Also really interested to see if people will need and/or benefit from periodic re-treatment. I guess they can figure that part out if it makes it to market.
Also, since no other vaccines are custom to each patient, using the term “vaccine” could cause confusion. Do we really want to give people the idea that they can be “vaccinated against melanoma” when the reality is that they can receive a treatment to prevent their specific melanoma, which they have to have already had, from recurring? It seems laden with confusion. Personally, I’ll just call it immunotherapy.
This is a common misconception, and that's whythe U.S. CDC is now emphasizing that vaccines can do more to help people.
The most important recent example is the world's widespread rollout of COVID vaccines. These are primarily aimed at better protection against severe illness, hospitalization, and death; these are not primarily aimed at preventing an individual from ever being infected by any COVID variant.
Name another example. The flu vaccine, maybe? But that’s because they don’t know which strains to target.
Both the CDC director at the time and Biden said the vaccine would prevent you from getting COVID.
It’s insane we’re changing the definition of words because the COVID vaccines were kinda crappy and that would be bad politically.
Not that the vaccine discussed here shouldn’t be called one - it absolutely is.
Don't get me wrong, it saved a lot of lives. Compared to every other vaccine we've all taken in our lives it's the absolute bottom of the barrel, and the fact that politically (and possibly for public health reasons) a good portion of politicians effectively lied about that made it so companies didn't feel like they should invest in making a better vaccine. I've had Covid twice and both times I was very sick - I'd love a better, more broad, vaccine.
I'd argue it's definitely not as effective as flu vaccines vs omicron. On a good year the flu vaccine can prevent 50% of flu cases in those that take it. Everyone I know has gotten Covid, vaccinated or not.
Omicron was considerably more virulent than flu - the risk of getting an infection is also a function of prevalence.
I'm not arguing that vaccines can't or shouldn't be much better. Just that they actually were considerably good if we take everything we should into account.
Sure, another example is the flu vaccine as you mention. The primary aim of the flu vaccine in the U.S. medical system is to protect high-risk people from life-threatening symptoms, even during infections from different strains.
Another example is the shingles vaccine. The primary aim is to prevent severe symptoms (such as neural damage and long term pain) during a reactivation of an existing chronic infection.
> It’s insane we’re changing the definition of words
The semantic meaning of the word vaccine hasn't changed. All that's changed is the U.S. CDC official definition text, to clarify that the primary aim of vaccines is to activate the body's immune system, rather than solely to prevent a new specific infection.
If you're curious about the language exactness, beyond the U.S. CDC, the U.S. FDA is also involved. For example, the U.S. FDA during COVID stated that a vaccine would need to be at least 50% effective for diminishing the severity of COVID-19 symptoms to obtain regulatory and marketing approval. In other words, the primary aim was to help people reduce damage; the primary aim was not to full-stop prevent infection.
It's using the same mechanism as vaccines (exposure to the proteins in question), it's utterly bizarre to conflate it with gene therapy.
It's probably reasonable to call it a vaccine based immunotherapy.
>In 1986, a meeting at the Institute Of Medicine defined gene therapy as the addition or replacement of a gene in a targeted cell type. In the same year, the FDA announced that it had jurisdiction over approving "gene therapy" without defining the term. The FDA added a very broad definition in 1993 of any treatment that would ‘modify or manipulate the expression of genetic material or to alter the biological properties of living cells’. In 2018 this was narrowed to ‘products that mediate their effects by transcription or translation of transferred genetic material or by specifically altering host (human) genetic sequences’
https://en.wikipedia.org/wiki/Gene_therapy#Classification
mRNA vaccines don't alter the host genome, hence not gene therapy. You could use a broader definition I suppose since (ideally) they lead to the production of certain immune cells; and that would also include all other vaccines.
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...
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.
In normal operation the genes are the master blueprints from which work orders (in the form of mRNA) are generated. The cells use that mRNA to build the requested proteins. The mRNA vaccines are bogus work orders slipped into the production queue and they go nowhere near the DNA.
If you think of the gene in RNA form (transcribed from DNA), it's a gene being translated to aminos. The gene is therapy.
I get gene therapy isn't used that way but I was trying to fairly interpret what people could mean.
The fact that it's target isn't realistically transmissible has no bearing on it's nature. We don't give people rabies vaccine to people to keep them from spreading it, either. In humans the R0 for rabies is exceedingly close to zero in any society that understands what rabies is.