> Public health bureaucrats have some weird habits in how they reason under uncertainty and how they communicate to the public. It might help if they sought out experts from economics, sociology, psychology, etc., instead of telling everyone to stay in the their lane.
The individual blood clots that birth control increases the risk of has nothing to do with the massive immune system induced clotting that these vaccine cause. The former is rarely lethal, the latter most often is.
Is it too much to bother with details, or we'd rather generously assume everyone is dumb except on Internet forums?
> The former is rarely lethal, the latter most often is.
Again, we're looking at one in a million stats for getting the clots, and one in six deaths amongst that tiny group of cases - without information yet on their comorbidities.
COVID itself causes clots. A lot more than 1/1,000,000. If you're afraid of clots, get the vaccines. Even the J&J one.
I agree that on the surface these numbers are not alarming. That said I trust that the government agencies know what they are doing here. If anything there is tremendous political pressure to NOT scrutinize the vaccines.
There is enough anti-vaccine & Covid rhetoric that we should all cool it a little bit and let the experts do their jobs.
> That said I trust that the government agencies know what they are doing here.
If 2020 didn't finally shatter that trust, is there anything that can? FDA was already obviously a regulatory capture vehicle for pharma. And CDC got nearly everything wrong in the ebola outbreak of 2014. Then, both of them blundered their way through this pandemic.
For example, we know from the email leaks that FDA felt it was under pressure from Trump to approve vaccines[0], and then never disclosed this fact to the public. That doesn't seem like dispassionate science and expertise to me.
By contrast, many of the medical journals, preprint houses, and academic institutions have looked like far more stable sources of knowledge.
It seems to me that the internet age asks us to replace our state institutions of expertise with something more thoughtful and genuinely connected to science.
They're letting perfect -- even a single death is too many -- get in the way of good -- a small number may have shitty outcomes, but the overwhelming majority will not.
Same framework that's lead to all of the poor policy decisions over the past year.
Possibly they are nervous because it could signal deeper problems. If there is anything people should have learned from the pandemic is that it takes a few months for the medical profession to sort themselves out when new data appears on the scene.
This is the thing. A similar issue was seen with heparin a decade or so back. Basically the heparin molecule (an impurity I believe) was causing an immune reaction that cross reacted with a protein that activates platelets. Not a minor side effect and until the full extent of the issue is known (who is at high risk? How do we treat if it happens) I don’t blame them for being cautious.
Your sympathy for them being cautious begs the question of whether the vaccine, with its uncertainty, is worth using. The cost of waiting to use it is significant - people will die from COVID.
It's not enough to say you're being cautious. You have to explain why you think it is better to be cautious about administering the vaccine with its attendant risks or to pay the QALYs incurred by the delay when people who would have received this vaccine don't.
All of a sudden we need a QALY analysis to justify an immediate reaction from the government? Things sure have changed in the past couple hours when it comes to What people think is required of America’s COVID19 response.
Pausing this one vaccine type to collect data and determine appropriate actions to mitigate this side effect is reasonable.
This is a low probability event, and the appropriate mitigation may be to do nothing; but there may be some common factor for these patients that might indicate use of a different vaccine or maybe informing people of symptoms of blood clots and what to do if they see symptoms.
The real risk here is eroding confidence in government health sources in general, and vaccines in specific. There were certainly unknown risks before, but now there is a known risk which deserves some study.
We've now got a known risk that's quantifiable, but hasn't been quantified. You can estimate the risk based on the current information, but now that it's a known risk, I would expect to have more complete information in a few weeks.
If this turns out to be about what it looks like now, unpause and go forward. If it turns out to be much more significant, all the better for having stopped; maybe restrict this vaccine to populations at higher risk of COVID or lower risk of blood clots (if that risk can be determined). Both mRNA vaccines and modified adenovirus vaccines are new types of vaccines not used before on a wide scale; pausing to get clarity on a major negative side effect is warranted.
You've hinted at a framework for making a decision but left out an important component.
A credible decision would give your estimates of harm/benefit for delaying vaccinating people. You seem all too willing to ignore the people who will become sick or die because of delaying the vaccine. You are only looking at potential harm from not delaying the vaccine. Unfortunately, you have a lot of company.
The risk isn't just the blood clots, it's that the vaccine is perceived as rushed (it was) and warning signs were ignored, so maybe other things were ignored.
Leading to more people delaying their vaccination. Supply is currently at a level that all doses available are administered, but to the extent lost confidence results in longer delay for high risk patients, that has a cost. When supply exceeds demand, lost confidence will have a cost for those low risk people who delay, as well as the general population which loses out on wider immunity. Delaying the vaccine now certainly also has some cost of the same type, but it's bounded. Another case of a vaccine campaign ignoring warning signs and proceeding without pausing to consider appropriate response to issues as they arise will affect this campaign as well as future campaigns.
I don't think anyone would disagree that if there were no cost to delaying supplies of the vaccine then we should do that. But that's simply not credible. The governor of Michigan seems to think that additional vaccine does would be helpful.[1]
Suggesting that effects on the order of the ones seen here is a good reason to delay the vaccine should make people doubt the ability of our public health authorities to make reasonable tradeoffs.
> A credible decision would give your estimates of harm/benefit for delaying vaccinating people.
It seems to me that the delay imposed by a pause in use of the J&J vaccine to make sure healthcare providers are informed of and have appropriately updated diagnostic and treatment protocols is minor, its basically pulling forward by a few days the effects of the 80% week-over-week drop in J&J vaccine supply that was just in the news.
People keep repeating this myth of birth control. I don't know how doctors do their job in other countries but if they look at the patients health history this number is a myth. Luckily health officials here (ETA: Denmark) inform about these myths on television whenever the government holds a press conference about new Covid-19 measures but this isn't so everywhere so please stop spreading FUD.
ETA: I see you made ninja edits to your comment....
Edit 2: So now you replied that you only added a word or two and then deleted you comment while I were replying. Your comment was only half as long when I replied (all the Twitter stuff wasn't there for example).
Something that has fascinated me about the last year is that the pandemic has sped up the feedback loop on decisions like this. Seeing the impact of this decision won't take years and the outcome won't be unclear. In another few weeks, we'll very likely know that this was an overly cautious call that directly led to even more vaccine hesitancy, and lives lost as a result.
* Hormonal birth control - years of research. Years of evidence and practice. Knowing what to do when this and that happens. Recommendations for women with known conditions not to take this and that hormonal birth control.
* Novel vaccination - barely month of research. Weeks of evidence and practice. We don't have best practices yet.
I'm fine with anyone to make a decision on them own to take these vaccinations. As someone with a not-so-uncommon mutation causing thrombosis easily, I'm happy I hesitated and haven't received either J&J or AstraZeneca.
> * Novel vaccination - barely month of research. Weeks of evidence and practice. We don't have best practices yet.
That is completely untrue. This vaccine has been through several clinical trials for months. We know that there are no side effects that are common enough to be of real concern. The reason we are only seeing this one now is that it is so rare.
Not a doctor, but from what I've heard from immunologists, vaccines in general are incredibly unlikely to have long-term side effects on the scales that you think about. When an immunologist talks about "long-term side effects" of a vaccination, they're usually considering time ranges on the order of 6-8 weeks. Meanwhile, the 10000s of patients from the big Phase 3 trials have been vaccinated for 6-9 months, so the usual scale of long-term side effects has long been registered.
That's not to say that it's completely out of the question that there will be long-long-term side effects. But if anything is going to cause long-term issues, my money is on the virus, not any vaccine.
Plenty of replication deficient things cause cancer, for example asbestos or igf-1. I highly doubt you can rule out accidental crosstalk between elicited immune antibodies and every oncogenic human receptor.
Apparently there were studies on adenovirus 5 vector vaccines against HIV in 2007. The vaccine was not successful, but I cannot find any data on long-term adverse effects.
mRNA vaccines are a new way to cause the body to develop an immune response - it's not using dead/deactivated tissue of the virus that the body detects and then its holistic system develops a response to. From my current understanding with this new type of vaccine it's skipping step(s), bypassing mechanisms, that leads to the body producing something that targets the "spike" of the virus - basically making it inoperable.
I don't think we know long-term how this may impact the immune system: does bypassing certain systems/mechanisms cause other problems with future immune response?
It took how long for us to realize as common sense that use of antibiotics allows superbugs to more likely evolve?
> Not a doctor, but from what I've heard from immunologists, vaccines in general are incredibly unlikely to have long-term side effects on the scales that you think about.
Fair enough, but the comment I responded to said: "We know that there are no side effects that are common enough to be of real concern."
Given this statement is not qualified for timescale, I want to know what the basis for it is.
How does the person who made it know there are no side effects on the order of six months or a year that are common enough to be a concern?
Look I am all happy chappy with the vaccine, I will inject that sweet MRNA Pfizer or Moderna vaccines as soon as someone lets me at it, but I still think we need to avoid what Fauci does, which is knowingly lie in order to get people to do what we want them to do.
There is blood clotting risk from AZ? Great, tell me what the risk is and I can deal with it, but lie to me and we are done talking.
mRNA has a short life span. It merely tricks the body into producing the spike protein. It breaks down in the body fairly rapidly. What long term effects would you anticipate from this?
There is a good chance for long term effects from covid. Completely the opposite for the vaccine.
> What long term effects would you anticipate from this?
Maybe you are responding to the wrong person? I never made any claims regarding what long term effects to anticipate. I asked how the person I responded to know there are no serious side effects on time scales longer than we have tested things on.
> There is a good chance for long term effects from covid. Completely the opposite for the vaccine.
I think the concerns would be around the delivery vehicle, which presumably is some big polycationic lipid thing.
From what I can gather, there’s not terribly much info on what’s known about what’s going into people’s bodies, and what info does exist has arisen from a thick soup of trade secrets and conflicts-of-interest.
People need to remember that we're not taking the vaccine for fun, we're taking it because COVID is out there and we know for certain that it has some lethal side effects as well as non-lethal side effects and possibly other long-term side effects that we don't yet know about. We weigh that risk against the risk that there might be some long-term side effects of the vaccine. To the best of our knowledge, the risks posed by COVID are more dire than those posed by the vaccines and we basically have to choose one.
Maybe you responded to the wrong person. I am in no way suggesting it is better to not take the vaccine, or that there is good reason to think that the risks posed by COVID are less dire than those posed by the vaccines.
You can never know anything for sure. This is why science, medicine and drug approvals are all about probabilities and calculated risks. If everyone suddenly dropped dead 10 years after taking a drug that was approved in 2015 there is no way we could know that right now. But we know it's very, very unlikely, so we accept that risk.
With vaccines we know from decades of experience that severe side effects tend to occur very shortly (days or maybe weeks) after the injection. So this is why vaccine trials observe participants for weeks or months, not years, before concluding that the vaccine is safe. Of course this doesn't guarantee that the Covid vaccine don't happen to be an exception. But if that was the approach we took then we would never be able to approve anything, and never get the benefits we know for sure it brings.
Fair enough, I clearly should have phrased that differently. I simplified the wording at the cost of accuracy. The correct wording would be "We know that it is highly unlikely that there are any side effects that ...".
Thanks, that is a much more reasonable statement, and I agree. On the one hand we don't know, but on the other hand a lack of knowledge does not mean everything has equal probabilities.
I personally don't see any good reason to think that the risk for long term side effects from the vaccine is higher for the vaccine than for COVID itself.
Your deficiency is that you're not a time traveller. You can't know what the long term consequences are no matter how many studies you do, until the long term has come to pass.
You can however guess, and make good guesses (I'm planning on getting the vaccine). But it does no one any good to fail to outline unknowns that are steelmanned by "we can't possibly know".
> Given this statement is not qualified for timescale
Keep in mind that we also don't know the long-term effects of COVID-19. It's possible that people who were infected with mild cases drop dead 1 year and 6 months after the infection. The disease hasn't been around that long, so we simply don't know.
It was researched as quickly as possible on a for-profit basis. All my friends from college who went into biomed quit because of how corrupt it was and they would start with a profitable hypothesis and work backwards its antiscience and honestly capitalism has a proven track record of poising everyone and anyone to make a penny.
You kind of answer your own question : only time will tell, ironically, and nobody else.
Also, to all those saying "clinical trials have succeeded", I strongly suggest them to read said published trial results and look at _measured_ sample sizes used in the results, not total inoculation numbers.
Applying the precautionary principle, particularly if you are not at risk, is a perfectly reasonable position, IMHO.
> We know that there are no side effects that are common enough to be of real concern
No, we can't know that. Some affects don't show up for a long time. One example is women.
Women's bodies are complex because they go through so many changes. These changes affect how they respond to medical treatments. In other words:
- Just because pre-menopause women respond well doesn't mean post-menopause women will.
- Just because pre- or post-menopause women respond well doesn't mean women who are going through menopause respond well.
- Just because non-pregnant women respond well to the vaccine for a month doesn't mean that pregnant women will respond well.
- Just because 6-month pregnant women respond well doesn't mean 3-month pregnant women will respond well.
- Any issues with the vaccine during pregnancy may not show up until after the child is born.
- Women's hormones are fluctuating wildly at the beginning and after pregnancy. These are also times that need a lot of representation in the study.
In fact, the amount of change women's bodies undergo affects medical treatment so much that many clinical trials deliberately under-represent women to simplify the study, and then use the results of the trial to recommend prescriptions for women.
The clinical trials have been for months on limited numbers of people. Given this seems to be a 1 in a million situation the odds are against those trials discovering them.
Actually they did notice extra blood clots during the trials, but didn't think it was statistically significant [0] (15 blood clots versus 10 in the placebo group, in a trial of 20k people).
Factor V Leiden gang represent. Afaik AZ clotting is caused through a different mechanism though. Have there been any official recommendations for us thick-blooded folk?
It goes even deeper than that. I have seen that meme catch on in so many feminist Twitter and Instagram accounts that it is essential to look at the play here.
The "you woudn't care about women dying" narrative completely derails the essential discussion (aka when do we determine vaccine to be save) by selectively picking facts from a completely unrelated health area to turn it into an activist subject.
It reminds me on the magnet-troll-logic memes, only this one trying to come up with the completely insane narrative: "If you are concerned of a few more people dying because of a vaccine, you hate women."
The narrative - and I think it's a correct one - is "we accept far riskier interventions in our everyday lives already, of which birth control is one good example".
Citing "years of research" that nevertheless demonstrate a product has side effects as bad or worse as a reason something should be allowed is status quo bias.
This is a highly unusual situation insofar as phase III monitoring is far from complete and there is no 'phase IV' (confirmatory) trial data at all yet. In the normal course of research, this is how we'd catch rare but consistent adverse effects.
So, if we had complete trials on a normal timeframe, then obviously there's a different calculus to apply.
But given what we know at this moment, these six incidents might actually be far more normal than the crude use of six as numerator and seven million as a denominator.
A pause to assess the data and allow any lag to resolve seems prudent.
And, while this will be very difficult to quantify until much later, if then, I surmise that this will only create temporary vaccine hesitancy and only outside the high-risk tier, which is perfectly rational.
For people in the low-risk tier, there's nothing wrong with waiting until the conclusion of the RCT monitoring in the first place, even if adverse events weren't the basis of that decision.
That's the thing. Pausing the vaccine will kill people. Judging by the numbers so far - probably more people. But different and older people.
How does one do that math ethically? There are risks if you do and risks if you don't. The FDA is the wrong group to make that call, because they're only concerned with the first kind of risk.
In Canada we reserved the Astra Zenica vaccine for people over 55 because of the blood clot issue. I think that's probably the right call.
None of our societal systems are setup to do rational cost-benefit trade-offs in a pandemic.
“Don’t wear masks.” “No, no: wear masks.” “COVID kills over 10%.” “COVID kills less than 0.1%.” Once we realized the difference in makeup between the over-10% and sub-0.1% populations, we still couldn’t bring ourselves to make data-backed differentiations for many, many months (and still today have many small businesses closed or restricted based on what they do rather than the risk profile of their owners and employees).
These are difficult decisions to be sure, but when being seen as on the “safe side” confers benefits without a commensurate charge for the risk of the “safe” action, you get a society which moves in the direction of perceived safety (and where perceived safety may be strongly sub-optimal).
> 'These are difficult decisions to be sure, but when being seen as on the “safe side” confers benefits without a commensurate charge for the risk of the “safe” action, you get a society which moves in the direction of perceived safety (and where perceived safety may be strongly sub-optimal).'
yes, security theater abounds. it's a multidimensional optimization problem with no absolutely safe side in the long run, only relatively, but often initially unintuitively, safer non-linearly intertwined sets of actions. it's hypocritical to discount the tiny risk of vaccines while dramatizing the tiny (but larger) risk of death by covid. further, it's myopic to look at the risks of covid in isolation (which is what all the frenzy around it has been doing for over a year) rather than in relation to all the similar risks in our lives and couching our responses now within our existing responses to those other ongoing risks.
I don't disagree. But I will observe that many people in the low(er) risk tier are going to be traveling, eating out, having parties, etc. sooner rather than later--vaccine or not. In my very Blue state people are very obviously relaxing a whole lot more. So the question isn't whether things open up or not. It's whether people are vaccinated when they do. (Which doesn't mean all vaccines are equally safe.)
It seems like people in the low-risk tier might be more likely to get J&J. Firstly, it's just the one shot and secondly, people who are worried about COVID are vaccine shopping because they want the perceived "higher efficacy" of the mRNA vaccines vs J&J (whereas lower-risk people might be more interested in vaccine passports than preventing symptoms).
Maybe. In a lot of places you don't really have a choice and, in the US, AFAIK the mRNA vaccines are more common. Also, while "vaccine passports" have started being discussed, they're not really a factor yet--given how many people still need to vaccinated--and may never be outside of scenarios like schools. (That said, I have heard people who see getting a vaccine as more pro forma saying they prefer J&J because it's just a single shot.)
It's pretty easy to "vaccine shop" (if you care about it) at least in the US with all of the scheduling being done online. Sure, if you go to one of the big vaccination sites, you may not get a choice, but it seems that sites offering J&J have been advertising that and ones that don't indicate seem to be Pfizer & Moderna (or if J&J, give you a choice, at least around Massachusetts).
J&J is also widely used in the US for people who might have issues with scheduling a second shot, for example people who are homeless, or are home-bound.
Fair enough. It was still quite hard to get one when I scheduled and I was going to take whatever I could get even if I favored the mRNA ones. That said, if I didn't really care about getting a vaccine but was going to get one anyway, I'd probably just choose whatever I could get most easily.
Seriously I can't believe this is that simple. There is no way public health bureaucrats don't understand this common sense logic. Otherwise they would all become vaccine deniers.
Healthcare is extremely weak on science. The profession existed before the scientific method so there is a tendency to value authority over science.
Even today Physicians still think the body is Art, or a combination of Art and Science.
And the only reason we don't have a science based alternative to the Physician cartel is that they spent literally $400,000,000 on lobbying/bribery in the last 30 years.
Edit- for further reading look up "evidence based medicine debate"
> The profession existed before the scientific method so there is a tendency to value authority over science.
Anecdotally, my pediatrician has an inverted "trust pyramid" in some of their examination rooms. At the bottom—least trust—is "expert opinion."
> Even today Physicians still think the body is Art, or a combination of Art and Science.
I'm not sure why you would think these two things are opposed?
Science most broadly speaking means knowledge, and the scientific method is a means (but certainly not the only means) of acquiring knowledge. But what you do with it is art/craft. Separating the two seems unnecessarily dualistic.
