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by justsomeadvice0 1239 days ago
Nit: mRNA vaccines were used in human trials for cancer immunotherapy starting in 2001, rabies in 2013, ebola, zika, influenza, cytamegalovirus, etc followed. It's not accurate to say the technology had "never been used in humans before" COVID19; but the US FDA had never approved widespread use of it until then.
3 comments

> approved widespread use

This conflates 'approved' with the ongoing emergency use authorization. Long term studies will help determine if it can be approved for normal use and effectiveness is part of that determination.

good point
Fair enough, I overstated my case, thanks. I hope the intention, that they are an untested technology compared to traditional vaccination, is not lost though.

This vax technology is super impressive and promising. I would like to see it succeed, hopefully in a way that some of the loss in public trust can be restored.

This raises the question of why, despite being trialed for twenty years, the technology never was deemed ready for primetime until the emergence of COVID. Part of the reason is safety issues.

https://www.statnews.com/2017/01/10/moderna-trouble-mrna/

We assumed that the vaccine doses are low enough to not cause any unacceptable health risks, but after finding these vaccines do cause cardiac complications, particularly in youth, we are hesitant to consider that these vaccines may in fact do more harm than good in some cases.

You linked to an article wherein the company itself deemed its own research into a different mRNA-type vaccine for a separate disease as not yet safe for human trials. This sounds like the type of caution you want to see from a vaccine research company.

Personally I would speculate the much larger "part of the issue" was that there was never any real need to seek authorization for mRNA vaccines in the US before COVID19, as alternatives for their targets existed. I would also speculate cardiovascular issues in mRNA COVID19 vaccines (which are real certainly) have something to do with spikey proteins in your bloodstream, and one can imagine what a more prevalent spikey virus might do to the same person. But I am not a doctor or medical researcher, just some guy on the internet who reads things; so I would not really put any stock into my speculations.

edit: my point is: it's good to be skeptical of things. Yes. It's not good to share inaccurate information, as the post above yours did.

> I would also speculate cardiovascular issues in mRNA COVID19 vaccines (which are real certainly) have something to do with spikey proteins in your bloodstream...

All COVID vaccines deliver spike proteins into your bloodstream, but not all of them substantially raise the risk of Myocarditis.

> ...and one can imagine what a more prevalent spikey virus might do to the same person.

Imagination is not enough, we're going to need some hard data. COVID vaccines don't prevent infection. Is there a net risk reduction? This is further complicated by underestimating the number of COVID infections. Many studies presume to have found a higher risk of Myocarditis with COVID infection, but these cases tend to be biased towards health care settings. For comparison, the difference between infection fatality rate and case fatality rate may be an order of magnitude. In this study, COVID was not associated with an increased risk of Myocarditis in the unvaccinated:

https://pubmed.ncbi.nlm.nih.gov/35456309/

> Imagination is not enough, we're going to need some hard data

Yes and I literally agree with you in my post. The problem is, as you admit, that data exists to point toward either conclusion; then you immediately speculate that the difference must be because:

> these cases tend to be biased towards health care settings

Unless you get 100% of infections tracked, the risk from COVID will always be measured to be higher than the true risk. That part is not speculation.

Also, if a large study measured no effect, there likely is no effect, even if troves of smaller studies disagree. Publication bias.

I’m confused by your link. It describes Moderna trying to use a drug to produce a liver enzyme and that was never safe, so Moderna ended up lowering their expectations with the safer and less profitable vaccines. If anything it shoes vaccines are the way to go with mRNA and the primary issue is profit.
Again, it was just an assumption that vaccines would be "safe enough", despite no mRNA vaccine having ever been rolled out at scale. The "profit" issue disappeared with COVID vaccines. You now have the FDA proposing annual COVID boosters and combined mRNA-COVID/Influenza shots for everyone, whereas European countries are age-restricting COVID boosters. If that doesn't smell like regulatory capture to you, you might suffer from COVID-induced anosmia.
You’re saying a lot to dodge the fact you made a claim using a source that doesn’t actually back your claim. You claimed this article showed mrna vaccines weren’t widely distributed because they weren’t considered safe. But this article isn’t saying that and all, and you’re misrepresenting it.
I never made this claim. I said the technology had safety issues, which the article supports. In the following paragraph, I claim that mRNA vaccines were assumed to be safe enough due to the lower dosage. Again, the article supports this.
> Again, it was just an assumption that vaccines would be "safe enough", despite no mRNA vaccine having ever been rolled out at scale.

Why is this a criterium we should pay attention to? If you never roll anything out, you'll never have data about a roll out. So instead we do studies and statistical analyses. Are you aware of any studies that "normal"/previous vaccines had to go through, which mRNA COVID vaccines did not? If so, could you please share them?

I'm not aware of any approved vaccine where the observation period in the RCT was a mere four months and the control group was vaccinated thereafter. If there is another such vaccine, I would be hesitant to take that one as well.

There's no controlled experiment to suggest that mRNA vaccines provide a survival advantage to a healthy individual. The brief RCTs certainly don't support it. The increased cardiac risk, small as it may be, may well put the vaccine into negative benefit territory for some, but we'll probably never know for sure, because none of our data is robust enough to draw such conclusions.