Hey guys- This data leak looks like the work of a misinformation campaign. The very first thing this article says is the data is from a cyberattack on European Medicines Agency (EMA), and the data was sent anonymously to journalists. A Reuters article claims that the Russian and Chinese are behind this: https://www.reuters.com/article/us-eu-cyber/russian-chinese-.... May be it's true that there is mRNA instability, but the efficacy data says the Moderna vaccine works extremely well. mRNA in intrinsic in your cellular biology with all of its instability, and your body manages to deal with it just fine.
> May be it's true that there is mRNA instability, but the efficacy data says the Moderna vaccine works extremely well
The efficacy data was based on clinical trial batches though, and the challenge seemed to be with lower manufacturing quality in the large scale commercial batches : "changes were made in their processes to ensure that the integrity was improved and brought in line with what was seen for clinical trial batches."
To be honest, we do also have real world data now (Israel mainly) that confirms the benefit/risk balance to be extremely good.
From https://www.ema.europa.eu/en/news/cyberattack-ema-update-6 the EMA has acknowledge that the individual emails are authentic, though "data from different users were selected and aggregated, screenshots from multiple folders and mailboxes have been created and additional titles were added by the perpetrators in a way which could undermine trust in vaccines."
>This data leak looks like the work of a misinformation campaign. The very first thing this article says is the data is from a cyberattack on European Medicines Agency (EMA), and the data was sent anonymously to journalists
What exactly of the above makes this a "misinformation campaign" (a term so vague as to be misinformation itself)? Nowhere in what you say above says the data are falsified or wrong.
Hackers have leaked data from organizations almost as long as there were computers - and giving them to journalists and/or posting them just as often. People also did it before computers.
The difference being that then we saluted getting access to raw data, whereas now we are being conditioned to consider them "misinformation".
instability of mRNA is not an issue under the following proviso, the truncated fragments of the whole mRNA must not destroy the structure of the epitope regions; and beyond this level there are still PAMPs [pathogen associated molecular patterns] that will trigger an immune response pathway as well. https://en.wikipedia.org/wiki/Innate_immune_system
> Hey guys- This data leak looks like the work of a misinformation campaign.
Setting aside the misinformation / disinformation rhetoric for a moment, a product that gets injected in virtually every human being alive needs to go through a generous amount of scrutiny to ensure it works as intended and does not cause more harm than good.
Biotech is a vastly complex field and taking the stance of "it works, trust me" is not exactly wise.
The leaked information requires analysis to identify the valid and relevant parts which should be treated as feedback for health policies and vaccine development.
> The very first thing this article says is the data is from a cyberattack on European Medicines Agency (EMA), and the data was sent anonymously to journalists.
It could just as likely be a hacker acting out of altruism, similarly to the one who broke into that italian company a few years ago. If someone didn't trust that the megacorp was acting in good faith, what they did here is probably the most effective (though morally ambiguous) way to hold them accountable.
The only question now is, are we going to brush their work aside without examination, blithely labelling it "misinformation", without any further thought?
Everything looks like a misinformation campaign perpetrated by 'them' anymore. This well could be. It also might not be. The data could have been manipulated. It might not have been.
We do what we can with what information is offered to us. Lies, half-truths, and all.
Intactness of 55% vs 75% should make no real difference to your view either of efficacy or of danger. Because:
Efficacy: the mRNA vaccines have a large margin for error with respect to dose. 55% of several times more than enough is still more than enough.
Danger: suppose the danger of broken-up mRNA to increase linearly with the amount given. Then the increase of danger would be by a factor of (100-55)/(100-78) ~= 2. The substantiated near-term danger of Pfizer is very low. We're at 5.2 million people vaxxed in Israel now… Twice of very low is very low. In order to argue for "too much" danger you have to argue either for non-linearity or for long-term high danger. If you argue for the latter then you already think the danger to be high, so there's no real difference between your view now and your view before. If you want to argue non-linearity of danger then you are arguing for a very remarkable biological coincidence. You also have to explain why the occasional 5x overdoses, which happen when a someone is given a whole vial by mistake, don't seem to be doing any harm. Never mind that it would have come out in the animal trials.