There's lots of other things to compare it to as well. It's a roughly 1 in a million chance of dying - which is called a Micromort https://en.wikipedia.org/wiki/Micromort
We 'spend' about one micromort of risk per day of being alive. Or you can spend one walking for 6 hours, or driving 250 miles (or 6 miles on a motorbike)
I just made a website to show all the other stuff we do all the time without worrying with the same (extremely low) level of risk
Ah yes, that is true! This site is based on AZ, but you're right it might be a different story with J+J. I wonder if as well, they'll get better at spotting the blood clots and treating which could also be happening - but that's just conjecture / hopeful thinking at this point.
One caution here; at least with AZ, apparent rate of clots varied dramatically by country, and rates generally went up once people knew what they were looking for. It's plausible that a lot of early ones were missed entirely or misattributed.
That's 6 unusual/dangerous cerebral clots per 7 million doses, not all blood clots. There were 50% more clots of any types in the vaccine trials of 20k people [0] (15 blood clots in vaccinated group versus 10 in the placebo group).
I see IPv4 A records. I am guessing what's happening is that when you look up the DNS over IPv6, it gives you AAAA records instead of A records. Or, it can depend on locality. Cloudflare is not a DNS provider that gives the same answer to everyone -- its goal is to direct traffic to the cache that's closest to the end user.
Edit: I looked into it more and I can get IPv6 and IPv4 DNS servers to serve me both A and AAAA records. The site is now down, however :)
It meant that anyone not using IPv6 or a dual stack provider wouldn't be able to view the site through the non-www domain. However, they look identical now, so you're good.
Paraphrasing one famous science commenter, we're playing Pandemic Trolley Problem and running over hundreds of people because we're not sure if the other path has one or two persons.
It may be ridiculous, but it seems necessary if you're managing populations of people:
Build a dam, which if it broke would kill hundreds-of-thousands, or let millions die for lack of water? Oh, we'll just over-engineer it, now we can't afford to buy food to keep the people alive long enough to need the dam; or the lead engineering firm embezzles the money and installs dodgy iron.
We can't wait around for long term studies, whatever point we decide to start vaccines - where they can still be effective for the current population - it's always possible we should have waited a bit longer.
Deaths by COVID implies that those at risk will forego all other options to decrease risk of infection, such as masks, distancing, etc. Those options are opt in the same as a vaccine, though the vaccine is 2x and done.
Nonetheless, just because version 1/2 COVID vaccines are good enough for you does not others should just jump on board when other options exist that can vastly reduce risk of infectionand/or death.
In short, blowing the death problem our of proportion unless the options are only nothing vs vaccine.
> Deaths by COVID implies that those at risk will forego all other options to decrease risk of infection, such as masks, distancing, etc.
Masks are supposed to protect others from you. Wearing a mask is not meant to help a person who may be at risk decrease his/her own risk of infection.
In any event, now that spring weather is here in the northern hemisphere and the vaccination campaign has given people hope, social-distancing rules are being flaunted in many countries and at-risk populations may find it hard to properly distance when they leave their homes for e.g. basic shopping. So, since the "other options" don’t always work, keeping up the vaccination campaign is very important to reducing infections.
While mask effectiveness may be skewed the direction you state, you can't tell me that wearing one along with other precautions has no positive impact on your own infection risk.
For those willing to receive vaccination right now under informed consent, I'm all for it. I agree people are over the pandemic and making the situation worse. I disagree with many commenters here that are shaming and/or implying that people like myself are anti-vax vs simply being willing to wait for much more evidence before jumping on board with incredibly widespread usage of an incredibly not well understood treatment.
> shaming and/or implying that people like myself are anti-vax.
I'm in a low risk bracket. My country saw an uptick in people canceling vaccination appointments. 40% of 60+ people here are now 'unsure' of taking the vaccine.
I've done nothing but work and follow the rules since this whole thing began. Young people without partners, or young people in general, that are active, have a social life did a complete 180* in their "allowed lifestyles".
I've paid with money, time, a year of my otherwise busy life, for people in risky age brackets, at _little_ benefit to myself. *
But I'm so done, don't tell me you're asking people like me to be stuck in our anti-social and unhealthy living arrangements, while there's a solution that's _safer_ than going to a covid shower?
People like me are done paying, I'm not going to wait around another year, you take the vaccine or you take covid for all I care.
Also: losing weight, getting more exercise, improving your diet, getting proper amounts of vitamins. All things that will greatly reduce your risk of death from many causes, not just COVID. But requires some effort compared to taking a pill or a shot.
I doubt the correct communication strategy is obvious. Rumors about people dying from a vaccine can be worse than a pause.
A legitimate reason for the pause is to assess whether the people impacted have anything else in common. There are alternative vaccines that can be used if a commonality is identified.
As far as hesitancy, the idiot media already does a story for every vaccinated person that gets sick, this isn't going to tip huge swaths of people in either direction.
Note that in EU it also started with 7 cases ~1 month ago. Then doctors went through the records and now there are 200+ sick, 25 people dead from CVST alone (clotting that causes bleeding in the brain) with incidence in Norway 5 out of 130000 vaccinated. If you look at women only it will probably go even higher. And if you compare that to CFR from COVID for person <50 years old without diabetes and hypertension it will be within an order of magnitude
> Then doctors went through the records and now there are 200+ sick, 25 people dead from CVST alone (clotting that causes bleeding in the brain) with incidence in Norway 5 out of 130000 vaccinated.
The point he’s trying to make is that if you’re in a low risk group (let’s say under 30 for example) maybe it’s a better idea to just skip the vaccine.
I would still take the vaccine but the point I'm making is that it's serious enough to offer younger people some other vaccine, investigate why is it happening, how to fix it (use a different vector, adjuvant or dosage?) and roll it out safely. Call it version 1.1
Wait, that doesn't sound quite right: the benefit of taking the vaccine goes not only to you, it's also to the people you would have otherwise infected by spreading the virus yourself.
It's highly likely that natural infection provides worse protection that vaccination and we have real world evidence that already suggests this.
1. Two exposures to the spike protein are likely to create a much better long term immune response simply because of multiple exposures in a short period of time.
2. The spike protein produced by the mRNA and J&J vaccines is engineered to produce better response against variants.
3. We've already seen evidence of natural infection performing poorly in rural parts of Brazil with very high initial infection rates (> 70% which is near the herd immunity threshold) like Manaus where we're seeing significant evidence of reinfection where it should be have been difficult for COVID to spread.
1. The current mRNA vaccine, only produces antibodies to the spike protein. A natural immunity produces antibodies to several components of the virus. If the virus mutates its spike, a natural immunity will still provide some protection.
2. A vaccine producing (IIRC) two orders of magnitude more antibodies than natural immunity is not necessarily a good thing.
Put your life on the line for the community, comrade! And sign away your right to legal recourse should you die as a result. You're on your own! You owe the community your life, and the community owes you nothing!
I'd rather all the people gaslighting the public by saying the vaccines are completely safe, totally worth any risk, "trust the experts", etc - when in reality young people seem to have a better chance of dying from CVT than COVID - move to a deserted island.
If the real argument is "the cure has a better chance of killing you than the disease, but please risk your life for the community", I'd rather people be honest and say that in the first place.
Please link results of the study that supports your statements of mortality among young people. In USA alone more than 10k young people died from COVID so far. JJ vaccine has one potentially linked death after 6 million doses.
I think there's a really big difference between being FORCED to get the vaccine, and being reminded that your actions have consequences on other people and not just on yourself. Nobody is saying that you should be required to get vaccinated. So really this is just a straw man that you're burning down.
Can't you still spread covid if you are vaccinated? Don't you still have to wear a mask and social distance? That doesn't add up with what we are being told.
> Can't you still spread covid if you are vaccinated? Don't you still have to wear a mask and social distance?
There's been jumbled messaging on this.
The "you still need to wear a mask" thing was, if you dig in on the actual statements instead of the media headlines, "because we don't know yet". An abundance of caution.
Since then, we've gotten quite a bit of good data on that front.
> Data analysis in a study by the Israeli Health Ministry and Pfizer Inc found the Pfizer vaccine developed with Germany’s BioNTech reduces infection, including in asymptomatic cases, by 89.4% and in syptomatic cases by 93.7%.
I was just riding a government-run subway, and they had an automated announcement saying “Masks are required over the mouth and nose even for fully vaccinated people as vaccinated people can still spread coronavirus.” There was nothing muddled at all about the message. (Of course the message itself is probably wrong, but the public messaging itself is pretty clear.)
We have been told we have to wear masks and socially distance with or without vaccine, so you can ABSOLUTELY still spread it even if fully vaccinated. Please follow the health guidelines and do not spread disinformation.
> "It may be that we will show that if the level of virus in your nasopharynx because you're vaccinated is so low that you don't have to worry about transmitting, that's going to be a game changer for what a vaccinated person can or cannot do," Fauci said.
> The doctor explained that if the findings are corroborated, Americans will likely see a pulling back on some restrictions, but emphasized "we're not there yet."
Note that other vaccine's that prevent infection also reduce your risk of spreading the disease (measles etc).
So the fact that COVID spreads (not just in rare cases, but enough we all have to remain masked AND socially distant even if vaccinated) is a CRAZY big difference here.
The messaging has been clear - even if vaccinated you MUST wear masks and socially distance - which shows how different this is then other viruses. Given that, it's understandable that people are a bit more meh on the vaccines - because you can still spread it to others either way.
I do wonder about the experts messaging at times. Initially I thought airbone virus, began wearing my leftover N95's from wildfire season. Then they said those don't stop this airborne virus and to take them off. Then they said put them back on. and on it goes.
If I'm vaccinated, I'm protected. I don't really care if anyone else is vaccinated or not, as I'm not at risk from their decision. Or is this not true?
No, vaccines effectiveness can be substantially lower than 100%, so if you're vaccinated, depending on the vaccine type, you still might not be protected. It's much like the normal vaccines for the normal diseases, you don't always know if you're fully protected yourself so you end up relying on other people being vaccinated too.
1 in a million chance of vaccine death for AZ. Maybe 1 in 10m for JJ. 0 in 10 for the mrna vaccines.
10 in a million chance of death from covid in the 5-9 age group (the lowest risk group)
This is the perfect example of anti-vacc logic. They pick the latter because they heighten the risk of the former in their mind, while ignoring or downplaying the risk of the latter. Looking at the actual numbers, it makes no sense for anyone at any age to take their chances with covid over the vaccine.
I'm not saying your calculus is wrong but this does make an assumption that all clots are created equal and I don't believe that is the case.
The specific issue being observed is "cerebral venous sinus thrombosis (CVST)" in combination with "low levels of blood platelets (thrombocytopenia)" per the Joint CDC and FDA statement (1).
Low blood platelets means anti-clotting treatments can pose a substantial bleeding increase, making this already dangerous condition difficult to treat.
And we know adenoviruses interfere with the coagulation cascade through FX binding, so it’s well worth taking a pause and taking a closer look into what’s going on. With two well-tolerated and safe mRNA vaccines in the market, we can afford — to a degree! — to put Ad-based vaccines through additional scrutiny, especially since they’re likely to be the primary vaccine type on a global level.
I agree if you're in the US or in any other place with abundant supply of other vaccines. If you're in a place like the EU, like myself, every single dose counts and a setback can seriously screw things up.
Sorry, what’s the effect adenoviruses have on FX? I’m a male with a mild hypercoag disorder and history of DVT. Am scheduled to get the JJ vax today and will be skipping and seeking out mRNA instead.
Not a doctor, so talk to your hematologist! Ads bind to blood factors (Ad5s to FX, HAdVs to FIX, etc), which facilitates organ uptake and interferes with the coagulation cascade and triggers complement activation. Thrombotic thrombocytopenia is a known complication from gene therapy studies, so it’s not surprising, but concerning, that rare but serious coagulatory disorders are appearing in the widespread use of a zoonotic adenovirus. I’m certain quite a few other folks on here are better-informed than me, so hopefully we’ll get some more discussions going on this topic.
I’ll also say that the most significant risk is probably mistreatment of clots, since most doctors probably wouldn’t go right to non-heparin/warfarin DTIs unless they had reason to suspect HIT or had gotten a CBC back.
Yeah, that “to a degree” is US-centric and, even then, doing a lot of work — in the US, J&J is probably about 1/3 of the total vaccinations when accounting for the prime/boost mRNA protocol, so even here it’s a mess, and we’re in much better shape than the rest of the world.
> Cerebral venous sinus thrombosis is rare, with an estimated 3-4 cases per million annual incidence in adults. While it may occur in all age groups, it is most common in the third decade. 75% are female. [0]
6 cases in 7 million over 3 months with mostly women being affected is exactly what we'd expect to see.
To add, from the German Federal Institute for Vaccines (regarding AZ not J&J):
> Birth control pills can also cause thrombosis. So why is there all the fuss about the COVID-19 Vaccine AstraZeneca?
> It is true that for birth control pills thromboses, even with fatal outcome, are known as a very rare side effect. They are listed in the Summary of Product Characteristics (SmPC). The birth control pill is available only on prescription. Every woman must be informed of this risk by the prescribing physician. For the COVID-19 Vaccine AstraZeneca, there is currently a suspected very rare side effect of sinus vein thrombosis with accompanying platelet deficiency, sometimes fatal. It is not listed in the SmPC.
Seems like a “damned if you do, damned if you don’t” kind of scenario. If you don’t pause the rollout, there will be news articles that the government ignored deadly side effects, resulting in lack of trust and vaccine hesitancy. If you do pause the rollout, you get vaccine hesitancy.
Agreed that if everyone is rational/good at math the optimal outcome is proceed with dosing, but sadly that is not the world we live in and the “broken trust” scenario might be more damaging.
Who cares how many clots birth controls produce? What matters is the outcome compared to the thing birth controls prevent - pregnancy.
Do you get more blood clots from being pregnant or from being on the pill? It's order of magnitudes more from being pregnant, therefore if you're sexually active it's safer to be on the pill compared to not.
How is this the top post? People have no knowledge of basic Bayesian statistics.
I don't see your point. The J&J vaccine also presumably prevents much more blood clot-related harm than it's causing. OP is pointing out that we seem to have weirdly high standards for COVID vaccines vs. stuff we're used to.
Also, how does Bayes' Theorem apply to your comment?
J&J is paused because there are alternatives that don't have clotting to the same degree.
A comparison with birth control makes no sense. Is there some magical birth control that's used orders of magnitude more (Pfizer) and orders of magnitude safer with respect to blood clotting and also prevents pregnancy?
The primary concern people have here isn't the review, it's the immediate withdrawal. People who had appointments to get the J&J vaccine will now go vaccine-less until they can be rescheduled, even if they would have been happy to take it knowing about the blood clots.
There currently isn't enough vaccine to meet demand. Pausing J&J distribution will cause a larger gap between supply and demand. The 7 day average of deaths from Covid in the U.S. is 985. Even a week's delay in getting to full deployment of the vaccine thus means thousands of deaths.
I am not saying outright that the pause is not justified. But it has a substantial cost, and it would be good to see that our health authorities have considered this and weighed the balance of costs and benefits. e.g. it might have made sense to pause J&J for under age X and continue it for over age X, based on relative risk.
I don't agree with your analysis, I think you can see it entirely the other way, that both this pause and the initial "wait and see" attitude towards Covid are the result of an excessive bias towards the status quo. I remember back in January-February 2020 when people were saying it would be crazy to just shut down air travel, think of the massive economic cost.
No, because there are other vaccines that don't give you blood clots at all. Your entire point is moot. Pausing temporarily to investigate is hardly controversial. The comparison with birth control is nonsensical.
A vaccination for COVID is not the same as getting birth control. Even if it was, why would you get J&J if you could get Pfizer that doesn't have the same issue?
If all vaccinations had the same blood clotting issue then perhaps you and the original poster would have a point. Given a huge disparity between them with regards to blood clotting taking a moment to investigate this is simply prudent. Making nonsensical comparisons to birth control, well, is not.
Sure, but J&J isn't being permanently discontinued. Why are you against simply pausing vaccinations to investigate this? If the USA was this prudent with COVID in its beginning we wouldn't even be having this conversation.
Your argument would be reasonable if it was being permanently suspended.
> The skepticism shows no sign of slowing, YouGov reports. While trust for the Pfizer and Moderna vaccines rose in all country surveys between December and March, trust for the AZ vaccine slipped in Germany over that span. By early March, 40% said the AZ vaccine was unsafe, an increase of 10% since its earlier December poll.
> The result? Anecdotal reports in Germany and across Europe of people refusing the AZ vaccine and supplies sitting unused in warehouse, YouGov reported—real-world evidence of “the extent of the damage done to the perceived safety of AstraZeneca vaccine.”
> The AstraZeneca jab, which is cheaper to produce and easier to store and distribute than the vaccines currently being administered across Europe from Pfizer-BioNTech and Moderna, was meant to be a workhorse of the continent’s vaccination drive. That plan could be in trouble, however, if citizens across Europe continue to believe that the AstraZeneca vaccine is unsafe and, as a result, refuse to bare their arms for it.
I believe there are significant public health implications to how information is released to the public that need to be considered better than they have been in the case of this pause and the similar case with the AZ vaccine.
I believe, as with software, that immediate release of unvetted, incomplete, and still-being-investigated information can be actively harmful to people.
People keep saying this will add to vaccine hesitancy but I'm not convinced. The vaccine-hesitant are already skeptical of authorities and aren't going to be especially reassured just because US agencies say it's fine, when it's already hit the news that European agencies have halted J&J.
Seeing US agencies halting J&J while continuing the other vaccines could even be reassuring. It shows that US agencies really are pretty cautious, and are willing to halt vaccines that show signs of problems.
What you will find is that the vaccine-hesitant are perfectly happy to take the word of authorities who say "this vaccine is unsafe" and only have trouble accepting the word of authorities who say "this vaccine is safe".
For people who won't accept the vaccine regardless, it doesn't matter either way. For people who can be convinced, I think that obvious evidence of caution may be helpful in convincing them.
I think that is likely because the two states have different levels of confidence, similar to how "not guilty" is not the same state as "innocent". It is relatively easy to identify unsafe, especially when negative effects arise quickly. It is harder to reliably determine safe as it may just be a matter of time before negative effects arise.
What we've seen in the US is that the J&J was the choice of people who legitimately wanted a vaccine but were leery of the novelty of the mRNA vaccines. This is going to crush that group of candidates and some non-zero number of them will wind up in the camp of people who don't get vaccinated at all.
Also, and perhaps more relevant, covid kills about 0.5% of people. Presumably whoever set this policy divided things out, and decided that’s about 1 in a million.
I honestly don’t understand how we’ve managed to put people that demonstrate this level of incompetence in charge.
Why is it relevant? So far nobody forces me to take birth control and threatens for exclude me from the society if I refuse to do so (UK wants to require vaccine passports to go to cinema, for example). Nobody paints me as stupid anti-vaxxer if I just say I don't want to take BC pills. Nobody tells me that I won't be able to travel unless I agree to take BC.
I am a guy, so maybe I don't know what I am talking about. But I have a strong suspicion that the consequences for young women that chose not to take birth control pills can be felt as well and that they often feel quite a pressure from friends, boyfriends, parents, etc. to take the pill.
I am sorry, this is the whole other level. First of all, you are not obliged to discuss your medication with friends or parents. Second, your reply is pretty much like:
>> In China you disappear if you publicly say bad things about CCP.
> Yeah, I know what you mean, I called somebody motherfucker and got banned on HN. Freedom of speech is nowhere these days.
