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US agencies call for pause in Johnson & Johnson vaccine

• ceejayoz 6y ago
  Six cases in seven million administered doses. One death. Meanwhile, 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 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.
  • slver 6y ago
    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?
    • ceejayoz 6y ago
      > 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. https://health.ucsd.edu/news/releases/Pages/2020-11-23-study-covid-19-infection-combined-with-blood-clots-worsen-patient-outcomes.aspx 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...
  • bognition 6y ago
    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.
    • jMyles 6y ago
      I generally agree with your comment, but > 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 https://www.bmj.com/content/372/bmj.n627
    • crazy1van 6y ago
      > That said I trust that the government agencies know what they are doing here. 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.
    • huffmsa 6y ago
      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.
  • roenxi 6y ago
    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.
    • refurb 6y ago
      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.
      • mhb 6y ago
        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.
        • abduhl 6y ago
          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.
        • toast0 6y ago
          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.
  • Daho0n 6y ago
    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).
    • deleted 6y ago
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    • ceejayoz 6y ago
      Yes, I realized I'd edited to add the quote. Retracted my comment.
    • peytn 6y ago
      Keeping on the myth of birth control... > 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.
  • kbos87 6y ago
    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.
  • Eduard 6y ago
    This is kneejerk statistics 101 reaction. * 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.
    • DangerousPie 6y ago
      > * 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.
      • cheph 6y ago
        > We know that there are no side effects that are common enough to be of real concern How did they establish that there are no long term side effects?
        • _Understated_ 6y ago
          You've been unfairly downvoted. Your question is perfectly reasonable. 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?
        • abduhl 6y ago
          Probably the same way they established that long covid is an apparent death sentence.
        • majewsky 6y ago
  • jMyles 6y ago
    This take seems a little short-shrift to me. 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.
    • ceejayoz 6y ago
      > A pause to assess the data and allow any lag to resolve seems prudent. 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.
      • eloff 6y ago
        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.
      • sokoloff 6y ago
        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).
  • temp8964 6y ago
    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.
    • goonogle 6y ago
      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"
      • memling 6y ago
        > 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.
        • goonogle 6y ago
          When you have a Physician recommend a dangerous procedure because of their feelings over scientifically proven procedure it's dualistic. This actually happened.
  • huffmsa 6y ago
    Being obese also causes deep vein thrombosis at a rate of 1/1000, but we're perfectly okay with people eating their way to blood clots.
    • pbak 6y ago
      The difference being that you can't "catch" being obese with a viral infection.
      • throwawayboise 6y ago
        The plot twist being that the virus we're discussing is by far more dangerous to the obese than to the healthy.
        • pbak 6y ago
          Touché my friend, touché indeed. ;-)
  • jonplackett 6y ago
    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 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 https://whatoneinamillionmeans.com https://whatoneinamillionmeans.com
    • graeme 6y ago
      Less, no? 1/million is the risk so far of clots, not of death.
      • jonplackett 6y ago
        There's about 1/250,000 risk of clots, but they are treatable. In the UK there's been 19 people die after ~20 million vaccinations.
        • graeme 6y ago
          That’s assuming J and J has same incidence as AZ. J and J so far has had 6 clots for seven million doses. Of course some more may show up in coming days from prior vaccinations.
          • jonplackett 6y ago
            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.
          • rsynnott 6y ago
            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.
  • raverbashing 6y ago
    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's ridiculous. Or as per someone that actually knows statistics: https://twitter.com/NateSilver538/status/1381925025964515330 https://twitter.com/NateSilver538/status/1381925025964515330
    • pbhjpbhj 6y ago
      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.
      • raverbashing 6y ago
        You're blowing the problem out of proportion 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 https://twitter.com/VikiLovesFACS/status/1379833789334089734
        • pbak 6y ago
          If we are talking death, OK, but what about other issues in the "harm spectrum" in either the case of Covid or Vaccine ? I mean there's still stuff between "fully healthy" or "deadly dead".
        • calvano915 6y ago
          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.
  • maxerickson 6y ago
    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.
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  • yread 6y ago
    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 www.medscape.com/viewarticle/949108
    • ceejayoz 6y 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. Per https://vaccinetracker.ecdc.europa.eu/public/extensions/COVID-19/vaccine-tracker.html#distribution-tab 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.
      • symlinkk 6y ago
        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.
        • yread 6y ago
          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
        • conistonwater 6y ago
          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.
  • johnnyapol 6y ago
    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. (1) https://www.fda.gov/news-events/press-announcements/joint-cdc-and-fda-statement-johnson-johnson-covid-19-vaccine https://www.fda.gov/news-events/press-announcements/joint-cd...
    • HillRat 6y ago
      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.
      • lbeltrame 6y ago
        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.
      • krooj 6y ago
        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.
        • HillRat 6y ago
          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.
  • yojo 6y ago
    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.
  • lovedswain 6y ago
    Put another way, you're about 38 times more likely to develop a blood clot than win the UK's national lottery.
  • endisneigh 6y ago
    Why do people keep posting this nonsense? 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.
    • endtime 6y ago
      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?
      • endisneigh 6y ago
        There's no "high standard" to begin with. 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.
        • SpicyLemonZest 6y ago
          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.
          • endisneigh 6y ago
            Sure, but my point is that a comparison with birth control is stupid at best, harmful at worst. 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.
  • DennisP 6y ago
    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.
    • jellicle 6y ago
      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".
      • DennisP 6y ago
        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.
      • vageli 6y ago
        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.
    • jghn 6y ago
      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.
  • hedora 6y ago
    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.
  • shmel 6y ago
    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.
    • ceejayoz 6y ago
      If your fetus could spread to other people while you're pregnant, those would all be great points.
    • flexie 6y ago
      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.
      • shmel 6y ago
        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.
  • dahfizz 6y ago
    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.
  • mikem170 6y ago
    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) [0] https://www.cnn.com/2021/04/13/health/johnson-vaccine-blood-clots-cdc-fda/index.html https://www.cnn.com/2021/04/13/health/johnson-vaccine-blood-...
• baldfat 6y ago
  We are never getting anywhere with these vaccines being used by 80% of the population when less then 1:1,000,000 issues are a cause to pause.
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  • mschuster91 6y ago
    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.
    • Trasmatta 6y ago
      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.
    • captainredbeard 6y ago
      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. Lying through statistics is easy, easy, easy.
• jonplackett 6y ago
  I just made this website to show you how really, really small the risks are, and how they compare to risks we happily take every single day. 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.
  • pithon 6y ago
    "That’s the same risk as driving London to Liverpool" This was the first one your website presented and I have no idea what it means.
    • jonplackett 6y ago
      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 ;)
    • shawabawa3 6y ago
      They are 2 cities in the UK that are ~220 miles apart, so 1 in a million people die every 220 miles driven
    • happytoexplain 6y ago
      Not to be rude, but are you aware that Liverpool (like London) is a city? I guess I'm unsure what the confusion is.
    • alistairSH 6y ago
      London and Liverpool are major cities in England. 200 miles, 4 hours drive time, roughly. Similar distance/time as DC to NYC.