Apologies, but I must have missed it when you said:
“If you want to argue non-linearity of danger then you are arguing for a very remarkable biological coincidence.“
What do you mean here? Can you give a bit more info?
Note, I am pretty well versed on nonlinearities from a mathematical-engineering point of view, but know very very little about biology. (If that’s of any use to know)
I had looked at these emails when they leaked.
To be clear: If you'd offer me one of those mRNA vaccines like right now I wouldn't hesitate for a second and take it.
But I do think this raises some questions around transparency. If the EMA has concerns about the production of these vaccines then I think this is something that should be discussed in public - so the scientific community can weight in and review this issue. If the EMA thinks that this is a solved issue - which the emails imply is what they thought before they authorized the vaccine - then that's what they should communicate.
It's a technical concern. Publishing will only cause fear and doubt.
In any case, it's a matter of weighing risks. Even if there's a 10⁻⁶ probability of complications, giving the vaccine and stopping serious illness/deaths is still a better decision overall. Even if it means hundreds of cases of complications across Europe. And then, the complications might turn out to be statistically difficult to discern from uniform random anyway.
A probability of 10⁻⁶ is difficult to conceptualize so if it is published with scary words, people might interpret it as "will probably happen to me". Then if that affects vaccine roll-out negatively, publishing might be a bad decision.
Millions of people in the UK have received the AZ vaccine, which has demonstrated safety and efficacy.
The efficacy metric means protection against infection, which is not complete. But as far as I've heard, not one person who has received either Pfizer or AZ has become seriously ill or died. In other words, it "flattens the curve" instantly.
You know you're in a cult when you must preface your fealty before voicing the softest of logical hardballs. This entire thread is 50% prefacing. We've lost our ability for true discourse.
Hey I'm all for the vaccine, but lets be real about it. Humans struggle with productization. Games, phones, cars, and everything else we make have problems initially (and frequently after any small changes) because we have to come up with a repeatable and robust process for producing, packaging, shipping, delivery, etc, which may have totally different requirements from prototyping and development. Furthermore, these processes have a myriad of unknown unknowns -- with failure points we don't anticipate until they happen (complex systems).
This is another (very very) complex system with a relatively untested technology in an extremely noisy deployment environment. Every user is running a different OS basically, and every deployment corrupts the deployment image to some degree (RNA breakdown). Problems were bound to occur, and yes, the extent of those challenges are likely being downplayed to avoid panic and to get people to take the vaccine.
On the question of motivation: global pandemic, billions in R&D spent, pressure from people on politicians, etc. The usual set of unavoidable human reasons to release products before they are 100% tested (since 100% testing can only really happen in the wild anyway). Combine that with politicization of every topic, and the inability of the public at large to handle any nuance (e.g. "there may be some problems in production, but we believe overall it is worth the risks and won't pose a major problem because of X, Y, and Z.")
> the agency told The BMJ that the levels of truncated mRNA “and the amounts of a potential protein produced by the truncated mRNA would be too low to constitute a safety risk.”
I still plan on getting vaccinated, but I always wondered about the failure modes of the mRNA as it decays and what materials it could produce. I'm hoping prions are not possible, but are they?
The story also asks what happens to the lipid nanoparticles, but I am wondering about another aspect of these crafted mRNA sequences. The "U" in the mRNA has been replaced 1-methyl-3’-pseudouridylyl, denoted by Ψ in their sequences. What happens to the Ψ and its byproducts as it decays or is metabolized?
prions are fairly specific sequences to begin with, and then there is the folding issue that apparently makes some prions an active concern, the most concerning being those that are autotemplates and replicate themselves. commonly prions are not digestible by protease enzymes, thus accumulate like a factory floor full of broken, off spec parts.
its not good odds at all to bet on a viral mRNA fragment spontaneously creating a prion protien sequence. this is not beyond the realm of possibilities however the probability nonexistent, compared to the probability that anyone at random could have a nasty interferon mediated cytokine cascade, and sequential inflamatory response to the virus.