The obvious difference is that the vaccine is being forced upon people. A woman can talk to her doctor, understand the risk, and decide to take birth control or not.
The vaccine was given to people, under threat of exclusion from society, without knowledge of the side effects. Not comparable.
This article [0] mentions 50% more blood clots observed during vaccine trials, which at the time was characterized as a slight numerical imbalance (15 blood clots versus 10 in the placebo group, in a trial of 20k people)
Agreed, anti-vaxxers are already using this for their propaganda efforts. The core problem is that statistics isn't something that's well taught in schools, and so people can't understand effects of scale.
330M people means that (assuming an 1:1M incidence and a 80% vaxx rate) there will be 264 people dying from thrombosis. Which is bad, but nowhere near as bad as the millions that would die from an actual covid19 case.
Your math is off, there was only one death after around 7 million shots. And this has only been seen with the J&J, which will only be a fraction of the total shots given.
The bigger problem is that many people no longer trust the institutions providing the data. As such, they can understand statistics but will mistrust the conclusion as the data could be bunk.
Good point! I was focussing on the UK since that's where the majority of AZ vaccine users are, but you're right. I'll swap in a more international first risk!
Maybe tonight I can work out do an IP address lookup and personalise it for your locality ;)
Risk of... dying? Being injured? Being hospitalized? Developing a life-threatening clot? Also it's missing a word "from" but I worked that out. Thanks for your contribution.
I guess you may be confused by the missing "from". It should be "driving from London to Liverpool", whereas the present phrasing suggests we move a city with millions of inhabitants.
That might actually be the problem - however, it's kind of a stretch to say it "should" be expressed that way. "Driving A to B" is a common phrase (as for whether it's technically correct, despite the ambiguity of meaning, I actually am not sure).
Haha! This was not my intention! I deliberately tried to find things that you could not worry about. I'd already seen a lot of comparisons like 'don't worry about a 1/1,000,000 blood clot, you have a 1/100 chance of getting a brain tumour in your lifetime' and thought that would freak you out more.
(It's true though by the way, go enjoy the sun while you still can...)
I appreciate what you’re doing but I’m still avoiding the vaccine as long as I can. I’ve got a class 1 medical , a PPL and I hope [ha] one day to get paid to fly planes. I really don’t want another Pandemrix because with my luck I’d end up with the side effect. Also I’m MASSIVELY allergic to certain drugs and I get the NHS third choice for antibiotics and anti inflammatories.
Everyone should make their own decisions. I'm just trying to put out some truth about the risks so people can make informed choices.
TBH I've made this site for myself as much as anyone - I'm just under 40 so the risk/benefit is tight for me personally, but I want to do my bit for everyone else and stop the spread so I'll take any vaccine they'll give me.
FAA mandates only a two day wait after vaccination. I suggest the risks from "long covid" should you recover from an initial infection are worse than most problems a vaccine could cause. I waited too, but after millions of okay doses of Pfizer I took one. I did suffer two days of 2nd shot malaise (fevers and lethargy) which is expected as my immune system ramped up to fight the mRNA "invasion" of the spike protein.
I'll gladly accept additional micromorts (I do dangerous things often) but it must come with an appreciably worthwhile reward. My chances of dying from COVID (if you include the risk of catching it weighted by dying from it) isn't large enough to make the "gap" worth it. It may not be pro-social but there's no requirement in society to be pro-social.
We’ve completely transformed human civilization in a desperate attempt to slow down the spread of this virus that kills 1 in 200 people, and now we don’t want to use one of the miracle cures because of a literal one in a million chance of issues.
People are absolute garbage at thinking about scale.
It’s not a sim city decision. In young healthy people the risk of covid death is much lower than 1/200 , so you gotta see why this would make people hesitate.
As a young healthy people myself, I'm not tremendously concerned about either risk on a personal level, but I'm very concerned about getting vaccinated as fast as possible so I can do what I'd like without spreading disease. (To their credit, the agencies seem to have evaluated this and concluded the pause won't have a huge impact on vaccination timelines - but that won't do much for the people who were hoping to get it today!)
Deaths from COVID aren't seen as the direct 'fault' of the regulatory bodies. Deaths from a vaccine will be... and fundamentally, regulatory bodies aren't really incentivised to take risks anyway.
If they follow your line of thinking and it's all fine... no-one's going to be writing articles praising them.
If they follow your line of thinking and more people die form blood clots... people will write articles attacking them. Questions will be asked, and careers may be harmed. Etc.
It kills less than that in the demographic in question, not to mention that is only of those who contract the virus.
> People are absolute garbage at thinking about scale.
I don’t think it is that, I think it is that for better or worse humans tend to view wrongs through inaction as less atrocious than wrongs through action. Additionally - they already have better alternatives and plenty of supply in the US (Moderna and Pfizer vaccines) so they are opting to just use those at the moment.
Second, there’s evidence that even if people don’t die, there can be long term neurological effects [2].
Third, even if we accept your number, 1 in 200 would still be 1.5 million Americans dead, not even considering the rest of the world. I am personally not comfortable doing nothing to stop that number.
I agree that being super worried about a 1 in a million blood clot might be short sighted, especially since the death rate from catching the virus is 2 in 100.
That's probably true, so maybe the 2% death rate is too high, again, let's assume that the OP's point of 0.5% is accurate.
As I said, that still implies that if everyone in the United States got it, 1.5 million of them would die (320,000,000 * .005). That's a lot of people.
If a government did nothing to prevent a terrorist attack that killed 1.5 million people, most people would (rightly) be pretty upset.
EDIT:
Also, forgot to mention, it's totally disingenuous to only look at "deaths". We do not fully know the long term health effects, but as I stated there's potential neurological effects, potential risks of type 1 diabetes, and people permanently losing smell.
While I can appreciate where you are coming from, countering a terrorist attack typically has something that we don't have with COVID and that is information. The world was introduced and expected to react to this disease without any sort of "tactical" knowledge. Even if you include the other four variants of coronavirus, the availability of information can still be considered sorely lacking. Discounting government-provided information, even medical sources had a harder time providing a consensus on how the disease was transmitted during the first few months. That the larger questions like why we have such a large population that appears to be asymptomatic remains unanswered while we are still being pushed to "one-size-fits-all" remedy (and a remedy that appears to only be there to debase the severity of symptoms) doesn't help. Unfortunately, we need information, and information is going to take time. The long term arguments for health side effects are on both sides of the coin here.
It's also similarly absolutely disingenuous to use any other number that's not based on measured (or measurable) facts. CFR is the only one we have right now, what else do you suggest?
This is absolute and total BS. 2% death rate? Who comes up with this total garbage?
You have 100M infected in US as the estimate. A 2% death rate is 2M deaths from COVID alone. I've not seen anything like that as credible death rates - it's at least half if not a quarter of this rate - more like 0.5% or less. Do the same thing in countries with 70% infected rates - if fatality was really 2%+ death counts would be insane.
You really start to understand how people start to doubt the crap COVID "experts" put out when basic math shows it is garbage.
Johns Hopkins University. I don't feel like that's typically considered a bad source. Maybe it's a bit high or they're looking at different data sets.
But again, and I cannot overstate this enough, even if I accept the 0.5% number, that's still a lot of deaths, about 1.5 million if everyone in the US gets it.
According to the NYTimes [1], there's been about half a million deaths from COVID. If your provided number of 100M infected people is correct, then that would be consistent with 1.5M dying if everyone gets infected (US population ~= 3 * 100M, 3 * 500,000 = 1.5M).
1 in 200 people? Maybe if you're above the age of 75 and have significant comorbities. If it was 1 in 200 for all age groups you wouldn't have to convince people that lockdowns and maskwearing isn't all theater, they'd be so scared you wouldn't have to convince them of anything.
> If it was 1 in 200 for all age groups you wouldn't have to convince people that lockdowns and maskwearing isn't all theater, they'd be so scared you wouldn't have to convince them of anything.
Not really. 1 in 200 is fewer than how many die a year anyway of all causes.
Why only this 2 companies? Why don't we mobilize all pharma of the world to produce more mRNA vaccines quickly? Intellectual property? I think it's an extraordinary time so we should all agree to vaccinate all earthlings quicker is much higher priority than commercial interests.
> Novartis announced today that it has signed an initial agreement to leverage its manufacturing capacity and capabilities in order to address the COVID-19 pandemic by supporting the production of the Pfizer-BioNTech COVID-19 Vaccine. The agreement will see Novartis utilizing its aseptic manufacturing facilities at its site in Stein, Switzerland.
> On March 2, we announced a partnership with Johnson & Johnson to expand manufacturing capacity and supply of its COVID-19 vaccine. Under the Biomedical Advanced Research and Development Authority (BARDA) agreement, our company is adapting and making available some of our existing manufacturing sites to accelerate manufacturing efforts for the vaccine and enable more timely delivery and administration.
> Under the terms of the agreement, the companies plan to establish manufacturing suites at Lonza’s facilities in the United States and Switzerland for the manufacture of mRNA-1273 at both sites. Technology transfer is expected to begin in June 2020, and the companies intend to manufacture the first batches of mRNA-1273 at Lonza U.S. in July 2020.
> AstraZeneca and IDT Biologika also intend to strengthen Europe’s vaccine manufacturing capability with a joint investment to build large additional drug substance capacity for the future. Details of the agreement are to be finalised. Both companies plan to invest in capacity expansion at IDT Biologika’s production site in Dessau, Germany to build up to five 2,000-litre bioreactors capable of making tens of millions of doses per month of AstraZeneca’s COVID-19 vaccine. The new assets are estimated to be operational by the end of 2022.
intellectual property is one reason[1] but for the mRNA vaccines, the technology/machinery required to mass produce them is also part of the bottleneck along with raw materials[2]
I don’t think the parent comment meant to downplay the virus. I read it more like “we had to make great sacrifices to contain a 1 in 200 death problem but now we’re turning our noses at a cure that has a 1 in 1M serious side effect rate”.
There is a well established link between oestrogen and increased blood coagulability. Whilst it is possible females are more affected by the vaccine I suspect one factor is that their baseline coagulation risk increases their likelihood of thrombus due “reaction induced coagulability” compared to males.
CVST normally affects women at significantly higher rates than men.
> Cerebral venous sinus thrombosis is rare, with an estimated 3-4 cases per million annual incidence in adults. While it may occur in all age groups, it is most common in the third decade. 75% are female. [0]
Not fucking again, we had enough of this scaring with the AZ vaccine. While it definitely is sensible to investigate what causes thrombosis in the covid vaccines, the risk of thrombosis caused by either Covid19 itself or by everyday medication such as the anti-baby pill is many orders of magnitude larger.
It would be great if media still had actual science reporters who could inform their readers that while, yes, there is a thrombosis risk from the vaccine, you're way more likely to get a thrombosis from your contraceptive.
Unfortunately, most media these days rather prefers scare-mongering for clicks.
The Food and Drug Administration (FDA) said it was acting "out of an abundance of caution".
How is putting millions of people at risk of long-term (or fatal) complications from COVID-19 an abundance of caution? An abundance of caution would mean you give people the vaccine because that way, less people will die! Unless a thousand people are dying from the vaccine a day, the math is simple!
The FDA are honestly being way too conservative in their vaccine ethics. They are letting deontological ethics trump consequentialism. My motto lately is FDA PLEASE GET OUT OF MY WAY.
I think that simple news reporting inadvertently screws up how the general public perceives low-probability events.
Whether it's an airplane crash or a blood clot caused by a vaccine, human minds simply can't 'feel' that a phenomenon is rare when it is repeated over and over again in their newsfeed.
Here's a question for someone smarter than me. Is there a chance that this number (six cases in seven million doses) will rise as regulators comb through previous reports of adverse effects?
I'm probably not smarter, but based on what happen with AZ I don't think it will rise. AZ clot cases rised after people became more aware of the issue so it was reported more often as the vaccine side effect
Not an expert in but one of those expert drug regulators is my friend.
1 per million adverse effects is nothing. If that would be a solid fact, there would be no reason to pause vaccinations. The pause happens very early so that experts have time to check the data and methodology and verify that it's all that there is.
When a new drug is given for emergency evaluation or a new side effect is discovered he works 14 hours per day 7 days a week with a team going through a massive amount of data and documentation to verify and check everything.
The media and most commentators don't understand why decisions can take weeks. Why you don't have the scheduled emergency approval meeting just now. They fail to understand that fact-finding is not happening in the meeting just by people giving their expert opinions. Experts work around the clock without taking any time off to figure out what is happening. But lazy bureaucratic regulators, right?
I have some friends in this field as well (though they are in small sample size things, like specific breast cancer trials). Some of the fact-finding looks like calling up every patient who has gone through their treatment, but they have agreed to cooperate extensively in order to get into their trials. I can't imagine how painful it is to do fact-finding on this scale.
Yes, but not from previous reports. See the other responses about how previous reports are handled. I would expect cases to rise as unreported things get reported, and as doctors start to ask the right questions when they see these events and report things that previously wouldn't have been reported but probably should have. Not to mention that with these reports I expect doctors to ask the right questions and so previously misdiagnosed events get diagnosed correctly (some of these might be unrelated to the vaccine though making the data messy).
These vaccines have only got emergency approval . It is true that reliability of vaccines have caused some nervousness in society and that is obvious because no vaccine in history is out so early for use Must read https://www.weforum.org/agenda/2020/06/vaccine-development-b...
Whole world is going through tough time. I hope suffering ends sooner than later
So this past year the government has been willing to let unemployment, suicides and drug overdoses jump due to isolation and loneliness caused by lockdowns, child abuse to skyrocket and mental health to plumment due to schools being kept closed, all because we needed to stop covid at any cost. Now one person dies out of almost 7 million who received the vaccine, and we need to stop administering the J&J vaccine "out of an abundance of caution"? I'm starting to think more and more that the shitty decisions regarding covid in the past year were because it was an election year.
Government over-reactions to COVID19 have been disastrous. There would have been an economic hit for sure but things would have returned to near normal by August 2020 if they had respected freedom (or if people had disobeyed in mass).
Yeah. The US is apparently already at ~50% antibodies, not counting vaccination. So, there’s a floor on the upside of the vaccine: It did no more than halve deaths. We’re in the middle of a surge, and it looks like most of the remaining 50% will end up catching covid before being vaccinated, so the percentage saved by vaccination will continue to drop.
The ideal strategy without hindsight was conventional wisdom: Protect the vulnerable and stiff upper lip for the rest. That would have more than halved casualties.
With the benefit of hindsight, a 3 month shutdown while hospitals got their acts together (combined with protecting the vulnerable) would have roughly quartered the remaining deaths, but at far lower cost than the full shutdown.
This was predicted by some of the old-guard epidemiologists, which is why they were against the shutdown in the first place.
The cancel culture folks lumped them in with MAGA anti-vaxxers (I blame both sides) and got them censored by the big platforms. Here we are, with 100,000’s unnecessarily dead, trillions squandered, and many careers, businesses and educations ruined.
I suspect roughly zero people have learned a lesson from this. Hopefully I’m overly cynical.
I suspect a lot of folks learned (in the US) is that if you have a president who politicizes a pandemic and shits the bed on leadership, the populous is screwed.
Let's not pretend that rational discourse was ever an option, and the media isn't the place for blame.
I don't know. Seems like a sane, sober, professional, mature, and objective media would go quite far in moderating the overheated partisan rhetoric from politicians.
And then we had excess deaths in NY State because Governor Cuomo FORCED nursing homes to take in infected patients! And then he gave immunity to the whole industry from liability if they didn’t take precautions.
And he became the darling of the media and even won an Emmy.
> With the benefit of hindsight, a 3 month shutdown while hospitals got their acts together (combined with protecting the vulnerable) would have roughly quartered the remaining deaths, but at far lower cost than the full shutdown.
Where was this "full shutdown" you speak of? Not anywhere in the US. In Wuhan, and some other Asian countries, sure.
Didn't we kind of have the 3 month shutdown-lite you're referring to? Mid-March through about June for most places were at varying levels of shutdown in the US. But recall things started opening up in June of 2020. And cases started rising again into July.
> The US is apparently already at ~50% antibodies, not counting vaccination.
Citation? That seems like about 3X the most optimistic numbers I've heard from credible sources.
As for shutdown vs shutdown lite: No; the economy didn’t completely reopen in July. The recommendations from March 2020 were for more strict targeted shutdown protocols, but over a shorter duration (Strict reverse quarantines for nursing homes, but only for a few months for example.). The idea was to get less vulnerable groups to herd immunity faster. I’m saying a general, country wide shutdown for three months, concurrently with a strict targeted lockdown for about 5-6 months would have been more effective and cheaper (and, we’d have been done by last August, as the parent of my other post suggested.)
Source for 50%: Wall street journal. We were above 33% (based on random sampling, not confirmed cases) a few months ago.
This one from Feb predicted herd immunity a bit too early. They ran one with updated numbers last week, but I can’t find it:
Additionally, you make a few glib statements that don’t really check out - you say give hospitals three weeks to prepare - how? There’s been a lot made of hospitals getting ready, but for the most part, the limiting factor for covid treatment has been how many icu care teams are available. More ventilators don’t help much if there’s nobody to use them. Second, I’m not sure how you protect senior citizens when everyone else, including the people who provide their care, is swimming in a soup of COVID.
Like a while bunch of places did in March and April last year: build emergency capacity during what was supposed to be only a short several-week lockdown. Instead, when the capacity went mostly unused during the lockdown, it was quietly dismantled and lockdowns continued.
Also, we knew by April last year that ventilators were a bad choice: Doctors were jumping to it because of a specific weird symptom (blood oxygen levels impossibly low), but they had to keep turning the ventilators to higher settings to get an effect - to the point it was causing further lung damage. There's a bunch of less damaging ways to get more oxygen into a patient they'd been shifting to: https://www.statnews.com/2020/04/08/doctors-say-ventilators-...
Putting aside that these claims are presented without any evidence, “most” of 50% of the US population is a minimum of 82M people. ~31M have contracted COVID so far. That we’re going to see almost 3x the number of cases, concentrated in half the population, as we enter summer, and with 3-4M vaccines administered per day, is a pretty bold claim.
> The ideal strategy without hindsight was conventional wisdom: Protect the vulnerable and stiff upper lip for the rest.
China, Vietnam, Australia and New Zealand used strict lockdowns to eliminate community spread, and then largely opened things up again. People in those countries have been able to live much more normal lives than people elsewhere during the pandemic. With hindsight, that was clearly the correct strategy: eliminate the virus, then reopen and keep a hawk eye out for any new cases.
2/4 of those examples are affluent island nations with low population densities.
Another one of those examples has been actively censoring covid information from the start, and thus cannot be trusted.
As for Vietnam, it is an interesting case, and we don't have enough data to rule out cross reactivity or other factors playing a role.
Extrapolating these data points to the entire world with wildly varying sociological, biological, environmental, and countless other factors and saying this is clearly the correct (and implicity achieveable) strategy for all 8 billion people on the earth is at best hypothetical.
> 2/4 of those examples are affluent island nations with low population densities.
Australia and NZ have densely populated cities, and what does being an island have to do with anything? Countries can close their borders. In fact, Australian states closed their borders to one another.
> Another one of those examples has been actively censoring covid information from the start, and thus cannot be trusted.
You don't have to trust the government. Just ask people you know in China what's going on there. Things have been mostly open for a year now, with no sign of the virus (outside of a few localized outbreaks, which have been dealt with through local lockdowns and blanket testing of the population). China is not the black box that many people think it is.
