You should trust the system and the process. No, AZ does not cause blood clots. It's being investigated for it. And even if it does cause, you should take into account the probability. Which seems to be extremely low compared to your chances of succumbing to covid. (Of course, the latter is a function of a lot of things, but if someone makes a claim that "AZ cuases bloog clots", I'm not sure if they ever looked into estimating and then comparing the said probabilities.)
It's not hard to imagine that rushed trials, rushed production and pressured approvals might not lead to the best process.
Next to that: Over the last 50-60 years approved medicines with the backing of more extensive clinical trials have been withdrawn. So the whole process in itself isn't flawless.
I'm not saying the vaccines are unsafe or all the processes are wrong, but many people who are wary are often put in a corner of conspiracy theorists and I don't think this is fair.
Fast doesn't mean rushed. The trials were fast because it was easy to gather huge numbers of participants, and the phases were carried out in parallel rather than sequentially (normally, to save money/resources, phase II would only start after a successful phase I).
> and pressured approvals
Immense pressure to make sure it's safe, too. Like this precautionary pause for what seems like a lower blood-clot rate than would be expected just by chance in that size of population.
It's not flawless. But the point is not that it is flawless or that it should be (because, I don't think such a complex process can ever be). The point is that it gives you the best possible result as of now. Meaning, you have the highest chance for survival/avoiding a permanent health damage (which COVID can cause too) is taking an EMA/FDA approved vaccine.
> but many people who are wary are often put in a corner of conspiracy theorists and I don't think this is fair.
I think think this happens for at least two reasons. First, they are often simply conspiracy theorists who just try to phrase their thoughts in a way that doesn't seem like conspiracy theory at first. I've talked to a lot of people (mostly online) and I can tell you that it happens a lot. And the same people will start the same conversations again and again along the same patterns, pretending they are not conspiracy theorists or anti-vaxxers for that matter but go down the same path and show themselves if you engage in a discussion.
Second, because of the above phenomenon, some people will just jump to the conclusion that anyone who raises concerns are indeed conspiracy theorists. (Again, because a lot of them will pretend that they are indeed sane people having sane questions.) It's not ideal, but not surprising either.
> It's not hard to imagine that rushed trials, rushed production and pressured approvals might not lead to the best process.
Fun fact: thalidomide, the drug that caused birth defects, would have passed the trials that the Moderna vaccine's been though, because pregnant women weren't included in the study participants.
If I'm supposed to be ok with small risks, why aren't any of the pharmaceuticals ok with the small risk that they've made a mistake and should be held liable?
Why did they seek indemnity if there's no chance the vaccine could risk my health?
I don't oppose the vaccine but this has never sat right with me.
This is an interesting question and has several responses beyond the knee-jerk one. First of all, the process was expedited at the request of the authorities, so it's natural that they try to reduce their risks. Also, even if we disregard the expedited process, the release (the rate of production and administering it) is faster than you'd expect normally, which in itself imposes a greater financial/business risk by exposing more people quicker to the same amount of risk.
To say it in a less abstract way: given the normal/expected risk levels (say it's 1:100000), they'd get say a 100 complaints a year for a new vaccine that gets administered to 10 million people. Say they may get brought to the court in one out of those 100 and lose with a 50% chance. And, of course it turns out that something's not right (and say 1:100000 actually dies because of the vaccine, they can still stop it at the 1M or 10M mark).
Now if they roll out the vaccine to 1B people a year, that means 100x more exposure. And it may not worth it business wise. Especially since at least some of the companies forgo (at least some of) the profit. So you have increased risk with decreased profit but increased demand. Perfectly logical move.
If we are talking about us, then let's not forget that while the vaccine definitely poses a higher risk than one that's been on the market for say a decade or more, the choice is not between:
a) I take the vaccine and accept the (small) risk
b) I don't take the vaccine and I don't expose myself to any additional risk
Because dying of covid has a pretty f*&^ high risk when compared to dying from the vaccine. (And covid also seems to cause long term health damage to way more people than it kills.)
But even if we add all this: the EU (and rightly so) did not give indemnity to the pharmaceuticals. (Because while there is logic for them to seek it, there is also logic in not giving it to them.)
I don't think it's appropriate to say up front that they don't have to worry about tail risk. If something happens, then we have the discussion about whether to bail them out. Maybe we should. But only after the fact.