    • Y_Y 6y ago
      > I have no idea what it means You have the whole internet available. I bet you can work it out without too much effort.
• umanwizard 6y ago
  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.
  • rel2thr 6y ago
    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.
    • SpicyLemonZest 6y ago
      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!)
  • mft_ 6y ago
    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.
  • jjcon 6y ago
    > kills 1 in 200 people 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.
• sjg007 6y ago
  Why are women adversely affected?
  • graeme 6y ago
    If it’s an autoimmune reaction, autoimmune diseases generally are more common in women. That’s not an explanation, of course, I don’t know the reason. But it places this in a larger category.
    • novaRom 6y ago
      Yes, new analysis of those deadly issues with AstraZeneca shows it's autoimmunity: https://covid19-sciencetable.ca/sciencebrief/vaccine-induced-prothrombotic-immune-thrombocytopenia-vipit-following-astrazeneca-covid-19-vaccination/ https://covid19-sciencetable.ca/sciencebrief/vaccine-induced...
  • thornjm 6y ago
    Med Student here so possibly wrong but... 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.
  • ideamotor 6y ago
    I read there is a bias in the data due to young women being the moat common demographic for nursing jobs.
  • jjk166 6y ago
    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] [0] https://en.wikipedia.org/wiki/Cerebral_venous_sinus_thrombosis#:~:text=Low%20molecular%20weight%20heparin,of%20the%20body%2C%20and%20seizures https://en.wikipedia.org/wiki/Cerebral_venous_sinus_thrombos....
• roody15 6y ago
  Just a hunch but I suspect there may be more than “6” cases of blood clotting with the vaccine in the US.
• mschuster91 6y ago
  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.
  • Y_Y 6y ago
    > anti-baby pill German is such a pretty language.
• throwaway823882 6y ago
  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!
  • Y_Y 6y ago
    This is the trolley-problem/CYA type of caution.
  • fasteddie31003 6y ago
    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.
    • Der_Einzige 6y ago
      Deontology is the worst thing that ever happened to ethical philosophy. Kant can rot in hell where he belongs for it.
• smiley1437 6y ago
  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.
• jdhn 6y ago
  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?
  • exyi 6y ago
    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
  • Nokinside 6y ago
    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?
    • nscalf 6y ago
      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.
  • bluGill 6y ago
    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).
• sbehlasp 6y ago
  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-barriers-coronavirus/ https://www.weforum.org/agenda/2020/06/vaccine-development-b... Whole world is going through tough time. I hope suffering ends sooner than later
• hn8788 6y ago
  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.
  • captainredbeard 6y ago
    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).
    • hedora 6y ago
      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.
      • UncleOxidant 6y ago
• laplacesdemon48 6y ago
  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? 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-vaccines-work.html https://www.nytimes.com/interactive/2021/health/how-covid-19...
  • ceejayoz 6y ago
    Being in the nucleus and being integrated into your chromosomes so that they are copied during cell division aren't the same thing. https://www.medpagetoday.com/special-reports/exclusives/91604 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.
    • dahfizz 6y ago
      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).
      • ipaddr 6y ago
• rantwasp 6y ago
  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.
  • opinicus 6y ago
    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.
• lsllc 6y ago
  Massachusetts DPH has now shutdown administering J&J vaccines (of which MA got a large batch last week) and have been cancelling J&J appointments: https://twitter.com/MassDPH/status/1381947053287354368?s=20 https://twitter.com/MassDPH/status/1381947053287354368?s=20
• bitcurious 6y ago
  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.
  • opinicus 6y ago
    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.
    • convexfunction 6y ago
      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.
    • peytn 6y ago
      > 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.
  • 6y ago
• quercusa 6y ago
  From the article: “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.
• ravenstine 6y ago
  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? I'm baffled, but perhaps I'm a fool.
  • jsight 6y ago
    Yes, but the risk is death and there are alternatives that do not appear to have this risk. Why not pause until it is more well understood? In the US, the other vaccines are starting to become really readily available.
    • lisper 6y ago
      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.
      • jsight 6y ago
        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. Maybe other parts of the country are different.
        • lisper 6y ago
          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.
• daemoens 6y ago
  A pause on vaccines will cause far more deaths than a 1 in 1 million chance of blood clots.
  • ars 6y ago
    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.
  • dragonwriter 6y ago
    > 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.
• endisneigh 6y ago
  Makes sense. 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.
  • stickfigure 6y ago
    > different than 1 in 150 chance of contracting and dying from COVID Fixed that for you.
    • endisneigh 6y ago
      What? I never claimed that contracting and dying was a 1 in a million chance?
  • deleted 6y ago
    [deleted]
  • bentlegen 6y ago
    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”.
    • endisneigh 6y ago
      My point isn't to say that 1 in a million die of COVID, my point is that psychologically the decision makes sense.
      • stickfigure 6y ago
        We don't need to have abstract philosophical conversations about hypothetical numbers. We know the real ones.
• baggy_trough 6y ago
  Awful decision. Everyone involved should be fired or removed from office for grotesque lack of judgement leading to a significant net increase in mortality.
• ars 6y ago
  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.
  • kevin_nisbet 6y ago
    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.
    • bluGill 6y ago
      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.
  • mmcdermott 6y ago
    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?
• ChadHomenim 6y ago
  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. Edit 2: The top comment on the other thread literally says the same thing as my comment https://news.ycombinator.com/item?id=26790922 https://news.ycombinator.com/item?id=26790922
  • endisneigh 6y ago
    > yet we hand that out like candy to little girls. 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.
    • ChadHomenim 6y ago
      Yes, we do, and a cursory Google search will confirm this. Stop spreading disinformation and FUD.
      • endisneigh 6y ago
        Please then, post your source and post the alternative that doesn't have the issue (orders of magnitude more).
        • ChadHomenim 6y ago
          "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.
          • theli0nheart 6y ago
• 0xfaded 6y ago
  > “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 ...
  • jhoechtl 6y ago
    ... JJ stopped to deliver to Europe due to the decision which has been taken in the US.
• gdubs 6y ago
  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.
  • mzs 6y ago
    decent layman's explanation - basically similar to heparin induced thrombocytopenia and you should be able to find more describing that: https://www.theguardian.com/world/2021/apr/13/astrazeneca-blood-clotting-what-is-this-rare-syndrome-and-how-is-it-caused https://www.theguardian.com/world/2021/apr/13/astrazeneca-bl...
• endisneigh 6y ago
  I love how people are complaining about this decision without addressing the fact that there are two other vaccines that don't have this issue that have been used orders of magnitude more. Why wouldn't you pause J&J? It's just a drop in the bucket in total vaccinations anyway and the other two don't have this issue.
  • xwdv 6y ago
    J&J was the best option for those who didn't want to dabble in experimental vaccine tech. Now there is no choice.
    • endisneigh 6y ago
      J&J is objectively more dangerous. So what argument do you have to not pause it given the "experimental" tech is orders of magnitude safer?
