I feel like mRNA vaccines have huge potential, but I am really, really concerned about potential side effects. Does anyone know which other helper-substances are inside the vaccine, besides the RNA?
>6. PHARMACEUTICAL PARTICULARS
>6.1 List of excipients
ALC-0315 = (4-hydroxybutyl) azanediyl)bis (hexane-6,1-diyl)bis(2-hexyldecanoate),
ALC-0159 = 2-[(polyethylene glycol)-2000]-N,N-ditetradecylacetamide,
1,2-Distearoyl-sn-glycero-3-phosphocholine,
cholesterol,
potassium chloride,
potassium dihydrogen phosphate,
sodium chloride,
disodium hydrogen phosphate dihydrate,
sucrose,
water for injections
Source is the pdf from this UK Gov page:
https://www.gov.uk/government/publications/regulatory-approv...
I have no idea at all about vaccines, healthcare or bio chem so please correct me but. ..
The first 2 are the RNA right?
Sodium and potassium chloride are standard in table salt and saline drips right?
Sucrose and cholesterol occur naturally in humans I think (sucrose comes from breaking down fructose?).
Potassium dihydrogen phosphate is harder. No real idea what that is, but apparently they put it in gatorade?
https://en.m.wikipedia.org/wiki/Monopotassium_phosphate
Disodium hydrogen phosphate dihydrate is (I think) also used in food (condensed milk) and water softeners!
Anyone know what 1,2-Distearoyl-sn-glycero-3-phosphocholine is? Or
I'm sort of impressed it doesn't have 1001 complex chemicals.
Any idea if thoseipid vesicles are "standard"?
In case you care, I have no objections to the vaccine. I'm too young (36 and not working in care) to get it any time soon. But I'd take it tomorrow if it were available for me.
So I don't think those are really standard components, there are a lot of ways to create different systems here with different properties.
As a more general comment on this concern about additives, this is typically targeted at vaccines with adjuvants. Adjuvants are designed to create a stronger immune response, the lipids here are not adjuvants and as far as I understand the mRNA vaccines don't contain any adjuvants. I don't agree with the general concerns about adjuvants (though of course each vaccine has to prove safety in the studies on their own), but they are an additive with an inherently higher risk than something more inert. The immune system is extremely complex and highly dangerous.
It's reasonable to ask what the risks are, but unspecific ramblings about risks aren't helpful and it's unreasonable to highlight very hypothetical risks compared to the very real risks of getting Covid-19.
Right now the risk issue seems pretty clearcut: There were no serious sideeffects in the trials. What gave me additional confidence is hearing in an interview with Paul Offit (one of the world's leading vaccine expers) that almost all serious vaccine sideeffects that appeared in the past with other vaccines would appear relatively quickly (within weeks). Thus if there would be common sideeffects we would know by now.
Thus we can with reasonable confidence say that if there are any serious sideeffects from the promising Covid-19 vaccines then in all likelyhood they will be rare. It seems almost impossible that the vaccines pose a greater risk than the risk of not using them.
If the OP were spreading unsubstantiated panic then I would take a different view of it, but to me it appears as an honest concern about a novel medical procedure.
Where was this ramblings on OP's comment? He genuinly asked a question without mentioning any side effects. Why is it being downvoted?
So you can't ask a question for more clarification unless you spend hours researching the subject?. I can get that if it's a coding question and someone was looking for a solution. But this is a scientific subject and there is a pool of knowledgeable HN users who can help with this kind of questions.
If they had simply removed the "really really" from the question I don't believe it would have been perceived in the way I gave above. You are trying to claim that this was a perfectly innocent question which it may well have been but you should also be aware how it might be interpreted differently. You have not mentioned how you believe bad faith questions should be treated on HN but I would guess you would agree that some of them would be deserving of downvotes.
