Wouldn't this be the first mRNA vaccine approved for the public?
I know very little about the pharmaceutical underpinnings of mRNA vaccines and how theoretically likely adverse long-term results are, but I do think caution by laymen is not unwarranted for a new type of vaccine that has been fast-tracked through trials (albeit for good reason!)
I understand that, I just have concerns regarding the safety of this particular vaccine. They say it is revolutionary, but if this is really that, then is this not a new vaccine with unknown long-term risks? I read this on CDC's website: "There are currently no licensed mRNA vaccines in the United States. However, researchers have been studying them for decades.". This is not too convincing still.
We also don't know what the adverse reactions to this one are likely to be. mRNA vaccines are very new, and they've never been approved for human use before. If there are long-term adverse side effects, we don't know what they are.
> Given the novel nature of the mechanism of action of RNA vaccines, and their drug delivery vehicles, little is known about the medium and longer-term side effects.
> Up until December 2020, no mRNA vaccine, drug, or technology platform, had ever been approved for use in humans, and before 2020, mRNA was only considered a theoretical or experimental candidate for use in humans.
My main concern is reading that there are no mRNA vaccines on the market but this would be the first. Really want to believe and hope in this vaccine but there are some red flags.
Well, mRNA vaccines have been in development for a number of years, unsurprisingly. It was first identified as a treatment vector in the 80s, and started development for vaccines in about 2008 AFAICT, with human trials for some of them (a prospective cancer vaccine from what I can tell) going back about ten years.
> When was the first time that any mRNA vaccine has been approved for human use?
Approved for widespread use? Certainly, this is the first, but that doesn't mean we don't have useful data on the likely effects.
Yes but these are known variables. Hypothetically the newer mrna vaccines should be safe .... but there honestly is no long term information. A MRna vaccine has never been approved for human use until now.
Thanks for the additional context. This is interesting because the has been some worry about the safety of the new and relatively untested mRNA technology, but this makes it seem like traditional vaccines are just that with extra steps. Should that be a license to feel safer about mRNA?
Help me understand what risk you're concerned about. Have there been other mRNA vaccines where an adverse effect showed up in general use that wasn't caught in clinical trials?
No mRNA vaccine has been approved before, but from clinical trials of mRNA vaccines dating back to 2008 [1] there’s evidence of short-term side effects but no reason to suspect long-term safety concerns. mRNA vaccines don’t present the risk that attenuated vaccines pose to immunocompromised individuals or pregnant women, and they don’t stay in the body long enough to be a long-term threat. We can’t guarantee 100% because our bodies are complex, but I wouldn’t characterize it as “significant increased risk” for people under (or over) 40.
One other factor to consider is that this is an mRNA vaccine, which is of a newer generation of technology in vaccine production.
From what I've read it is the first large scale adoption of mRNA vaccines so the really long term risks are less known. That said, theoretically mRNA vaccines should have a lot of advantages. Later in 2021 there may be a few other options for vaccines to take as well, so I'd do some research at least.
So I've heard this is will be the first mRNA vaccine on the market, ever. How worried should I be, given the political pressure to get a COVID19 vaccine to market as quickly as possible?
> It is a new type called an mRNA vaccine...An mRNA vaccine has never been approved for use in humans before, although people have received them in clinical trials.
Wait... This doesn't scare anybody?
Why has this not been approved before?
Would an mRNA vaccine be approved under less pressing circumstances...?
Exactly. The vaccines did not go through the FDA’s typical approval process, they got emergency approval, but the standard approval process is still ongoing. mRNA vaccines have never been used in a large scale setting outside of clinical trials before. Are they safe? Almost certainly. Do we know that for sure yet? No. Do the benefits outweigh the risks? For me, yes.
It's also not like this is the first vaccine, or even the first mRNA vaccine. So we have analogs and precedents we can use. My understanding is that was heavily used in the clinical trials before roll out -- an understanding from previous vaccines that if someone majority were to go wrong it would go wrong in the first few months, and not 5+ years later.
There was never a major mRNA vaccine roll out ever. mRNA possibly does not compare to traditional vaccines, there's evidence it is a different beast entirely.
Enough reason to be cautious, wait out the hidden/late-onset side effect, and not give it to those not too vulnerable to covid.
But authorities claim it's totally safe for all ages, while they have no data to back this up (that'd need a long trial, and those taking it ARE the long trial).
As far as I know the vaccine got emergency use authorization it is not fully approved by FDA yet and what I as a layman need to know about newly invented mRNA vaccine. Scientists say that it is not a gene therapy but what are long term consequences on human DNA of mRNA vaccine nobody knows or has examined as of today.
I know very little about the pharmaceutical underpinnings of mRNA vaccines and how theoretically likely adverse long-term results are, but I do think caution by laymen is not unwarranted for a new type of vaccine that has been fast-tracked through trials (albeit for good reason!)
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