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Moderna's mRNA cancer vaccine works better than thought

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Re: Moderna's mRNA cancer vaccine works better than thought

#191

Post by justsee »

DonsDiscountGas wrote: post #183
base698 wrote: post #169

Earlier quoted context omitted.

Because it transcribes something from a gene?

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…

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...

Re: Moderna's mRNA cancer vaccine works better than thought

#192

Post by beowulfey »

jonhohle wrote: post #180
beowulfey wrote: post #155

Earlier quoted context omitted.

That's not the definition of a vaccine. A vaccine is something that registers our active immune system against an antigen, so that our body detects and eradicates it upon detection. The timing doesn't really matter and there are a lot of therapeutic vaccines [1]. [1] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9729511/

I took it as the literal and previously accepted definition was uniformly changed by both government and secular organizations in near unison. As late as January 2021 vaccines were thought of as dead pathogens - https://web.archive.org/web/20210118194713/https://www.merri...

it started as live pathogens (cowpox) so it must have gone through many iterations if that were the case

Re: Moderna's mRNA cancer vaccine works better than thought

#193

Post by labster »

beowulfey wrote: post #192
jonhohle wrote: post #180

Earlier quoted context omitted.

I took it as the literal and previously accepted definition was uniformly changed by both government and secular organizations in near unison. As late as January 2021 vaccines were thought of as dead pathogens - https://web.archive.org/web/20210118194713/https://www.merri...

it started as live pathogens (cowpox) so it must have gone through many iterations if that were the case

Live poliovirus vaccine continues to be used, and continues to cause occasional active cases and transmission.

Re: Moderna's mRNA cancer vaccine works better than thought

#194

Post by signatoremo »

bugglebeetle wrote: post #174
reissbaker wrote: post #167

Earlier quoted context omitted.

IMO they resulted in massive reductions of death across the world. In a world where pharma companies needed to surrender their IP if it was too useful, Moderna wouldn't have gotten funded to pioneer this new and difficult technology, and mRNA vaccines simply wouldn't exist. Having publicly-funded research doesn't mean you can ignore profit either — the public funding for mRNA was that the initial research was done at…

A long wall of obfuscation and pharmaceutical industry apologetics that can be trivially dismissed by simply pointing at myriad other vaccines that were also publicly-funded, are not constrained by IP, and saved millions of lives. Your last point is also hysterical because yes, the research needs massive investment, the state provides it, and then allows private companies to run off with it and charge them again for…

> Your last point is also hysterical because yes, the research needs massive investment, the state provides it, and then allows private companies to run off with it

A research is only the beginning. It usually takes many years and lot of investment to bring a drug to the market. There is also high risk that none of the investment will be recouped. That’s the role that private companies can do well. They don’t just “run off with it”.

ASML, for example, benefits heavily from EUV research done in the US with public fund. Yet you can’t say they ran off with it. They invested heavily, and it took them many years to perfect the technology.

Re: Moderna's mRNA cancer vaccine works better than thought

#195

Post by pseudalopex »

jonhohle wrote: post #180
beowulfey wrote: post #155

Earlier quoted context omitted.

That's not the definition of a vaccine. A vaccine is something that registers our active immune system against an antigen, so that our body detects and eradicates it upon detection. The timing doesn't really matter and there are a lot of therapeutic vaccines [1]. [1] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9729511/

I took it as the literal and previously accepted definition was uniformly changed by both government and secular organizations in near unison. As late as January 2021 vaccines were thought of as dead pathogens - https://web.archive.org/web/20210118194713/https://www.merri...

Merriam Webster's old definition did not exclude therapeutic vaccines. But it did exclude vaccines prepared from viruses.[1]

Probably you heard about diphtheria and tetanus vaccines before 2020. They are prepared from toxins.

Other definitions did not restrict what a vaccine must contain.[2]

[1] http://web.archive.org/web/20190118214500/https://www.merria...

[2] https://web.archive.org/web/20160402152957/https://www.dicti...

Re: Moderna's mRNA cancer vaccine works better than thought

#196

Post by bugglebeetle »

signatoremo wrote: post #194
bugglebeetle wrote: post #174

Earlier quoted context omitted.

