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US Recommends 'Pause' For J&J Vaccine Over Clot Reports (apnews.com) 260

iggymanz writes: The U.S. is recommending a "pause" in using the single-dose Johnson & Johnson COVID-19 vaccine to investigate reports of potentially dangerous blood clots. The Centers for Disease Control and Prevention and the Food and Drug Administration said Tuesday they were investigating unusual clots that occurred 6 to 13 days after vaccination. The clots occurred in veins that drain blood from the brain and occurred together with low platelets. All six cases were in women between the ages of 18 and 48; there was one death and all remained under investigation. The reports appear similar to a rare, unusual type of clotting disorder that European authorities say is possibly linked to another COVID-19 vaccine not yet cleared in the U.S., from AstraZeneca. More than 6.8 million doses of the J&J vaccine have been administered in the U.S., the vast majority with no or mild side effects.
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US Recommends 'Pause' For J&J Vaccine Over Clot Reports

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  • Some Context... (Score:5, Insightful)

    by Thelasko ( 1196535 ) on Tuesday April 13, 2021 @10:01AM (#61268534) Journal
    6 out of 7 million people had blood clots. That's a 1 in a million chance on average. The average probability of getting struck by lightning in the US is 1 in 500,000 each year. [cdc.gov]

    That's right, the average person is more likely to be struck by lightning, and they are pausing the J&J vaccine.

    Now, if you are a premenopausal woman, your odds are comparable to being struck by lightning. However, if you are a farmer, or have another occupation that requires you to work outdoors, you are far more likely to be struck by lightning in a given year than have this side effect.

    If the risk of blood clots scares you away from J&J, don't go outside!
    • Re:Some Context... (Score:5, Interesting)

      by iggymanz ( 596061 ) on Tuesday April 13, 2021 @10:08AM (#61268576)

      Wrong. Six people had the condition detected and correlated with getting vaccination. There literally could be thousands more that had blood clots in veins; maybe condition not detected, maybe condition lost in other problems, maybe in veins in other areas, etc.

      • Re: (Score:3, Insightful)

        by Thelasko ( 1196535 )

        There literally could be thousands more that had blood clots in veins; maybe condition not detected, maybe condition lost in other problems, maybe in veins in other areas, etc.

        Whoa! Are you saying this this could be far more prevalent, but not detected in a clinical trial with tens of thousands of samples? Ridiculously improbable.

        To find a side effect more likely than random occurrences like a lightning strike after clinical trials of this magnitude would be unheard of. Such a thing would most likely be the result of data manipulation on behalf of the the drug company.

        It also sounds like you are concerned about benign blood clots. I'm not going to worry over something that

        • Re:Some Context... (Score:5, Informative)

          by AuMatar ( 183847 ) on Tuesday April 13, 2021 @12:31PM (#61269286)

          The clinical trial didn't have 10s of thousands of samples. It had 40K participants. 20K of them received placebo. So that leaves 20K. All patients with the issue so far have been women, so if the 2 sexes were controlled that leaves 10K. Now we're assuming there's not a cofactor (such as being on birth control) which would reduce the numbers far lower.

          SO is there a chance of major side effect that slipped through? Yes, very much so. It would be something that happens to only a small percentage of people and may be worth the risk, but its something that should be studied regardless.

      • These 6 people could also have blood clots for other reasons, unrelated to the vaccine. The rate is supposed to be 1-3 per 1000 yearly in the USA:
        https://www.stoptheclot.org/bl... [stoptheclot.org]

        6 out of 7 million is nothing but noise. Even if you multiply by 26 to get a yearly rate instead of a 2 weeks period.

        • 6 out of 7 million is nothing but noise.

          I think this approach is too casual. It's difficult to decipher signal versus noise with something as infrequent as this, but it doesn't mean a signal isn't there. However, it's not a good reason to halt the roll out during a pandemic either.

    • Re:Some Context... (Score:5, Insightful)

      by Brain-Fu ( 1274756 ) on Tuesday April 13, 2021 @10:12AM (#61268608) Homepage Journal

      Thank you for that perspective. Personally I approve of this pause from the "abundance of caution" angle. There is a widespread sentiment that we are being reckless with these vaccines, and rolling them out with too little testing, and ignoring the warnings and problems.