> As for Vietnam, it is an interesting case, and we don't have enough data to rule out cross reactivity or other factors playing a role.
Vietnamese people are not somehow immune to SARS-CoV-2. They're susceptible, just like everyone else.
> Extrapolating these data points to the entire world
This is the wrong way to think about this. These aren't data points generated by some semi-random process. They're countries that effectively implemented a strategy that we know should work, based on the basic principles of epidemiology. The virus is spread between people who are in close proximity to one another. If you drastically reduce contacts between people, the virus has far fewer chances to spread, and the epidemic recedes. If you do that long enough, you get down to a small enough number of cases that you can trace every single one and snuff out the virus completely. After that, you have to have strict measures at the border in order to catch imported cases, and you have to do regular testing in the population to make sure you don't miss the beginnings of any new outbreak.
There's nothing to "extrapolate." The strategy works because of very basic principles of how the virus spreads. The only question is whether each county has the organizational capacity and societal will to carry this strategy out.
>question is whether each county has the organizational capacity and societal will to carry this strategy out.
Indeed, that's a critical question to the long term success of the strategy.
If the world is unable to put 8 billion people in solitary confinement (nevermind the disastrous effects that would cause) indefinitely until the virus is eliminated (nevermind the fact that we are incapabale of validating if it was actually completely erradicated), the virus is only going to pop back up.
There is no evidence of such a strategy working at scale across the world.
The scientists on the covid team at the WHO have said as much: lockdowns should only be used as a last resort to buy time to scale up health care resources. Should we listen to those scientists?
It's not indefinite. The longest lockdown in China was 76 days, in Wuhan. Elsewhere, it was significantly shorter. Because they had a strict lockdown early on, they have been living with far fewer restrictions than most of the world for about a year now.
> the virus is only going to pop back up.
It does indeed pop up every once in a while, because the borders can never be 100% sealed. There have been outbreaks in Beijing, Qingdao, border towns in Heilongjiang and Yunnan, and elsewhere. But the government is understandably on high alert, and these outbreaks were caught early enough to be stopped with local lockdowns, coupled with blanket testing of the population (i.e., testing everyone in a city in a few days).
There was a brief "second wave" in China this winter, in which an outbreak managed to spread to several cities, but it was ended with relatively short lockdowns and mass testing. The number of new infections per day peaked around 100.
The basic lesson here is that you can both have near-zero case counts and let people live their lives almost as normal if you first act decisively to bring cases to zero, by using temporary, strict lockdowns, quarantines and mass testing.
> There is no evidence of such a strategy working at scale across the world.
China is the largest country in the world, so I'd call that "at scale." Vietnam is larger than any EU country. We're not talking about San Marino or Monaco here.
> The scientists on the covid team at the WHO have said as much: lockdowns should only be used as a last resort to buy time to scale up health care resources. Should we listen to those scientists?
A lot of recommendations will be reevaluated after the pandemic is over. Nothing like this has happened in 100 years.
> As for Vietnam, it is an interesting case, and we don't have enough data to rule out cross reactivity or other factors playing a role.
They took shit seriously and everyone prepared the minute news reached them of a possible pandemic. A good friend of mine is from VN and he was shipping PPE back home to his parents around August or October of 2019.
I think most Americans don't realize how common pandemics have been in east Asia. To them, it's like preparing for any other natural disaster. It's like comparing the Michiganders response to a blizzard to that of Texans.
This is why we need more data about cross reactivity playing a role in the relatively favorable health outcomes in Asia and Africa compared to the rest of the world.
As someone with a family member working in a hospital who still couldn't get reliable PPE after 3 months, I feel that you live in an entirely different universe than I do. Would that we would have lived in a country where PPE for nurses, physicians, and hospital workers were prioritized in summer 2020. Hah. Hospitals were not in a position to get their own; I saw them jockeying for shipments from China and Korea and it's just ludicrous to expect people to get their PPE in bidding wars that involve calling in favors from the chief cardiologist's wife's uncle who owns a factory in China.
The problem is the virus, not the government reaction to it. Personally, I tend to think governments under-reacted in most Western countries. I'm not sure how things would have returned to "normal" if the virus was raging out of control. A good precentage of people would see the deaths and still avoid going out to shop or whatever. I'm assuming you mean by "normal" that people would return to some normal pattern of economic activity - and even if 10 or 20% of people changed their behavior that would still impact the economy.
> A good precentage of people would see the deaths and still avoid going out to shop or whatever.
That seems hard to believe, since significantly more people die every year of all causes than could possibly have died of Covid, even if every single person in the world caught it. Most people probably wouldn’t have noticed anything was different.
> even if 10 or 20% of people changed their behavior that would still impact the economy.
Maybe so, but the economy is not the only or even the most important casualty of our Covid response. The importance of human social gatherings, the freedom to leave one’s home and go wherever one pleases, the education of children, and so on cannot be measured in economic terms.
> The problem is the virus, not the government reaction to it.
Places where there were very few or only brief restrictions, like Serbia, Belarus, or Florida, largely avoided the issues I described above with only a small or in some cases unmeasurable increase in all cause mortality for 2020.
It's not at all hard to believe. All the people in my family, for instance, have changed grocery habits and stopped discretionary shopping in stores essentially entirely. Why? Many are older and have risks yet also have full lives and want to live to play with their grandkids. We prioritized gathering with each other cautiously over spending money shopping and changed habits immediately (I started working from home March 12, before any US guidance).
Sweden is an interesting example. Comparing Sweden and Finland, for instance, older people essentially cloistered themselves in Sweden because they had no trust that they'd be safe in society, and their spending dropped by a higher amount than old people in Finland, who changed their habits less due to the swift and more stringent government response? My old-person family members in Finland were able to keep shopping, going to church, and having birthday parties with many families due to that response (as opposed to in the US where we limited ourselves to gatherings with max 3 households and did everything masked or outdoors due to several people still working on site).
Perhaps you live in a very different place. You certainly interpret statistics quite differently given your example of Florida.
How many dead people would that "normal" have been worth to you?
If, instead, people had behaved responsibly in mass and we had used the time we got from that to establish coherent contact tracing and testing, things would have returned to normal by August as well, only without many the deaths your way would cause.
Or if they just followed the plan for this exact scenario that was handed to them by the last administration, if we're talking about the US, where more than half a million people died preventable deaths.
I'd argue that the "response" at the Federal level was a massive under-reaction. Months of denial didn't seem to work out so well.
Like the article mentioned, there may be long term effects we can't foresee.
Seeing the chaos in the economy and current real estate prices make me concerned that anyone without a home/mortgage in 2020 will be permanently lower class and renting due to inflation.
Free government money for a year is like eating candy. The stomach ache has yet to come.
Besides, in the CDC table, "unintentional injuries" is up by way more than suicides are down. This includes things like car accidents, and is a little suspicious, like suicidal behavior led to a death that wasn't classified as suicide. Also note that the table is "deaths with covid or presumed covid", not "deaths by covid": https://jamanetwork.com/journals/jama/fullarticle/2778234
Both the AstraZeneca and J&J vaccines use an adenovirus to deliver DNA instead of mRNA wrapped in lipid (like Moderna & Pfizer).
Everywhere I read about the J&J vaccine, I see something like "the DNA vaccine doesn't alter your DNA". Can somebody please clear this up?
As far as I understand, the mRNA just stays in the cytoplasm of the cell and gets used up by the ribosome to create spike proteins. The adenovirus vector used in the J&J (and other vaccines) injects DNA in the cell's nucleus, which seems at odds with the widely circulated "it doesn't change your DNA" statement.
Do people make this claim because the cell displaying spike proteins is basically always eliminated by CD8 killer T cells?
> Adenoviruses -- even as they occur in nature -- just do not have the capacity to alter DNA. Unlike retroviruses such as HIV or lentiviruses, wild-type adenoviruses do not carry the enzymatic machinery necessary for integration into the host cell's DNA. That's exactly what makes them good vaccine platforms for infectious diseases, according to Coughlan.
> And, engineered adenoviruses used in vaccines have been further crippled by deleting chunks of their genome so that they cannot replicate, further increasing their safety.
This sounds a bit like a technicality. The DNA makes it into the cell nucleus and is used by the cell machinery to make proteins. The changes aren't carried over after cell division, but lots of cells in your body last your whole life (nerves, brain cells, eye cells, important stuff).
Loss of neurons and cardiac muscle cells is permanent. Emergency medical personnel are usually taught "time is brain" and "time is heart" for this reason.
I think the argument hinges on the technicality that it's not splicing itself into the host genome, so no chance of it becoming a retrovirus or something like that (in the event that the cell's lineage is not extinguished by the immune system).
I'm not a genetic engineer (what a time to be alive, eh?), but I'm pretty sure an adenovirus that did permanently modify cell DNA would be more like CRISPR, including the risks that entails (such as the risk of incorrectly splicing the host genome and potentially creating a precancerous mutation)
I want to be perfectly clear that I didn't bring this up to be alarmist. Jesse Gelsinger's death shed a lot of light on the risks involved with adenoviruses [1]. Those lessons have been carried forward.
>> An autopsy and subsequent studies indicated that his death was caused by a fulminant immune reaction (with high serum levels of the cytokines interleukin-6 and interleukin-10) to the adenoviral vector.
>> The data suggested that the high dose of Ad [adenoviral] vector, delivered by infusion directly to the liver, quickly saturated available receptors ... within that organ and then spilled into the circulatory and other organ systems including the bone marrow, thus inducing the systemic immune response.
He was injected with >3 × 10^13 viruses [2]. The typical J&J dose contain: low-dose (5x10^10 viral particles) or high-dose (1x10^11 viral particles) [3].
I'm a bioengineer. Everyone that gives an answer mostly ignores epigenetics and the fact that RNA can permanently alter the _shape_ (or conformation) of how your DNA is tightly wound up. For example, RNA can direct methylation of DNA and alter histones, which can lead to transgenerational epigenetic effects on gene expression and phenotype [1]. The fact is, molecular cell biology is incredibly complex and the models we have are just that, models. Saying that these mRNA strands don't affect the genome long-term may be correct, but this is an educated guess based on theoretical models. There's a reason why FDA approvals traditionally took 10+ years, we normally verify our educated guesses empirically.
It almost certainly won't have long-term affects, but it may not be trivial to identify if mRNA vaccines have been altering epigenetics.
Everything in life has potential epigenetic effects! Not sure what you are trying to communicate with your comment but it sounds like you are saying people should avoid the mRNA vax but then you also say “almost certainly no long term effects.” Your thesis seems to be that 10 years is enough time to know for sure that they are safe. Why is 10 years the right amount of time? Why not 50 years or 5? In other words what’s your model for relative risk/reward and why is it better than what is being done in terms of public health outcomes?
50 would certainly cover all life stages of humans. I assume you could be sure with shorter.
I have an aviation, biochem, and skydiving background. My rule is for aviation: "if it hasn't been out five years you're a test jumper."
Humans are way more complex than airplanes. I personally wouldn't take the mRNA vaccine because of this rule. Coupled with being unable to sue or get help from the government I think people IN LOW RISK groups have been way too enthusiastic to sign up.
I'd be happy to take the vaccine if I was in a higher risk group and I'll be happy to take the vaccine in a year or two, but right now I just don't think it's right decision for someone like myself.
Given my risk is very low I'm not too worried about COVID, but I am a little worried (perhaps wrongly) about the risk of finding out about some long-term side effect from these vaccines a few months down the road. I suffer from long-term side effects from another drug I took in the past, and at the time I was told there was no risk of long-term side effects and that it was safe to take. Only recently has the labeling been updated to reflect the discovery that permanent side effects can occur in some cases and for me it's too late, but I learnt my lesson to allow others to be the guinea pig for new drugs wherever possible.
It's really quite alarming how little we know about the body, espically considering the certainty of some "experts" about how extremely low the risk of adverse effects are from newly approved vaccines. I'm aware of a number of drugs which are approved and frequently perscribed which we don't even understand the mechanism of action for -- accutane, for example. Of course in this situation, we do know the mechanism of action, but it would still be wrong to assume we know the full surface area of possible side effects which could occur because our model of the human body is so basic.
I'm happy for someone to explain why I'm wrong on this. I'm obviously not an expert, just an average guy trying to assess the relative risk of two very unlikely events.
There is no reason to expect that side effects from the vaccine are not present or actually dramatically higher from the live virus. An infection by the virus, even if asymptomatic, will likely introduce way more alien genetic material and viral proteins into your body than the non-reproducing vaccine ever would. So one should trust the FDA panel of experts on risk unless there's strong evidence pointing otherwise.
> I think people IN LOW RISK groups have been way too enthusiastic to sign up.
About that...
> In December, we asked, “What percentage of people who have been infected by the coronavirus needed to be hospitalized?”
> The correct answer is not precisely known, but it is highly likely to be between 1% and 5% according to the best available estimates, and it is unlikely to be much higher or lower. We discuss the data and logic behind this conclusion in the appendix.
> Less than one in five U.S. adults (18%) give a correct answer of between 1 and 5%. Many adults (35%) say that at least half of infected people need hospitalization.
From what I can deduce using CDC data my chance of hospitalization is 0.5 to 2%. Assuming linear relationship of obesity in the population and assuming the same risk at the top of my cohort to the bottom.
Or maybe people are just terrible at judging acute risks? This isn't unique to covid - ask them about flying on an airliner or living next to a nuclear power plant and you would get some equally comical numbers. At any rate risk of hospitalization/death isn't the complete picture since some of those young people are ostensibly doing it to protect the people around them.
So let’s say hypothetically that white people were low risk relative people of color. You would have white people not get vaccinated because the consequences for their group, alone, might be slightly better?
Does that not seem a bit ... immoral?
I assume you eschew all other medical advances that are less than 50 years old? Would you eschew remdesivir? Sorry for the questions but thinking such as yours intrigues me and I want to grasp the logic behind it. Why not avoid all new technology for 50 years? Getting vaccinated seems to me like the logical and moral thing to do, but maybe I’m overlooking something.
You seem to be putting a lot of words in OPs mouth. I didn't see OP making any sort of suggestion about whether to avoid the vaccine or not. It looked like they were simply explaining some possible outcomes of the vaccine that are unknown.
OP also didn't say 10 years is enough time to know the long-term effects of these vaccines, just that it's traditionally been the minimum amount of time needed for some other drugs.
Follow-up question: Do these effects (which are very unlikely) differ between vaccine and the virus itself? Or maybe: Is the epigenetic risk higher/different?
Would this be an advantage for the Novavax vaccine as it doesn't do anything to hijack cellular machinery to create the spike protein, it just (as I understand it) has a bunch of pre-made spike proteins.
Parent specifically stated DNA viruses. From your article:
> Most of these viral genes come from retroviruses, RNA viruses that insert DNA copies of their own genes into our genomes when they infect cells. HHV-6 is unique because it is the only known human DNA herpesvirus that integrates into the human genome and can be routinely inherited.
I think this is an example of where government transparency would greatly aid the discourse and build trust.
Where is the math that suggests that pausing the J&J vaccine is prudent? Inputs being risk of getting covid, risk of getting a blood clot, risk of injury/death from covid, risk of a new covid variant appearing, etc.
Without that transparency we’re all just guessing.
An analysis of the relative risks is obviously the objectively correct answer from a rational perspective, but most people aren't making decisions based on that kind of statistical reasoning (though we'd doubtless have better outcomes if they did). There's a serious risk that problems like this can spark a backlash against all COVID vaccines if not handled conservatively--there are plenty of people just waiting to have their anti-vaccine confirmation biases triggered. How to handle these events is as much a question of social behavior and public relations as it is of science.
One could argue (and many have, persuasively, I think) that Europe making a big show of being highly conservative about the blood clot non-issue with the AZ vaccine caused people to dramatically overestimate the risk of getting any kind of COVID vaccine. e.g., I recall an anecdote about a person in the US, who was going to get a different vaccine in any case, who decided to not get a vaccine because a family member from Europe assured them that blood clots were a serious risk that they should definitely be worried about.
> there are plenty of people just waiting to have their anti-vaccine confirmation biases triggered
You’re probably right, but if we keep trying to front-run people’s reactions to events over and over again, I’m not sure we’re going to get great results in the long run. I get the impression that anticipating how people will respond to news is engendering more extreme responses to future events.
I'll guess that you might be aware this is the reason, but just in case, I'm pretty sure the reason is that nobody who makes these decisions is actually doing any cost-benefit analysis (aside from the costs and benefits to them personally and their organization, maybe).
Looks like it was 6 cases after about 7 million doses. Even if it were caused the vaccine, the risk there is incredibly low. Much lower than the risk of an adverse COVID case, I would think.
Does pausing to investigate such an incredibly rare occurrence increase the public's trust in vaccines (because they see the government is being extra careful with safety data) or decrease it (because skeptics will use this as evidence that there are problems with the vaccines)? I feel like it's mostly the latter, but I dunno.
Not to mention all the COVID cases that might have been prevented while the rollout is paused to investigate a potential side effect that's less than one in a million.
> Looks like it was 6 cases after about 7 million doses. Even if it were caused the vaccine, the risk there is incredibly low. Much lower than the risk of an adverse COVID case, I would think.
Right, but the clots happened about 2 weeks after the vaccine, so that what portion of those ~7 million were administered over two weeks ago? Clots happened to a similar demographic, so what portion of those ~7 million were to women in the right age group? What about clots that cause damage that’s not immediately obvious (and thus not spotted).
I hesitate to dismiss the risk outright, but I do think that we should hold the CDC/FDA to the standard of “methodical.”
The comment by Barleyman on the Ars Technica article on this [1] has a graphic from someplace called the Winston Centre for Risk Analysis that shows the benefits in COVID reduction vs the harms from the AZ vaccine by age group.
According to that graphic, if you are in a time of medium COVID infection rates (60 per 100k per day), the risk from COVID outweighs the vaccine risks in that age group. If you in a time of low rates (20 per 100k per day) the vaccine risks outweigh the COVID risks.
The vaccine risk goes down as patient age goes up, and the COVID risk goes up as age goes up.
The J&J risks will probably follow a similar pattern and it also appears that the J&J clots require unusual treatment. That suggests a pause to at least figure out where the risk curves cross and to make sure that doctors and hospitals are prepared to recognize and treat the J&J clots.
That’s excellent, thank you for sharing! The comment you linked to suggests that the gender disparity can be attributed to women being over-represented in getting the vaccine, but I’m not sure the logic holds. Medical professionals were mostly done being vaccinated prior to J&J being approved.
“I think this is a very low risk issue, even if causally linked
to the vaccine: 6 cases with about 7 million doses (lower than
the risk of clots with oral contraceptives) is not something to
panic about,” Dr. Amesh Adalja, an infectious disease expert
at the Johns Hopkins Center for Health Security in Baltimore,
said in an email.
I'm trying to understand why this isn't ridiculous, and I'm not sure what that reason could be.
The disease left to its own accord has the potential to kill millions (someone please correct me on this). Why would we pause a vaccine because 6 people in 7 million got blood clots? Why would we do that and risk fueling anti-vaccine viewpoints?
Because the rate of vaccination is still supply-limited at the moment. If everyone who would have received the J&J vaccine could get a safer alternative in the same time frame this might make sense. But they can't, so it doesn't. Do the math. It is all but certain that more people will die as a result of this pause than without it, even if you assume a worst-case clotting risk scenario under the current data.
I only know my corner of the globe well. In this area, vaccine appointments are pretty easy to get and everyone 16+ is eligible. It certainly looks like any delay caused by this would be minimal.