A long wall of obfuscation and pharmaceutical industry apologetics that can be trivially dismissed by simply pointing at myriad other vaccines that were also publicly-funded, are not constrained by IP, and saved millions of lives. Your last point is also hysterical because yes, the research needs massive investment, the state provides it, and then allows private companies to run off with it and charge them again for…

> Your last point is also hysterical because yes, the research needs massive investment, the state provides it, and then allows private companies to run off with it A research is only the beginning. It usually takes many years and lot of investment to bring a drug to the market. There is also high risk that none of the investment will be recouped. That’s the role that private companies can do well. They don’t just “r…

Refer, again, to the example of Cuba’s COVID vaccine.

Re: Moderna's mRNA cancer vaccine works better than thought

#197

Post by LorenPechtel »

bawolff wrote: post #7
squarefoot wrote: post #2

If this turns out to work as promised, in a idealistic universe, Moderna gets a big influx of money from all countries in the world and they immediately publish details and surrender any patent allowing the treatment to be produced worldwide and be affordable for everyone.

I imagine an individually customized vaccine would still be expensive even if produced at-cost. Things get cheap when they can be mass produced.

From what they said it doesn't actually need to be individually produced. Rather, there are 34 possible targets, which ones are actually used depends on the patient's cancer. You aim at the targets which the tumor expresses, the others would simply cause side effects for no gain.

Thus, instead of custom manufacture your distribution system is 34 separate compounds, the patient receives whatever combination would be best for their tumor. Probably not viable at the ordinary pharmacy level, but viable at the cancer center level or a compounding pharmacy.

Re: Moderna's mRNA cancer vaccine works better than thought

#198

Post by mcmoor »

Terr_ wrote: post #115
JumpCrisscross wrote: post #25

Earlier quoted context omitted.

> bar for side effects is much stricter for preventative treatments like vaccines These vaccines are for treatment. They don’t prevent cancer. They treat it. They’re vaccines because they work by arming your immune system versus doing the fighting themselves.

A comparison with rabies vaccine may be useful here. On the scope of the entire human body, the virus usually enters first, before the vaccine is used. However on the scope of individual tissues and cells, the vaccine is often the first on the scene, prepping your cells before the (sneaky, slow) virus makes its main attack.

From what I've heard it's still usually "preventative" because we can't confirm that the rabies infection will successfully infect until it's too late. So we vaccine anyone with (very) likely case.

Re: Moderna's mRNA cancer vaccine works better than thought

#199

Post by LorenPechtel »

oldgradstudent wrote: post #182
blackbear_ wrote: post #136

Earlier quoted context omitted.

Vaccines are not intended to prevent people from getting the disease. Their purpose is to make the body defeat the disease faster while taking less damage.

This claim would come as a great surprise to the FDA, as they approved it soley for prevention of COVID.

No vaccine in existence actually prevents infection. Rather, it primes the immune system so the battle is typically a total rout, the invader losing very quickly and the patient never noticing. That's what they got against Covid/Wuhan and the world actually did achieve herd immunity--against Covid/Wuhan. (The Wuhan strain has been extinct for some time.)

Unfortunately, it turned out to mutate quite rapidly (like the flu) and soon the battles weren't always a rout. It still reduces severity, though, and thus is still used.

Re: Moderna's mRNA cancer vaccine works better than thought

#200

Post by LorenPechtel »

SV_BubbleTime wrote: post #147
lame-robot-hoax wrote: post #132

Earlier quoted context omitted.

Why is that the question to ask?

Maybe we found out in 20 years there is an mRNA to DNA long term issue? Maybe it’s good to not just one-path cancer treatments?

Our body has been using mRNA for at least hundreds of millions of years if not billions. (I'm not going to bother to look up how far back it goes.) We have DNA to mRNA proteins, we do not have mRNA to DNA proteins.

Why should our body suddenly start doing something that has never happened? The mRNA vaccines are simply slipping some bogus production orders into the job queue, they go nowhere near the master blueprints. There are various forces that would like you to believe otherwise. Mostly originating in Beijing and Moscow.

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