      And that is false. These vaccines all went through intense testing, whereas COVID-19 has gone through zero testing and is known to present an unacceptably high risk of death. The vaccine absolutely without question improves your odds of survival significantly. And even when something as trivial as this one-in-a-million risk crops up, we are still pausing the vaccine because our health officials have decided that even that trivial risk is unacceptable.

      So nobody is being reckless. We are collectively making the wisest choice possible by embracing these vaccines.

      • There is a widespread sentiment that we are being reckless with these vaccines, and rolling them out with too little testing, and ignoring the warnings and problems.

        A panicky reaction to stop using the vaccine after a few wonky cases will only strengthen the idea that the rollout was rushed. And worse: when they do decide that these cases are so few that they might as well continue administering the vaccines (as they inevitably will), it will strengthen the idea that they are playing hard and fast with our lives. This is the worst policy imaginable, and it’s exactly the one we are following in Europe with the AZ jab.

        • What exactly do you propose? While the blood clots are rare in general, there might be a specific demographic for which it's certain death, and it would be immoral to just continue vaccinating people.

          • What exactly do you propose? While the blood clots are rare in general, there might be a specific demographic for which it's certain death, and it would be immoral to just continue vaccinating people.

            Might there be a specific demographic for which COVID-19 is certain death, but doesn't have the known risk factors (age, various comorbidities)? This is at least as likely.

        • and itâ(TM)s exactly the one we are following in Europe with the AZ jab.
          Strange. Last time I heard "jabs" are voluntarily. And the AZ jabs are now only for people over 60, which seem for odd reasons to be unaffected from blood clods linked to the vaccine.

          Where do you live that AZ jabs are forced on you?

      • Brain-fu went straight to the heart of the matter. The relevant issue is the risk of vaccines versus the risks of not getting vaccines. The J&J vaccine is uniquely well suited to high-mobility populations and people out of reach of ultra-cold chains. Even as supply ramps up, the mRNA vaccines may not be an adequate substitute.

        On the other hand my contrarian side wonders whether a one in a million chance is like an O-ring burned a third of the way through. When something should not happen at all, do you

    • Guess what actually does cause blood clots? COVID-19.

    • Re:Some Context... (Score:5, Interesting)

      by PacoSuarez ( 530275 ) on Tuesday April 13, 2021 @10:14AM (#61268624)
      There are a number of other simple ways to get a feel for how big a risk this is. You can compute how much your life expectancy is changed by the possibility of getting one of these blood clots, assuming it would kill you immediately with certainty. My back-of-the-envelope calculation results in about 30 minutes if you are in your 20s, but less if you are older.

      You can also think of what would happen if you were to give this to the entire adult US population: You'd get 300 people with blood clots, to be compared with about 1,000 people dying every single day. So if using the vaccine can make us get to herd immunity a few hours earlier, it's totally worth it.

      The people issuing this recommendation migth think they are acting with an abundance of caution, but the result is going to be hundreds or thousands of additional deaths.
      • There are a number of other simple ways to get a feel for how big a risk this is. You can compute how much your life expectancy is changed by the possibility of getting one of these blood clots, assuming it would kill you immediately with certainty. My back-of-the-envelope calculation results in about 30 minutes if you are in your 20s, but less if you are older.

        That's only looking at the downside of the vaccine. There's a ~0.2% chance a person in their 20s could die of COVID without it. It's a net improvement in life expectancy by far!

      • by flink ( 18449 )

        You are assuming everyone behaves absolutely rationally. If a small but real chance of serious clots exist and the authorities are seen to be doing nothing or worse perceived to be sweeping it under the rug, people will reject the J&J vaccine. Worse, they might start distrusting all vaccines. There has to be a little bit of extra theatre around it to maintain trust in the institutions.

        Therefore, pausing one vaccine among many available while they look into it, even if it's just to appease people's un

      • I am heartened by the abundance of Dr. Strangeloves on Slashdot making informed risk assessments.