How about to a baby, or an unborn baby? The relative risk is almost certainly higher to a baby, but how high? We don't know, since there haven't been any longitudinal studies (for starters.) Which is why it would be unethical outside a clinical trial to administer it to younger people en masse.
Eventually the relative risk will be quantifiable, but it will take years. It took ~4 years for the increased risk of narcolepsy in children due to the H1N1 vaccine (Pandemrix) to be reported, for example.
Also the increased rate of narcolepsy was 0.005%. That's why it took several months before anyone noticed it.
Additionally the flu itself can cause the same kind of narcolepsy, which means that this vaccine was worse than other vaccines, but still potentially better than no vaccine at all.
There's no 'potentially' to consider, the Swedish Medical Products Agency reported the relative risk in 2011:
... The relative risk of narcolepsy was four times higher in vaccinated children and adolescents (born from 1990) compared to unvaccinated individuals.
So, incorrect, when considering the relative risk, which is all people should be interested in. Catching bird flu/covid isn't inevitable for most people, far from it in fact.
Because of that, that study can't say that the 4x higher number is the relative risk of taking Pandermrix.
There are also issues with potential over diagnosis and recall bias because of public awareness of the issue through the media [1].
The real problem is that this effect is so small, not that the effect takes years to develop. We're talking 4 cases of narcolepsy per 100k kids. Even a 10 year long study of 30k Phase 3 vaccine participants is unlikely to discover something like that.
Nearly all new drugs that are released could have similar side effects. It's just not feasible to conduct studies large enough to discover them until you start rolling it out to millions of people.
This seems at odds with the gung-ho "it's 100% safe" rhetoric of our politicians.
I am by no means an anti-vaxxer, but I'm already finding it creepy the way any concerns are simply being dismissed. It's also just bad policy: it means that any unexpected side-effects that do emerge (even if very rare / not serious) will look much worse and immediately stink of a cover-up.
What's wrong with saying: "We are confident, to a reasonable degree of certainty, that the risk of taking this vaccine is lower than the risk of contracting Covid"? Not "This vaccine is definitely safe". I am sick of politicians treating the electorate as if they are morons who can't understand the slightest bit of nuance.
As you mention, vaccines can cause harm and have done in the past. Some degree of caution might be warranted.
"JCVI recognises that the MHRA’s advice is based on the absence of evidence in pregnancy, and not on the presence of evidence to implicate toxicity in pregnancy."
It's all laid out for anyone with true concerns. Here you go: https://assets.publishing.service.gov.uk/government/uploads/...
But concerns absolutely are being dismissed. I've personally listened to Matt Hancock and other ministers doing it.
The idea that someone might want to wait just a little longer to see if any side effects emerge is not necessarily irrational.
Would you not concede that, if and when any unexpected side-effects do emerge (however rare or insignificant), this gung-ho attitude will backfire?
In general, yes it is irrational. There is evidence that the benefits of vaccines (including this one) far outweigh the risks of side effects.
> Would you not concede that, if and when any unexpected side-effects do emerge (however rare or insignificant), this gung-ho attitude will backfire?
Sorry, but no, this is wildly irrational. Why are rare and insignificant side effects concerning when the lives of more than 60,000 people in the UK have already ended due to this virus?
At least in the UK and US this is misinformation and false. Cause of death is certified by doctors or coroners and added to a database that reported COVID deaths are pulled from. Family members do not have to sign anything before cause of death is determined. I'd wager that Greece is no different.
COVID deaths are well known. There are many scholarly articles out there on how they are counted for people who don't get their information from Facebook. Here's a quick little article for example. https://www.scientificamerican.com/article/how-covid-19-deat...
"and added to a database that reported COVID deaths are pulled from." database or excel spreadsheet? https://news.ycombinator.com/item?id=24689247
I don't use facebook, my sources are my aunt (my uncle died 5 days ago due to falling and hitting his head, combined with a stroke history) and a family friend who is a doctor (and claims to be aware of 11 of such cases), note that said doctor and my aunt do not know each other.
