The EMA Covid-19 data leak, and what it tells us about mRNA instability

https://www.bmj.com/content/372/bmj.n627

by walterbell • 5 years ago

128 160 5 years ago

hannob• 5 years ago

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.

YinglingLight• 5 years ago

To be clear

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.

coldtea5• 5 years ago

If we can't entertain the idea that drug companies lie about their results and efficaccy to gain multi-billion contracts, their managers cover their arses either way, fast-track vaccine orders are problematic, and that it's at least suspect that vaccines that took decades to be created for other variants were now made in less than a year to be the "truth" - and we consider rational to proclaim that we'd "take" the vaccine "without hesitation", then yes, we've lost our ability for true discourse...

FpUser• 5 years ago

In here I think this is direct result of downvoting.

johbjo• 5 years ago

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.

matwood• 5 years ago

people might interpret it as

Unfortunately we/they are in a damned if you do, damned if you don't situation. If it was published, you can be sure the misinformation around what it meant would be through the roof. Having it hidden, and now come out may end up lending more credence to the conspiracy theories.

coldtea5• 5 years ago

It's a technical concern. Publishing will only cause fear and doubt.

And who appointed them as arbiters or censors of truth for "the public's own good" as opposed to researchers that should make their results public whatever they are?

flyinglizard• 5 years ago

On weighing risks, in a pandemic like that your choices are statistically limited to either getting vaccinated or getting ill. Not getting either, over time, is not a viable option.

dehrmann3• 5 years ago

Publishing will only cause fear and doubt.

Less fear and doubt than if it gets leaked.

meepmorp• 5 years ago

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

Worth noting

throwaway4good• 5 years ago

Did they (ema) publish exactly what was doctored?

isitdopamine2• 5 years ago

Anyone would say that a leak is doctored...

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.

raverbashing3• 5 years ago

they have to demonstrate the leaks are doctored.

So the victims of a cyberattack have to prove their data has not been manipulated? Cool

There’s pretty damning information in there

No, there isn't, unless you're buying manipulated information and believe in 5G vaccines.

The data presented sounds like a regulator doing its job and not rubberstamping every decision (cough cough 737Max)

lhnz• 5 years ago

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.

logicchains3• 5 years ago

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.

What is this, some kind of cult in which nobody dare question?

fuoqi3• 5 years ago

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.

srj• 5 years ago

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.

the-dude• 5 years ago

Sounds like journalism to me.

generalizations2• 5 years ago

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.

program_whiz• 5 years ago

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.")

maxerickson7• 5 years ago

Humans have relatively little genetic variation, you overstate things with the weird analogy to operating systems.

yomly• 5 years ago

And you are under appreciating the myriad ways differences can express themselves in nature. We share 50% of the same DNA as a banana, and we're 98.8% the same as a chimpanzee.

Spurious examples aside, the pandemic has highlighted ethnic differences in reactions to both pathogen and vaccine.

And from personal experience in the field, seemingly "random" confounding factors can have drastic effects - supposedly safe gadolinium based contrast agents caused NSF if you happened to have bad kidneys.

Aggregation occludes all nuance, essentially by definition.

Decisions that are correct for the aggregate can often be wrong for the individual.

But I guess that kind of thinking is why the pandemic has been such a crapshoot in the first place.

mark_l_watson• 5 years ago

I agree that there is so much variation in people’s reaction to the vaccine. My 99 year old Dad had very little negative reaction. I felt shitty for one day after my second vaccination. My Dentist has been missing about 1/3 of work days, periodically feeling very poorly for a few days. Most of my friends and family had just mild reactions.

I am in general skeptical about some vaccines, especially loading infants up on many vaccines all at once. However, with COVID-19, I think the general risk is worth keeping the global economy from complete collapse (if that is even possible).

prithee• 5 years ago

My understanding is that this "reaction" is just immune response, and since you likely have a strong immune system than your father you saw a stronger reaction, both of which would likely be less deleterious than if your father contracted COVID directly.

AndrewBissell3• 5 years ago

However, with COVID-19, I think the general risk is worth keeping the global economy from complete collapse (if that is even possible).