It's one thing to say "we can't make vaccines at a substantial loss", which is reasonable. It's another entirely to say "you have to promise to preserve us from all unknown unknowns". The basic goal of society is not to eliminate all risks from collective enterprise, it's to take the risks off of individuals and put them on the collectives.
As a matter of principle, it just doesn't seem right, and I've never been convinced why nuclear power should get a liability exemption either.
I do think bailouts can be ok. "Socializing the losses" is a feature of living in a society. But what's corrupt is to promise it before we know what the catastrophe might be, that's completely different. In general, organizations (and people) can cause damage far beyond what they can fix. That's life, and bankruptcy. And we don't want to destroy what is left that is valuable. But when that happens, their assets should be systematically divvied up and/or ownership transferred. The people who can make restitution should be required to do so, e.g. the stockholders and/or bondholders. That's what they're there for.
Society already is on the hook if the worst happens, so it's not legitimate to make demands.
> Also, even if we disregard the expedited process, the release (the rate of production and administering it) is faster than you'd expect normally, which in itself imposes a greater financial/business risk by exposing more people quicker to the same amount of risk.
All this seems to dance around the fact that it's the first vaccine of its kind. It induces side effects that are not normal. And the process has been greatly expedited far beyond the usual liberal sentiment that the FDA is indispensable and we should be taking extraordinary amounts of time to approve medicines, etc.
Perhaps there is an asymmetric aggregated risk "exposure" for pharmaceuticals. But I still don't see a huge upside to someone like me who's relatively young, fit and who's had tons of relatives, friends, etc. who've gotten the virus and not only survived but really didn't notice any lasting effects.
> it's the first vaccine of its kind. It induces side effects that are not normal.
It wasn't clear that you were specifically talking about the mRNA vaccines (or maybe just the Pfizer vaccine) as the comment I was replying to mentioned both this and the AstraZeneca one. Also, I'm not sure what non-normal side effects you are talking about WRT the mRNA vaccines. Israel basically ran a huge trial for Pfizer with several million people. I'm pretty sure we know (or will have the data very soon) for all the possible side effects.
> But I still don't see a huge upside to someone like me who's relatively young, fit and who's had tons of relatives,
That's a different question. As I said (maybe in a different comment) you should calculate the probabilities yourself. What you feel doesn't matter. Also, what you see around yourself doesn't matter. What you call a huge upside is up to you, but it's hard to imagine that there is anyone who doesn't get at least a 10x upside. But again, look at the statistics, there are some that tell you how likely you are to die from covid based on your age.
I don't know how old you are, I don't remember all the numbers, but e.g. with the AstraZeneca vaccine in the UK they estimate that 40 out of 17M people had blood clotting problems. (And it's being investigated, which is good.) I don't think there is a single age group with lower COVID mortality than that. Definitely not among adults. So it's worth checking the numbers.
A second thing is that since the vaccines don't provide a 100% immunity, it's never just about yourself, of course, and the circulating virus can (and does) mutate and it may do so in the wrong direction. (It may also mutate towards a simple common cold.)
But since older people have a higher risk of dying from covid, the younger you are the longer you can wait, which means the better you will know the safety because the more people will get it before you. So your best strategy is convincing older people to take the vaccine, because it's what's best for them and you. And then if a few months you'll know better. (I'm pretty sure it will take months until you can get a vaccine if you are that young and healthy. Wherever you live.)
I look at the vaccine vs. virus risk profile quite differently.
I am in my mid-30s, with good levels of vitamin D, and I'm prepared to treat any Covid infection I do get with a protocol including ivermectin and various vitamins which has proven effective where it has been tried in India in Mexico. I'm not going to die from it (certainly don't have a "pretty f*&^ high risk"). The long haul risk is a little bit more substantial, but having a treatment lined up reduces my risk a lot there too, and in the vast majority of cases it is not debilitating and I'm optimistic that treatment methods will be found.
So the "risk of ruin" from the virus is basically nonexistent. What's my risk of ruin from the vaccines? We really have no idea because they're new and almost completely untested (in some cases this is even true of the techniques used). If there's even a 0.1% chance of the vaccine causing some sort of debilitating, significant harm, that's a far worse bargain for me than taking my chances with the virus. The chances of something like antibody dependent enhancement are essentially impossible to predict until the vaccine's interaction with the circulating virus has been observed for many more months (ideally through another winter season). It will probably take at least a couple of years of seeing the vaccine in widespread use for this risk calculus to tilt the other way for me.
which is not proven to have any relevance to Covid-19, unfortunately.