What part of the country are you in? And what counts as "pretty easy to get"? In California, the most populous state, people under 50 are not generally even eligible to try to get an appointment for another two days. I don't know how it is in other states, but I don't think this is unusual.
That the vaccination rate is supply-limited is manifest in the fact that less than a third of the U.S. population has been vaccinated at all.
Yes, there are places where there are vaccine surpluses, but this is not because the supply isn't the limiting factor. It's because in some rural areas there are large numbers of vaccine denialists who are choosing to forego the vaccine altogether. That leaves some localized surpluses. But overall supply is still the limiting factor, and it will continue to be until everyone who wants a vaccine can get one without having to wait.
South Carolina -- availability varies, but most parts of the state have at least some appointments and they seem to be becoming more readily available.
> there are large numbers of vaccine denialists who are choosing to forego the vaccine altogether. That leaves some localized surpluses.
The people that do not want the vaccine are a part of why. There are different reasons for this, with some just wanting others to get a chance first. But noone is going to force people to take it.
Its also really unfair to characterize this as "rural areas" with "large numbers of vaccine denialists". We have urban areas with vaccines available and rural areas with full appointment books.
Be careful to click through to the actual pharmacies, though. It is often out of date with actual availability being lower than indicated. Our state has also been running mobile events that have generally not been fully booked.
I'm in no hurry personally, but I'm not seeing where it would be difficult to get for me.
> It is often out of date with actual availability being lower than indicated
My experience with VF was the exact opposite: it was showing lots of availability where in fact there was none.
But the burden of proof is still on you: what urban areas in the U.S. has good vaccine availability? By which I mean: anyone who wants one can get one same-or-next day.
All of these vaccines are approved under emergency authorization- the long-term effects are still unknown. At this same rate (6 in 6 million+), there could easily be unnoticed issues lurking in the alternatives as well.
What we do know is that the alternative to not being vaccinated is much worse.
It's bad policy. But it's important to get the analysis right: the choice here isn't between a very safe vaccine and an unvaccinated world population facing a pandemic to completion (which matches "the potential to kill millions").
It's between "continued rapid vaccination with all three approved US vaccines" and "somewhat delayed vaccination with one of the three approved US vaccines". That's not remotely a million-person delta, though the number is surely much higher than the 1/1M case rate on these blood clots.
Honestly the worst effect isn't with the vaccinations per se, it's the potential that this may delay vaccine acceptance rates among people sitting on the edge, due simply to fear.
Isn't that as true, if not greater, for the mRNA based vaccines, despite them not having that observed side effect? For all we know, everyone's butts might fall off because of them in the future. (yes, I'm being somewhat facetious)
My understanding is the that AstraZeneca and J&J are also new tech. Vector-based and mRNA are different than attenuated (weakened) form of the virus which is used in most vaccines.
(I'd be good if someone with more knowledge could comment)
For many people the risk of serious complications from COVID is similar. I am a young, healthy introvert working from home and enjoying the social isolation in a location that does not have explosive spread right now. The product of "probability of getting COVID" * "having serious long term effects or death" is in the same ballpark for me.
I would still get this vaccine (or the AZ one) if offered because I consider it my duty to be part of the herd immunity. But not everyone will do that, and the moment you have people in privileged position refusing one of the vaccines, you start (1) exacerbating inequalities (2) fueling conspiracy theories, mistrust, and vaccine hesitancy.
If you assume that the world is perfectly rational, then you are right, but it is a running joke on HN to point out how economists used to make that same mistake and derive silly conclusions.
The risk of a vaccine is very low. But emotionally it is hard to accept.
It is my actual choice to have the vaccine and go from 0 chance of vaccine-related blood clots to some non-zero value. Whereas catching covid feels more like I'm in control of not catching it by not leaving the flat, and even if I did catch it, chances are it'd not affect me that much.
I know this is not totally logical, but it is difficult to get past emotionally. Imagine if I did get blood clots from the vaccine - I'd go from safe in my flat and healthy, to dead, and for what? To protect me from a virus that has an even lower chance of causing long-term problems, and from which I can protect myself by being careful.
> Why would we pause a vaccine because 6 people in 7 million got blood clots?
Because J&J isn’t the only vaccine in the inventory, and the others don’t have that problem (or, IIRC, the same level of other adverse reactions), and because:
> Why would we do that and risk fueling anti-vaccine viewpoints?
What risks fueling anti-vaccine viewpoints is ignoring adverse impacts which are known and plowing forward, especially giveb that people often don’t have a choice of which vaccine they are administered.
> What risks fueling anti-vaccine viewpoints is ignoring adverse impacts which are known and plowing forward, especially giveb that people often don’t have a choice of which vaccine they are administered.
Your point about other vaccines being available is totally valid and sound, but... what is our standard here, then? For absolute-zero people to die of any vaccine we produce? What if it was 1 person who got a blood clot? It probably sounds like I'm being pedantic, but I'm serious in that I want to know why people find it reasonable to pull an otherwise effective vaccine because of this. It just doesn't seem worth it to tell everyone that the vaccine is dangerous enough that it had to be pulled entirely.
Ignoring adverse impacts definitely fuels anti-vaccine sentiment, but so does giving people concrete evidence that the vaccine can possibly kill people, possibly leading them to be resistant to getting any COVID vaccine at all until they're forced to get it. I mean, if I were at all skeptical of getting a COVID vaccine, and I was told the J&J vaccine was so dangerous they had to pause it, why would I get any of the more experimental vaccines knowing that they also have the potential to kill me but we don't even know yet because they're experimental?
I don't think people on HN realize the full magnitude to which the public can be timid and irrational. It just doesn't seem worth it to me for us to possibly fuck up the rollout of vaccinations when we are facing a possible 4th wave of COVID and more virulent variants.
Let's compare some numbers here.
The number of known blood clot cases with the J&J vaccine seems to be 6 in 7 million. That's a ~0.00000085% chance of getting a blood clot caused by the vaccine, give or take a zero since I suck at math and calculators refuse to not use scientific notation. According to the CDC, around 100,000 people die of blood clots in the United States every year, and the US population is 308,401,808, meaning that Americans have a ~0.0003% chance of dying of a blood clot in their lifetime. The only concerning factor as far as I can tell is that the people who got the blood clots were women under 50.
I mean, fine, if that's a risk profile we are averse to, then so be it. I don't really understand that.
> Your point about other vaccines being available is totally valid and sound, but... what is our standard here, then?
The standard is not to distribute a vaccine with a known side effect that standard treatment protocols will catastrophically fail for without pausing to get information about it to healthcare poviders needed to implement protocols to identify and properly treat it.
That’s explicitly what the pause is for per the article.
> The number of known blood clot cases with the J&J vaccine seems to be 6 in 7 million.
It’s not, because the effect is seen 6-13 days after vaccination, and much of the 7 million (per the article, 6.45 million is the most recent cumulative figure I can find elsewhere but its two days old, if both are accurate that's over 0.5 million doses in the last two days...) J&J doses that have been delivered are within 13 (and even 6) days. And the clots have all been in women 18-48, who aren't the only people getting the vaccine, so, unless that’s a fluke (and the numbers are small enough that that’s merely unlikely but not implausible) the prevalence in that demographic is even higher.
I agree with your numbers above. But wondered about factoring the below into these calculations [0]:
> During Johnson & Johnson's clinical trial, there were reports of other types of blood clots, too. Some are relatively common, such as deep vein thrombosis, so it wasn't surprising that among roughly 20,000 participants who received the vaccine, some would experience those clots.
> What made FDA scientists take note, however, is that in the trial, about the same number of people received a placebo -- a shot of saline that does nothing -- as received the vaccine. However, when comparing the two groups, more study participants developed clots after receiving the vaccine than the placebo.
> Calling it a "slight numerical imbalance," the FDA noted that there were 15 events in 14 participants who received the vaccine, compared to 10 events in 10 participants who received the placebo.
I think the 6 in 7 million people are the serious and unusual blood clots, but would not include the +50% increase in blood clots of any type noted above. However I appreciate that you did include the extra data about 100,000 people dying per blood clots per year.
I also like to pay attention to the numbers for this stuff. I was scheduled for a J&J shot today, which was cancelled. It wasn't my first vaccine choice. I'll be trying to get an appointment for one of the other vaccines, I guess.
What you may be overlooking is that this is a biology problem, not a physics problem, so you cannot assume a uniform population of spherical humans with identical characteristics. :-)
COVID risk goes up with age. In the other COVID vaccine with a clotting issue (the AZ vaccine) clotting risk goes down with age. If that turns out to also be the case with J&J, then for a lot of people in the US (up to 20% or so) at the current levels of COVID the vaccine has a good chance of being more of a danger to them than COVID.
A short pause to determine if they should add a minimum age (possibly a variable minimum age that depends on the overall COVID rates) for J&J is prudent.
so, let me get this straight. you have vaccines that use a new tech (mrna) that are awesome and vaccines that use “old tech” and at least 2 of then produce blood clots?
something is weird here. i’m not saying this is due to mass hysteria generated by people that don’t want the vaccine but this does sure look like a case where we don’t understand relative risk.
i may be ignorant and not understand all the factors but I don’t see the data that allows me to understand if suspending this vaccine is a good thing or nkt.
The J&J and AstraZeneca vaccines are both based on adenovirus vectors. This platform has a little more history, having been used in a recent ebola vaccine, but the number of doses administered has been relatively tiny. I'd say both vector-based and mRNA very new, pioneering tech.
It's unethical to give people a vaccines that can cause a blood clot without informing them first of the risk.
It doesn't matter that globally it could cause more deaths. It's not the job of the FDA or CDC to act as your parent and decide for you what risk is and isn't acceptable.
Informed consent is a cornerstone of medical policy.
What will happen is they will modify the consent form to let people know about the risk, and let them decide for themselves.
> A pause on vaccines will cause far more deaths than a 1 in 1 million chance of blood clots.
Its not “a pause on vaccines” it’s a pause on one vaccine. And its not 1 in 1 million, because many of the 6.45 million doses administered of J&J are still, or even not yet, within the 1-2 week window after administration where this complication has been observed. And the pause is to get information to healthcare providers and permit them to establish appropriate protocols for handling the clots, not for open ended study. And it coincides with the timing of a short-term supply drop (-80% from prior week) in J&J vaccines that was going to force a sharp drop in the rate of adninistration at some point in the very near future anyway.
Given there are some organizations that are forcing you to get a vaccination. 1 in a million chance of dying from something you were forced to do is different than 1 in a million chance of a pseudo-random event. Makes no sense to continue with J&J given the other two don't have this issue at the moment.
Of course, the utilitarian approach is to simply continue vaccinating with J&J since surely more people are helped than harmed. I'm sure they'll reverse this decision soon enough.
As of today about 560,000 people in the US have died of COVID, or roughly 1 in 574. I think it’s safe to say the odds are higher than “1 in a million”.
What organizations are forcing you to get vaccinated. I’ve heard a lot of speculation and honestly there should be more forceful, but I’m not aware of any. Plenty of jobs force you to drive which is absurdly risky
Awful decision. Everyone involved should be fired or removed from office for grotesque lack of judgement leading to a significant net increase in mortality.
Message to anti-vaxxers: As you can see the government is very carefully tracking any kind of safety issues with vaccines. They are being open and telling you about issues despite people fearing it would cause vaccine hesitancy.
So this should actually give you more confidence in vaccine safety, because if there are problem, you will be informed.
Unfortunately I think the anti-vaxxers can twist the logic however they want. The government is putting on a show about how transparent they are to win trust... etc.
I'm not sure how to get through that... from what I understand it takes alot of effort and time per person.
Sadly, as news papers discovered years ago, publishing corrections makes you seem less trust worthy than papers that never publish any, even though the later at best equal, and often worse.
I see this as making the safety of the specific vaccines an unfalsifiable proposition. If the absence of side effects proves that it's safe to vaccinate and the identification of side effects proves it's safe to vaccinate, what could ever prove that a specific vaccine is unsafe?
Hormonal birth control boasts clot rates of 1 per 10k, yet we hand that out like candy to little girls. Yet this is considered "too dangerous..."
Edit: mods locked my account for this, lol. Some of the idiots replying are purposely conflating progestogen stats with non-progestogen stats, which is dishonest at best and willfully evil at worst. 2/3 of the market causing clots is fine? What a braindead take. I expected better of the HN crowd.
"Citation needed" is a lazy way to throw FUD at an argument; if someone who didn't even leave the comment you are responding to can spend 30 seconds to find the citation on Google to answer your question, you could have done so yourself instead of demanding other people cite every single thing they say lest they aren't believed.
Whoa - you can't post flamewar comments like this one and others. We've banned this account. If you don't want to be banned, you're welcome to email hn@ycombinator.com and give us reason to believe that you'll follow the rules in the future. They're here: https://news.ycombinator.com/newsguidelines.html.
> Hormonal birth control boasts clot rates of 1 per 10k
This differs depending on the age from my research. Your overall seems too high when risk adjusted. I asked you to post your source so we could discuss from the same source. In any case per (https://www.healthline.com/health/birth-control/pulmonary-em...):
- Out of every 10,000 women taking birth control pills, 3 to 9 of them will develop a blood clot.
- Out of every 10,000 women who are not pregnant and who do not use birth control pills, 1 to 5 of them will develop a blood clot.
- Out of every 10,000 pregnant women, 5 to 20 of them will develop a blood clot.
- Out of every 10,000 women in the first 12 weeks after giving birth, 40 to 65 of them will develop a blood clot.
In other words, taking birth control pills actually reduces blot clot rates compared to pregnancy, the very thing birth control pills prevent. Your entire point is moot.
Not the OP, but my take is that the name is terrible. The concept is probably needed in some places, though. It'd be fairly shocking if there aren't some strict entry requirements on crowded venues for a while, though maybe a recent test can substitute for a vaccine.
At least a third of the market of hormonal birth control is progestogen-only pills, and those do not raise the risk of blood clots. At best your comment is reductive, at worst misleading and the tone is uncalled for.
While this is an interesting point to consider it's not completely equivalent. In short, taking an action that might harm in exchange for a small possibility of a benefit is much less appealing than taking an action which might harm you but will definitely bring a benefit.
To expand, people accept a level of risk depending upon the benefit they expect to get from it. In the case of the contraceptive pill the user has a clear & definite benefit (e.g. they are very unlikely to get pregnant from the sex they are definitely having). The benefit of the vaccine for the individual is less clear & loosely defined. It's another probability that's hard to know. The recipient might not get Covid-19 and if they did they might not get it badly. So it's a much more difficult benefit to weigh against the risk.
The assessment is easier the more at risk the recipient is (hence restricting use to older generations) and on a larger scale, where policy makers can compare that 1 in a million increase to the x in a million that will die from Covid-19. But for individuals, most people are not good at making those judgements correctly.
> “This announcement will not have a significant impact on our vaccination plan: Johnson & Johnson vaccine makes up less than 5 percent of the recorded shots in arms in the United States to date,” White House Covid-19 response coordinator Jeff Zients said in a statement.
At least they have alternatives. Meanwhile, in Europe ...
The online argument about this is raging about whether this is a stupid decision and I’d like to side step that well-trodden path of vitriol to ask more broadly: what’s the deal with Covid and blood clotting?
I know personally a long hauler who has blood clotting issues and low platelets. They fall into the demographic of concern with the JJ and AZ vaccine. Anecdotally we have lost both a close relative and a young and healthy friend to Covid blood clotting related issues.
Again, I’m not weighing in on the FDA’s job. But just saying: as someone who’s anecdotally been hyper-aware of the blood related aspects of Covid, this thread has picked up my ears and I’m really interested in finding out what the linkage here is.
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[ 3.1 ms ] story [ 379 ms ] threadMeanwhile, hormonal birth control causes clots in 1/1,000 women. No one blinks an eye.
The vaccine hesitancy this engenders is likely gonna kill more than that one person.
https://twitter.com/NateSilver538/status/1381936112311148548
> Public health bureaucrats have some weird habits in how they reason under uncertainty and how they communicate to the public. It might help if they sought out experts from economics, sociology, psychology, etc., instead of telling everyone to stay in the their lane.
Is it too much to bother with details, or we'd rather generously assume everyone is dumb except on Internet forums?
Again, we're looking at one in a million stats for getting the clots, and one in six deaths amongst that tiny group of cases - without information yet on their comorbidities.
COVID itself causes clots. A lot more than 1/1,000,000. If you're afraid of clots, get the vaccines. Even the J&J one.
https://health.ucsd.edu/news/releases/Pages/2020-11-23-study...
> Overall, 20 percent of the COVID-19 patients were found to have blood clots in the veins...
There is enough anti-vaccine & Covid rhetoric that we should all cool it a little bit and let the experts do their jobs.
> That said I trust that the government agencies know what they are doing here.
If 2020 didn't finally shatter that trust, is there anything that can? FDA was already obviously a regulatory capture vehicle for pharma. And CDC got nearly everything wrong in the ebola outbreak of 2014. Then, both of them blundered their way through this pandemic.
For example, we know from the email leaks that FDA felt it was under pressure from Trump to approve vaccines[0], and then never disclosed this fact to the public. That doesn't seem like dispassionate science and expertise to me.
By contrast, many of the medical journals, preprint houses, and academic institutions have looked like far more stable sources of knowledge.
It seems to me that the internet age asks us to replace our state institutions of expertise with something more thoughtful and genuinely connected to science.
0: https://www.bmj.com/content/372/bmj.n627
I’m the opposite. Covid caused my trust in them to plummet. Perhaps made with the best of intentions, but all the noble lies have eroded my trust.
Same framework that's lead to all of the poor policy decisions over the past year.
It's not enough to say you're being cautious. You have to explain why you think it is better to be cautious about administering the vaccine with its attendant risks or to pay the QALYs incurred by the delay when people who would have received this vaccine don't.
This is a low probability event, and the appropriate mitigation may be to do nothing; but there may be some common factor for these patients that might indicate use of a different vaccine or maybe informing people of symptoms of blood clots and what to do if they see symptoms.
The real risk here is eroding confidence in government health sources in general, and vaccines in specific. There were certainly unknown risks before, but now there is a known risk which deserves some study.
What erodes confidence is the complete absence of cost/benefit discussions about virtually any decision that has been made. Including this one.
If this turns out to be about what it looks like now, unpause and go forward. If it turns out to be much more significant, all the better for having stopped; maybe restrict this vaccine to populations at higher risk of COVID or lower risk of blood clots (if that risk can be determined). Both mRNA vaccines and modified adenovirus vaccines are new types of vaccines not used before on a wide scale; pausing to get clarity on a major negative side effect is warranted.
A credible decision would give your estimates of harm/benefit for delaying vaccinating people. You seem all too willing to ignore the people who will become sick or die because of delaying the vaccine. You are only looking at potential harm from not delaying the vaccine. Unfortunately, you have a lot of company.
Leading to more people delaying their vaccination. Supply is currently at a level that all doses available are administered, but to the extent lost confidence results in longer delay for high risk patients, that has a cost. When supply exceeds demand, lost confidence will have a cost for those low risk people who delay, as well as the general population which loses out on wider immunity. Delaying the vaccine now certainly also has some cost of the same type, but it's bounded. Another case of a vaccine campaign ignoring warning signs and proceeding without pausing to consider appropriate response to issues as they arise will affect this campaign as well as future campaigns.
Suggesting that effects on the order of the ones seen here is a good reason to delay the vaccine should make people doubt the ability of our public health authorities to make reasonable tradeoffs.