We could simply reopen the economy at any point. There are more than enough counterexamples around to demonstrate that lockdowns do not eliminate Covid-19, and that a lack of lockdowns does not lead to endless piles of dead bodies in the streets. Lack of sufficient vaccination is not what is keeping the economy closed -- its usefulness in driving forward certain agendas is. The vaccines aren't even promising anything close to 100% effectiveness, particularly not among the highest risk groups (who were excluded from the clinical trials).

"We can go back to normal soon if everyone just does this one thing" has been the carrot dangled in front of people's noses to get them agreeing to measures of dubious effectiveness since the start of the pandemic. If the virus mutates in the fall and winter and boosters have to be rolled out again, we'll either "have to" shut the economy back down until everyone gets shots in their arms again (in which case these vaccines are a poor preventative against economic damage) or we'll accept the need to live with some amount of endemic Covid spread (in which case it was certainly not lack of vaccines keeping us from reopening).

atleta• 5 years ago

You can never test "100%", especially if you don't define what it means. But you've set it up to be an unsatisfiable expectation anyway, saying that "100%" means "testing in the wild". Which means releasing it. So you provide a definition that is always true: you can't adequately test a product before release, because you can only test it adequately after the release.

That's not that much different from the self deceiving mind trick those say who claim this is a "human experiment". Which is, of course it is! I mean the process for testing and certifying a medication has to include a phase where we experiment on humans.

And the whole process is designed with this in mind: increasing number of participants during phase 1-2-3 trials and then it gets released, without being tested "100%", if you will, and it enters phase 4, that is basically tracking it while being "out in the wild". Though you could argue that phase 3 is just as much out in the wild.

I think what you can see from how these vaccines are being tested and released is that these are the most rigorously tested products out there.

Pyramus• 5 years ago

Another way to skin the same cat: Safety is not a binary variable even though we have this mental model of safe/unsafe. In fact safety is continuous ranging from high risk (unsafe) to low risk (safe).

With more information (more trials/subjects) we get a better estimate (with less uncertainty) of the associated risk. The properties (safety/risk) of the vaccine don't change. What changes is the uncertainty around our estimations.

This is still a simplification (e.g. there could be unknown unkowns) but I find it a better heuristic than safe/unsafe.

ArkanExplorer• 5 years ago

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.

maxerickson7• 5 years ago

On a per country basis, the roll outs are focusing on the elderly.

usrusr• 5 years ago

Are there rollouts that don't focus on the elderly?

EdwardDiego• 5 years ago

Well, in NZ the elderly come third, but that's because we're trying to keep it out, rather than contain an existing infection. (MIQ = "Managed Isolation/Quarantine")

Group 1 – Border and MIQ workers and the people they live with
Group 2 – Frontline workers and people living in high-risk settings
Group 3 – People at higher risk of serious outcomes or illness
Group 4 – General population

https://www.health.govt.nz/our-work/diseases-and-conditions/...

purple-again• 5 years ago

In the US at least they absolute have been doing the oldest first and then lowering the age bracket slowly as more vaccines have ramped up.

bronco21016• 5 years ago

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.

firebird84• 5 years ago

...Aren't they, though? At least in my country/state they are.

passerby1• 5 years ago

The question is why the leaked information was classified if it's so important for the public good.

londons_explore• 5 years ago

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.

possiblelion• 5 years ago

Wait, so what effect does potential RNA instability really have?

maxerickson7• 5 years ago

The mRNA is the instruction that the body follows to produce the viral proteins that lead to an immune response. If the mRNA in a batch of vaccine degrades more than they have allowed for in the treatment protocol, it may not work.

(This is one of the reasons they have very specific handling rules and throw out vaccine that is improperly handled)

walterbell2• 5 years ago

https://www.modernatx.com/about-us

Welcome to Moderna. We believe mRNA is the “software of life." Every cell in the body uses mRNA to provide real-time instructions to make the proteins necessary to drive all aspects of biology, including in human health and disease.

What's the metaphorical software equivalent of "mRNA instability": undefined reference, memory corruption, incomplete download, installation failure, program crash, ...?

nobrains• 5 years ago

https://remyhax.xyz/posts/bitsquatting-windows/

maxerickson7• 5 years ago

There isn't one.

Mitochondria won't decode the corrupted mRNA and it will be broken down into constituent parts that are reused by the body.

