[james4beach]

Both the Pfizer and Moderna vaccines use a completely new technology that is radically different than previous vaccines. None of us have ever taken a vaccine of this type before. I think that these two are the world's first vaccines that use mRNA technology, which have passed from human clinical trials to regulator approval.

mRNA injections into the body have been attempted by several pharma companies, but were mostly abandoned [article], because getting mRNA into cells had nasty side effects. Even Moderna struggled with the technology. Low doses were ineffective, and high doses were toxic to patients.

Previous attempts at mRNA-into-cells were unsafe, but it's great to see that the pharma company has solved the problems and made it safe ... and in record fast time!

This video explains the mechanics of the brand new technology

 

[Beaver101]

^ Very complex technology to understand even for someone who studied microbiology (a year or 2 in Uni but sadly a subject mostly forgotten).

I think the "key" to getting this type of vaccine to work (or elicit an immune response) is the development of the "lipid nano-technology" mechanism and its successful deployment.

Despite the vaccines have passed regulatory approval, (from my POV), I still see the use of these vaccines somewhat as being experimental since we really don't know what the "unknown" long term (even a couple of years) side effects . At the same time, do we have another choice (other than don't get the shots) given there is no other known vaccine that works and there's the urgency of quelling the pandemic.

Just hope (aka having faith, just like with flu shots) that these vaccines do work as intended on Covid19 + and possibly combating other future viral pathogens.

 

[Eclectic12]

Keep in mind that this "new technology" was demonstrated in mice in the '90's where a key issue was solved in 2005.

As for previous attempt being "unsafe" - the companies publishing human trial results as safe for rabies, influenza, cytomegalovirus and Zika mRNA vaccines would be surprised. Perhaps you are referring to the pre-2005 testing in animals where there mixed results with a few successes and safety issues?

It's not the level of confidence as getting a licensed vaccine that has made it through all levels of trials but it is different than the blanket "previous attempts were unsafe" implies.


Cheers

 

[Eclectic12]

... Despite the vaccines have passed regulatory approval, (from my POV), I still see the use of these vaccines somewhat as being experimental since we really don't know what the "unknown" long term (even a couple of years) side effects ...

Sort of ... there are people walking around who were injected with the mRNA rabies vaccine candidate in 2013 so there is more history for the method in humans than most articles imply.

Cheers

 

[Beaver101]

Keep in mind that this "new technology" was demonstrated in mice in the '90's where a key issue was solved in 2005.

As for previous attempt being "unsafe" - the companies publishing human trial results as safe for rabies, influenza, cytomegalovirus and Zika mRNA vaccines would be surprised. Perhaps you are referring to the pre-2005 testing in animals where there mixed results with a few successes and safety issues?

It's not the level of confidence as getting a licensed vaccine that has made it through all levels of trials but it is different than the blanket "previous attempts were unsafe" implies.


Cheers

... are you saying that the current annual flu vaccine uses this same technology? Since I haven't been following the specifics. If so, then most of us will be eagerly be rolling up our sleeves when it becomes available to us. And I would expect the # of anti-vaxxers (if not shut up on protesting) to come down, possibly dramatically.

 

[sags]

I think people see all the ads from lawyers suing drug companies for bad side effects and it leaves them wondering about this vaccine won't be the same years down the road.

I doubt it........but a constant bombardment of those ads chips away at public confidence.

 

[bgc_fan]

... are you saying that the current annual flu vaccine uses this same technology? Since I haven't been following the specifics. If so, then most of us will be eagerly be rolling up our sleeves when it becomes available to us. And I would expect the # of anti-vaxxers (if not shut up on protesting) to come down, possibly dramatically.

The current annual flu vaccine doesn't use this technology. The CDC has a site with an explanation of the types of flu vaccines: How Influenza (Flu) Vaccines Are Made | CDC

mRNA vaccines have been researched, so they aren't new in that sense. However, they hadn't offered much advantage over the existing vaccines due to the disadvantage of cold storage.

But, once you sequence the virus genome, and isolate the spike protein sequence, you can cut and paste into the mRNA delivery vehicle which means you can theoretically develop a vaccine faster than the traditional methods.