>>The story also asks what happens to the lipid nanoparticles<<
these lipid particles are incorporated into the cell membrane during vesicular fusion. Expression of the mRNA results in S protien being expressed on the surface of this cell, Antibodies of complementary clonal type bind to this spike in numerous locations the now adulterated cell is labelled as antigenic thus is destroyed by macrophages, the pieces of this cell are then compared to the self/nonself portfolio of patterns and further antibodies are produced.
all the while this cell is in distress due to the presence of foriegn nucleotides and this incurrs an interferon mediated response that spreads among cells and likewise induces interferon response
> What happens to the Ψ and its byproducts as it decays or is metabolized?
I had the same question. What I found in a long paper about mRNA vaccines is that they do not really know, but they assume you'll be fine, since they didn't see any immediate effects and because the quantities are tiny.
The question is why we allow information about a patented innovation to be kept secret, when the very point of a patent is that the inventor gets exclusivity in return for disclosure.
> EMA says the leaked information was partially doctored, explaining in a statement that “whilst individual emails are authentic, data from different users were selected and aggregated, screenshots from multiple folders and mailboxes have been created, and additional titles were added by the perpetrators.”3
The article by the BMJ is responding to the leak as if the information within it is believed to be correct.
Is the EMA suggesting that this isn't the case or are they just telling us that it was editorialised by whoever disseminated it?
Doctored is the word you'd use if the contents have been changed in order to deceive people. However this could be an attempt at damage control if they want people to dispute the veracity of the leak.
Edit: Since I'm questioning the EMA here I'll add that "Vaccines are Good" and that we should await expert opinion before making idle speculation.
It looks like none of the data was actually altered. What actual difference does an additional screenshot make, or the renaming of a file, or the reshuffling of user files? If the data was valid before those changes, those kinds of changes aren't going to invalidate it.
They can easily show discrepancies by publishing everything without hiding the important information. But for some reason they don't. AFAIK they even haven't bothered to specifically indicate which parts exactly are not authentic.
I find this part highly suspicious and it calls into question the motives of the "leaker" and wisdom of publishing this article. If someone wanted to discredit the vaccine finding some internal document around a process failure (even a temporary one), doctoring parts of it to make it more dramatic, and finding someone who will write about it is a good way to go about it.
By the time the correction is published for the doctored material, or the matter is contextualized, the fear will have already spread.
Even the Clinton team tried to say the Wikileaks were doctored, despite the vast majority of them having a DKIM signature confirming their authenticity.
The ball is in EMA’s field now: they have to demonstrate the leaks are doctored.
There’s pretty damning information in there, it’s in their interest to demonstrate it’s false.
Is there a good way to test that an mRNA vaccine batch was stored improperly and in result has reduced efficiency? In the US supply chain may not be a problem, but if exported, in some countries it's possible that people will get near useless vaccine shots, thus hurting reputation of mRNA vaccines in general.
I hope it's not too political to say, that using tried and true methods is better in an emergency, shouldn't be time for experiments on people. mRNA vaccines seem to be more expensive and harder to store, so what are the benefits? Or who benefits?
It is worth being aware that according to the US state department, Russia and possibly other states are currently involved in vaccine disinformation campaigns.
I have taken the Moderna vaccine. So I'm obviously not an anti-vaxxer.
However, it does concern me to a great deal about all of this, and it reflects my previous worries. My biggest concern is that from the article, these mRNA strands appear to have not only degraded but formed into new "species". What if the mRNA causes the body to produce prions that leads to something like Mad Cow Disease? The fact that Moderna isn't saying anything is very disconcerting.