    • amluto 6y ago
      J&J is an adenovirus vector vaccine, which is barely less experimental than mRNA. AFAICT the only licensed adenovirus vector vaccines are for Ebola, and those have not been used very widely. Earlier attempts to use adenovirus vectors for gene therapy had issues due to, wait for it, thrombocytopenia. The the one and only COVID vaccine that uses more or less tried and true technology and looked excellent in trials is Novavax. (AIUI Novavax’s adjuvant is newish, fancy, and not necessarily that easy to scale, and it may well be responsible for the excellent performance.)
  • stickfigure 6y ago
    According to the article, 6.8 million people in the US have received the J&J shot. Without the J&J vaccine, those people (6.8 million others) would not be vaccinated due to lack of supply. The US CDC website[1] currently says the 7-day death rate per 100k people is 1.4. Without the J&J vaccine, that's almost 100 additional people dying per week - and just in the US. [1] https://covid.cdc.gov/covid-data-tracker/#cases_deathsper100klast7days https://covid.cdc.gov/covid-data-tracker/#cases_deathsper100...
• mumblemumble 6y ago
  Meta-comment: The ratio of downvoting to discussion in here is rather worrisome. The current top thread isn't really even about COVID vaccines; it's primarily an argument of the "this isn't an argument, this is contradiction" variety about birth control, of all things. It should be possible to have a mature, good-faith conversation about this, even on a pseudonymous web forum.
  • throwawayboise 6y ago
    It should be possible, but for many people, another person's opinion on these vaccines is a binary value. It's either right or wrong, and if it's wrong the person is summarily dismissed as having any relevant input to the conversation. Worrisome is correct.
• washedup 6y ago
  The 9 day median length to development of the condition leads me to believe that this number will grow, and that they are smart to pause for a week or two to see what the real numbers are.
  • jsight 6y ago
    They also need to make sure the information is out there on how to identify and treat the condition if it does occur. Proper warnings and information are pretty important.
• fasteddie31003 6y ago
  The CDC and FDA have done a terrible job in my opinion with the pandemic. They are prime example of government institutional decay. The consiquentalists will win because the J&J vax helps more people than it hurts. This will only add to vax hesitancy. When the dust settles this decision will kill more people than it saves. I had the J&J vax. I got side effects but I now have some immunity to COVID-19 and it's worth it.
• supportlocal4h 6y ago
  We allow people to receive no vaccination at all. But we won't allow them to get this vaccine if they want it? This reminds me about all those governments that allow people to buy and sell cigarettes, but ban the sale of raw milk. Can we just name this "Raw Milk Syndrome"?
  • mumblemumble 6y ago
    I think it's more an application of the principle of non-maleficence. (https://en.wikipedia.org/wiki/Primum_non_nocere https://en.wikipedia.org/wiki/Primum_non_nocere) Consider this a temporary pause while they make sure they understand the relative risk factors. Cigarettes and raw milk are, regrettably, a specious comparison. In the USA, the rules concerning both are handled by different governing bodies. For the longest time, cigarettes had been explicitly excluded from the FDA's jurisdiction, according to a law passed by Congress, and confirmed by a Supreme Court decision. And rules concerning raw milk vary from state to state, but are generally also set by legislatures. In both cases, what you see there is political interests come into conflict with, and perhaps override, the more level-headed, science-driven, technocratic approach that the FDA is theoretically expected to take.
• cblconfederate 6y ago
  Is there an understanding of why the vaccines cause the clots?
  • clon 6y ago
    As for the AZ vaccine, we are still learning: https://www.nejm.org/doi/full/10.1056/NEJMoa2104840 https://www.nejm.org/doi/full/10.1056/NEJMoa2104840 The paper details several cases (and index case in more detail) as well as a plausible mechanism behind the thrombotic events. Even better, there are some therapeutic possibilities as well arising from the heparin induced analogue condition.
  • stevenwoo 6y ago
    The theory is that it is the same reaction that a tiny percentage of people have to heparin (AZ vaccine in this study but mechanism presumably the same) There is a treatment but imperative that doctor knows that this is the cause for appropriate response. https://www.nejm.org/doi/full/10.1056/NEJMoa2104840 https://www.nejm.org/doi/full/10.1056/NEJMoa2104840
• _wldu 6y ago
  Covid itself causes blood clotting in many seriously ill patients. A friend, who was in ICU in March 2020, was given Herparin (due to clotting concerns), and was told to take aspirin at home after release. Is it surprising that the vaccines cause clotting too? Isn't this sort of obvious?
  • kian 6y ago
    Vaccines for tetanus don't cause lockjaw. Vaccines for measles don't give you bumps all over your body. Most vaccines, except for those that used to work by actually infecting you with a related virus, do not cause the same symptoms as the diseases they treat.
  • m-ee 6y ago
    No this is a very different form of clotting caused by auto antibodies that causes both clotting and low platelet counts. It's similar to HIT. Giving heparin in this situation would make things worse. https://en.wikipedia.org/wiki/Heparin-induced_thrombocytopenia https://en.wikipedia.org/wiki/Heparin-induced_thrombocytopen...
    • wonminute 6y ago
      aspirin != heparin. Question, would taking aspirin prior to and after Janssen vaccination lower this risk?
      • m-ee 6y ago
        No it would not. There have been a couple papers focused on the AZ vaccine that get into possible treatments.
• xiphias2 6y ago
  Why didn't they stop the vaccinations in women under age of 60/65? I'm a 40 year old man, if I were a woman I wouldn't take J&J or AstraZeneca, but as I'm a man, I think it's worth to take the risk of the side effects of the vaccination.
  • throwaway0a5e 6y ago
    Using a machete when you should be using a scalpel (though to be fair at the time it looked like a filet knife was the tool for the job) has been more or less how this pandemic has been handled since day 1. Why would that change now?
  • bilbo0s 6y ago
    Now you have the logistical challenges of shipping 2 vaccines to some small town. One for the men, another for the women. Additionally, that town needs the not insubstantial refrigeration capabilities anyway. So what’s the point if you’re a public health admin? Just get the moderna or Pfizer and save yourself and your staff a lot of headache. The logistical benefits of J&J mean that it’s only logistically beneficial if it can be used for everyone.
    • hedora 6y ago
      Better to write the town off to the pandemic. I mean, we’re in the middle of a fourth surge, so realistically, double digit percentages of the town are likely to get covid if we delay even a few weeks, but 10% of 0.5% the population dying from covid and increased spreading of the new variants are reasonable prices to pay to avoid 1 in a million side effects. We can make a statue for the people that die in the following weeks protecting the rest of us from the J&J vaccine. They’ll be heroes. Sorry. Really pissed off about this.
      • robrenaud 6y ago
        The informed old people are vaccinated already. The IFR is way down from around .5 percent. Still agree that covid is a way bigger threat than the J&J vaccine though.
• myrandomcomment 6y ago
  Okay so I want to make something very clear here. The rule is to put it very very simply, is you can ship any drug that is approved but you have to list the side effects. This drug was approved under an emergency order and this side effect was not listed. This will get paused long enough for the side effects to be updated and then used again. The arguments about “well the birth control pill has a higher risk” are using a fact that while it is true, is not relevant as that data has no relationship to the rules that have to be followed. The valid argument would be, those that issue the emergence order for use to should amend the order to acknowledge the issue but not block use immediately.