[1] Michigan's Democratic Gov. Gretchen Whitmer declared her state a "COVID hotspot" as cases continue to rise and has asked the federal government to increase vaccines in response. https://abcnews.go.com/Politics/cdc-director-michigan-vaccin...
It seems to me that the delay imposed by a pause in use of the J&J vaccine to make sure healthcare providers are informed of and have appropriately updated diagnostic and treatment protocols is minor, its basically pulling forward by a few days the effects of the 80% week-over-week drop in J&J vaccine supply that was just in the news.
ETA: I see you made ninja edits to your comment....
Edit 2: So now you replied that you only added a word or two and then deleted you comment while I were replying. Your comment was only half as long when I replied (all the Twitter stuff wasn't there for example).
> A joint statement from the FDA and CDC clarified that the blood clotting was cerebral venous sinus thrombosis (CVST).
I don’t believe birth control is associated with CVST at a rate of 1/1000. It feels very misleading to use it as a point of comparison.
* Hormonal birth control - years of research. Years of evidence and practice. Knowing what to do when this and that happens. Recommendations for women with known conditions not to take this and that hormonal birth control.
* Novel vaccination - barely month of research. Weeks of evidence and practice. We don't have best practices yet.
I'm fine with anyone to make a decision on them own to take these vaccinations. As someone with a not-so-uncommon mutation causing thrombosis easily, I'm happy I hesitated and haven't received either J&J or AstraZeneca.
That is completely untrue. This vaccine has been through several clinical trials for months. We know that there are no side effects that are common enough to be of real concern. The reason we are only seeing this one now is that it is so rare.
How did they establish that there are no long term side effects?
This seems to be characteristic of HN in the last couple of years... very reminiscent of Reddit imo.
Long-term effects are one of the main points of study in clinical trials so why would these drugs ben any different?
That's not to say that it's completely out of the question that there will be long-long-term side effects. But if anything is going to cause long-term issues, my money is on the virus, not any vaccine.
Past performance...
Vaccines are not the stock market. No one doubts gravity because "past performance is not indicative of future results".
How many genetically engineered adenovirus vaccines have there been before?
The vaccines that are your prior are typically attenuated or inactivated virus.
Majorly different category, we are in untreaded space (I'm still planning on getting one)
I don't think we know long-term how this may impact the immune system: does bypassing certain systems/mechanisms cause other problems with future immune response?
It took how long for us to realize as common sense that use of antibiotics allows superbugs to more likely evolve?
Fair enough, but the comment I responded to said: "We know that there are no side effects that are common enough to be of real concern."
Given this statement is not qualified for timescale, I want to know what the basis for it is.
How does the person who made it know there are no side effects on the order of six months or a year that are common enough to be a concern?
Look I am all happy chappy with the vaccine, I will inject that sweet MRNA Pfizer or Moderna vaccines as soon as someone lets me at it, but I still think we need to avoid what Fauci does, which is knowingly lie in order to get people to do what we want them to do.
There is blood clotting risk from AZ? Great, tell me what the risk is and I can deal with it, but lie to me and we are done talking.
There is a good chance for long term effects from covid. Completely the opposite for the vaccine.
Maybe you are responding to the wrong person? I never made any claims regarding what long term effects to anticipate. I asked how the person I responded to know there are no serious side effects on time scales longer than we have tested things on.
> There is a good chance for long term effects from covid. Completely the opposite for the vaccine.
Yes. I know.
From what I can gather, there’s not terribly much info on what’s known about what’s going into people’s bodies, and what info does exist has arisen from a thick soup of trade secrets and conflicts-of-interest.
With vaccines we know from decades of experience that severe side effects tend to occur very shortly (days or maybe weeks) after the injection. So this is why vaccine trials observe participants for weeks or months, not years, before concluding that the vaccine is safe. Of course this doesn't guarantee that the Covid vaccine don't happen to be an exception. But if that was the approach we took then we would never be able to approve anything, and never get the benefits we know for sure it brings.
But you can? e.g. "We know that there are no side effects that are common enough to be of real concern."?
What deficiency do I have that prevents me from knowing anything for sure that you don't have?
I personally don't see any good reason to think that the risk for long term side effects from the vaccine is higher for the vaccine than for COVID itself.
You can however guess, and make good guesses (I'm planning on getting the vaccine). But it does no one any good to fail to outline unknowns that are steelmanned by "we can't possibly know".
This is a common, but confusing, use of "you" in American English.
Keep in mind that we also don't know the long-term effects of COVID-19. It's possible that people who were infected with mild cases drop dead 1 year and 6 months after the infection. The disease hasn't been around that long, so we simply don't know.
Also, to all those saying "clinical trials have succeeded", I strongly suggest them to read said published trial results and look at _measured_ sample sizes used in the results, not total inoculation numbers.
Applying the precautionary principle, particularly if you are not at risk, is a perfectly reasonable position, IMHO.
No, we can't know that. Some affects don't show up for a long time. One example is women.
Women's bodies are complex because they go through so many changes. These changes affect how they respond to medical treatments. In other words:
- Just because pre-menopause women respond well doesn't mean post-menopause women will.
- Just because pre- or post-menopause women respond well doesn't mean women who are going through menopause respond well.
- Just because non-pregnant women respond well to the vaccine for a month doesn't mean that pregnant women will respond well.
- Just because 6-month pregnant women respond well doesn't mean 3-month pregnant women will respond well.
- Any issues with the vaccine during pregnancy may not show up until after the child is born.
- Women's hormones are fluctuating wildly at the beginning and after pregnancy. These are also times that need a lot of representation in the study.
In fact, the amount of change women's bodies undergo affects medical treatment so much that many clinical trials deliberately under-represent women to simplify the study, and then use the results of the trial to recommend prescriptions for women.
[0] https://www.cnn.com/2021/04/13/health/johnson-vaccine-blood-...
The "you woudn't care about women dying" narrative completely derails the essential discussion (aka when do we determine vaccine to be save) by selectively picking facts from a completely unrelated health area to turn it into an activist subject.
It reminds me on the magnet-troll-logic memes, only this one trying to come up with the completely insane narrative: "If you are concerned of a few more people dying because of a vaccine, you hate women."
Sometimes the answer is easy.
> Hormonal birth control - years of research
This is kneejerk status quo bias.
> I'm fine with anyone to make a decision on them own to take these vaccinations.
Great, but the FDA is not. That's the issue here.
> This is kneejerk status quo bias.
mind expanding why years of research is a 'bias'?
This is a highly unusual situation insofar as phase III monitoring is far from complete and there is no 'phase IV' (confirmatory) trial data at all yet. In the normal course of research, this is how we'd catch rare but consistent adverse effects.
So, if we had complete trials on a normal timeframe, then obviously there's a different calculus to apply.
But given what we know at this moment, these six incidents might actually be far more normal than the crude use of six as numerator and seven million as a denominator.
A pause to assess the data and allow any lag to resolve seems prudent.
And, while this will be very difficult to quantify until much later, if then, I surmise that this will only create temporary vaccine hesitancy and only outside the high-risk tier, which is perfectly rational.
For people in the low-risk tier, there's nothing wrong with waiting until the conclusion of the RCT monitoring in the first place, even if adverse events weren't the basis of that decision.
I don't think the drug safety system is set up to effectively evaluate the cost/benefit of the pause itself in a pandemic scenario.
How does one do that math ethically? There are risks if you do and risks if you don't. The FDA is the wrong group to make that call, because they're only concerned with the first kind of risk.
In Canada we reserved the Astra Zenica vaccine for people over 55 because of the blood clot issue. I think that's probably the right call.
“Don’t wear masks.” “No, no: wear masks.” “COVID kills over 10%.” “COVID kills less than 0.1%.” Once we realized the difference in makeup between the over-10% and sub-0.1% populations, we still couldn’t bring ourselves to make data-backed differentiations for many, many months (and still today have many small businesses closed or restricted based on what they do rather than the risk profile of their owners and employees).
These are difficult decisions to be sure, but when being seen as on the “safe side” confers benefits without a commensurate charge for the risk of the “safe” action, you get a society which moves in the direction of perceived safety (and where perceived safety may be strongly sub-optimal).
yes, security theater abounds. it's a multidimensional optimization problem with no absolutely safe side in the long run, only relatively, but often initially unintuitively, safer non-linearly intertwined sets of actions. it's hypocritical to discount the tiny risk of vaccines while dramatizing the tiny (but larger) risk of death by covid. further, it's myopic to look at the risks of covid in isolation (which is what all the frenzy around it has been doing for over a year) rather than in relation to all the similar risks in our lives and couching our responses now within our existing responses to those other ongoing risks.
I don't disagree. But I will observe that many people in the low(er) risk tier are going to be traveling, eating out, having parties, etc. sooner rather than later--vaccine or not. In my very Blue state people are very obviously relaxing a whole lot more. So the question isn't whether things open up or not. It's whether people are vaccinated when they do. (Which doesn't mean all vaccines are equally safe.)
J&J is also widely used in the US for people who might have issues with scheduling a second shot, for example people who are homeless, or are home-bound.
Even today Physicians still think the body is Art, or a combination of Art and Science.
And the only reason we don't have a science based alternative to the Physician cartel is that they spent literally $400,000,000 on lobbying/bribery in the last 30 years.
Edit- for further reading look up "evidence based medicine debate"
Anecdotally, my pediatrician has an inverted "trust pyramid" in some of their examination rooms. At the bottom—least trust—is "expert opinion."
> Even today Physicians still think the body is Art, or a combination of Art and Science.
I'm not sure why you would think these two things are opposed?
Science most broadly speaking means knowledge, and the scientific method is a means (but certainly not the only means) of acquiring knowledge. But what you do with it is art/craft. Separating the two seems unnecessarily dualistic.
This actually happened.
We 'spend' about one micromort of risk per day of being alive. Or you can spend one walking for 6 hours, or driving 250 miles (or 6 miles on a motorbike)
I just made a website to show all the other stuff we do all the time without worrying with the same (extremely low) level of risk
https://whatoneinamillionmeans.com
In the UK there's been 19 people die after ~20 million vaccinations.
Of course some more may show up in coming days from prior vaccinations.
[0] https://www.cnn.com/2021/04/13/health/johnson-vaccine-blood-...
Edit: I looked into it more and I can get IPv6 and IPv4 DNS servers to serve me both A and AAAA records. The site is now down, however :)
Yeah I banked too much on Cloudflare... I've ramped up its dyno a bit now too. Hopefully that'll keep it up!
It's ridiculous.
Or as per someone that actually knows statistics: https://twitter.com/NateSilver538/status/1381925025964515330
Build a dam, which if it broke would kill hundreds-of-thousands, or let millions die for lack of water? Oh, we'll just over-engineer it, now we can't afford to buy food to keep the people alive long enough to need the dam; or the lead engineering firm embezzles the money and installs dodgy iron.
We can't wait around for long term studies, whatever point we decide to start vaccines - where they can still be effective for the current population - it's always possible we should have waited a bit longer.
Deaths by Covid are still much more likely than deaths by the vaccine.
Hospitalizations as well, except for the 20-29 cohort https://twitter.com/VikiLovesFACS/status/1379833789334089734
I mean there's still stuff between "fully healthy" or "deadly dead".
Nonetheless, just because version 1/2 COVID vaccines are good enough for you does not others should just jump on board when other options exist that can vastly reduce risk of infectionand/or death.
In short, blowing the death problem our of proportion unless the options are only nothing vs vaccine.
Masks are supposed to protect others from you. Wearing a mask is not meant to help a person who may be at risk decrease his/her own risk of infection.
In any event, now that spring weather is here in the northern hemisphere and the vaccination campaign has given people hope, social-distancing rules are being flaunted in many countries and at-risk populations may find it hard to properly distance when they leave their homes for e.g. basic shopping. So, since the "other options" don’t always work, keeping up the vaccination campaign is very important to reducing infections.
For those willing to receive vaccination right now under informed consent, I'm all for it. I agree people are over the pandemic and making the situation worse. I disagree with many commenters here that are shaming and/or implying that people like myself are anti-vax vs simply being willing to wait for much more evidence before jumping on board with incredibly widespread usage of an incredibly not well understood treatment.
I'm in a low risk bracket. My country saw an uptick in people canceling vaccination appointments. 40% of 60+ people here are now 'unsure' of taking the vaccine.
I've done nothing but work and follow the rules since this whole thing began. Young people without partners, or young people in general, that are active, have a social life did a complete 180* in their "allowed lifestyles".
I've paid with money, time, a year of my otherwise busy life, for people in risky age brackets, at _little_ benefit to myself. *
But I'm so done, don't tell me you're asking people like me to be stuck in our anti-social and unhealthy living arrangements, while there's a solution that's _safer_ than going to a covid shower?
People like me are done paying, I'm not going to wait around another year, you take the vaccine or you take covid for all I care.
This is what vaccine delays cost us
A legitimate reason for the pause is to assess whether the people impacted have anything else in common. There are alternative vaccines that can be used if a commonality is identified.
As far as hesitancy, the idiot media already does a story for every vaccinated person that gets sick, this isn't going to tip huge swaths of people in either direction.
www.medscape.com/viewarticle/949108
Per https://vaccinetracker.ecdc.europa.eu/public/extensions/COVI..., that's 30M AZ doses. You're still talking about one in a million chance of death here.
> And if you compare that to CFR from COVID for person <50 years old without diabetes and hypertension
Add a few more exclusions and no one dies of COVID, sure.
It's highly likely that natural infection provides worse protection that vaccination and we have real world evidence that already suggests this.
1. Two exposures to the spike protein are likely to create a much better long term immune response simply because of multiple exposures in a short period of time.
2. The spike protein produced by the mRNA and J&J vaccines is engineered to produce better response against variants.
3. We've already seen evidence of natural infection performing poorly in rural parts of Brazil with very high initial infection rates (> 70% which is near the herd immunity threshold) like Manaus where we're seeing significant evidence of reinfection where it should be have been difficult for COVID to spread.
https://www.bmj.com/content/372/bmj.n394
2. A vaccine producing (IIRC) two orders of magnitude more antibodies than natural immunity is not necessarily a good thing.
If the real argument is "the cure has a better chance of killing you than the disease, but please risk your life for the community", I'd rather people be honest and say that in the first place.
Everyone else is doing the same thing you are, thus the community is giving you the same thing you're giving to the community.
There's been jumbled messaging on this.
The "you still need to wear a mask" thing was, if you dig in on the actual statements instead of the media headlines, "because we don't know yet". An abundance of caution.
Since then, we've gotten quite a bit of good data on that front.
https://www.reuters.com/article/health-coronavirus-israel-va...
> Data analysis in a study by the Israeli Health Ministry and Pfizer Inc found the Pfizer vaccine developed with Germany’s BioNTech reduces infection, including in asymptomatic cases, by 89.4% and in syptomatic cases by 93.7%.
I think it's the wrong call, though, as we saw with masks.
I do not believe the government response has been exceptionally data-driven throughout this whole mess.
There'll be new guidance issued if it pans out.
https://www.nbcchicago.com/news/local/dr-fauci-explains-why-...
> "It may be that we will show that if the level of virus in your nasopharynx because you're vaccinated is so low that you don't have to worry about transmitting, that's going to be a game changer for what a vaccinated person can or cannot do," Fauci said.
> The doctor explained that if the findings are corroborated, Americans will likely see a pulling back on some restrictions, but emphasized "we're not there yet."
Note that other vaccine's that prevent infection also reduce your risk of spreading the disease (measles etc).
So the fact that COVID spreads (not just in rare cases, but enough we all have to remain masked AND socially distant even if vaccinated) is a CRAZY big difference here.
The messaging has been clear - even if vaccinated you MUST wear masks and socially distance - which shows how different this is then other viruses. Given that, it's understandable that people are a bit more meh on the vaccines - because you can still spread it to others either way.
I do wonder about the experts messaging at times. Initially I thought airbone virus, began wearing my leftover N95's from wildfire season. Then they said those don't stop this airborne virus and to take them off. Then they said put them back on. and on it goes.
That's been the media summary of it, but Fauci and others have been pretty clear in their actual statements on this to say "for now", not "forever".
10 in a million chance of death from covid in the 5-9 age group (the lowest risk group)
This is the perfect example of anti-vacc logic. They pick the latter because they heighten the risk of the former in their mind, while ignoring or downplaying the risk of the latter. Looking at the actual numbers, it makes no sense for anyone at any age to take their chances with covid over the vaccine.
The specific issue being observed is "cerebral venous sinus thrombosis (CVST)" in combination with "low levels of blood platelets (thrombocytopenia)" per the Joint CDC and FDA statement (1).
Low blood platelets means anti-clotting treatments can pose a substantial bleeding increase, making this already dangerous condition difficult to treat.
(1) https://www.fda.gov/news-events/press-announcements/joint-cd...
This assumes that we have enough safe vaccines, which we wildly don't.
6 cases in 7 million over 3 months with mostly women being affected is exactly what we'd expect to see.
[0] https://en.wikipedia.org/wiki/Cerebral_venous_sinus_thrombos....
> Birth control pills can also cause thrombosis. So why is there all the fuss about the COVID-19 Vaccine AstraZeneca? > It is true that for birth control pills thromboses, even with fatal outcome, are known as a very rare side effect. They are listed in the Summary of Product Characteristics (SmPC). The birth control pill is available only on prescription. Every woman must be informed of this risk by the prescribing physician. For the COVID-19 Vaccine AstraZeneca, there is currently a suspected very rare side effect of sinus vein thrombosis with accompanying platelet deficiency, sometimes fatal. It is not listed in the SmPC.
https://www.pei.de/EN/service/faq/coronavirus/faq-coronaviru...
Agreed that if everyone is rational/good at math the optimal outcome is proceed with dosing, but sadly that is not the world we live in and the “broken trust” scenario might be more damaging.
Who cares how many clots birth controls produce? What matters is the outcome compared to the thing birth controls prevent - pregnancy.
Do you get more blood clots from being pregnant or from being on the pill? It's order of magnitudes more from being pregnant, therefore if you're sexually active it's safer to be on the pill compared to not.
How is this the top post? People have no knowledge of basic Bayesian statistics.
Also, how does Bayes' Theorem apply to your comment?
J&J is paused because there are alternatives that don't have clotting to the same degree.
A comparison with birth control makes no sense. Is there some magical birth control that's used orders of magnitude more (Pfizer) and orders of magnitude safer with respect to blood clotting and also prevents pregnancy?
No? Then the comparison is stupid.
J&J isn't being permanently suspended - I bet you within the coming days this ban will be reversed and people can get J&J if they'd like.
IMO that lack of caution is why the USA is in this situation to begin with.
I don't agree with your analysis, I think you can see it entirely the other way, that both this pause and the initial "wait and see" attitude towards Covid are the result of an excessive bias towards the status quo. I remember back in January-February 2020 when people were saying it would be crazy to just shut down air travel, think of the massive economic cost.
Same with the vaccine.
> Do you get more blood clots from being pregnant or from being on the pill?
Again, same with the vaccine. COVID itself causes clots, in a very substantial percentage of hospitalized patients.
"The benefits of this medical intervention are worthwhile, despite the risks, given the alternative" is precisely the point being made.
No, because there are other vaccines that don't give you blood clots at all. Your entire point is moot. Pausing temporarily to investigate is hardly controversial. The comparison with birth control is nonsensical.
A vaccination for COVID is not the same as getting birth control. Even if it was, why would you get J&J if you could get Pfizer that doesn't have the same issue?
If all vaccinations had the same blood clotting issue then perhaps you and the original poster would have a point. Given a huge disparity between them with regards to blood clotting taking a moment to investigate this is simply prudent. Making nonsensical comparisons to birth control, well, is not.