> I'm prepared to treat any Covid infection I do get with a protocol including ivermectin and various vitamins which has proven effective where it has been tried in India in Mexico.
Please do not spread potentially dangerous health misinformation and false hopes, even in good faith. If there was such a protocol that worked, the world would know.
Now that Hydroxychloroquine for Covid-19 has been thoroughly debunked, snake oil peddlers have apparently moved on to Ivermectin. Efficacy-wise it seems to be taking the exact same path as HCQ, unfortunately. Hopefully this time around, no more precious research time and resources than strictly necessary will be wasted trying to prove again and again that the "Internet's miracle cure" does. not. work.
> Please do not spread potentially dangerous health misinformation and false hopes, even in good faith. If there was such a protocol that worked, the world would know.
Just because you have convinced yourself that legitimate treatments for Covid could never possibly be suppressed because they are not profitable, does not mean that is actually the case. Your attempts at ideological discipline disguised as "just trying to keep the forum free of dangerous misinformation" are not going to work with me.
The pattern of "HCQ didn't work, therefore Covid is untreatable and any other suggested therapies are quackery" has certainly gotten a lot of mileage since HCQ flamed out as a standalone treatment, but it is baldly anti-scientific thinking. Some other good signs of motivated, un-scientific reasoning are peppered throughout the blog post you linked (which by the way was written long before the release of numerous RCTs demonstrating ivermectin's effectiveness), such as frequent use of the term "Covidiots" or using the Surgisphere researchers (who as far as I can tell were grifters paid to discredit HCQ) to tar ivermectin because they mentioned it once.
The NIH finally had to withdraw its recommendation against ivermectin in mid-January. Of course they're still maintaining the line of "there's insufficient studies to recommend its use and we're certainly not going to fund any!" but the trend is continuing in this direction and RCTs are continuing to pile up showing its effectiveness in fending off severe cases when taken early.
Also, good news! HCQ has actually been shown to be effective in combination with other drugs like bromhexine which block the virus entry pathways that HCQ misses. Perhaps not as significant now that far better treatments like fluvoxamine and ivermectin are out there, but it still show that HCQ is a far cry from "snake oil." https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7175911/
> Between one in six and one in three people, to be precise. A "little bit more" indeed.
Is it your serious contention that up to one in three people who are infected with SARS-CoV-2 develop long haul symptoms?
> 76% of hospitalised patients still have symptoms after 6 months.
Yes, and in how many of those cases are those symptoms debilitating? What percentage of people infected are even hospitalized in the first place?
> Yes, and in how many of those cases are those symptoms debilitating? What percentage of
> people infected are even hospitalized in the first place?
Yes, how many? Shouldn't you know it if you are advocating (or at least considering) just catching the virus instead of getting vaccinated? Esp. since we do know the risks of the latter with a pretty high confidence and the scientific consensus is that you should definitely choose the vaccine and not get infected.
But to give you a number I heard: here in Hungary 3% were hospitalized for the "base" variant. Now we have the UK variant and it seems to present a higher hospitalization rate. According to a UK study it has a 55% higher fatality rate too. So with 3% you get 2.28% chance of having symptoms after 6 months (or dying). Doesn't sound good at all. That's 1 in 40 people. More than a million times the risk of getting a blood clot from e.g. AstraZeneca if it is real (and if they've discovered all the cases, of course).
I'm pretty sure it doesn't apply to the HN crowd, but on a side note, I found it quite interesting how people consistently get probabilities wrong. They may be afraid of something happening with say 1:100 000 chance (severe vaccination side effect) and saying that something else, with more severe consequences shouldn't be afraid of, because it happens pretty infrequently (dying of covid infection which we don't know exactly but is somewhere between 2:100 - 1:1000). Usually, of course, people say these in different conversations, or at least in separate comments (if online) but they'll have a hard time reconcile these even if you point out that these are numbers that they can actually compare. (Of course, I get it's the cognitive dissonance and their irrational fear of vaccines, or maybe the loss of control, still it's fascinating.)
Like many of us here, you clearly seem to be a smart person, with expertise in one or several technical fields, and confidence in your ability to learn a new one and apply your existing knowledge and mental models to it. You've probably done this many times before.