  • barsonme 6y ago
    I don’t understand why you have to pause then restart. Just update the side effects as you go. Or pause for the affected groups.
    • chrisandchris 6y ago
      I guess it‘s protocol. The same protocol that states that you need to list side-effects probably says if your side-effect list is wrong you have to re-list and get approved again. Until your approval is not done you don‘t get to sell. Otherwise you could delay your updating your side-effects listing because you know FDA will take your druf off-market (and this delay will/could cause harm to people).
    • seoaeu 6y ago
      The pause is to figure out exactly which groups are affected, and to decide if/how to update guidance. They are presumably working as fast as possible on that. Don't forget that the doses aren't going to go bad, so it is just a short delay in administering them
    • effie 6y ago
      Distributing the new document only would not be responsible. In this case, the new side effect kills people. Very rarely, but if you belong to some unlucky group, you're screwed. It is better to figure out which people are endangered. The recommendations and documents have to be good for everybody, not just for the good statistics.
• Ericson2314 6y ago
  Well this seems stupid. The thing I'm trying to understand is whether Johnson & Johnson and AstraZeneca are meaningfully different. All the media just assumes they are (until proven equivalent), but is the genetic code publicly known so we can compare? The Pfizer and Moderna ones are extremely similar. Now, I imagine the adenovirus ones have an order of magnitude more genetic material, but is the code publicly know to compare? As far as I can tell, they both should have been approved ages ago, if only to depress prices and get more redundancy.
  • viklove 6y ago
    Yes, they are meaningfully different. For one, Pfizer and Moderna are mRNA vaccines, while J&J and AZ are not.
    • Moto7451 6y ago
      That’s not the difference the parent is asking about. He’s asking if the adenovirus based vaccines available are meaningfully different. Reaching beyond the parent’s words, both AstraZeneca and J&J have now had issues with blood clots. If it’s a similar formulation then perhaps you’ve found something and Adenovirus vaccines with a different formulation are unaffected. If they’re very different then perhaps other variations of Adenovirus vaccines need more attention.
      • viklove 6y ago
        The mechanism of delivery isn't a meaningful difference? Okay, if you just want to ignore half of the equation be my guest.
        • ivalm 6y ago
          They are comparing jj and astro zeneca, both use adenovirus delivery. Albeit very different variants.
        • GavinMcG 6y ago
          The parent comment wondered > whether Johnson & Johnson and AstraZeneca are meaningfully different Grammatically, that asks about the difference between J&J & AZ. Your response instead compared them collectively to the mRNA vaccines, rather than comparing them to each other. Thus the response saying "[t]hat’s not the difference the parent is asking about."
• InTheArena 6y ago
  I see a lot of arguments that are basically "people are too stupid to understand risk". That, in turn, comes from the fact that the FDA/CDC/NIH has not covered itself in Glory the last many years. Covid just uncovered the rot, while Trump danced around it, and poured gasoline on the fire. The best thing to get people to understand risk is to actually follow the process in the EUA. Pause, evaluate the outcomes, change the labels and dosing. Which this does. At the same time, the FDA/CDC need to start taking other countries data into account. At this point, there is no excuse not to be using a UK style "first dose first" strategy, especially if mRNA is all we have for a while.
  • hedora 6y ago
    I’m not sure I understand your argument (and I’m guessing the downvoters aren’t either). This is a situation where the process will definitely, unambiguously, kill more people than moving forward with the vaccine. I guess you’re suggesting culling a small fraction of the population might encourage better behavior at the voting booth? We already have plenty of historical evidence suggesting that’s not true.
    • edmundsauto 6y ago
      I'm not sure how your last graph followed from GP's post - are you replying to the right comment? GP was saying that the US health agencies haven't looked very good in the past few years, and on Covid, they really have fumbled the comms execution. Before Covid, these issues existed in the agencies, but that was highlighted by the emergency + executive branch that was either incapable or unwilling to make it a priority. That's when it's even more important for our processes, led by our major agencies, to be crisp. None of this past year was unpredictable. If these health agencies are so affected by the whims of politics, it reveals a systemic flaw.
  • RIMR 6y ago
    "Killing people to teach them about risk" seems like a bad decision, especially if the endgame is to save lives.
• jdauriemma 6y ago
  Behold, the vaccine experts of Hacker News!
  • throwaway0a5e 6y ago
    Who are just as accurate, trustworthy and impartial as the technology experts on the 5pm news and the life coaches of Reddit.
  • symlinkk 6y ago
    Are we not allowed to discuss something unless we have a PhD in that field?
    • weakfish 6y ago
      You can discuss it, but platforms tend to allow echo chambers to pop up where people listen to non-experts to confirm their biases. We should only be taking medical advice from PhD, I would argue.
• gnfargbl 6y ago
  For AstraZeneca and not J&J, but these slides from the University of Cambridge do a better job of communicating the balance of risks than I possibly could: https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/976877/CovidStats_07-04-21-final.pdf https://assets.publishing.service.gov.uk/government/uploads/...
  • fastball 6y ago
    Yeah, the problem though is that we have a Tragedy of the Commons situation on our hands. There is a non-negligible portion of the population that wants to have its cake and eat it too – reduce the risk that they will suffer health consequences from COVID-19 by letting everyone else get the vaccine, but not getting the vax themselves, therefore putting their risk from vax at zero.
    • josephcsible 6y ago
      That seems like it'd be easy to fix: the government just needs to say "as soon as you're fully vaccinated, you don't need to social distance or wear a mask in public anymore". Since that isn't their position, there's basically zero incentive for young, healthy people to risk the vaccine side effects.
      • bluGill 6y ago
        That is one option. Which is why so many anti-vac people have jumped on the no vaccine passport bandwagon. If there is no way to prove you have been vaccinated, then they can lie about it and take part in non-masked public activity (I'm not sure why they are against the mask). There are other options. Give everyone who has got the vaccine some money is one I've heard more than once. Maybe someone else has a different idea.
        • Invictus0 6y ago
          Krispy Kreme gave vaccinated people free donuts and it led to an anti-vax outrage here in the States.