        Actually, it was General "Buck" Turgidson who offered an option where "I'm not saying we wouldn't get our hair mussed. But I do say no more than ten to twenty million killed, tops. Uh, depending on the breaks."

    • by fermion ( 181285 )
      Further context. We knew that we were going to see some effects that could be attributed to the vaccine. The rollout was rushed, and millions of does are administered in a very short time.

      The fact that we are monitoring this closely and have been able to discern these side effects is a testament to how careful we are really being. This is not what happens in a normal roll out, where these side effects are minimized.

      Clearly J&J vaccine should not given to certain women. Britain is allowing young peop

      • If this happened 6 times in 7 million does, then you were pretty much guaranteed to never see this in any clinical trial, even if you spent 5 years doing the trials, except maybe 1 case out of pure luck. And if it were just 1 case you'd have nothing at all to go buy to figure out what caused it. This appears to be the type of situation where there was pretty much 0% chance of detection in any clinical trial.

    • 6 out of 7 million people had blood clots.

      For further context, the same cohort that had blood clots have a 1 in 30 chance of being hospitalized due to COVID, and a 1 in 500 chance of dying from it.

      • Well,

        to get a blood clot from a vaccine, there is one fundamental thing to account for: some one has to stab you with a syringe and administer it to you.

        To die from COVID-19, there is also one fundamental thing to account for: you have to catch it first.

        So, I leave it to you to figure the difference.

        • To die from COVID-19, there is also one fundamental thing to account for: you have to catch it first.

          If you live in Australia, New Zealand, or Taiwan, avoiding COVID and the vaccine might be an option for you. However, if you live in the US and think you won't catch COVID sooner or later, you are delusional.

    • That's right, the average person is more likely to be struck by lightning, and they are pausing the J&J vaccine.

      The average person isn't being told to stand outside in a thunderstorm because it's safe. And the country doesn't depend on people believing that they won't get struck by lightning.

      The world is full of enough retards who believe vaccines cause TEH AUTISMS! despite precisely no link ever being established. It's good that they hold back the use of the vaccine where a link has been established, even if its low, if for no other reason than to ensure people have faith in a vaccination program and actually go and

    • I think this is probably the right move. They say the reason for the pause (and again emphasis on pause) is to update clinical monitoring recommendations. When we had anaphylaxis we built a protocol around that: sit in the chair for 15 minutes at the vaccination site which has an epi pen before leaving.

      Is there a common set of symptoms to watch out for that could catch all of these clotting cases before they turn deadly? Doctors and emergency rooms are hyper vigilant about catching appendicitis symptoms

    • I mean, if the choice was J&J or nothing, sure. But if it's that or Pfizer/Moderna, might as well go with the safer one.

    • 1) News would get out and be warped and misunderstood anyway; creating problems with vaccinations
      2) If you HIDE the data it will get out and amplify the same problems
      3) If you ALLOW it despite the risks, you look like an asshole who doesn't care to probably most the public - undermining TRUST; which is our biggest problem.
      4) If you pause it, you look over-protective. If you later find Birth Control or some medication to blame, then you can unpause with more trust... or simply tell women to not get the J the

  • by Anonymous Coward on Tuesday April 13, 2021 @10:04AM (#61268554)

    Your anti-vax friends and relatives are going to have a field day with this, even though it demonstrates our safety protocols.

    The fact that when vaccine reactions are observed the vaccine's use is paused and studied rather than swept under the rug like in some fevered conspiracy theory.

    Still, can't entirely blame the anti-vax folks from taking a victory lap when the government feel a need to pause vaccinations scheduled for today. As in, what about the folks who got the shot yesterday.

    Still, I took my second shot of Moderna, and if my only choice was J&J or waiting for Covid, I'd be first in line to take a canceled vaccine appointment.

    • Yeah detecting one in a million side-effects should be very encouraging to anyone worried about vaccine side effects. The monitoring process is clearly working.

    • by gtall ( 79522 )

      Yes I can entirely blame the anti-vax folks for being superb dolts. The arrogance of those bastards is astounding: No, I refuse to get vaxxed because I don't trust vaccines. Okay, how about subjecting your kids to polio or measles or any of the other fun diseases. Your kids will respect you for it while they suffer.

