter cell DNA and could act as a source of side effects, mRNA-based medicines are designed to not irreversibly change cell DNA; however, side effects observed in gene therapy could negatively impact the perception of mRNA medicines despite the differences in mechanism.

In addition, because no product in which mRNA is the primary active ingredient has been approved, the regulatory pathway for approval is uncertain. The number and design of the clinical trials and preclinical studies required for the approval of these types of medicines have not been established, may be different from those required for gene therapy products, or may require safety testing like gene therapy products. Moreover, the length of time necessary to complete clinical trials and to submit an application for marketing approval for a final decision by a regulatory authority varies significantly from one pharmaceutical product to the next, and may be difficult to predict."

The industry itself was quite open about mRNA being a gene therapy [2].

At some point there were clearly industry and marketing concerns, and we saw a sharp u-turn into asserting they were vaccines, and additionally that any claim they were gene therapies was the mark of an ignorant rube.

On the marketing front: probably a concern that uninformed memes formed around the "changes your DNA" fears, which at the time were unfounded.

On the regulatory front: I seem to recall some potentially more rigorous regulatory approval if they were considered gene therapies instead of vaccines.

It seems rather clear: they are a gene therapy, and because that adds uncertainty in terms of the regulatory pathways, and consumer acceptance, commercial interests worked hard to recategorise them as a more palatable 'vaccine'.

That the term 'gene therapy' is being redefined to exclude mRNA seems an exercise in commerce rather than science, given the history available to anyone who cares to look.

[1] https://www.sec.gov/Archives/edgar/data/1682852/000168285220...

[2] https://asgct.org/publications/news/november-2020/covid-19-m...

[DonsDiscountGas]

Your first link shows is about the FDAs legal definition, and I don't know what the second link is supposed to mean, other than somebody somewhere called it a gene therapy.

I have no commercial interest in any of this, and my opinion is that any definition of "gene therapy" which includes mRNA vaccines is overly broad. "Change the host genome" is clearly what the average person things when they hear "gene therapy", and legal definitions should match that.