Edit: Oops, ribosomes, not mitochondria.

ceejayoz2• 5 years ago

What's the metaphorical software equivalent of "mRNA instability"

“This shitty app doesn’t work. Uninstall.”

That’s about it here.

hef19898• 5 years ago

Somehow I always have to think about the articles from a while ago covering Russian propaganda campaigns against Covid vaccines. Leaking emails would fit.

fuoqi3• 5 years ago

Not a surprising reaction after the (mostly baseless) smear campaign against Sputnik V.

dehrmann3• 5 years ago

Let's just hope Sputnik V goes better than Sputnik II.

trhway• 5 years ago

Covid being a global thing has thus naturally become another battlefield in the modern cold war :

from an official US HHS report https://www.hhs.gov/sites/default/files/2020-annual-report.p...

" OGA coordinated with other U.S. government agencies to strengthen diplomatic ties and offer technical and humanitarian assistance to dissuade countries in the region from accepting aid from these ill intentioned states. Examples include using OGA’s Health Attaché office to persuade Brazil to reject the Russian COVID-19 vaccine,"

pacman2• 5 years ago

Where can I download the leak? I am very interested in the production methods since I have some ideas how to improve them. Would appreciate a link.

raverbashing3• 5 years ago

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.

fuoqi3• 5 years ago

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.

topynate4• 5 years ago

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.

ppf2• 5 years ago

It's not the percentage of intact mRNA that's the problem, it's what the other bits of mRNA happen to do.

et2o2• 5 years ago

Encode smaller bits of the same protein? Who cares.

Otherwise, the mRNAs aren’t present in high enough quantities to do significant signaling or silencing things, and it’s going in the deltoid... not really a medically interesting place. You could inject 1mL of dilute HCl there and it wouldn’t be a big problem.

cfu282• 5 years ago

Anything particular reason you're worried about extra mRNA fragments? mRNA needs a initiation sequence in order to be translated into a protein, which only exists at the front. It also needs a polyA tail to maintain stability or it would just degrade. Random fragments don't do anything on their own

rolph7• 5 years ago

these fragments of mRNA will be recognized as antigens, until the point that the folded structure of the epitopes is destroyed, these smaller fragments are still recognized as viral PAMPs and evoke innate immune responses.

topynate4• 5 years ago

Didn't I cover that in "danger"? The leaks are talking about maybe twice as much broken bits of mRNA in early batches. That's assuming all the not-intact stuff is broken mRNA rather than simple amino acids or something else just as boring. That shouldn't make much difference to anyone's view. If you think it's "doing" stuff that makes you not want to get vaccinated, well you probably thought that before you read this report, too.

tobmlt5• 5 years ago

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)

topynate4• 5 years ago

Just that increases in risk are usually approximated pretty well by a linear change with dose. Radiation, poison, allergens, etc. Drugs too – the ones where the toxic dose is close to the therapeutic dose are generally pretty nasty even when used as intended. It's possible for there to be a transition between "very safe" and "noticably unsafe" as the quantity of something increases twofold, but a priori unlikely. For this to happen not only in vaccines, but through an unknown mechanism that operates precisely in this particular range, would be truly rotten luck. It's also contradicted (a posteriori) by the evidence I referred to (overdoses and animal models).

woofie114• 5 years ago

Let's say a piece of mRNA has a 1E-12 chance of causing you to grow a third arm by virtue of a defect. Two pieces of mRNA would have very close to a 2E-12 chance of causing you to grow a third arm. That's linearity. If you've doubled the defect rate, you've doubled the risk.

This contrast with e.g. sports brain trauma, where one sports brain trauma might be relatively moderate risk, but two might be very high risk (much more than double). Or risk from ibuprofen, where 600mg is has close to zero risk, but an overdose of 60,000mg poses a significant risk of death (much more than 100x the risk of death of a 600mg dose). That's nonlinear.

I'm not sure how risk from mRNA defects would be anything but linear. It would take an extraordinary set of coincidences.

jberryman• 5 years ago

Your efficacy point should be obvious from just realizing that a 300lb man gets the same dose as a 80lb child.

molticrystal• 5 years ago

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?

hkktlgkfdn• 5 years ago

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.

cfu282• 5 years ago

Ψ

Ψ is naturally found in tRNA, so its not really something to be concerned about.