  • Statistically this really seems like a non-issue, many have pointed out the risk of blood clots from birth control is far higher, not even mentioning auto-travel, bicycling and many other activities we do and drugs we take.

    Is the government just really gun-shy about the holdouts and those who will use to propagandize this information to justify their stance? I say yes and it's unfortunate and no good way about it. Keep it cool and publish the side effects as "normal" and it will be weaponized as a coverup-

  • Monstrously Stupid (Score:3, Insightful)

    by SuperKendall ( 25149 ) on Tuesday April 13, 2021 @10:12AM (#61268602)

    Already I've been reading reports of thousands of people having vaccination appointments cancelled because of this.

    Well I'm really glad Covid must be absolutely fine at this point, because otherwise it is the height of stupidity to fail to vaccinate millions of people sooner rather than later, over a one in a million chance you might get blood clots!

    Almost certainly more than seven people will get Covid than would not have otherwise because they got a shot, and Covid has a high correlation of deep vein thrombosis [podiatrytoday.com] in something like 20% of patients...

    I hate to say it, but at this point, for the health of the nation, it is imperative we stop listening to the CDC.

    • by Brain-Fu ( 1274756 ) on Tuesday April 13, 2021 @10:27AM (#61268684) Homepage Journal

      No, they have to pause. If they don't, it will drive even more people to skip the vaccine out of fear that we are being reckless and ignoring the risks of the vaccines. There are a whole heaping lot of people who are afraid of these vaccines. Their fear is irrational and misguided, but saying this does not make it go away. If our rollout is seen as being reckless that will push them right over the line.

      I know several people who are normally pro-vaxers that are afraid of this vaccine, and are refusing to accept it. I have read plenty of Internet posts to that effect, as well. The situation is sensitive, and so we must do everything we can to encourage those who are on the fence (excluding making it mandatory, of course, since one's authority over one's own body is a sacred right).

      • (excluding making it mandatory, of course, since one's authority over one's own body is a sacred right).

        Except in Texas.

      • No, they have to pause. If they don't, it will drive even more people to skip the vaccine out of fear that we are being reckless and ignoring the risks of the vaccines.

        Do you really think people will trust the vaccine when they resume it?
        Pausing a vaccine with no data to back it up is a stupid decision. Just look at Europe. They still aren't out of their AstraZeneca mess, despite the fact that there is only 222 cases out of 34 million injected doses.

        The average joe doesn't understand statistics.

        • We need to stop making policy geared towards average Joe. Average Joe is going to be be fearful and stupid no matter what. He will probably make a lot of noise, about it too.
          What needs to be done and what is lacking is a clear communication channel to the average Joe to explain what is going on, and why they are doing what they are doing.
          What we have now is a set of New Companies all with the agenda to make money by making the news entertaining. So they will push doom and gloom, and support their customer

        • The average joe doesn't understand statistics.
          Neither does the average joe understand legal terms like:
          * Mayhem
          * willful endangerment
          * compensations - in case of avoidable complications caused by willful endangerment

          Lose of your "License to practice" if you are working for a CDC like organization and take the wrong steps in questions regarding safety of medications or vaccines.

          So, what exactly was your point? You are sad that you do not live in China where they could force a certain vaccine down your throat

    • 20% of patients ADMITTED TO THE ICU.

      That's a huge fucking difference between 20% of people that simply get COVID.

      Missportraying statistics like this are why you get the crazy people that think they're going to die if they go outside and the other crazy people that think COVID is a hoax.
    • You are the one monstrously stupid. There could be tens of thousands of people with damaging clots perhaps in other areas of body; and J&J vaccine isn't the only one stopped because of this problem, a slew of European countries have stopped a vaccine too.

      You false assume only six people have a problem, it is not yet known how many. Experts smarter than your ignorant self in not just the CDC say the vaccine should be stop (e.g. FDA too) and problem studied.