Not enough to go around. Pfizer's goal is 2B doses (1B people) this year. Moderna's is even smaller. 8B people in the world.
Your argument would be reasonable if it was being permanently suspended.
Should the government also just not disclose any side effects? By definition any bad information will make the public lose trust.
The goal is to avoid this sort of consequence:
https://www.fiercepharma.com/marketing/yougov-poll-finds-dis...
> The skepticism shows no sign of slowing, YouGov reports. While trust for the Pfizer and Moderna vaccines rose in all country surveys between December and March, trust for the AZ vaccine slipped in Germany over that span. By early March, 40% said the AZ vaccine was unsafe, an increase of 10% since its earlier December poll.
> The result? Anecdotal reports in Germany and across Europe of people refusing the AZ vaccine and supplies sitting unused in warehouse, YouGov reported—real-world evidence of “the extent of the damage done to the perceived safety of AstraZeneca vaccine.”
https://www.economist.com/graphic-detail/2021/03/22/increasi...
> The AstraZeneca jab, which is cheaper to produce and easier to store and distribute than the vaccines currently being administered across Europe from Pfizer-BioNTech and Moderna, was meant to be a workhorse of the continent’s vaccination drive. That plan could be in trouble, however, if citizens across Europe continue to believe that the AstraZeneca vaccine is unsafe and, as a result, refuse to bare their arms for it.
I believe, as with software, that immediate release of unvetted, incomplete, and still-being-investigated information can be actively harmful to people.
Seeing US agencies halting J&J while continuing the other vaccines could even be reassuring. It shows that US agencies really are pretty cautious, and are willing to halt vaccines that show signs of problems.
I honestly don’t understand how we’ve managed to put people that demonstrate this level of incompetence in charge.
>> In China you disappear if you publicly say bad things about CCP.
> Yeah, I know what you mean, I called somebody motherfucker and got banned on HN. Freedom of speech is nowhere these days.
The vaccine was given to people, under threat of exclusion from society, without knowledge of the side effects. Not comparable.
[0] https://www.cnn.com/2021/04/13/health/johnson-vaccine-blood-...
330M people means that (assuming an 1:1M incidence and a 80% vaxx rate) there will be 264 people dying from thrombosis. Which is bad, but nowhere near as bad as the millions that would die from an actual covid19 case.
Lying through statistics is easy, easy, easy.
whatoneinamillionmeans.com
If you're not willing to take 1 in a million chances, it's gonna be pretty hard for you to get out of bed today.
This vaccine seems to have about the same rate, which makes sense as I think it uses the same technology.
This was the first one your website presented and I have no idea what it means.
Maybe tonight I can work out do an IP address lookup and personalise it for your locality ;)
Similar distance/time as DC to NYC.
You have the whole internet available. I bet you can work it out without too much effort.
(It's true though by the way, go enjoy the sun while you still can...)
TBH I've made this site for myself as much as anyone - I'm just under 40 so the risk/benefit is tight for me personally, but I want to do my bit for everyone else and stop the spread so I'll take any vaccine they'll give me.
Good luck with you flying dreams and say safe!
People are absolute garbage at thinking about scale.
If they follow your line of thinking and it's all fine... no-one's going to be writing articles praising them.
If they follow your line of thinking and more people die form blood clots... people will write articles attacking them. Questions will be asked, and careers may be harmed. Etc.
It kills less than that in the demographic in question, not to mention that is only of those who contract the virus.
> People are absolute garbage at thinking about scale.
I don’t think it is that, I think it is that for better or worse humans tend to view wrongs through inaction as less atrocious than wrongs through action. Additionally - they already have better alternatives and plenty of supply in the US (Moderna and Pfizer vaccines) so they are opting to just use those at the moment.
Second, there’s evidence that even if people don’t die, there can be long term neurological effects [2].
Third, even if we accept your number, 1 in 200 would still be 1.5 million Americans dead, not even considering the rest of the world. I am personally not comfortable doing nothing to stop that number.
I agree that being super worried about a 1 in a million blood clot might be short sighted, especially since the death rate from catching the virus is 2 in 100.
[1] https://coronavirus.jhu.edu/data/mortality
[2] https://www.reuters.com/article/idUSKBN2BT2ZI
People with asymptomatic infections (which are the majority of them) do not have any reason to get tested, so they do not count as "cases".
As I said, that still implies that if everyone in the United States got it, 1.5 million of them would die (320,000,000 * .005). That's a lot of people.
If a government did nothing to prevent a terrorist attack that killed 1.5 million people, most people would (rightly) be pretty upset.
EDIT: Also, forgot to mention, it's totally disingenuous to only look at "deaths". We do not fully know the long term health effects, but as I stated there's potential neurological effects, potential risks of type 1 diabetes, and people permanently losing smell.
You have 100M infected in US as the estimate. A 2% death rate is 2M deaths from COVID alone. I've not seen anything like that as credible death rates - it's at least half if not a quarter of this rate - more like 0.5% or less. Do the same thing in countries with 70% infected rates - if fatality was really 2%+ death counts would be insane.
You really start to understand how people start to doubt the crap COVID "experts" put out when basic math shows it is garbage.
Johns Hopkins University. I don't feel like that's typically considered a bad source. Maybe it's a bit high or they're looking at different data sets.
But again, and I cannot overstate this enough, even if I accept the 0.5% number, that's still a lot of deaths, about 1.5 million if everyone in the US gets it.
According to the NYTimes [1], there's been about half a million deaths from COVID. If your provided number of 100M infected people is correct, then that would be consistent with 1.5M dying if everyone gets infected (US population ~= 3 * 100M, 3 * 500,000 = 1.5M).
[1] https://www.nytimes.com/interactive/2020/us/coronavirus-us-c...
Not really. 1 in 200 is fewer than how many die a year anyway of all causes.
Surprisingly, even the elderly and sick people often do not understand the risks.
We want if there are safer options. Not all vaccines are equal. Important question is why we unable to scale up production of mRNA vaccines?
Where are you getting the idea that we can't?
Hundreds of millions of doses of the Pfizer and Moderna vaccines have already been made. Pfizer expects to make 2 billion doses this year.
https://www.novartis.com/news/media-releases/novartis-signs-...
> Novartis announced today that it has signed an initial agreement to leverage its manufacturing capacity and capabilities in order to address the COVID-19 pandemic by supporting the production of the Pfizer-BioNTech COVID-19 Vaccine. The agreement will see Novartis utilizing its aseptic manufacturing facilities at its site in Stein, Switzerland.
https://www.merck.com/stories/why-were-excited-to-partner-on...
> On March 2, we announced a partnership with Johnson & Johnson to expand manufacturing capacity and supply of its COVID-19 vaccine. Under the Biomedical Advanced Research and Development Authority (BARDA) agreement, our company is adapting and making available some of our existing manufacturing sites to accelerate manufacturing efforts for the vaccine and enable more timely delivery and administration.
https://investors.modernatx.com/news-releases/news-release-d...
> Under the terms of the agreement, the companies plan to establish manufacturing suites at Lonza’s facilities in the United States and Switzerland for the manufacture of mRNA-1273 at both sites. Technology transfer is expected to begin in June 2020, and the companies intend to manufacture the first batches of mRNA-1273 at Lonza U.S. in July 2020.
https://www.astrazeneca.com/media-centre/press-releases/2021...
> AstraZeneca and IDT Biologika also intend to strengthen Europe’s vaccine manufacturing capability with a joint investment to build large additional drug substance capacity for the future. Details of the agreement are to be finalised. Both companies plan to invest in capacity expansion at IDT Biologika’s production site in Dessau, Germany to build up to five 2,000-litre bioreactors capable of making tens of millions of doses per month of AstraZeneca’s COVID-19 vaccine. The new assets are estimated to be operational by the end of 2022.
1. https://theconversation.com/how-patent-laws-get-in-the-way-o...
2. https://www.thedailybeast.com/heres-why-it-will-be-hard-to-r...
That’s not an explanation, of course, I don’t know the reason. But it places this in a larger category.
https://covid19-sciencetable.ca/sciencebrief/vaccine-induced...
There is a well established link between oestrogen and increased blood coagulability. Whilst it is possible females are more affected by the vaccine I suspect one factor is that their baseline coagulation risk increases their likelihood of thrombus due “reaction induced coagulability” compared to males.
> Cerebral venous sinus thrombosis is rare, with an estimated 3-4 cases per million annual incidence in adults. While it may occur in all age groups, it is most common in the third decade. 75% are female. [0]
[0] https://en.wikipedia.org/wiki/Cerebral_venous_sinus_thrombos....
It would be great if media still had actual science reporters who could inform their readers that while, yes, there is a thrombosis risk from the vaccine, you're way more likely to get a thrombosis from your contraceptive.
Unfortunately, most media these days rather prefers scare-mongering for clicks.
German is such a pretty language.
How is putting millions of people at risk of long-term (or fatal) complications from COVID-19 an abundance of caution? An abundance of caution would mean you give people the vaccine because that way, less people will die! Unless a thousand people are dying from the vaccine a day, the math is simple!
Whether it's an airplane crash or a blood clot caused by a vaccine, human minds simply can't 'feel' that a phenomenon is rare when it is repeated over and over again in their newsfeed.
1 per million adverse effects is nothing. If that would be a solid fact, there would be no reason to pause vaccinations. The pause happens very early so that experts have time to check the data and methodology and verify that it's all that there is.
When a new drug is given for emergency evaluation or a new side effect is discovered he works 14 hours per day 7 days a week with a team going through a massive amount of data and documentation to verify and check everything.
The media and most commentators don't understand why decisions can take weeks. Why you don't have the scheduled emergency approval meeting just now. They fail to understand that fact-finding is not happening in the meeting just by people giving their expert opinions. Experts work around the clock without taking any time off to figure out what is happening. But lazy bureaucratic regulators, right?
The ideal strategy without hindsight was conventional wisdom: Protect the vulnerable and stiff upper lip for the rest. That would have more than halved casualties.
With the benefit of hindsight, a 3 month shutdown while hospitals got their acts together (combined with protecting the vulnerable) would have roughly quartered the remaining deaths, but at far lower cost than the full shutdown.
This was predicted by some of the old-guard epidemiologists, which is why they were against the shutdown in the first place.
The cancel culture folks lumped them in with MAGA anti-vaxxers (I blame both sides) and got them censored by the big platforms. Here we are, with 100,000’s unnecessarily dead, trillions squandered, and many careers, businesses and educations ruined.
I suspect roughly zero people have learned a lesson from this. Hopefully I’m overly cynical.
Let's not pretend that rational discourse was ever an option, and the media isn't the place for blame.
If true, then social distancing, masks, and lockdowns couldn't have done anything for the rest of us for the past year either.
The argument for "protect the vulnerable" is that these precautions could be more targeted and so, hopefully, more effective.
And he became the darling of the media and even won an Emmy.
https://www.vanityfair.com/news/2021/03/cuomos-nursing-home-...
Where was this "full shutdown" you speak of? Not anywhere in the US. In Wuhan, and some other Asian countries, sure.
Didn't we kind of have the 3 month shutdown-lite you're referring to? Mid-March through about June for most places were at varying levels of shutdown in the US. But recall things started opening up in June of 2020. And cases started rising again into July.
> The US is apparently already at ~50% antibodies, not counting vaccination.
Citation? That seems like about 3X the most optimistic numbers I've heard from credible sources.
Source for 50%: Wall street journal. We were above 33% (based on random sampling, not confirmed cases) a few months ago.
This one from Feb predicted herd immunity a bit too early. They ran one with updated numbers last week, but I can’t find it:
https://www.wsj.com/articles/well-have-herd-immunity-by-apri...
Additionally, you make a few glib statements that don’t really check out - you say give hospitals three weeks to prepare - how? There’s been a lot made of hospitals getting ready, but for the most part, the limiting factor for covid treatment has been how many icu care teams are available. More ventilators don’t help much if there’s nobody to use them. Second, I’m not sure how you protect senior citizens when everyone else, including the people who provide their care, is swimming in a soup of COVID.
Also, we knew by April last year that ventilators were a bad choice: Doctors were jumping to it because of a specific weird symptom (blood oxygen levels impossibly low), but they had to keep turning the ventilators to higher settings to get an effect - to the point it was causing further lung damage. There's a bunch of less damaging ways to get more oxygen into a patient they'd been shifting to: https://www.statnews.com/2020/04/08/doctors-say-ventilators-...
China, Vietnam, Australia and New Zealand used strict lockdowns to eliminate community spread, and then largely opened things up again. People in those countries have been able to live much more normal lives than people elsewhere during the pandemic. With hindsight, that was clearly the correct strategy: eliminate the virus, then reopen and keep a hawk eye out for any new cases.
Another one of those examples has been actively censoring covid information from the start, and thus cannot be trusted.
As for Vietnam, it is an interesting case, and we don't have enough data to rule out cross reactivity or other factors playing a role.
Extrapolating these data points to the entire world with wildly varying sociological, biological, environmental, and countless other factors and saying this is clearly the correct (and implicity achieveable) strategy for all 8 billion people on the earth is at best hypothetical.
Australia and NZ have densely populated cities, and what does being an island have to do with anything? Countries can close their borders. In fact, Australian states closed their borders to one another.
> Another one of those examples has been actively censoring covid information from the start, and thus cannot be trusted.
You don't have to trust the government. Just ask people you know in China what's going on there. Things have been mostly open for a year now, with no sign of the virus (outside of a few localized outbreaks, which have been dealt with through local lockdowns and blanket testing of the population). China is not the black box that many people think it is.
> As for Vietnam, it is an interesting case, and we don't have enough data to rule out cross reactivity or other factors playing a role.
Vietnamese people are not somehow immune to SARS-CoV-2. They're susceptible, just like everyone else.
> Extrapolating these data points to the entire world
This is the wrong way to think about this. These aren't data points generated by some semi-random process. They're countries that effectively implemented a strategy that we know should work, based on the basic principles of epidemiology. The virus is spread between people who are in close proximity to one another. If you drastically reduce contacts between people, the virus has far fewer chances to spread, and the epidemic recedes. If you do that long enough, you get down to a small enough number of cases that you can trace every single one and snuff out the virus completely. After that, you have to have strict measures at the border in order to catch imported cases, and you have to do regular testing in the population to make sure you don't miss the beginnings of any new outbreak.
There's nothing to "extrapolate." The strategy works because of very basic principles of how the virus spreads. The only question is whether each county has the organizational capacity and societal will to carry this strategy out.
Indeed, that's a critical question to the long term success of the strategy.
If the world is unable to put 8 billion people in solitary confinement (nevermind the disastrous effects that would cause) indefinitely until the virus is eliminated (nevermind the fact that we are incapabale of validating if it was actually completely erradicated), the virus is only going to pop back up.
There is no evidence of such a strategy working at scale across the world.
The scientists on the covid team at the WHO have said as much: lockdowns should only be used as a last resort to buy time to scale up health care resources. Should we listen to those scientists?
> the virus is only going to pop back up.
It does indeed pop up every once in a while, because the borders can never be 100% sealed. There have been outbreaks in Beijing, Qingdao, border towns in Heilongjiang and Yunnan, and elsewhere. But the government is understandably on high alert, and these outbreaks were caught early enough to be stopped with local lockdowns, coupled with blanket testing of the population (i.e., testing everyone in a city in a few days).
There was a brief "second wave" in China this winter, in which an outbreak managed to spread to several cities, but it was ended with relatively short lockdowns and mass testing. The number of new infections per day peaked around 100.
The basic lesson here is that you can both have near-zero case counts and let people live their lives almost as normal if you first act decisively to bring cases to zero, by using temporary, strict lockdowns, quarantines and mass testing.
> There is no evidence of such a strategy working at scale across the world.
China is the largest country in the world, so I'd call that "at scale." Vietnam is larger than any EU country. We're not talking about San Marino or Monaco here.
> The scientists on the covid team at the WHO have said as much: lockdowns should only be used as a last resort to buy time to scale up health care resources. Should we listen to those scientists?
A lot of recommendations will be reevaluated after the pandemic is over. Nothing like this has happened in 100 years.
They took shit seriously and everyone prepared the minute news reached them of a possible pandemic. A good friend of mine is from VN and he was shipping PPE back home to his parents around August or October of 2019.
I think most Americans don't realize how common pandemics have been in east Asia. To them, it's like preparing for any other natural disaster. It's like comparing the Michiganders response to a blizzard to that of Texans.
This is why we need more data about cross reactivity playing a role in the relatively favorable health outcomes in Asia and Africa compared to the rest of the world.
Agreed
The problem is the virus, not the government reaction to it. Personally, I tend to think governments under-reacted in most Western countries. I'm not sure how things would have returned to "normal" if the virus was raging out of control. A good precentage of people would see the deaths and still avoid going out to shop or whatever. I'm assuming you mean by "normal" that people would return to some normal pattern of economic activity - and even if 10 or 20% of people changed their behavior that would still impact the economy.
That seems hard to believe, since significantly more people die every year of all causes than could possibly have died of Covid, even if every single person in the world caught it. Most people probably wouldn’t have noticed anything was different.
> even if 10 or 20% of people changed their behavior that would still impact the economy.
Maybe so, but the economy is not the only or even the most important casualty of our Covid response. The importance of human social gatherings, the freedom to leave one’s home and go wherever one pleases, the education of children, and so on cannot be measured in economic terms.
> The problem is the virus, not the government reaction to it.
Places where there were very few or only brief restrictions, like Serbia, Belarus, or Florida, largely avoided the issues I described above with only a small or in some cases unmeasurable increase in all cause mortality for 2020.
Sweden is an interesting example. Comparing Sweden and Finland, for instance, older people essentially cloistered themselves in Sweden because they had no trust that they'd be safe in society, and their spending dropped by a higher amount than old people in Finland, who changed their habits less due to the swift and more stringent government response? My old-person family members in Finland were able to keep shopping, going to church, and having birthday parties with many families due to that response (as opposed to in the US where we limited ourselves to gatherings with max 3 households and did everything masked or outdoors due to several people still working on site).
Perhaps you live in a very different place. You certainly interpret statistics quite differently given your example of Florida.
If, instead, people had behaved responsibly in mass and we had used the time we got from that to establish coherent contact tracing and testing, things would have returned to normal by August as well, only without many the deaths your way would cause.
A lot
I'd argue that the "response" at the Federal level was a massive under-reaction. Months of denial didn't seem to work out so well.
https://www.marketwatch.com/story/deaths-of-despair-during-c...
Seeing the chaos in the economy and current real estate prices make me concerned that anyone without a home/mortgage in 2020 will be permanently lower class and renting due to inflation.
Free government money for a year is like eating candy. The stomach ache has yet to come.
Besides, in the CDC table, "unintentional injuries" is up by way more than suicides are down. This includes things like car accidents, and is a little suspicious, like suicidal behavior led to a death that wasn't classified as suicide. Also note that the table is "deaths with covid or presumed covid", not "deaths by covid": https://jamanetwork.com/journals/jama/fullarticle/2778234
Everywhere I read about the J&J vaccine, I see something like "the DNA vaccine doesn't alter your DNA". Can somebody please clear this up?
As far as I understand, the mRNA just stays in the cytoplasm of the cell and gets used up by the ribosome to create spike proteins. The adenovirus vector used in the J&J (and other vaccines) injects DNA in the cell's nucleus, which seems at odds with the widely circulated "it doesn't change your DNA" statement.