• Mvandenbergh 6y ago
  Interesting. Almost definitely something to do with adenoviruses then. I would imagine that Sputnik probably also has this side-effect. I wonder if "wild" adenovirus infection does this too. Deciding whom to give these vaccines to is a complicated decision for each country to make and depends on: a) The incidence rate for each demographic of CSVT-type clotting from the vaccine[s]. b) The expected distribution of clinical outcomes from those events, making reasonable assumptions about likelihood of early detection and outcomes with treatment for heparin induced thrombosis. Those two give you the clinical cost. Then you compare those with the clinical benefit from: 1) The relative likelihood of infection for a person, given their demographics, personal exposure profile etc. 2) The absolute likelihood of infection in the country / region in question based on assumptions about the future of the pandemic 3) The expected distribution of clinical outcomes from infection given the person's characteristics (2) is important because you're comparing a one-time risk of side-effects with a time-related risk of infection. Clearly, the same person in Manaus or Adelaide is not really making the same trade-off even if in the abstract, the side-effects and IFR are the same. You also need the counterfactual: If you decide not to give an ad vectored vaccine, you are not deciding never to vaccinate, you are deciding that this person will get a different vaccine, probably later. How much later depends on the location. If you're in the US, you've got Moderna and Pfizer/Biontech coming out of your ears so it might only delay any individual vaccination by a few weeks. If you're a healthy 25 year old who can work from home, the risk trade-off of having to wait an extra 6 days is very different than that same person if they have to wait another 6 months. As a result, different countries, looking at the same data will rationally make different decisions. The US has lots of mRNA vaccines so will choose one thing, the EU has been badly hit by the failure of Sanofi/GSK to deliver a working vaccine (and by AstraZeneca scaling problems) but has quite a lot Pfizer production capacity, the UK has used up its Pfizer stocks and will now only use it for second shots. CureVac and Novavax may be able to supply some doses at some point but aren't in the picture yet. Several European countries are negotiating to get Sputnik but that is also ad vectored so may have the same problem. That changes the risk calculation because it changes the time that people will remain unvaccinated in the counterfactual where ad vectored vaccines are not used for their age group. All of this is before the complicated public health element of keeping messages for the public simple and the issues caused by changing that message frequently. I don't know to what degree countries that had set relatively high minimum ages for the use of AZ had been counting on J&J for younger people. In many cases, AZ deliveries were sufficiently slow due to yield problems that it was "free" from a scheduling point of view to restrict it to only the oldest since the expectation was that they would only receive enough for those anyway and could use other vaccines for younger groups. If J&J was a big part of that, then they now have to update that calculation because the counterfactual to using AZ for those people is no longer "do them with J&J next week". That may be hard to communicate to people who had been told that a particular vaccine was not safe in their age group previously but may now be asked to take it anyway. I'm glad that I don't have to make these decisions. They are not easy ones.
• wdb 6y ago
  I like how BBC calls the vaccine made in the UK the Oxford-AV vaccine but can't call this correctly the Janssen vaccine.
  • em500 6y ago
    It probably works the same in most places. In the Netherlands it's usually called Janssen, while the Oxford one is called AstraZeneca. I'm guessing in the US they usually leave out BioNTech, while in Germany BioNTech comes before Pfizer.
• UncleOxidant 6y ago
  John Campbell suggested on his video the other day that perhaps this is happening because some injectors are not aspirating. What that means is that when an intramuscular injection is given you want to ensure that it goes into the muscle and not into a vein. So the proper way to do this is for the person doing the injection to first pull out the syringe (after it's been stuck into the arm) a bit to make sure there's no blood coming out. Then if not, the vaccine is pushed in. If blood is seen then a new site has to be chosen. Apparently Denmark has included aspiration in their directions for usage of the AZ vaccine.
  • y-c-o-m-b 6y ago
    That's interesting to know. When I got my Pfizer jab, the lady said "oops, I did it wrong" and blood came out. She didn't jab me again though and I just assumed it was good to go. Should she have done it again at a different site? I was told elsewhere that it doesn't make the vaccine any less effective, but I'm curious what others on here think now...
    • UncleOxidant 6y ago
      As I understand it the concern isn't effectiveness so much as potential for side effects. An intramuscular injection is meant to stay pretty much in a small area of muscle tissue. If it goes into the vein the vaccine then travels into tissues all over the body.
      • robbiep 6y ago
        That’s not really true, we give lots of drugs IM because the muscle is highly vascular so it generally shoots out all over the body really quickly. Ie want to take down a patient with Ice (crystal meth) induced psychosis? IM. Also, it’s hard to miss most of the time. If you want something to sit around for a long time, you go for less vascular areas. (Ie insulin for diabetics, subcut abdominal fat) IM is preferred because of the vascularity which helps in the immune response (ie quick immune response, antigen distributed around the body) as well as any immune reaction confined to the muscle rather than, say the skin. (0) is a quick and dirty on mechanisms of administration. To your earlier point about ‘into’ a vein, I’d never heard of Dr Campbell before you mentioned him, he seems to have great credentials, but I can’t easily explain why an accidental IV administration of an IM vaccine would cause CVST, my gut is that it’s a bit of a hand wave but who knows. (0) https://www.forbes.com/sites/quora/2017/11/07/why-arent-vaccines-given-intravenously/?sh=4cbb5da6798c https://www.forbes.com/sites/quora/2017/11/07/why-arent-vacc...
• yboris 6y ago
  Relevant tweet: https://twitter.com/robertwiblin/status/1381967753234411530 https://twitter.com/robertwiblin/status/1381967753234411530 J&J doses delivered: 7 million. Reported blood clotting events: 6. Daily risk of dying of COVID19 in the US: 1 in 330,000. CDC and FDA: Pause the J&J vaccine. Draw your own conclusion on how aligned these folks are with your interests.
  • nscalf 6y ago
    I think this is an illustration of an issue that has been seen throughout the entire pandemic. Medicine != Public Health Policy. In general, I would say medicine is too dogmatic to decide on public policy, and public policy is too loose to operate medicine.
  • ChrisLomont 6y ago
    That tweet ignores that there are alternatives to the J&J vaccine, so implying that there is a binary decision between J&J or 1 in 330k death chance is flawed reasoning.
    • mr_cyborg 6y ago
      Also ignores risk by age group, which can be significant and relevant to someone’s risk profile.
  • UncleOxidant 6y ago
    But there are 2 other vaccines that are still available so it's not like they're stopping all vaccinations. Another consideraton: J&J was/is having production problems so deliveries have been cut considerably - as such this probably won't be a very significant change to vaccination rates. I suspect the FDA will allow J&J vaccinations to resume in a couple of weeks. Maybe they'll recommend it not be used in women under 60 as has been done with the AZ vaccine in Europe. Even if they do that there would still be plenty of men eligible to get the J&J.
  • ceilingcorner 6y ago
    This is misleading. If you’re young and healthy, the chances of dying from COVID are basically zero. The chances of dying from a blood clot from a rushed vaccine are not. The people who died from blood clots probably would still be alive had they not taken the vaccine.
• textman 6y ago
  "The incidence of cerebral venous thrombosis (CVT) varies between studies, but it is estimated to be between 2 and 5 per million per year. A recent study in the Netherlands with comprehensive ascertainment suggested a much higher incidence." https://www.ahajournals.org/doi/full/10.1161/STROKEAHA.116.013617 https://www.ahajournals.org/doi/full/10.1161/STROKEAHA.116.0... So the six reported cases in 6.8 million vaccinations seems low. Glad I read about all this because I got the J&J vaccine 12 days ago. No noticeable side effects so far. I exercise a lot and did a 5 mile hike four days ago that resulted in a slightly strained a calf muscle. I have been taking it easy the past few days, meaning sitting and reading a lot more than usual. So after learning about the blood clotting, have started exercising the legs frequently. My optimistic thinking is that even if the vaccine does cause an increased risk of CVST that risk can be eliminated via exercise. It will be most interesting to learn if those six cases involved people at high risk, if they exercise regularly, etc.