What the data leak tells us about mRNA vaccine: it is manufactured in the same fashion and by the same types of executives as Boeing 737 Max 8. “Ladies and gentlemen, fasten your seatbelts and prepare for takeoff”.
Not a "Data leak", it's a cyberattack plus editorialization/manipulation
Of course the details of drug approval are not "discussed in the open" because a) trade secrets b) the public doesn't know how sausages are made and can (and do) make a mountain out of a molehill
mRNA instability is probably not such a big deal. Sure you want a high number because that's going to cause the immune reaction, if you have a lower number it's potentially less targets. But having imperfect mRNA strands are not a big deal.
The vaccine does not have to be 100% "perfect", it has to be safer than the virus. I know where to take my chances.
Somehow I always have to think about the articles from a while ago covering Russian propaganda campaigns against Covid vaccines. Leaking emails would fit.
The risk profile for vaccines overlaps almost perfectly with the risk profile for COVID.
That is, the age groups most at-risk from the virus (ages 70+, with comorbidities) are also going to live the shortest, and so suffer from fewer side-effects as well as not reproducing.
So why aren't the rollouts focused on vaccinating the elderly first? By the time this is done the kinks will be ironed out.
There certainly was a large effort to reach the elderly first. For a host of reasons though the population was not vaccinated 100%. Issues with scheduling appointments, getting people to clinics, doubts over safety, etc. At some point the number of doses still coming in is increasing but the number of those for example 70+ began to dwindle and so it has to opened up so these doses can be put in people’s arms.
[+] [-] rediguanayum|5 years ago|reply
[+] [-] renaudg|5 years ago|reply
The efficacy data was based on clinical trial batches though, and the challenge seemed to be with lower manufacturing quality in the large scale commercial batches : "changes were made in their processes to ensure that the integrity was improved and brought in line with what was seen for clinical trial batches."
To be honest, we do also have real world data now (Israel mainly) that confirms the benefit/risk balance to be extremely good.
[+] [-] pjo90|5 years ago|reply
[+] [-] coldtea|5 years ago|reply
What exactly of the above makes this a "misinformation campaign" (a term so vague as to be misinformation itself)? Nowhere in what you say above says the data are falsified or wrong.
Hackers have leaked data from organizations almost as long as there were computers - and giving them to journalists and/or posting them just as often. People also did it before computers.
The difference being that then we saluted getting access to raw data, whereas now we are being conditioned to consider them "misinformation".
[+] [-] rolph|5 years ago|reply
[+] [-] alexbiet|5 years ago|reply
Setting aside the misinformation / disinformation rhetoric for a moment, a product that gets injected in virtually every human being alive needs to go through a generous amount of scrutiny to ensure it works as intended and does not cause more harm than good.
Biotech is a vastly complex field and taking the stance of "it works, trust me" is not exactly wise.
The leaked information requires analysis to identify the valid and relevant parts which should be treated as feedback for health policies and vaccine development.
[+] [-] generalizations|5 years ago|reply
It could just as likely be a hacker acting out of altruism, similarly to the one who broke into that italian company a few years ago. If someone didn't trust that the megacorp was acting in good faith, what they did here is probably the most effective (though morally ambiguous) way to hold them accountable.
The only question now is, are we going to brush their work aside without examination, blithely labelling it "misinformation", without any further thought?
[+] [-] boobabooba|5 years ago|reply
[deleted]
[+] [-] crocodiletears|5 years ago|reply
We do what we can with what information is offered to us. Lies, half-truths, and all.
[+] [-] topynate|5 years ago|reply
Efficacy: the mRNA vaccines have a large margin for error with respect to dose. 55% of several times more than enough is still more than enough.
Danger: suppose the danger of broken-up mRNA to increase linearly with the amount given. Then the increase of danger would be by a factor of (100-55)/(100-78) ~= 2. The substantiated near-term danger of Pfizer is very low. We're at 5.2 million people vaxxed in Israel now… Twice of very low is very low. In order to argue for "too much" danger you have to argue either for non-linearity or for long-term high danger. If you argue for the latter then you already think the danger to be high, so there's no real difference between your view now and your view before. If you want to argue non-linearity of danger then you are arguing for a very remarkable biological coincidence. You also have to explain why the occasional 5x overdoses, which happen when a someone is given a whole vial by mistake, don't seem to be doing any harm. Never mind that it would have come out in the animal trials.