Do people make this claim because the cell displaying spike proteins is basically always eliminated by CD8 killer T cells?
Btw here's a nice high-level summary by the NYT about how all the vaccines work: https://www.nytimes.com/interactive/2021/health/how-covid-19...
https://www.medpagetoday.com/special-reports/exclusives/9160...
> Adenoviruses -- even as they occur in nature -- just do not have the capacity to alter DNA. Unlike retroviruses such as HIV or lentiviruses, wild-type adenoviruses do not carry the enzymatic machinery necessary for integration into the host cell's DNA. That's exactly what makes them good vaccine platforms for infectious diseases, according to Coughlan.
> And, engineered adenoviruses used in vaccines have been further crippled by deleting chunks of their genome so that they cannot replicate, further increasing their safety.
Some body cells can bounce back after serious trauma, liver cells being a prime example: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2701258/
I'm not a genetic engineer (what a time to be alive, eh?), but I'm pretty sure an adenovirus that did permanently modify cell DNA would be more like CRISPR, including the risks that entails (such as the risk of incorrectly splicing the host genome and potentially creating a precancerous mutation)
But there's a very well known case where DNA delivered via an adenovirus killed a teenager during a genetic engineering study: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC81135/
>> "No one realized that the vector itself might pose a risk"
I'm sure the dosage, type of adenovirus, and modifications to the adenovirus are different. But there are obviously still risks we don't know about.
>> An autopsy and subsequent studies indicated that his death was caused by a fulminant immune reaction (with high serum levels of the cytokines interleukin-6 and interleukin-10) to the adenoviral vector.
>> The data suggested that the high dose of Ad [adenoviral] vector, delivered by infusion directly to the liver, quickly saturated available receptors ... within that organ and then spilled into the circulatory and other organ systems including the bone marrow, thus inducing the systemic immune response.
He was injected with >3 × 10^13 viruses [2]. The typical J&J dose contain: low-dose (5x10^10 viral particles) or high-dose (1x10^11 viral particles) [3].
[1] https://www.uab.edu/ccts/images/steinbrook_Gelsinger_-_Oxfor...
[2] https://www.cell.com/molecular-therapy-family/molecular-ther...
[3] https://www.jwatch.org/na53085/2021/01/26/adenovirus-vectore...
It almost certainly won't have long-term affects, but it may not be trivial to identify if mRNA vaccines have been altering epigenetics.
[1] https://en.wikipedia.org/wiki/RNA-directed_DNA_methylation
I have an aviation, biochem, and skydiving background. My rule is for aviation: "if it hasn't been out five years you're a test jumper."
Humans are way more complex than airplanes. I personally wouldn't take the mRNA vaccine because of this rule. Coupled with being unable to sue or get help from the government I think people IN LOW RISK groups have been way too enthusiastic to sign up.
https://www.cnbc.com/2020/12/16/covid-vaccine-side-effects-c...
Given my risk is very low I'm not too worried about COVID, but I am a little worried (perhaps wrongly) about the risk of finding out about some long-term side effect from these vaccines a few months down the road. I suffer from long-term side effects from another drug I took in the past, and at the time I was told there was no risk of long-term side effects and that it was safe to take. Only recently has the labeling been updated to reflect the discovery that permanent side effects can occur in some cases and for me it's too late, but I learnt my lesson to allow others to be the guinea pig for new drugs wherever possible.
It's really quite alarming how little we know about the body, espically considering the certainty of some "experts" about how extremely low the risk of adverse effects are from newly approved vaccines. I'm aware of a number of drugs which are approved and frequently perscribed which we don't even understand the mechanism of action for -- accutane, for example. Of course in this situation, we do know the mechanism of action, but it would still be wrong to assume we know the full surface area of possible side effects which could occur because our model of the human body is so basic.
I'm happy for someone to explain why I'm wrong on this. I'm obviously not an expert, just an average guy trying to assess the relative risk of two very unlikely events.
About that...
> In December, we asked, “What percentage of people who have been infected by the coronavirus needed to be hospitalized?”
> The correct answer is not precisely known, but it is highly likely to be between 1% and 5% according to the best available estimates, and it is unlikely to be much higher or lower. We discuss the data and logic behind this conclusion in the appendix.
> Less than one in five U.S. adults (18%) give a correct answer of between 1 and 5%. Many adults (35%) say that at least half of infected people need hospitalization.
https://www.brookings.edu/research/how-misinformation-is-dis...
> Many adults (35%) say that at least half of infected people need hospitalization.
This is why so many in low-risk groups have been so enthusiastic - misinformation that has them thinking it really is the Black Death.
Does that not seem a bit ... immoral?
I assume you eschew all other medical advances that are less than 50 years old? Would you eschew remdesivir? Sorry for the questions but thinking such as yours intrigues me and I want to grasp the logic behind it. Why not avoid all new technology for 50 years? Getting vaccinated seems to me like the logical and moral thing to do, but maybe I’m overlooking something.
OP also didn't say 10 years is enough time to know the long-term effects of these vaccines, just that it's traditionally been the minimum amount of time needed for some other drugs.
Love that quote! That's going to be my standard comment from now on when I see a pull request that doesn't include any test cases :-)
Is it possible to do something like tagging the molecules with radioisotopes and following their path?
Here's an example: https://www.nejm.org/doi/full/10.1056/NEJM199001253220403
Pointless FUD to worry about that or even bring it up.
https://newsroom.uw.edu/news/genes-%E2%80%98fossil%E2%80%99-...
> Most of these viral genes come from retroviruses, RNA viruses that insert DNA copies of their own genes into our genomes when they infect cells. HHV-6 is unique because it is the only known human DNA herpesvirus that integrates into the human genome and can be routinely inherited.
Where is the math that suggests that pausing the J&J vaccine is prudent? Inputs being risk of getting covid, risk of getting a blood clot, risk of injury/death from covid, risk of a new covid variant appearing, etc.
Without that transparency we’re all just guessing.
You’re probably right, but if we keep trying to front-run people’s reactions to events over and over again, I’m not sure we’re going to get great results in the long run. I get the impression that anticipating how people will respond to news is engendering more extreme responses to future events.
Does pausing to investigate such an incredibly rare occurrence increase the public's trust in vaccines (because they see the government is being extra careful with safety data) or decrease it (because skeptics will use this as evidence that there are problems with the vaccines)? I feel like it's mostly the latter, but I dunno.
Not to mention all the COVID cases that might have been prevented while the rollout is paused to investigate a potential side effect that's less than one in a million.
Right, but the clots happened about 2 weeks after the vaccine, so that what portion of those ~7 million were administered over two weeks ago? Clots happened to a similar demographic, so what portion of those ~7 million were to women in the right age group? What about clots that cause damage that’s not immediately obvious (and thus not spotted).
I hesitate to dismiss the risk outright, but I do think that we should hold the CDC/FDA to the standard of “methodical.”
According to that graphic, if you are in a time of medium COVID infection rates (60 per 100k per day), the risk from COVID outweighs the vaccine risks in that age group. If you in a time of low rates (20 per 100k per day) the vaccine risks outweigh the COVID risks.
The vaccine risk goes down as patient age goes up, and the COVID risk goes up as age goes up.
The J&J risks will probably follow a similar pattern and it also appears that the J&J clots require unusual treatment. That suggests a pause to at least figure out where the risk curves cross and to make sure that doctors and hospitals are prepared to recognize and treat the J&J clots.
[1] https://arstechnica.com/science/2021/04/us-cdc-fda-call-for-...
“I think this is a very low risk issue, even if causally linked to the vaccine: 6 cases with about 7 million doses (lower than the risk of clots with oral contraceptives) is not something to panic about,” Dr. Amesh Adalja, an infectious disease expert at the Johns Hopkins Center for Health Security in Baltimore, said in an email.
The disease left to its own accord has the potential to kill millions (someone please correct me on this). Why would we pause a vaccine because 6 people in 7 million got blood clots? Why would we do that and risk fueling anti-vaccine viewpoints?
I'm baffled, but perhaps I'm a fool.
In the US, the other vaccines are starting to become really readily available.
Maybe other parts of the country are different.
That the vaccination rate is supply-limited is manifest in the fact that less than a third of the U.S. population has been vaccinated at all.
Yes, there are places where there are vaccine surpluses, but this is not because the supply isn't the limiting factor. It's because in some rural areas there are large numbers of vaccine denialists who are choosing to forego the vaccine altogether. That leaves some localized surpluses. But overall supply is still the limiting factor, and it will continue to be until everyone who wants a vaccine can get one without having to wait.
> there are large numbers of vaccine denialists who are choosing to forego the vaccine altogether. That leaves some localized surpluses.
The people that do not want the vaccine are a part of why. There are different reasons for this, with some just wanting others to get a chance first. But noone is going to force people to take it.
Its also really unfair to characterize this as "rural areas" with "large numbers of vaccine denialists". We have urban areas with vaccines available and rural areas with full appointment books.
Really? Where?
Be careful to click through to the actual pharmacies, though. It is often out of date with actual availability being lower than indicated. Our state has also been running mobile events that have generally not been fully booked.
I'm in no hurry personally, but I'm not seeing where it would be difficult to get for me.
My experience with VF was the exact opposite: it was showing lots of availability where in fact there was none.
But the burden of proof is still on you: what urban areas in the U.S. has good vaccine availability? By which I mean: anyone who wants one can get one same-or-next day.
That's exactly what I said, actually. Though it wasn't none, just low. Be sure to check back after a day or so. Availability swings pretty quickly.
It is starting to become really easy to get this vaccine in the US now with just Pfizer and Moderna.
What we do know is that the alternative to not being vaccinated is much worse.
It's between "continued rapid vaccination with all three approved US vaccines" and "somewhat delayed vaccination with one of the three approved US vaccines". That's not remotely a million-person delta, though the number is surely much higher than the 1/1M case rate on these blood clots.
Honestly the worst effect isn't with the vaccinations per se, it's the potential that this may delay vaccine acceptance rates among people sitting on the edge, due simply to fear.
The communication that public gets is outrageously bad.
(I'd be good if someone with more knowledge could comment)
I would still get this vaccine (or the AZ one) if offered because I consider it my duty to be part of the herd immunity. But not everyone will do that, and the moment you have people in privileged position refusing one of the vaccines, you start (1) exacerbating inequalities (2) fueling conspiracy theories, mistrust, and vaccine hesitancy.
If you assume that the world is perfectly rational, then you are right, but it is a running joke on HN to point out how economists used to make that same mistake and derive silly conclusions.
It is my actual choice to have the vaccine and go from 0 chance of vaccine-related blood clots to some non-zero value. Whereas catching covid feels more like I'm in control of not catching it by not leaving the flat, and even if I did catch it, chances are it'd not affect me that much.
I know this is not totally logical, but it is difficult to get past emotionally. Imagine if I did get blood clots from the vaccine - I'd go from safe in my flat and healthy, to dead, and for what? To protect me from a virus that has an even lower chance of causing long-term problems, and from which I can protect myself by being careful.
Because J&J isn’t the only vaccine in the inventory, and the others don’t have that problem (or, IIRC, the same level of other adverse reactions), and because:
> Why would we do that and risk fueling anti-vaccine viewpoints?
What risks fueling anti-vaccine viewpoints is ignoring adverse impacts which are known and plowing forward, especially giveb that people often don’t have a choice of which vaccine they are administered.
Your point about other vaccines being available is totally valid and sound, but... what is our standard here, then? For absolute-zero people to die of any vaccine we produce? What if it was 1 person who got a blood clot? It probably sounds like I'm being pedantic, but I'm serious in that I want to know why people find it reasonable to pull an otherwise effective vaccine because of this. It just doesn't seem worth it to tell everyone that the vaccine is dangerous enough that it had to be pulled entirely.
Ignoring adverse impacts definitely fuels anti-vaccine sentiment, but so does giving people concrete evidence that the vaccine can possibly kill people, possibly leading them to be resistant to getting any COVID vaccine at all until they're forced to get it. I mean, if I were at all skeptical of getting a COVID vaccine, and I was told the J&J vaccine was so dangerous they had to pause it, why would I get any of the more experimental vaccines knowing that they also have the potential to kill me but we don't even know yet because they're experimental?
I don't think people on HN realize the full magnitude to which the public can be timid and irrational. It just doesn't seem worth it to me for us to possibly fuck up the rollout of vaccinations when we are facing a possible 4th wave of COVID and more virulent variants.
Let's compare some numbers here.
The number of known blood clot cases with the J&J vaccine seems to be 6 in 7 million. That's a ~0.00000085% chance of getting a blood clot caused by the vaccine, give or take a zero since I suck at math and calculators refuse to not use scientific notation. According to the CDC, around 100,000 people die of blood clots in the United States every year, and the US population is 308,401,808, meaning that Americans have a ~0.0003% chance of dying of a blood clot in their lifetime. The only concerning factor as far as I can tell is that the people who got the blood clots were women under 50.
I mean, fine, if that's a risk profile we are averse to, then so be it. I don't really understand that.
The standard is not to distribute a vaccine with a known side effect that standard treatment protocols will catastrophically fail for without pausing to get information about it to healthcare poviders needed to implement protocols to identify and properly treat it.
That’s explicitly what the pause is for per the article.
> The number of known blood clot cases with the J&J vaccine seems to be 6 in 7 million.
It’s not, because the effect is seen 6-13 days after vaccination, and much of the 7 million (per the article, 6.45 million is the most recent cumulative figure I can find elsewhere but its two days old, if both are accurate that's over 0.5 million doses in the last two days...) J&J doses that have been delivered are within 13 (and even 6) days. And the clots have all been in women 18-48, who aren't the only people getting the vaccine, so, unless that’s a fluke (and the numbers are small enough that that’s merely unlikely but not implausible) the prevalence in that demographic is even higher.
> During Johnson & Johnson's clinical trial, there were reports of other types of blood clots, too. Some are relatively common, such as deep vein thrombosis, so it wasn't surprising that among roughly 20,000 participants who received the vaccine, some would experience those clots.
> What made FDA scientists take note, however, is that in the trial, about the same number of people received a placebo -- a shot of saline that does nothing -- as received the vaccine. However, when comparing the two groups, more study participants developed clots after receiving the vaccine than the placebo.
> Calling it a "slight numerical imbalance," the FDA noted that there were 15 events in 14 participants who received the vaccine, compared to 10 events in 10 participants who received the placebo.
I think the 6 in 7 million people are the serious and unusual blood clots, but would not include the +50% increase in blood clots of any type noted above. However I appreciate that you did include the extra data about 100,000 people dying per blood clots per year.
I also like to pay attention to the numbers for this stuff. I was scheduled for a J&J shot today, which was cancelled. It wasn't my first vaccine choice. I'll be trying to get an appointment for one of the other vaccines, I guess.
[0] https://www.cnn.com/2021/04/13/health/johnson-vaccine-blood-...
COVID risk goes up with age. In the other COVID vaccine with a clotting issue (the AZ vaccine) clotting risk goes down with age. If that turns out to also be the case with J&J, then for a lot of people in the US (up to 20% or so) at the current levels of COVID the vaccine has a good chance of being more of a danger to them than COVID.
A short pause to determine if they should add a minimum age (possibly a variable minimum age that depends on the overall COVID rates) for J&J is prudent.
something is weird here. i’m not saying this is due to mass hysteria generated by people that don’t want the vaccine but this does sure look like a case where we don’t understand relative risk.
i may be ignorant and not understand all the factors but I don’t see the data that allows me to understand if suspending this vaccine is a good thing or nkt.
https://twitter.com/MassDPH/status/1381947053287354368?s=20
It doesn't matter that globally it could cause more deaths. It's not the job of the FDA or CDC to act as your parent and decide for you what risk is and isn't acceptable.
Informed consent is a cornerstone of medical policy.
What will happen is they will modify the consent form to let people know about the risk, and let them decide for themselves.
Its not “a pause on vaccines” it’s a pause on one vaccine. And its not 1 in 1 million, because many of the 6.45 million doses administered of J&J are still, or even not yet, within the 1-2 week window after administration where this complication has been observed. And the pause is to get information to healthcare providers and permit them to establish appropriate protocols for handling the clots, not for open ended study. And it coincides with the timing of a short-term supply drop (-80% from prior week) in J&J vaccines that was going to force a sharp drop in the rate of adninistration at some point in the very near future anyway.
Given there are some organizations that are forcing you to get a vaccination. 1 in a million chance of dying from something you were forced to do is different than 1 in a million chance of a pseudo-random event. Makes no sense to continue with J&J given the other two don't have this issue at the moment.
Of course, the utilitarian approach is to simply continue vaccinating with J&J since surely more people are helped than harmed. I'm sure they'll reverse this decision soon enough.
Fixed that for you.
If the article was saying J&J was permanently discontinued perhaps I'd agree with you.
There are also jobs. I don't disagree with the forced vaccinations, but it is what it is.
So this should actually give you more confidence in vaccine safety, because if there are problem, you will be informed.
I'm not sure how to get through that... from what I understand it takes alot of effort and time per person.
Edit: mods locked my account for this, lol. Some of the idiots replying are purposely conflating progestogen stats with non-progestogen stats, which is dishonest at best and willfully evil at worst. 2/3 of the market causing clots is fine? What a braindead take. I expected better of the HN crowd.
Edit 2: The top comment on the other thread literally says the same thing as my comment https://news.ycombinator.com/item?id=26790922
Do we? What a silly post. And if there were an alternative that was 1 in a billion I'm sure that would be paused, too.
> Hormonal birth control boasts clot rates of 1 per 10k
This differs depending on the age from my research. Your overall seems too high when risk adjusted. I asked you to post your source so we could discuss from the same source. In any case per (https://www.healthline.com/health/birth-control/pulmonary-em...):
- Out of every 10,000 women taking birth control pills, 3 to 9 of them will develop a blood clot.
- Out of every 10,000 women who are not pregnant and who do not use birth control pills, 1 to 5 of them will develop a blood clot.
- Out of every 10,000 pregnant women, 5 to 20 of them will develop a blood clot.
- Out of every 10,000 women in the first 12 weeks after giving birth, 40 to 65 of them will develop a blood clot.
In other words, taking birth control pills actually reduces blot clot rates compared to pregnancy, the very thing birth control pills prevent. Your entire point is moot.
If you warn people about the small risk of blood clots from the vaccine, then you can let them decide if to receive it.
That's what informed consent is all about.
To expand, people accept a level of risk depending upon the benefit they expect to get from it. In the case of the contraceptive pill the user has a clear & definite benefit (e.g. they are very unlikely to get pregnant from the sex they are definitely having). The benefit of the vaccine for the individual is less clear & loosely defined. It's another probability that's hard to know. The recipient might not get Covid-19 and if they did they might not get it badly. So it's a much more difficult benefit to weigh against the risk.
The assessment is easier the more at risk the recipient is (hence restricting use to older generations) and on a larger scale, where policy makers can compare that 1 in a million increase to the x in a million that will die from Covid-19. But for individuals, most people are not good at making those judgements correctly.
At least they have alternatives. Meanwhile, in Europe ...
I know personally a long hauler who has blood clotting issues and low platelets. They fall into the demographic of concern with the JJ and AZ vaccine. Anecdotally we have lost both a close relative and a young and healthy friend to Covid blood clotting related issues.
Again, I’m not weighing in on the FDA’s job. But just saying: as someone who’s anecdotally been hyper-aware of the blood related aspects of Covid, this thread has picked up my ears and I’m really interested in finding out what the linkage here is.
https://www.theguardian.com/world/2021/apr/13/astrazeneca-bl...