  • robbiep 6y ago
    If you’re doing the calf exercises to ward off a DVT, (and not to just stretch your strained calf!) you may be barking up the wrong tree. The preliminary theories (backed by the thrombocytopaenia) are that, if there’s a vaccine induced thrombosis with thrombocytopenia, it is probably immune-mediated (similar to HITT - heparin induced thrombocytopenia and thrombosis). And then there’s some weird thing that makes them form in your venous sinus. But there were also reports of more typical blood clots (ie DVTs), the first European Medicines Agency advisory (0) said that this was within the level of noise (im now talking AstraZeneca, so apologies for shifting vaccine as generally they should be considered separately until the evidence catches up, although everyone is quickly drawing parallels between them) (0) https://www.ema.europa.eu/en/news/covid-19-vaccine-astrazeneca-benefits-still-outweigh-risks-despite-possible-link-rare-blood-clots https://www.ema.europa.eu/en/news/covid-19-vaccine-astrazene... Ps apologies for not referencing around HITTs and theories around antibody-mediation for CVT. Basically it’s all pretty noisy anyway at the moment and so my here-say from the medical tea rooms is as good a gossip as any, as long as everyone is aware that no one really has any definitive idea what may be going on yet
    • 6y ago
• jjk166 6y ago
  6 cases in 7 million doses over 3 months is exactly the rate that CVST would normally be expected at. While that doesn't mean we shouldn't investigate, it does mean there is no reason to be alarmed at this time. > 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_thrombosis#:~:text=Low%20molecular%20weight%20heparin,of%20the%20body%2C%20and%20seizures https://en.wikipedia.org/wiki/Cerebral_venous_sinus_thrombos....
  • vincentmarle 6y ago
    > While that doesn't mean we shouldn't investigate, it does mean there is no reason to be alarmed at this time. Except to the general public this overcautious behavior and resulting media hype raises vaccine suspicions, and will decrease public trust in J&J (and even vaccines in general) as a result. It’s already happening.
    • mStreamTeam 6y ago
      Public trust in J&J has been low ever since they got caught putting asbestos in baby powder https://www.reuters.com/investigates/special-report/johnsonandjohnson-cancer/ https://www.reuters.com/investigates/special-report/johnsona...
  • fspeech 6y ago
    There's the question of timing too. It's not clear if the number includes all CVST incidences or only those ocurring in a time window after vaccination. (Update: according to NYT these cases are 1-3 weeks after vaccination, so the background rate is too low to matter here). If there is a strong correlation in timing you can not simply use frequency data to rule out causation.
    • jjk166 6y ago
      Of course the cases are shortly after vaccination, the data is symptoms reported shortly after vaccination which might be side effects. You're not going to have anyone who got a clot before the vaccine or long afterwards in the dataset, but those cases still did/will exist. There is no evidence yet of a correlation in timing.
• ineedasername 6y ago
  6 cases doesn't seem high enough to rise above the baseline incidence rate that I would expect for a population of millions that have received the vaccine. The reported data simply doesn't explain stopping use of this vaccine. It seems like either: 1) They are overreacting based on sparse data, which will cast doubt on the validity of their actions. 2) There is information being withheld that implicates, though perhaps without certainty, that the vaccine is the specific cause of these issues. Either way, the net result will be more distrust & greater reluctance to get vaccinated. There has to be a better way to handle this problem.
  • bluGill 6y ago
    This vaccine is similar to the AZ one which seems to have an elevated rate over a much larger sample size. Thus a pattern here that matches patterns we expect of the AZ vaccine suggests this has the same problem even though if we take the data alone it is still within the range of normal. As such 1 is no longer correct, if we didn't have a compare these numbers are high but within expected chance. However these numbers are looking like within the range of the compare even more than normal.
    • ineedasername 6y ago
      I agree that 1 seems unlikely, and yet #2 just feels too close to a conspiracy theory. The only explanation for #2 that I can think of that doesn't verge into crazy land of coverups is that there may be very specific reasons to believe the vaccine is the cause, but not enough confidence in that conclusion to release the details publicly without risking the vaccination effort if it turns out the vaccine was not the issue. It would help if details were released about the physical condition of the 6 people impacted by this. If all of them were otherwise perfectly healthy people with no risk factors for this sort of issue, then yes-- that's a bit of a smoking gun. But where things stand right now I just don't know what to make of the issues, which is just so damn frustrating because I know it gives ample reason to anyone inclines to doubt the experts or avoid vaccination a reason to do so.
• throwaway5752 6y ago
  I trust the experts here in the FDA and the CDC. These are people that have been working their entire lives in vaccines and vaccine approval. They understand the medicine, the understand the policy.. if there's anything that most people here could think of, the odds are astronomically low that they haven't considered it. It is very encouraging that this appears to be a science led decision. Unsure why I've been downvoted, but if you've worked in FAANG level tech and with scientific staff of the CDC/FDA, you would not think that the caliber of people on either side was much different. There are a very, very large number of Moderna and Pfizer/Biontech doses going out at this point. The bigger risk is 501Y.V2 and company evolving to escape the vaccine, and that is not going to be fixed by a week long pause in J&J/Jannsen to identify the source and treatment for the errant platelet response.
• paulcole 6y ago
  Everyone posting here confidently saying that the FDA is clearly wrong is pretty disappointing to me. I think of all the comments about how "MBAs" and "marketing people" just don't get software development. And then I look at software development people who seem to think they clearly get medical research and regulation.
  • benchaney 6y ago
    The problem is with how they are handling their data. You don’t have to know anything about biology per se to see the issue. It is entirely mathematical. By the way, the medical establishment has a terrible track record surround use of and understanding of statistics. I don’t think it’s right to suggest that self described experts are somehow infallible.
    • paulcole 6y ago
      I'll take self-described experts who work at the FDA over self-described experts on a social media site like HN.
• pablodavila 6y ago
  I was planning on getting the J&J because I will most likely only be able to get one dose. Is a single dose of the mRNA vaccines effective in any meaningful way?
  • Trasmatta 6y ago
    Yes, perhaps around 80% effective after one dose of mRNA: https://www.cnbc.com/2021/03/29/cdc-study-shows-single-dose-of-pfizer-or-moderna-covid-vaccines-was-80percent-effective.html https://www.cnbc.com/2021/03/29/cdc-study-shows-single-dose-...
  • jghn 6y ago
    It has similar efficacy as the single dose J&J
• jaegerpicker 6y ago
  7 people out of 7 million dose's. That's why they stopped. My wife and I got the J&J shot on Saturday so I'm directly at risk and I'd take it everytime even if the risk was 10 times what it currently is. I've already seen a bunch of anit-vaxers referring to this in new articles this morning. So let's see, 1 in a million chance that the vaccine will make you sick (only 1 person has died so far, which is terrible but it's 1 out of 7 million) vs a worldwide pandemic that has killed millions. All these anti-vaxers talking about living in fear of a virus that has 98% survival rate are AFRAID of a vaccine that has a 99.999998% ( 7/7,000,000 == 0.000001) survival rate, oh and is 100% effective at stopping you from dying. Literally no one that has received the vaccine has died from COVID19. The fact that modern society can be SO smart some times and yet so incredibly idiotic is so frustrating to me.