[+] [-] tobmlt|5 years ago|reply
“If you want to argue non-linearity of danger then you are arguing for a very remarkable biological coincidence.“
What do you mean here? Can you give a bit more info?
Note, I am pretty well versed on nonlinearities from a mathematical-engineering point of view, but know very very little about biology. (If that’s of any use to know)
[+] [-] ppf|5 years ago|reply
[+] [-] hannob|5 years ago|reply
But I do think this raises some questions around transparency. If the EMA has concerns about the production of these vaccines then I think this is something that should be discussed in public - so the scientific community can weight in and review this issue. If the EMA thinks that this is a solved issue - which the emails imply is what they thought before they authorized the vaccine - then that's what they should communicate.
[+] [-] johbjo|5 years ago|reply
In any case, it's a matter of weighing risks. Even if there's a 10⁻⁶ probability of complications, giving the vaccine and stopping serious illness/deaths is still a better decision overall. Even if it means hundreds of cases of complications across Europe. And then, the complications might turn out to be statistically difficult to discern from uniform random anyway.
A probability of 10⁻⁶ is difficult to conceptualize so if it is published with scary words, people might interpret it as "will probably happen to me". Then if that affects vaccine roll-out negatively, publishing might be a bad decision.
Millions of people in the UK have received the AZ vaccine, which has demonstrated safety and efficacy.
The efficacy metric means protection against infection, which is not complete. But as far as I've heard, not one person who has received either Pfizer or AZ has become seriously ill or died. In other words, it "flattens the curve" instantly.
[+] [-] hkktlgkfdn|5 years ago|reply
[deleted]
[+] [-] YinglingLight|5 years ago|reply
You know you're in a cult when you must preface your fealty before voicing the softest of logical hardballs. This entire thread is 50% prefacing. We've lost our ability for true discourse.
[+] [-] program_whiz|5 years ago|reply
This is another (very very) complex system with a relatively untested technology in an extremely noisy deployment environment. Every user is running a different OS basically, and every deployment corrupts the deployment image to some degree (RNA breakdown). Problems were bound to occur, and yes, the extent of those challenges are likely being downplayed to avoid panic and to get people to take the vaccine.
On the question of motivation: global pandemic, billions in R&D spent, pressure from people on politicians, etc. The usual set of unavoidable human reasons to release products before they are 100% tested (since 100% testing can only really happen in the wild anyway). Combine that with politicization of every topic, and the inability of the public at large to handle any nuance (e.g. "there may be some problems in production, but we believe overall it is worth the risks and won't pose a major problem because of X, Y, and Z.")
[+] [-] molticrystal|5 years ago|reply
I still plan on getting vaccinated, but I always wondered about the failure modes of the mRNA as it decays and what materials it could produce. I'm hoping prions are not possible, but are they?
The story also asks what happens to the lipid nanoparticles, but I am wondering about another aspect of these crafted mRNA sequences. The "U" in the mRNA has been replaced 1-methyl-3’-pseudouridylyl, denoted by Ψ in their sequences. What happens to the Ψ and its byproducts as it decays or is metabolized?
[+] [-] baxtr|5 years ago|reply
[+] [-] rolph|5 years ago|reply
its not good odds at all to bet on a viral mRNA fragment spontaneously creating a prion protien sequence. this is not beyond the realm of possibilities however the probability nonexistent, compared to the probability that anyone at random could have a nasty interferon mediated cytokine cascade, and sequential inflamatory response to the virus.