Please accept that this does not make you immune to the good old "Mt Stupid" phase of the Dunning-Krüger curve. In fact, "smart hackers" like us are really prime examples of people who might fall for it. I contend that you are currently stuck there on Covid, and together with other smart people you're finding yourself inadvertently aligned with very dumb run-of-the-mill conspiracy theorists that you would normally want nothing to do with. Please don't take that as an insult and bear with me for a moment :
Without even getting into a debate about Ivermectin, have you considered what else should be true in order for your current take on Covid severity and treatments to be correct ?
It would take a majority of people around the world who have dedicated their lives to this topic to be wrong, or careless, dumb or plain evil. Many of them are doctors and researchers who are not only acting in good faith and genuinely want nothing more than to help their patients or advance science, but perhaps more convincingly, also have personal, visceral, "can't lie about it" interests at stake, like desperately wanting to save a colleague, dear friend, or their own dad or spouse.
Please do not insult them (and delude yourself) by automatically assuming that you know better than them, that they failed to save their mom, dad or friend because they didn't want it enough.
If you believe that the powers that be (institutional research / politicians / regulators / big pharma / whatever) are broken / dysfunctional / stupid and prevent the truth from surfacing, and that people like yourself are gonna disrupt the shit out of the system, stop it now. This is the definition of arrogance, and you're deluding yourself.
I could stop here really.
But let me just answer a few of the points you raised (and then I'll consider my efforts at convincing a stranger done : do whatever you like with it) :
> Just because you have convinced yourself that legitimate treatments for Covid could never possibly be suppressed because they are not profitable,
This is a strawman argument, I do not think that. But I do use Occam's razor, and there is a much simpler explanation to the current absence of early stage treatments than a "suppression" conspiracy theory : that we really did try but simply have not found one that works yet.
This suppression theory was already untenable for the reasons most conspiracy theories are, but it should have been killed for good when 3 things happened :
1. A cheap generic drug, dexamethasone, is found to be our only effective treatment (albeit late stage only) with a 30% fatality reduction.
2. Remdesivir, the "big pharma contender" in an imaginary battle against HCQ that some insisted was happening, is found to be ineffective and is dropped without discussion.
3. In the same trials, HCQ is not outright dismissed just because it originated from quack doctors circles, but given the same fair chance as others.
> The pattern of "HCQ didn't work, therefore Covid is untreatable and any other suggested therapies are quackery
This is again a strawman argument. Covid may be treatable.
When it comes to prioritizing research, it is unlikely that a treatment touted by the same circles that touted HCQ, using the same flawed reasoning (something that does work in vitro should work in vivo) is going to be THE miracle cure. But it should still be allocated some resources to verify that. It has been, and the results are unsurprisingly, nothing to write home about.
> Is it your serious contention that up to one in three people who are infected with SARS-CoV-2 develop long haul symptoms?
"According to a recent survey done by the Centers for Disease Control and Prevention, 35% of nonhospitalized patients who had mild COVID-19 cases did not return to baseline health 14 to 21 days after their symptoms started. And this wasn’t just in older people or people with underlying health conditions. Twenty percent of previously healthy 18-to-34-year-olds had ongoing symptoms. Overall, research shows as many as one-third of individuals who had COVID-19 and weren’t hospitalized will still be experiencing symptoms up to three months later."
> Yes, and in how many of those cases are those symptoms debilitating? What percentage of people infected are even hospitalized in the first place?
I will let you look this up, and immediately after ask yourself whether it would make more sense to reason in absolute numbers to better visualize the burden it will cause on society (hint : it would)
We're talking about letting ICUs run at full capacity for months, causing widespread grief in families, unbearable pressure on doctors/nurses, and consequences for every age group (including the 20 year olds involved in a car accident and not getting the care they could have). Not to mention that every new case is a ticket in the evolution lottery for variants.
So yeah, you probably shouldn't be second-guessing the benefits/risk profile of vaccines for people your age, and in any case please stop with the "99.x% survive this thing"/"as a healthy 30-something I shouldn't be forced to ..." narrative. It doesn't make you look good and more importantly, it definitely hurts society and it could very well hurt you or someone you love directly.
> If you believe that the powers that be (institutional research / politicians / regulators / big pharma / whatever) are broken / dysfunctional / stupid and prevent the truth from surfacing
I don't believe it, I know it, because I read the news and don't shy away from its implications. Millions of lives were destroyed by the opioid epidemic, a crime which required the complicity and silence of almost all the institutions you cite. None of them have suffered any real consequences whatsoever. But hey, that's all in the past, I'm sure it's just crazy talk to think those same institutional imperatives could be creating any problems now.