Edit: scratch that, confusing pseudouridine with 1-methyl-3’-pseudouridylyl

baxtr• 5 years ago

Why would you assume prions? Isn't mRNA a standard cell product, which can be found in any of your body's cell at any time?

Izkata• 5 years ago

mRNA encodes instructions for creating proteins, and prions are mis-folded proteins. I think the concern is more, our bodies' natural mRNA is unlikely to create prions or it would be a common occurrence, but lab-created mRNA isn't made of the same parts and doesn't have that millennia of evidence behind it.

rolph7• 5 years ago

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.

rolph7• 5 years ago

>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

rediguanayum• 5 years ago

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.

rolph7• 5 years ago

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

renaudg2• 5 years ago

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.

abacadaba• 5 years ago

also the 2nd dose reaction, some of it's getting through at least

crocodiletears2• 5 years ago

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.

coldtea5• 5 years ago

Including the misnformation that this or that is misinformation...

pasquinelli• 5 years ago

it's very convenient to not even have to say something isn't true, but that russians or chinese dug it up.

coldtea5• 5 years ago

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".

quasirandom• 5 years ago

The difference being that then we saluted getting access to raw data, whereas now we are being conditioned to consider them "misinformation".

I like this point. I wish it would be reported as an "influence operation" rather than "misinformation". The most effective propaganda is 80% true.

SiempreViernes• 5 years ago

Official response from the EMA indicates that the "leakers" (lightly?) manipulated the data, and did not simply pass it on unmodified:

A closer investigation of the published material has revealed that not all of the documents were published in their integral, original form and may have been taken out of context. 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 in a way which could undermine trust in vaccines.

https://www.ema.europa.eu/en/news/cyberattack-ema-update-6

pjo90• 5 years ago

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."

luxuryballs3• 5 years ago

sounds like an excuse, it’s a little creepy that certain parties have such a stake in vaccines being extremely trustworthy, as if there’s something wrong with it being a different case per each individual’s health/risk status, they should be saying “talk to your doctor” rather than “everyone get the vaccine when it’s your turn”

generalizations2• 5 years ago

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?

alexbiet• 5 years ago

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.

ping_pong3• 5 years ago

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.

rolph7• 5 years ago

in this case "species" is in the context of Molecular species.

suppose we grabbed a molecule and then cut it in half, do this many times so you have a collection of first halfs, and second halfs. Each of these is a species of ribonucleic acid. It may sound sinister but its just tech jargon.

ping_pong3• 5 years ago

It's not molecular species. The full quote is: "truncated and modified mRNA species present in the finished product". It's specifically truncated and modified mRNA species.

happyconcepts2• 5 years ago

All the mRNA you speak of .... is wrapped in fat that is really, really small.

Would you not be more worried about all that lipid nanoparticle in your body?

ping_pong3• 5 years ago

No, I'm more concerned about the randomness of those degraded mRNA strands somehow degrading into instructions that cause harm. We know for a fact that prions exist that cause denaturing of nerve cells and brain cells. They are basically proteins that are misfolded that somehow cause a chain reaction of misfolding other proteins. Is there the possibility that just randomly the degraded mRNA will produce the wrong protein strands and cause people to experience the equivalent of Mad Cow Disease? It certainly sounds like it's possible, but I'm not sure if it's probable. But with them being so tight lipped about it besides pooh-poohing the idea, it really doesn't bring me much confidence.

AbrahamParangi• 5 years ago

It is worth being aware that according to the US state department, Russia and possibly other states are currently involved in vaccine disinformation campaigns.

Your mileage may vary but beware anonymous data.

xaduha4• 5 years ago

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?

dehrmann3• 5 years ago

what are the benefits

It was faster to produce candidate vaccines. There are also some production benefits because it doesn't involve replicating a virus in eggs.

xaduha4• 5 years ago

I don't think it involves eggs, they do it in bioreactors. As for candidate vaccines, didn't end up mattering much, did it?

https://www.nytimes.com/interactive/2020/science/coronavirus...

raadore• 5 years ago

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”.

The EMA Covid-19 data leak, and what it tells us about mRNA instability

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