[+] [-] rolph|5 years ago|reply
these lipid particles are incorporated into the cell membrane during vesicular fusion. Expression of the mRNA results in S protien being expressed on the surface of this cell, Antibodies of complementary clonal type bind to this spike in numerous locations the now adulterated cell is labelled as antigenic thus is destroyed by macrophages, the pieces of this cell are then compared to the self/nonself portfolio of patterns and further antibodies are produced.
all the while this cell is in distress due to the presence of foriegn nucleotides and this incurrs an interferon mediated response that spreads among cells and likewise induces interferon response
[+] [-] hkktlgkfdn|5 years ago|reply
I had the same question. What I found in a long paper about mRNA vaccines is that they do not really know, but they assume you'll be fine, since they didn't see any immediate effects and because the quantities are tiny.
[+] [-] passerby1|5 years ago|reply
[+] [-] londons_explore|5 years ago|reply
[+] [-] meepmorp|5 years ago|reply
Worth noting
[+] [-] lhnz|5 years ago|reply
Is the EMA suggesting that this isn't the case or are they just telling us that it was editorialised by whoever disseminated it?
Doctored is the word you'd use if the contents have been changed in order to deceive people. However this could be an attempt at damage control if they want people to dispute the veracity of the leak.
Edit: Since I'm questioning the EMA here I'll add that "Vaccines are Good" and that we should await expert opinion before making idle speculation.
[+] [-] generalizations|5 years ago|reply
[+] [-] fuoqi|5 years ago|reply
[+] [-] srj|5 years ago|reply
By the time the correction is published for the doctored material, or the matter is contextualized, the fear will have already spread.
[+] [-] throwaway4good|5 years ago|reply
[+] [-] isitdopamine|5 years ago|reply
Even the Clinton team tried to say the Wikileaks were doctored, despite the vast majority of them having a DKIM signature confirming their authenticity.
The ball is in EMA’s field now: they have to demonstrate the leaks are doctored.
There’s pretty damning information in there, it’s in their interest to demonstrate it’s false.
[+] [-] the-dude|5 years ago|reply
[+] [-] pacman2|5 years ago|reply
[+] [-] possiblelion|5 years ago|reply
[+] [-] fuoqi|5 years ago|reply
[+] [-] xaduha|5 years ago|reply
[+] [-] AbrahamParangi|5 years ago|reply
Your mileage may vary but beware anonymous data.
[+] [-] ping_pong|5 years ago|reply
However, it does concern me to a great deal about all of this, and it reflects my previous worries. My biggest concern is that from the article, these mRNA strands appear to have not only degraded but formed into new "species". What if the mRNA causes the body to produce prions that leads to something like Mad Cow Disease? The fact that Moderna isn't saying anything is very disconcerting.
[+] [-] raadore|5 years ago|reply
[+] [-] raverbashing|5 years ago|reply
Of course the details of drug approval are not "discussed in the open" because a) trade secrets b) the public doesn't know how sausages are made and can (and do) make a mountain out of a molehill
mRNA instability is probably not such a big deal. Sure you want a high number because that's going to cause the immune reaction, if you have a lower number it's potentially less targets. But having imperfect mRNA strands are not a big deal.
The vaccine does not have to be 100% "perfect", it has to be safer than the virus. I know where to take my chances.
[+] [-] buttholesurfer|5 years ago|reply
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[+] [-] quantumwoke|5 years ago|reply
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[+] [-] hef19898|5 years ago|reply
[+] [-] unknown|5 years ago|reply
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[+] [-] ArkanExplorer|5 years ago|reply
That is, the age groups most at-risk from the virus (ages 70+, with comorbidities) are also going to live the shortest, and so suffer from fewer side-effects as well as not reproducing.
So why aren't the rollouts focused on vaccinating the elderly first? By the time this is done the kinks will be ironed out.
[+] [-] bronco21016|5 years ago|reply
[+] [-] maxerickson|5 years ago|reply
[+] [-] usrusr|5 years ago|reply
[+] [-] purple-again|5 years ago|reply
[+] [-] firebird84|5 years ago|reply