 

[Beaver101]

^ Okay, thanks for the link and the quick point(s).

 

[james4beach]

Keep in mind that this "new technology" was demonstrated in mice in the '90's where a key issue was solved in 2005.

You're using the term 'demonstrated' pretty loosely here. Yes, the concept was demonstrated long ago, it's not a new idea.

What I'm saying is that no national regulator (such as the FDA) has ever approved an mRNA [using lipid nanoparticle / LNP ] vaccine before, as safe for the general public. The bar for FDA approval are multiple large scale clinical trials, plus impartial review.

The covid vaccines are the first -- of this mRNA technology -- to ever be approved by national regulators as "safe". And that only happened under pressure to hurry the process.

Sort of ... there are people walking around who were injected with the mRNA rabies vaccine candidate in 2013 so there is more history for the method in humans than most articles imply.

There are 'people walking around' with all kinds of experimental and potentially dangerous drugs in their system. But that was a tiny, 100 person, early phase clinical trial. The question is whether impartial, non-pharma company regulators ever believed it was safe and approved it.

This experimental and unproven drug you are referring to is called CV7201, from CureVac. Here's a release that describes that mRNA based rabies vaccine. The company which creates the drug says they believe it is safe based on 101 adults in the study.

You are introducing some spin here, @Eclectic12 . CV7201 has not made it to Phase 2 trials, not Phase 3, and has not been approved as safe by the regulator. The bar for 'safe' is very high.

Of course, drug companies are much quicker to claim something is "safe". I'm not interested in what the drug company claims is safe. Here's a press release from both the Pfizer covid partner and CureVac (the rabies drug co), both pressuring the federal regulator to lower the bar on clinical trials.

 

[james4beach]

Some other COVID vaccines being developed in the world use traditional vaccine technology instead of mRNA. China's Sinovac developed CoronaVac, which like all the influenza vaccines we've previously used, are based on dead or inactivated virus. This is the traditional vaccine tech and uses an old, very well proven technology.

From the BBC article: "mRNA vaccines are a new type of vaccine and there is [currently] no successful example [of them] being used in the population," Prof Luo adds.

I just want to recap this to be crystal clear because I think it's important:

Pfizer and Moderna vaccines use mRNA : a relatively new technology which has never been tested in large-scale human trials (source), and never been approved by government regulators up until a few days ago, and has never been used in the broad population until now.

Some others like SinoVac use dead virus : the old fashioned vaccine technology used in all flu shots. This technology has seen large scale human trials and has also been used on hundreds of millions, if not billions, of people worldwide

 

[Retired Peasant]

James, do you ever go a day without worrying about something? By the time vaccinations get around to your age group, mRNA will have been used on millions; also by that time SinoVac et al may be approved.
Chill.
Merry Christmas

 

[james4beach]

Seeking good scientific information has nothing to do with worrying. I have found this important information and am sharing it with others, because it clearly is not well known.

What I posted above came from conversations I've had in the last few days through relatives and their friends, doctors who work in immunology.

 

[Retired Peasant]

You do seem to worry a lot, and this was another example. It is well known to anyone who's been paying attention.

 

[sags]

I am wondering about this blood replacement therapy that Trump, Christie, Grassley and other high profile American politicians seem to receive.

All these politicians are in the high risk group and don't appear to have suffered the worst symptoms of their COVID infection.

Why isn't THAT therapy widely available to people with COVID ?

 

[james4beach]

You do seem to worry a lot, and this was another example. It is well known to anyone who's been paying attention.

It is not well known at all. Many people assumed this is just another, regular vaccine. And I seriously doubt most people (even those who heard this was a new technology) were aware that there have never been any large-scale human clinical trials with mRNA, or anything beyond Phase 1 trials.

Even I started off thinking this was a pretty typical vaccine. My original reasoning was: I never hesitate to get the annual flu shot, how is this any different? It turns out this one is very different.

When I learned of mRNA, I also incorrectly assumed that all covid vaccines would be mRNA tech. Not so. There are some traditional vaccines under development.