> Twenty percent of previously healthy 18-to-34-year-olds had ongoing symptoms. Overall, research shows as many as one-third of individuals who had COVID-19 and weren’t hospitalized will still be experiencing symptoms up to three months later."
There's a million variables at play here, is it a random twenty percent? My guess would be that at least in the US 20~40% all age groups are seriously unhealthy to begin with.
Even if you migh not have you health ruined by covid, getting infected still makes it possible for you to infect others who might not be so lucky.
While vaccination apparently doesn't completely prevent you from infecting others, all studies as far as I can tell say that they reduce the risk quite substantially.
I don't believe I am obligated to take an experimental vaccine in order to reduce the risk that I will transmit a virus with a 99.95% survival rate for people under 70. And while I'm optimistic about the prospect for these vaccines to reduce transmission in the short run, it remains to be seen how well they will work over the long term against the evolving virus.
They will work fine because this virus can't evolve for shit. It's only produced 2-3 strains and only has one external protein it can mutate. The current vaccines are still good enough against it, and it doesn't take long to edit an mRNA vaccine either.
> I will transmit a virus with a 99.95% survival rate for people under 70.
This math is wrong, you should think of it as getting a flu but ten times worse that also gives you a permanent heart condition. And remember that the flu is already ten times worse than you think it is, because the last thing you thought was a flu was just a cold.
> you should think of it as getting a flu but ten times worse that also gives you a permanent heart condition
Perhaps we should think of it as getting SARS-Cov-2 and as much as 1/3 of people don't even know they're infected.
Unhealthy people are often really hit hard, the most vulnerable have a substantial risk of death.
But an overwhelming number of healthy people are fine, and given the prolonged disruption of normal life, those people suffer vast consequences from interventions that outweigh catching the virus.
Children especially are being sacrificed for the elderly and chronically ill.
I’m glad that you’ve come to the conclusion that if you did get COVID that actually you’d be fine so it doesn’t matter.
You might be right. You very well could be wrong. There are plenty of people who thought they’d be fine or it didn’t even exist and a non-trivial number of them are dead now.
This is a backwards argument and doesn’t stand up to basic logical scrutiny. You’re inventing the numbers and deciding based on the numbers you’ve come up with the conclusion.
That’s your prerogative but let’s be clear that you’re not basing this math on anything other than your gut feelings.
I'm in the same boat, I'm not against vaccination either. I've taken every vaccine offered, I get the yearly flu vaccine and even went out of my way for the HPV vaccine.
This is not completely correct, at least in the EU there have not been any emergency vaccine authorisations by the EMA which means that pharmaceutical companies will be liable for mistakes that cause adverse health effects.
In the UK there was an emergency authorisation which means that they will not be liable to the same degree.
As for why they do this: There is always a small chance that the vaccine will cause adverse health effects because pharmaceutical stuff is very complex. Minimizing legal risks is a completely normal thing in all industries and part of the negotiation process. I would not draw the conclusion that they aren't 100% convinced of their vaccine but instead that their team of highly paid lawyers told them what was a good business decision.
You're being pretty generous, and I think it sounds reasonable but placed within the broader picture (and given how liberals generally consider profit-driven healthcare systems and industry in other circumstances...) it seems like people are looking to paper over some dastardly stuff and dismiss legitimate concerns so as to not "rock the boat."
For instance:
> Officials from Argentina and the other Latin American country, which cannot be named as it has signed a confidentiality agreement with Pfizer, said the company’s negotiators demanded more than the usual indemnity against civil claims filed by citizens who suffer serious adverse events after being inoculated. They said Pfizer also insisted the governments cover the potential costs of civil cases brought as a result of Pfizer’s own acts of negligence, fraud, or malice. In Argentina and Brazil, Pfizer asked for sovereign assets to be put up as collateral for any future legal costs.
Interesting points, I did not know about these actions in South America. I don't want to be too generous to Pfizer/Biontech and you rightly point out the need to be cautious with these companies especially if they are in such an influential position. However my guess would be that legal risks in countries with weaker rule of law protections (for reference see this report https://worldjusticeproject.org/rule-of-law-index/) is a lot higher. You might find yourself in a position where a court rules against you although you did not commit any crime – or you might presume that there is a possibility that you will be in such a position. If you want to protect yourself and have an extremely strong negotiation position, you might write very far-reaching liability clauses.