Also my fiancee, an ER doctor, assures me that this isn't the case in the US.
I mean really it's one of those things like driving to the shops that is pretty safe but not 100% and I think most people can figure that.
While this is a reasonable conclusion from what we've read in the media, it's worth noting that this is at odds with the official opinions of the EMA and the FDA.
They both believe more data is needed, or that the agencies need more time to analyze the data, before they can decree that the benefits most likely outweigh the risks. Otherwise, they'd have approved the vaccines already.
Fauci had to walk back[0] comments about the UK "rushing" the approval, stating
"The point that I was really trying to make [...] in the United States there is such a considerable amount of tension of pushing back on the credibility of the safety and of the efficacy that if we in the United States had done it as quickly as the UK did [...] that if we had for example had approved it yesterday or tomorrow there would have been push-back on an already scrutinising society that has really in some respects in the United States too much scepticism about the process."
Such politeness :-))
Most people outside the US don't call what's happening in the US "scepticism" :-(
There will be side effects, they will be dismissed by doctors, people will be marginalized, called uneducated morons and pushed towards more radical communities.
It won't stop until a critical mass of people realize this is no better than treating people differently for being gay.
Right now, the pharma/medical industries are all-powerful. Can't do anything significant without them involved, and if your doctors turn out to be idiots with a degree, well you're shit out of luck, especially in Europe, where the holy universal healthcare can not be questioned.
But Im not so sure what you expect will happen here? Of course there are side effects? Every medical treatment on earth - literally since humanity started - has had side effects. The question is if those side effects are justifiable in comparison to the prevented harm to society.
And if you ask me, the prospect of millions of dead people due to, or related to covid makes a pretty huge load of side-effects tolerable if you see it like that.
Everything in life has side effects. Everything in life has trade offs. It's not about the lack of side effects or even their magnitude or severity, it's about balance: do they help more than they harm?
The most innocent substance out there, water, can kill you. And I don't mean drowning.
https://en.m.wikipedia.org/wiki/Water_intoxication
Many of the arguments people make about modern medicine are:
A) uninformed
B) not made in good faith
Modern medicine is serving us quite well, so any counter argument better be rock solid.
I'd be curious what your specific complaint is and how you back it up.
I found a neat link a year ago about how the medical system happily pays for fabulously-expensive interventions, but won't pay for things patients actually need: "Which Interventions Can Be Paid For: The Explanatory Power of 'Prasad’s Law'"- https://news.ycombinator.com/item?id=21728864
> Right now, the pharma/medical industries are all-powerful. Can't do anything significant without them involved, and if your doctors turn out to be idiots with a degree, well you're shit out of luck, especially in Europe, where the holy universal healthcare can not be questioned.
Where such abuses are rarer. The US healthcare system is broken, at least keep an eye on what other countries are doing. If say, Iceland, Germany, Italy, Japan start vaccinating, maybe it's time to get vaccinated ;-)
However, we don't know the side-effects 10 years down the road for COVID-19. I, for one, am far less concerned about potential vaccine side-effects than I am about known lung scarring and whatever potential side-effects could emerge from COVID-19.
Otherwise all modern life would screech to a halt. For example, please stop using all new tech products developed in the last 10 years. And all the things developed with new materials science in the last 10 years.
We'd be back to the stone age. For these cases we measure short term effects and we extrapolate based on similar materials, structures, etc.
Today UK regulators have even warned people with history of allergies, so apparently my concerns were not unjustified: https://www.businessinsider.com/pfizer-vaccine-allergy-covid...
I guess some knowledge & intuitions don't generalize.
Reminds me of a tech-savvy Youtuber that stated "I'm teaching myself to trust Tesla autopilot and ignore my need to fearfully jump to the wheel every time FSD moves me too close to objects on the road", "I'm getting better at it"... implying that 100s of thousands of years of evolutionary development/intuition/skepticism can be discarded when 1st gen tech enters the room.