All these politicians are in the high risk group and don't appear to have suffered the worst symptoms of their COVID infection.

While some of the highest profile politicians survived it, we shouldn't forget that many politicians have actually died of the disease:

• Herman Cain (74), prominent Republican died of COVID
• David Andahl (55), newly elected Republican to ND, died before the election
• Roy Edwards (66), Republican in Wyoming, died
• Dick Hinch (71), Republican in NH
• Jerry Relph (76), Republican in MN
• Reggie Bagala (54), Republican in Louisiana
• Johnny Lee Baynes (64) of a local supreme court
• Stephen Fain Williams (83), a federal judge

 

[Eclectic12]

... are you saying that the current annual flu vaccine uses this same technology? Since I haven't been following the specifics ...

There's no reference to the mRNA influenza vaccine from being added to the annual flu vaccine so I don't think so.

The point is that contrary to "it's never been used before in humans" and "this is the first one of it's type that seems safe", it is the product of a long history instead of something dreamed up overnight.

... If so, then most of us will be eagerly be rolling up our sleeves when it becomes available to us. And I would expect the # of anti-vaxxers (if not shut up on protesting) to come down, possibly dramatically.

Some anti-vaxxers are against vaccines with a lot longer history, many more human subjects and a lot of follow up attention so I'm not so sure being in use would do much to convince them. I could be wrong though.

Cheers

 

[OptsyEagle]

You do seem to worry a lot, and this was another example. It is well known to anyone who's been paying attention.

If J4C didn't have any questions or concerns, why would he take the time to bring us this useful information. At least he didn't keep what he found out all to himself.

I do wish people would address their replies to the post and not the poster. Posters you don't like or get much from can simply be passed over or ignored.

Personally, I found this thread very interesting. I doubt it will change my opinion on getting vaccinated, since the danger from Covid-19 certainly still overwhelms the danger, that I can ascertain now, that might come from this vaccine. That said, I do like all the information I can get before I make important decisions.

 

[Eclectic12]

mRNA vaccines have been researched, so they aren't new in that sense. However, they hadn't offered much advantage over the existing vaccines due to the disadvantage of cold storage.[/QUOTE]Which may be why none of the mRNA candidates have been licensed.
Just like the SARS traditional method vaccine candidates in storage, practical/economic considerations instead of safety issues stopped the process.

Heck ... for the ;90's to 05 work, the safety challenge was considered too much of a problem so that funding was sparse and the prime person was demoted at her university.

... But, once you sequence the virus genome, and isolate the spike protein sequence, you can cut and paste into the mRNA delivery vehicle which means you can theoretically develop a vaccine faster than the traditional methods.

Theoretically?

My understanding is that traditional method vaccines take a year or more before testing on animals. With these two going through design, testing in animals, multiple phases of human testing in close to a year - it seems more proven than theory to me.


Cheers

 

[Retired Peasant]

It is not well known at all.

I'm sorry I upset you; forget I said anything at all.

 

[james4beach]

Personally, I found this thread very interesting. I doubt it will change my opinion on getting vaccinated, since the danger from Covid-19 certainly still overwhelms the danger, that I can ascertain now, that might come from this vaccine. That said, I do like all the information I can get before I make important decisions.

That's the real question. One has to balance the health risk versus benefits. There are some risks/uncertainties with mRNA vaccines, since they have never been tested on large populations of humans. On the other hand, we know with certainty that COVID is very dangerous (especially to those over age 60). For many people, taking the mRNA vaccines is a no-brainer.

But the story might change if you're talking about someone under 50 or under 40, perhaps. Here I would wonder: how much risk does COVID pose to the person? And how does that balance against the risks of mRNA vaccines and lipid nanoparticles (LNP), including the synthetic ingredients?

I asked my immunologist friend what happens to the LNP (the synthetic delivery vehicle) in the body. Could they have any toxic or lasting effects? He said he does not know -- nobody knows. So before taking Pfizer/Moderna, you have to decide whether you are willing to take that risk.

For many people the answer will be: absolutely yes, I'm willing to take that risk, because COVID is so much more dangerous.