This in itself could – imo rightfully – be seen as a deplorable strategy because you are dictating these rules for a life saving vaccine. But it does not imply that you are committing any crimes at the moment.
I don't know which system and process you mean specifically, but I don't think that the system of approval under the FDA in the United States generally deserves our admiration or support.
The current opioid crisis is a great case study in the tragedy of trust, profit, and death.
As a scientifically literate society, we can do much better.
I mean the scientific system and the vaccine/medication authorization process in general in the western world. (I don't know about the other parts, so can't comment.) Yes, I completely beleive that process of the FDA and/or the EMA can be improved and if so, it should. Still:
- your best bet is trusting the current system as of now
- improving the system is part of the system. That's what's hard for e.g. science denialists to understand. (Don't get me wrong, I'm not hinting you are one of them, just came to mind.)
I have great confidence in the scientific method, precisely because it doesn't ask for my trust. The "scientific system" seems to be largely designed to obfuscate the implementation of that method.
I can't help but notice that, even amidst social pressure for people to use these vaccines, the underlying data used to produce the reports remains unavailable, and will remain unavailable until the conclusion of the monitoring of phase III of the trials. I'm not sure I understand the reasons for that, and I'm quite sure that this is the first time in my life that mainstream scientists and medical journal editors have expressed such consternation about a vaccine approval process.
> and the vaccine/medication authorization process in general in the western world
I think it's not unfair to say that this process has failed and is no longer relevant in an internet-connected society. Countless cases demonstrate this, such as the capricious and scientifically unsound reject of cannabis happening contemporaneously with the approval of opioid preparations touted as non-habit forming, when even a single dose (of the drug and of common sense) easily refutes that claim.
> - your best bet is trusting the current system as of now
Why? When I can do my own research, access experts fairly directly, and make my own health care decisions?
> - improving the system is part of the system. That's what's hard for e.g. science denialists to understand. (Don't get me wrong, I'm not hinting you are one of them, just came to mind.)
I think everyone is interested in improvement. The question is which parts of "the system" have shown promise worth keeping. It seems to me that involvement of the state as a gatekeeper will necessarily result in this system being used for regulatory capture and profiteering first, and public health second or worse.
> I have great confidence in the scientific method, precisely because it doesn't ask for my trust.
> The "scientific system" seems to be largely designed to obfuscate the implementation of that method.
You are just playing around the specific words I've used. No one asked for your trust. I just said whoever is unsure about what to do, their best chance at the moment is trusting the system that is based on science (the scientific method). And also transparency. (Well, actually at any given moment. Besides working on trying to improve it.) Yes, there will always be inefficiencies and politics, etc. But even with that, your best bet is that. Because the alternatives are worse.
> the underlying data used to produce the reports remains unavailable, and will remain unavailable
Is this unusual? I don't know, just asking. What I know is that the Russian one, that we have bought a few millions here, doesn't have an EMA certificate yet but they have published their results in The Lancet. Now you can say that's still not the raw source data, and I agree, though scientists say that it's very unlikely to be falsified (and they are under the EMA process now anyway).
> first time in my life that mainstream scientists and medical journal editors have expressed such consternation about a vaccine approval process.
Who and where? Not trying to downplay it, but since it is happening under pressure (from the pandemic) since it is thus unusual it's unsurprising that there will be public criticism from inside the community as well. Under normal conditions, if they were about to change the process e.g. in preparation for something like this, it would be just a simple scientific/professional debate that we wouldn't hear about.
> Why? When I can do my own research, access experts fairly directly, and make my own health care decisions?
You can make your own decisions, of course. Everybody can. But you can't do your own research. I mean you can, but it's naive to think it will not be significantly worse than what's being done by the scientific community. You are alone, they are many (thousands, tens of thousands). You have basically no idea or very little idea, they have spent their life learning about one or two of the sub-fields that provide knowledge for vaccine development and safety testing. And, of course, these guys are doing it full time now, while you'll just invest a couple of hours (days, maybe weeks in the best case).
I see a lot of smart people fall into this trap. There is a big difference in trying to understand the scientific results, the state of the art for the sake of understanding and between trying to somehow at some (arbitrary) level 're-evaluate' or 'check' the results and draw a contradicting conclusion. Verify whether all those science guys were right. You can't do that. I'd say that your chances are pretty slim, but I think in practice they are close to 0. Because you don't know what you don't know. You don't know what you are missing out.