    • Well I'm really glad Covid must be absolutely fine at this point, because otherwise it is the height of stupidity to fail to vaccinate millions of people sooner rather than later

      Nope. The height of stupidity is giving antivaxxers more ammunition to not get vaccinated. The virus doesn't care about how fast you vaccinate. It cares about the total number of people. Defeating it depends on an unwavering belief in a vaccination program and people are too fucking stupid to risk assess the chance of getting a blood clot due to a vaccine.

  • We need them badly. We will even test them for you if you don't trust them.

  • by ZombieCatInABox ( 5665338 ) on Tuesday April 13, 2021 @10:31AM (#61268700)

    A long time ago, during caveman days, there used to be an evolutionary pressure against stupidity. You know: You act stupidely, you die, you don't reproduce.

    What pisses me off the most is that all these anti-vaxxers will also benefit from herd-immunity brought by the vaccination campain. And when the pandemic is finally reversed, they too will have survived, and claim that they didn't need the "Bill Gates" vaccine, or some other nonsense, and continue thinking that they are so much smarter and wiser that us "sheeple".

    None of those bastards has ever had to watch their child die of smallpox or polio, or had to care for their father confined to a wheelchair for the last 20 years of his life because of polio, like my mother had to.

    I'm sick and tired of making excuses for them. Anti-vaxxers disgust me.

    • What pisses me off the most is that all these anti-vaxxers will also benefit from herd-immunity brought by the vaccination campain. And when the pandemic is finally reversed, they too will have survived, and claim that they didn't need the "Bill Gates" vaccine, or some other nonsense, and continue thinking that they are so much smarter and wiser that us "sheeple".

      Sure, there will be a minority of people that get away with never getting vaccinated with no legitimate medical explanation as to why they felt the need to opt out. But as the pandemic drags on, you can bet that Federal officials are going to put pressure on state officials that are going to put pressure on public schools and workplaces to make vaccination mandatory.

      A lot of anti-vaxxers are going to be extremely upset when they aren't allowed to return to work until they get their vaccination.

    • by thegarbz ( 1787294 ) on Tuesday April 13, 2021 @11:21AM (#61268964)

      I'm sick and tired of making excuses for them. Anti-vaxxers disgust me.

      Likewise. Which is why we should supporting pausing the J&J and Astrazenica vaccines. By showing the world that a vaccine program and health of the vaccinated is taken very seriously you don't give any more ammunition to the antivaxx morons who already think that every damn vaccine comes with a free lifetime subscription to Autism magazine.

      • The interesting question is what those both have in common.
        I doubt it is the "vaccine itself" that causes the problem. I would assume it is the solution in which it is delivered. (But that is probably an to easy thought and the problem behind it, is more complex).

    • by jabuzz ( 182671 )

      In the USA there are two ways to improve vaccine take up IMHO. First remove medicare for the treatment of COVID-19 if you turned down a vaccine for it. Second pressure health insurance companies to do the same, if possible legislate for it, or at least make it excluded unless specifically noted on your policy.

      Choices have consequences, and the problem with anti-vaxers is that the cost of the choices is not being born by them. Make it potentially ruinously expensive to not take a vaccine to sharpen their foc

  • by wakeboarder ( 2695839 ) on Tuesday April 13, 2021 @10:41AM (#61268740)

    Your odds of dying from a fall or in a car accident are 1 in 100 over your lifetime. https://injuryfacts.nsc.org/al... [nsc.org]

    Your odds of dying from Covid 19 are about 1 in 1000 if you get it

    Your odds of dying from a vaccine are (according to me) over 1 in 1000000 (stats I'm using: 1 person could have died out of tens of millions of vaccines) (I am also assuming you'll only get the vaccine once in your lifetime).

    You have more of a risk of dying in a cataclysmic storm, or from lightning than a vaccine. So if you are truly risk adverse, you'd better not go outside during a storm or drive your whole life.

    There are multiple vaccines, so you don't have to get the J&J vaccine.

    • Wrong and false. More than one vaccine has this problem reported, in many European countries. There could be tens of thousands more of people who have clotting problem but didn't die. You don't know what the risks are, you're spewing false stats in ignorance.

      • Again: Massive fucking clots in the brain's biggest vein where it should never ever be big enougg to be able to clog anything. That's more than some deaths. That's an indicator that something is massively wrong. We need to adress that.