  • vibesngrooves 6y ago
    This really is a sad, sobering reality. "6 cases in 6.8 million", ~0.00000089% chance of death via J&J vaccination. Extremely disheartening to see, but rather telling, where priorities lie. Politics aside, this is sheer stupidity, as you mentioned. Brace for another year as mutations continue to develop throughout the developing world while we waffle over infinitesimally minimal risk.
    • vmception 6y ago
      There are 7 other vaccines in use simultaneously across major markets. JnJ has little effect on the strategy.
  • oceanplexian 6y ago
    Multiple advanced health care systems in the world are independently pulling these vaccines. I wouldn’t brush it off as the FDA being overly cautious. None of these vaccines have been tested in humans for more than 12 months. And you’re assuming that health authorities can wave a magic want and instantly know who is having some kind of undetected brain clotting? I think the risks are extremely unclear even though people are throwing statistics around like they mean anything.
• throwawaysea 6y ago
  It's interesting to me seeing the direct data-based reactions to the pause on the J&J vaccine. For example, Nate Silver of 538 wrote (https://twitter.com/NateSilver538/status/1381925025964515330 https://twitter.com/NateSilver538/status/1381925025964515330): > 6 cases out of 7 million people. What a disaster. This is going to get people killed. And it's going to create more vaccine hesitancy. These people don't understand cost-benefit analysis. They keep making mistakes by orders of magnitude. I am seeing this argument from people of all political views this morning, but I am most surprised to see it from the political left. Why isn't the same data-driven approach used when we're talking about policing, or gun violence, or traffic deaths? In all these cases, the frequency of negative outcomes (policing deaths of unarmed black people, homicides committed with guns, traffic fatalities per mile traveled) is very low and when weighed with the positive outcomes, it is clear that people are acting irrationally when they try to defund police, or ban firearms, or restrict driving. And yet, the data is never brought up so directly in those conversations by either everyday people or news media. The J&J vaccine issue is frankly less alarming to me than this open hypocrisy or disconnect in our societal discourse.
• CivBase 6y ago
  > The US has by far the most confirmed cases of Covid-19 - more than 31 million - with more than 562,000 deaths, another world high. The BBC is usually pretty good about sticking to relevant information (at least compared to US media), so I was a bit disappointed to see this blurb - especially since it's only the fourth sentence in the article. What does it add? It has nothing to do with the subject (ie the safety of the J&J vaccine) and isn't even particularly useful data in almost any other context aside from half-baked political jabs between nations.
  • mdavidn 6y ago
    It also ignores differences in population. Several European countries have more deaths per capita than the United States. So far, the UK had 200 more deaths per million (11% more). The Czech Republic had 900 more per million (53% more).
• hatty 6y ago
  I personally had an adverse reaction to this vaccine. I had a fever and extreme fatigue for 2 days. I am a relatively healthy 30-year-old male.
• mensetmanusman 6y ago
  Our entire political leadership is focused on risk mitigation, and it’s entirely tiresome.
• jkingsbery 6y ago
  I haven't seen any news articles provide a point of comparison of how the number of people receiving the J&J vaccine and experiencing this particular kind of clotting. The first academic-ish article on the subject I could find indicated a typical baseline of 15.7 cases per million (https://www.ahajournals.org/doi/full/10.1161/STROKEAHA.116.013617 https://www.ahajournals.org/doi/full/10.1161/STROKEAHA.116.0...). If that's true, I don't get it - why would we stop roll out of any vaccine when the baseline (15.7) is higher than the problem that is being claimed (1 per million)?
• kevinpet 6y ago
  Given COVID prevalence in my state (approx 1 out of 10,000 people test positive each day, so assume 20 out of 10,000 are infectious at the moment), and the IFR for those under 50 of about 0.01% (1 out of 10,000 coincidentally), I would have to come into close contact with 20 people over the time from when I could get the J&J shot to when I could get Pfizer or Moderna. That's not anti-vax denialism, those are the actual numbers. A one in a million risk isn't a good deal for the individual when case rates and IFR are low. This would be a good deal if you were in Michigan, or if you were over 65.
  • mzs 6y ago
    Birthday paradox means ten not 20 and while I MIGHT be able to go two weeks without encountering ten others my oldest son works at a restaurant, my wife at a school, and my youngest son is full-time HS student. They meet 20 people a day easily and live with me at home.
• _Microft 6y ago
  The section I have italicized here stood out in the statement from the FDA/CDC, in my opinion. This is not about putting vaccinations with the Johnson & Johnson vaccine on hold infinitely. For a good part, it seems to be about being aware of and prepared for this serious adverse effect, not to avoid it at all costs. "Until that process is complete, we are recommending a pause in the use of this vaccine out of an abundance of caution. This is important, in part, to ensure that the health care provider community is aware of the potential for these adverse events and can plan for proper recognition and management due to the unique treatment required with this type of blood clot.", from https://www.cdc.gov/media/releases/2021/s0413-JJ-vaccine.html https://www.cdc.gov/media/releases/2021/s0413-JJ-vaccine.htm...
• williesleg 6y ago
  No big deal, just get out and get some sunshine. Also, the vaccination only lasts about 6 months, you'll need another shot in the fall.
• atleta 6y ago
  It's a very interesting dilemma indeed. Obviously, if it's 7 out of 7 millions, then pausing it for the duration of the investigation does way more harm than good, given how many infections happen these days. On the other hand this extra cautiousness shows how robust the safety of the system is: even minor glitches get caught and examined which practically pretty much rules out that there are side effects of orders of magnitudes more likely that we don't realize. And that may indeed worth it overall. Though in practice it would still make more sense if they continued until it reached a higher threshold (if it is ever to reach it). Unfortunately, while this should be seen as very reassuring WRT the safety and the level of trust we can have in the vaccines, fear is irrational and for some people it proves that the vaccines are not safe. E.g. here in Hungary, we have the EMA licensed vaccines (same as the FDA licensed ones) and also a Chinese (Sinopharm) and a Russian (Sputnik-V), with a permission from the Hungarian authorities. Now when the blood clotting issue emerged with AstraZeneca, some started to say "see, that's how much the EMA license is worth. BUT the Sputnik-V is good because you never heard about such issues with it". Which is, needless to say, completely upside down. (Not suggesting that the Sputnik does have the same problem, though I wouldn't be surprised, since it's the same technology as the AZ and the J&J. Also, I wouldn't be surprised if all vaccines had the same issue as the virus itself causes clotting.)
• prof-dr-ir 6y ago
  As is typical for this comment thread, in this comment I will claim that pausing the Johnson & Johnson vaccine will lead to hundreds of thousands of deaths because that is how many people will die if we do not have a vaccine. All this to save 1 out of 7 million lives. In passing I would like to call everybody involved in the decision idiotic.
