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Should this really be called a “vaccine”? I feel like that is going to give people the wrong impression about what it does. I think labelling it gene therapy, i

Should this really be called a “vaccine”? I feel like that is going to give people the wrong impression about what it does. I think labelling it gene therapy, immune therapy, or something like that would be closer to what it actually does. 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.

satchlj 3y ago
Yes the word 'vaccine' seems misleading to me as well, as people tend to think of vaccinations as ways to prevent contagious illness. I think immune therapy is a much better term.
jph 3y ago
Yes this should really be called a vaccine. A vaccine is a preparation that stimulates the body's immune response against diseases. For example, a specific vaccine injection (such as a flu shot) can boost the body's own immune system to help protect against a specific disease (such as the year's flu variant).
- lumb63 3y ago
  All previous vaccines were aimed at preventing infectious diseases. None of them are (primarily) indicated for preventing recurrence of a non-infectious disease. Whether it meets the technical definition or not, we can probably agree this is fundamentally different to all other vaccines. 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.
  - chiefalchemist 3y ago
    The idea that marketed vaccines are safe & effective has been well marketed and deeply planted in the minds of the public. It's easier to leverage that familiarity than it is to build awareness and trust for "immunotherapy".
    - deleted 3y ago
      [deleted]
    - chiefalchemist 3y ago
      Down voted by those who don't understand marketing, human behavior, read the Heath Brother's "Made to Stick", etc.? Love you HN but you're jumping the shark.
  - jph 3y ago
    > All previous vaccines were aimed at preventing infectious diseases. 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.
    - Auracle 3y ago
      Well that’s just plain revisionist history. 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.
      - throwaway8877 3y ago
        No, covid vaccines were not kind of crappy, just the virus itself evolved so rapidly that the virus had evolved enough even before complete rollout of the vaccines. Yet even then the boosted vaccination was highly effective against the delta variant and still effective against omicron on the level par with flu vaccines. Omicron was just infectious on the level of measles and with very short incubation period giving the immune system very little time to ramp up the immune response.
        Auracle 3y ago
        I'd argue that a vaccine that allowed the virus to evolve rapidly out of it because it's only targeting on small section of the virus is pretty crappy by definition. 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.
- owlboy 3y ago
  Well, they could at least always say something like “…vaccine, but not like you are thinking. You, like billions of other people, have a misguided and frankly incomplete understanding of the word. …”
maxerickson 3y ago
Why do you wanna call a thing that stimulates an immune response to an antigen a gene therapy? 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.
- base698 3y ago
  Because it transcribes something from a gene?
  - DonsDiscountGas 3y ago
    That's not what gene therapy means. >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 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.
    - justsee 3y ago
      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/1682852/000168285220000017/mrna-20200630.htm https://www.sec.gov/Archives/edgar/data/1682852/000168285220... [2] https://asgct.org/publications/news/november-2020/covid-19-moderna-nih-vaccine https://asgct.org/publications/news/november-2020/covid-19-m...
Turing_Machine 3y ago
It is definitely not a gene therapy.
LorenPechtel 3y ago
It primes the immune system to be vigilant for certain patterns. That's a vaccine. It is not altering genes, it's not gene therapy. It is not otherwise boosting the immune system, it's not immune therapy. 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.

satchlj 3y ago

Yes the word 'vaccine' seems misleading to me as well, as people tend to think of vaccinations as ways to prevent contagious illness. I think immune therapy is a much better term.

jph 3y ago

Yes this should really be called a vaccine. A vaccine is a preparation that stimulates the body's immune response against diseases. For example, a specific vaccine injection (such as a flu shot) can boost the body's own immune system to help protect against a specific disease (such as the year's flu variant).

lumb63 3y ago
All previous vaccines were aimed at preventing infectious diseases. None of them are (primarily) indicated for preventing recurrence of a non-infectious disease. Whether it meets the technical definition or not, we can probably agree this is fundamentally different to all other vaccines. 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.
- chiefalchemist 3y ago
  The idea that marketed vaccines are safe & effective has been well marketed and deeply planted in the minds of the public. It's easier to leverage that familiarity than it is to build awareness and trust for "immunotherapy".
  - deleted 3y ago
    [deleted]
  - chiefalchemist 3y ago
    Down voted by those who don't understand marketing, human behavior, read the Heath Brother's "Made to Stick", etc.? Love you HN but you're jumping the shark.
- jph 3y ago
  > All previous vaccines were aimed at preventing infectious diseases. 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.
  - Auracle 3y ago
    Well that’s just plain revisionist history. 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.
    - throwaway8877 3y ago
      No, covid vaccines were not kind of crappy, just the virus itself evolved so rapidly that the virus had evolved enough even before complete rollout of the vaccines. Yet even then the boosted vaccination was highly effective against the delta variant and still effective against omicron on the level par with flu vaccines. Omicron was just infectious on the level of measles and with very short incubation period giving the immune system very little time to ramp up the immune response.
      - Auracle 3y ago
        I'd argue that a vaccine that allowed the virus to evolve rapidly out of it because it's only targeting on small section of the virus is pretty crappy by definition. 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.
owlboy 3y ago
Well, they could at least always say something like “…vaccine, but not like you are thinking. You, like billions of other people, have a misguided and frankly incomplete understanding of the word. …”

maxerickson 3y ago

Why do you wanna call a thing that stimulates an immune response to an antigen a gene therapy? 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.

base698 3y ago
Because it transcribes something from a gene?
- DonsDiscountGas 3y ago
  That's not what gene therapy means. >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 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.
  - justsee 3y ago
    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/1682852/000168285220000017/mrna-20200630.htm https://www.sec.gov/Archives/edgar/data/1682852/000168285220... [2] https://asgct.org/publications/news/november-2020/covid-19-moderna-nih-vaccine https://asgct.org/publications/news/november-2020/covid-19-m...

Turing_Machine 3y ago

It is definitely not a gene therapy.

LorenPechtel 3y ago

It primes the immune system to be vigilant for certain patterns. That's a vaccine. It is not altering genes, it's not gene therapy. It is not otherwise boosting the immune system, it's not immune therapy. 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.