        Also: Exponential growth means you always react "way too early".

    • by khb ( 266593 )

      "I am also assuming you'll only get the vaccine once in your lifetime"

      Given what we know about corona viri (most common colds) chances are this will become a yearly ritual, like flu shots. So well worth figuring out *why* some vaccines seem to be increasing the odds of _unusual_ blood clots.

      Also, the same technology is likely to be applied widely to other needs (faster flu so more targeted, possibly cancer, etc.) so it's a real issue.

      That said, you have a point about the relative risks, getting more folks v

      • I think we'll get boosters maybe, the coronaviruses don't mutate as fast as the flu (which has several DNA pairs which can mutate and swap whereas the coronavirus can only mutate).

      • The problem is that if you give knowingly a substance with (potential) deadly side effects, you will be sued int oblivion by the relatives. Hence, a pause for administering to figure for which part of the population it is save. Same as we did with the AZ vaccine in Europe.

    • Humans are terrible at assessing risk and even statistics. The number of people playing the lottery or gambling away their paycheck in a casino should tell you this. Humanity is not built to deal with these kinds of things rationally.
    • There are multiple vaccines, so you don't have to get the J&J vaccine.

      And because there are alternatives available the odds of properly defeating a virus are improved by showing the world how seriously you take health in a vaccination program by suspending the use of a vaccine even if the odds of it causing issues is extremely low.

      There are alternatives available, we don't need to give moron antivaxxers the impression we're taking unreasonable risks with their lives (even though we're not).

      • The problem with antivaxxers is they haven't seen the damage that real disease can do, like polio. We are so far removed from death from what death used to be. Both grandparents on both sides of my family told me horror stories of siblings that got polio. One of my great uncles was in a wheelchair for life. The other couldn't walk for several years. If we don't have proper vaccinations these diseases will come back. Some people already learned that lesson with measles a few years back.

    • Your odds of dying of COVID are much greater than 1 in 1000 if you get it.

      COVID has already killed 1 in every 573 people in the US and most of the people in the US have not had COVID.

      One more person will die from COVID for every day that 1 million vaccine doses are delayed.

    • So if you are truly risk adverse, you'd better not go outside during a storm
      That is actually what sane people do. At least at the places where I live.

  • AAV is effects (Score:5, Informative)

    by sugar and acid ( 88555 ) on Tuesday April 13, 2021 @10:57AM (#61268830)

    J&J vaccine is an adenovirus vector based vaccine, same as the Astrazeneca vaccine (and the sputnik 5). Similar very rare issues with clotting have been widely reported as well.

    This maybe a common rare problem with this type of vaccine vector. I believe the AZ vaccine was the first of this type of vector to be administered at this scale.

    Now stats, in both cases we are talking in the 1 in a million range (~0.0001%) for deaths from the clotting issue.

    Now risk of death from covid infection remains high without vaccination while it is so widespread. As a mid-40-year old in my case the infection fatality rate is 0.1%, the infection rate is at a low at the moment, but even then I estimate based on current new case rates my chance of catching Covid-19 as 0.1% in the next month where I live. Total that up it is 0.0001% chance of death from covid infection I could catch in the next month, or 10 times higher than the risk from the AZ vaccine, and this is at a low in the epidemic from a lockdown. Basically even at this epidemic low point it is worth me taking the AZ vaccine, if it is the only thing available to me this month. For the under 30s this equation changes around and is why the UK government is not going to give it to under 30s if they can avoid it.

  • I'm going to bet that the people who developed blood clots were infected with COVID-19 prior to vaccination and the development of the blood clots are a direct result of that infection and numerous other complicating factors-- high cholesterol, etc.
     

  • .... from what I have heard, all of the blood clotting found was in people who, upon closer investigation, had a biological predisposition towards a higher chance of clotting than normal in the first place, even if they had not been vaccinated.

    It appears to be the case that in these particular cases, the receiving of the vaccine may have led to clots that otherwise may not have happened, but tests *do* exist today which can determine the likelihood that a person can form such clots, so it is at least med

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