*Note: I don't see my comment when logged out, shadowbanned perhaps...I'm starting to understand what "the right" has been talking about free speech-wise...will the tech overlords grant me permission to share my view...? Time to pray.
You created a new account specifically for this comment. Is HN, in your eyes, allowed to gate the publication of your comment on passing some moderation queue within reasonable time?
If you're going to insinuate that the vaccines have significant risks, you should provide some evidence. (This bar should also be a bit higher in my opinion in the middle of a public health emergency.)
Compare a statement like "5g has great potential, but I'm really, really concerned about the health risks of 5g towers". I'd expect that to get voted down too unless you had some remarkable evidence.
This applies to everything from building bridges (University of Miami), through software products (Mars Climate Orbiter) to designing new medicines (thalidomide / paroxetine).
Arrogance that something is 100% safe is only ignorance. The point is we'd like to understand what the known risks are and the mechanisms are. Some of us would like to see a few hundred-thousand cars go over that new wobbly cantilever bridge design.
This is different from complete ignorance and denial which is a separate issue.
It's extremely rare for bridges to fail. I certainly wouldn't expect a bridge to fail given modern safety standards.
You might have marginally more confidence in the bridge after a few hundred thousand cars, but we have processes in place to be confident within reasonable doubt that things are safe before that.
No one is claiming that anything is "100% safe". That's an unachievable level of confidence. If everyone waited for a hundred thousand other people to do anything we'd never get anywhere.
It probably says something that neither of the ‘new medicines’ you cite (neither of which are or were vaccines) are >30 years old. Thalidomide was banned before most people on here were born.
There’s reason for scepticism in all things - but scepticism for its own sake, and without any evidence other than association is probably less than helpful.
What is wrong with people when simply asking about negative impacts of a rushed vaccine is considered a worthless distraction.
I thought the audience of hacker news users would also be curious, inquisitive folk.
I've been lurking here for at least 10 years and consider this to be the best place to discuss everything openly. But this sensivity to question anything related to vaccine is beyond ridiculous. Even asking what the side effects are like OP did gets you downvoted.
And by the way, I will take the vaccine asap because of my health issues, but this doesn't mean we can't even ask questions about it.
Humans err all the time, why is this an exception? Why is no one here skeptical, or at least curious? Why is critical thinking set aside?
Science is now relative. Not only do we have mass misinformation but the side effect is an overreaction seeing intelligent thinkers reject their principles in order to put as much distance as possible between them and the perceived thought cancer.
What we are witnessing is compulsory hard-line. Where will you be when the mob comes after your curiosity? How many friends will you lose, how many thoughts of your own will you be free to have?
I really don't get how everyone is ok with ushering in what would otherwise be seen as dystopia. And don't compare this to a war. Wars are to preserve freedom and our principles. This war is the complete opposite. We have given up on free thinking, western values are out the window, right or wrong, but make no mistake this is the reality and we should at least acknowledge it as such.
"Significant testing" is 20,000 people. We're preparing to roll it out to billions. That's not "significant testing". If there was a 1 in 500,000 side effect, you'd never see it in the trials.
And yes, these vaccines are doing something "magical". We've never had an mRNA vaccine rolled out to the general public before.
That said, I think the risk is manageable. The FDA and EMA will be monitoring closely for side effects and is prepare to adjust as necessary.
But don't underestimate the risks.
That is significant testing. It is correct that you might not see a 1 in 500,000 side-effect in testing, but a 1 in 500,000 adverse effect is probably a risk factor that most people could accept.
> And yes, these vaccines are doing something "magical". We've never had an mRNA vaccine rolled out to the general public before.
Our cells regularly process strands of mRNA by the billion. I don't believe the vaccine is doing anything particularly "magical". It's completely right that we should test that, but I don't think there's any reason to be more concerned than any other new type of treatment.
With the Covid vaccine we’re talking 10,000x expansion of patient population.