  • prof-dr-ir 6y ago
    As is typical for this comment thread, in this top-voted [0] reply to this comment I will point out that pausing one vaccine is not the same as stopping the entire vaccination program forever. I would in addition like to point out that once cannot simply compare the risks because they can vary wildly across populations, and that the one out of seven million might not be a reliable estimate. Might it not be good to wait until we know the actual risk, given also the abundance of other types of vaccine? [0] one can hope
  • prof-dr-ir 6y ago
    As is typical for this comment thread, in further replies we can happily claim the effect that this has on the anti-vaxxing crowd, whose thinking we are all extremely familiar with. Of course, since we are all careful people we will also balance the effects of the decision to pause the vaccine against the decision not to pause in the face of potential blood clotting issues.
• paulwilson05 6y ago
  J&J must not be paying the right people...
• klebe 6y ago
  I must say, the general state of discourse on HN has severely deteriorated over the past year (mostly in line with other online platforms, I suppose) COVID is the single worst thing to happen to civil discussion in my lifetime. The virus is obviously a risk. So are the vaccines. Acting any other way is just downright disingenuous. At the end of the day, any person with a working brain is free to calculate those risks on their own. No persuading, name-calling, or outright rudeness is needed. (Yes, the top 5 comments I'm talking about you) In times like this, I'm reminded of most historical calamities...in which a small minority stood on one side, another small minority on the other, but the vast majority simply stood in the middle and thought "Please let this end" Please upvote this if you're just an average person waiting in the middle.
  • ketamine__ 6y ago
    Being very conservative with vaccine rollout means more people will die. I think the risk-averse folks that approved of harsh lockdowns may want this harsh measure as well.
  • shadowgovt 6y ago
    The pandemic is one of those scenarios that challenges the soul of a nation like the US. Oh, your society believes, at a deep ethical and philosophical level, in individual freedoms, personal responsibility, and general laissez-faire attitude regarding behaviors that do no harm to others? Okay. Here's an invisible threat that is on average low-probability fatal but with wide error bars and a step-function if enough people decide to ignore it. If enough people take collective actions that are uncomfortable, inconvenient, and in some cases heavily disruptive (possibly resulting in loss of individuals' livelihoods), the odds of dying from it are minimized for everyone (but nonzero). If not enough people do these things, the odds spike up (hard to say by how much). In terms of personal responsibility, you don't know if you're spreading the disease and if someone catches it and dies, we only have probabilities to estimate responsibility regarding who it came from. Oh, and a handful of the mitigations might also have nonzero risk of harm or death, with some noteworthy error bars on the estimates. ... and all this on top of a population that barely understands what probability is in general, let alone error bars. Most citizens are, in fact, not nearly educated enough to calculate those risks. But they sure want to think they are, because we put personal responsibility for one's health on the person. It's like the crisis was hand-tuned to be everything Americans hate.
• js2 6y ago
  The risk of dying from a blood clot after receiving the J&J vaccine is six in 6,800,000 (6.8M). The world population is 7,900,000,000 (7.9B). If everyone on the planet got the J&J vaccine tomorrow, and if it is the cause of the clots, then 6,971 people would die from the vaccine. Yesterday, Covid19 killed 8,803 people (according to worldometers). We don't want anyone to die from vaccination, and we don't fully understand what the clotting issue is, so it probably makes sense to pause using J&J as long as the mRNA vaccines (Pfizer, Moderna) have not been implicated (which they haven't). OTOH, if this being in the news causes fewer people to get vaccinated, pausing it may be a mistake that will cause more overall deaths. Now, your risk of dying either from vaccination or Covid19 depends on various demographic factors not accounted for in my math above. But, nonetheless, the risk of dying from the J&J vaccine is really, really, really tiny. Like, if I knew there was a 0.00009% chance my car were going to explode every time I got in it and started it, I would not be at all nervous about starting my car everyday for the rest of my life. I'm way more likely, even accounting for my age demographic, to choke to death eating dinner tonight (5,051 deaths from choking in the U.S. in 2015 of which 2,848 were older than 74). Edit: lifetime risk of car exploding assuming I start it every day for 50 years is about 1.6%. Okay, maybe I wouldn't play that game.
  • Alex3917 6y ago
    > if this being in the news causes fewer people to get vaccinated, pausing it may be a mistake that will cause more overall deaths. Except for that the government covering up the MMR investigation instead of doing it openly is what caused the anti-vaxx movement in the first place. Compare that with the public rallying around J&J after their Tylenol recall.
  • TrevorJ 6y ago
    >The risk of dying from a blood clot after receiving the J&J vaccine is six in 6,800,000 (6.8M) that we know of. I suspect the lack of understanding about what is happening, and what other knock-on effects there might be is what is behind this. If a wing falls off of one airplane in a million, we still stop and try to figure out what happened because as far as we know, wings are not supposed to fall off any airplanes, so there's something about the system we need to learn more about.
• deleted 6y ago
  [deleted]
• yboris 6y ago
  Related: The J&J Vaccine Is Safer Than the Birth Control Millions of Women Take Every Day https://www.vice.com/en/article/z3xbk9/johnson-and-johnson-covid-vaccine-versus-birth-control-pill-blood-clots https://www.vice.com/en/article/z3xbk9/johnson-and-johnson-c...
• rainyMammoth 6y ago
  Nobody seem to discuss that this issue appears around 10 days after getting the vaccine. And I believe most of the doses have been given over the last 10 days. So we actually don't know yet the real incidence of this issue. It makes sense for the FDA to be cautious here, there are other vaccines which are fully available.
• brian_herman 6y ago
  I got the Johnson and Johnson vaccine and I feel fine but this news troubles me.
• marsven_422 6y ago
  Pfizers marketing department is on fire!
• hnburnsy 6y ago
  From the CDC, updated today... "Over 189 million doses of COVID-19 vaccines were administered in the United States from December 14, 2020, through April 12, 2021. During this time, VAERS received 3,005 reports of death (0.00158%) among people who received a COVID-19 vaccine." https://www.cdc.gov/coronavirus/2019-ncov/vaccines/safety/adverse-events.html https://www.cdc.gov/coronavirus/2019-ncov/vaccines/safety/ad...
• dawnerd 6y ago
  Honestly I think they should have had their meeting before telling the public. It seems unnecessary to pause it before figuring out if its worth it unless theres something else they're not telling us, which in that case it's also hurting trust in the system. No matter what they come back with, the JnJ vaccine is done. We might as well start shipping them out to other countries that desperately need them, especially if we supposedly have enough mrna vaccines coming for everyone.
• OnlyRepliesToBS 6y ago
  human experimentation for shareholder profits
• electrondood 6y ago
  Interesting to find out if this is again correlated to blood type. Type O has a lower risk of clots from COVID in general, thought to be related to the amount of von Willebrand factor in the blood: "...since the ACE2 receptor belongs to the renin-angiotensin system (it regulates blood pressure), the virus cannot but affect the blood vessels. Apparently, it is capable of causing local inflammation of the walls of blood vessels and capillaries. This results in an increased release of VWF into the blood, which, in turn, provokes clotting." [0] [0] https://www.news-medical.net/news/20200706/COVID-19-complications-may-be-associated-with-von-Willebrand-factor-in-the-blood.aspx https://www.news-medical.net/news/20200706/COVID-19-complica...
• iluvcommunism 6y ago
  Literally ONE person on here referred to VAERS. You people really do need to do more research instead of going in circles.