What you can do is try to make good decisions by trying to evaluate the the risks and the costs of the outcomes. E.g. you can say that getting a blood clot seems to be 1:167 000 from a vaccine (from the AZ one, but let's use that as an estimate for the others). You can get the numbers for the adverse outcomes for a COVID infection AND you can estimate your chance of actually contracting it. (Because the if you compare with the assumption that you get infected with a high chance then it's a no brainer.) Then you can adjust your behaviour, if it seems doable. E.g. you may be able to say that "OK, I'm waiting another year with the vaccine, because I'm not meeting anyone and not going to any closed public place, so my chances of contracting is really 0". That makes sense.
It is not unusual at this stage of research. What is unusual is that the EUA process has been used for a product meant for the well. Given that, it seems prudent, at least to me, to release data as if this were closer to the normal and established process.
It was very eye-opening to me to hear a BMJ forum focused on how much we still don't know.
> Not trying to downplay it, but since it is happening under pressure (from the pandemic) since it is thus unusual it's unsurprising that there will be public criticism from inside the community as well.
You say "from the pandemic", but the contents of this leak make it very obvious where the FDA felt the pressure was coming from. They felt they were being "pushed hard by Azar and US GOV". EMA's assessment was that "Azar and still under his influence. Trump is still pulling strings on this."
It's right there in black and white: these communications aren't an optimal scientific process. They are scared of the politics and making enormous adjustments.
> There is a big difference in trying to understand the scientific results, the state of the art for the sake of understanding and between trying to somehow at some (arbitrary) level 're-evaluate' or 'check' the results and draw a contradicting conclusion. Verify whether all those science guys were right.
I don't think that's the nature of individual research on topics of safety and health in the internet age. One needn't second-guess every expert; there is plenty of solid meta-research to consider.
What I am saying is that I think I can make better decisions about my own health in the absence of the regulatory capture happening at FDA.
>someone makes a claim that "AZ cuases bloog clots", I'm not sure if they ever looked into estimating and then comparing the said probabilities.
I understand the stakes here regarding this discussion topic, but your tone is undeserved and unwarranted.
>No, AZ does not cause blood clots. It's being investigated for it.
Why is it being investigated for that specific side-effect?
>You should trust the system and the process.
Which system? Which process?
If I'm German, French, Italian or Spanish then the system and process are at-odds with the AstraZeneca vaccine, no?
Do we all just trust that our particular governing body is the all-wise entity that GotItRight, when opinions across the world and their respective governing bodies don't necessarily agree with one another?
hard to blindly trust 'the system and process' at this point when 'the system and process' are fractured and dissimilar in nearly every region of the world.
Some government must be making worse decisions than the rest.
Blindly encouraging trust in unknown systems across the world at large isn't great for everyone.
>And even if it does cause, you should take into account the probability.
The answer to "Why are they investigating?" is simple and, in fact, driven in part by the pharmaceutical industry itself.
First: The rate of thrombosis in AZ recipients is the less than it is in the general population -- Gen pop, ~.1% [1], AZ ~ 0.001% [2]. There is no evidence that the vaccine causes substantially higher risk. Also, the populations being prioritized for vaccination are a higher risk population for DVT to begin with.[1]
AZ, along with effectively every pharma company out there of note, takes the reporting of adverse drug responses (ADRs) very, very seriously. Both FDA and EMA require ALL companies that produce a labeled product (aka a drug you can "buy" and isn't only available in a trial setting) to investigate and report on every instance of a reported potential ADR. Companies want to investigate because they want to be able to keep selling their drugs. Regulators want to investigate because they want to limit ADRs as much as possible.
From the therapeutic point of view, it is bad if the treatment causes ADRs but also some may be unavoidable because of how the treatment works -- think chemo and cancer. The safety window for a drug is determined by balancing the therapeutic gain of treatment (usually, shorter time to recovery, increased QOL, or, in the case of cancers, increased life span/PFS) with the number and severity of known adverse effects. You might hear about cancer patients "cycling" their treatments, this is to allow time for the body to recover from known/expected ADRs.
Any way, this was a long winded way of saying every entity involved -- drug manufacturer, regulators, doctors, patients -- wants reports of ADRs investigated.
> AZ, along with effectively every pharma company out there of note, takes the reporting of adverse drug responses (ADRs) very, very seriously.
This is the reason that a lot of medications list the thing they're treating as a side effect. It doesn't work perfectly, so people report they're still having the condition, and that has to go on the list.