And your body also uses neurotransmitters all the time but we don’t wave our hands and say antidepressants are ok because they just modify neurotransmitters. New technology means new "unknown unknowns".
But with that said, I'm not saying don't get the vaccine. I'm just saying, don't be so confident that there is no risk.
Just because there is a huge necessity to rush approval and dispersement doesn't mean the risks of unknown side effects are diminished. Lengthy approval processes and clinical trials are in place for a reason. And when you administer this vaccine to billions of people you are almost certain to see side effects. That's just simple science.
Then you haven't been paying much attention. Using downvote as 'disagree' is and has been very much the norm around here.
Also, if one was here to push their antivaxxer propaganda (not saying they are), that's the kind of innocent question they'd start with, and yours with a fresh account (not saying you're a sockpuppet) would be the similarly innocent continuation.
You are suspecting people and just adding "not saying". Which makes everything people say suspect.
by Ninja Nerd Lectures
This is the best science based informative video I have seen on how these different Covid vaccines actually work.
Would you mind expanding on this? Why are you severely concerned about side effects for mRNA vaccines in particular?
Considering that this doesn't seem to be a settled question, I'm not so sure that it makes sense to blindly trust that everything will be alright in the current, rushed, case.
According to [1], "The UK Health Protection Agency (now Public Health England) undertook a major study of 4- to 18-year-olds and found that around one in every 55,000 jabs led to narcolepsy."
Very rare frequency incidents that slip through testing shouldn't make us over-cautious to the enormous benefits of vaccination.
[1] https://www.narcolepsy.org.uk/resources/pandemrix-narcolepsy
In establishing the shorter-term safety nothing was "rushed" now compared to the processes performed before (it was tested on tens of thousands of people). Regarding the longer-term safety, who would be willing to wait e.g. two more years before any vaccine could be used?
As the vaccination will be voluntary for common people, as long at there are shortages, those who don't want to get it should indeed leave it to those who will.
To compare, there were more than 70,000 excess deaths in the UK since start of pandemics. Around 60 times more deaths than, in the case of vaccine, those still living with side effects.
But these side effects were apparently the strongest in just a part of the population: 4-18, which is 11 million, resulting is estimated 200 people with side effects.
Covid-19 luckily affects exactly that part of population less, but even then I'd guess that Covid-19 already made more damage to more than 200 people in it.
And that small number of cases just can't be detected unless the trial covers enough of those affected. If the total effect is 200 cases in the whole population, a trial would have to be performed on at least one 20th of it: as much as 600,000 children would have to be a part of the trial to even detect that issue. Not to mention that it took two years to recognize the issue.
Now, for the trial to recognize the problem, half would have to be placebo group. That gives once all outside of the trial are counted 97.5% of people unprotected for two years.
In the case of whole population, and even waiting for only 10 months, there would still be 68,000 deaths more if that kind of trial would be a condition for the acceptance of vaccine.
NB: I'm personally going to get the first SARS-CoV-2 vaccine I can get, and I'm incredibly excited about mRNA vaccines in general. But, it's true that any time you inject a chemical into your bloodstream you're taking a calculated risk.
mRNA vaccines had also (limited) human testing before these trials in the past years (mostly Phase 1).
All medicines represent calculated risks -- risks that are often worth taking, but still risks.
No. I am not a mindreader. And “vaccines are injected into the bloodstream” is a standard antivax lie.
Yes there’s a risk in receiving a vaccine, just as there’s a risk in receiving any prophylactic/therapeutic treatment, but severe side-effects are closer to 1-in-100K to 1-in-a-million. Compared to a disease that is currently killing 2-in-100, with significant sequelae likely much higher.
I’m happy to accept that “bloodstream” was a slip of the tongue, but really try not to make those malignant lying bastards’ jobs any easier, when people die because of them.
If your goal is actually to educate others, then educate others. Replying with snark achieves nothing but temporarily boosting your own ego.