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Yeah and we only just started to roll this vaccine out - so it's fair to say that the risk will likely grow beyond that. You're right that 7 / 7,000,000 are go

Yeah and we only just started to roll this vaccine out - so it's fair to say that the risk will likely grow beyond that. You're right that 7 / 7,000,000 are good odds, and most people would likely take them - but it would be unwise to not give people an educated choice between vaccines if there are known risks.

lamontcg 6y ago
> so it's fair to say that the risk will likely grow beyond that. not really. that's not how statistics work. it could grow, it could shrink.
- kube-system 6y ago
  In this case, the numerator lags the denominator. > All six cases were in women aged between 18 and 48, with symptoms appearing six to 13 days after vaccination. Presumably, some of the 7 million people who have gotten the vaccine did so in the prior 5-12 days. It is reasonable to expect to see more cases over the next 6-13 days from the moment we pause J&J vaccination.
  - caddemon 6y ago
    Also, if the effected group is only young women, the denominator isn't really the same as the total number vaccinated. Not saying it isn't still very rare, but in young people COVID deaths are also very rare. We have alternative vaccines, it makes perfect sense to advise young women against J&J for the time being while this is sorted out. And for anyone that thinks this is just normal incidence of blood clots being blamed on the vaccine - that's what was said about AstraZeneca originally, and if these clots are anything like those it is absolutely not the case. Those are serious clots that are very rare to see period, let alone in young people, and require different treatment than normal clots (they have surprisingly low platelet count). I suspect US agencies had good reason to want to pause J&J given all of that - the AZ vaccine issues were also disproportionately affecting women interestingly.
- joshjdr 6y ago
  Provided a larger sample size, doesn’t an increasing rate of an outcome suggest existence a confounding variable that the smaller previously tested sample failed to identify, and (not absolutely- but more likely than not) would apply increasingly at the larger scale? Not a statistician here- and honestly asking.
- FunnyLookinHat 6y ago
  I guess I wasn't being specific - good correction. Reporting medical side effects can easily lag with new treatments, especially when we're not sure what we're looking for. I suspect that, as soon as we start looking for blood clotting post-vaccine, then you'll find more cases that may have not been caught otherwise due to their not being severe enough to be noticed.
  - AndrewBissell 6y ago
    This exact thing happened with the AstraZeneca vaccine, which works very similarly to J&J. The EMA is now recognizing thrombocytopenia (not the same fatal issue but possibly related) as a "common" side effect, i.e. somewhere between 1 in 10 to 1 in 100. https://twitter.com/HamidMerchant/status/1381797044495466504 https://twitter.com/HamidMerchant/status/1381797044495466504
doikor 6y ago
Lets say these side effects only happen in certain populations. If that is the case we could then target this vaccine to the rest and have it be much safer while giving out the Pfizer-BioNTech or Moderna vaccines to this group. End result is everyone still getting their vaccine fast but less side effects (and possibly deaths due to worst case side effects). This is why we need more data or the time to study the data in this case most likely
lghh 6y ago
> but it would be unwise to not give people an educated choice between vaccines if there are known risks They are not giving people an educated choice, they are taking that choice away until they deem it okay to give it back. Education is knowing that 7/7,000,000 had a blood clot + the other tests that were done leading up to its release. We know that now. We're educated.
- FunnyLookinHat 6y ago
  Sorry you are correct - I should have been more specific in my wording. We should give people an educated choice. With unknown side effects we are not doing that. Thank you for pointing that out.
  - lghh 6y ago
    It is impossible to rule out unknown side effects. The blood clots are now known. Any side effect that is unknown will always remain unknown. You could always be the first person to experience a symptom, whether it's Tylenol or this vaccine.
  - 8note 6y ago
    We should be very specific though: If you take this vaccine, there's a 1 in 10 billion chance that a meteor strikes the pharmacy while you're in it. Make sure you cover every possible thing, no matter how unlikely.
- fspeech 6y ago
  It is CVST not just blood clots. There are a lot more blood clots with or without the vaccine. CVST is rare so is the proverbial canary in the coal mine here. The CVST incidents give a lower bound on risk. The trial data give a rough upper bound on risk (rough due to the small sample size). Knowledge is being refined here. We can't make educated choices without knowledge.
- josefx 6y ago
  > They are not giving people an educated choice Hard to give people an educated choice without looking into the issue first. Once they know what is going on it will most likely be back to normal. There was a similar issue in Europe, but that neatly overlapped with a delivery shortage of the affected vaccine.
dev_tty01 6y ago
Agreed. Another unknown is how many people may have had some clotting issues that were mild and unreported. As you note, even though the 7/7M odds are compelling, the effect is still unexpected and there are two other vaccine alternatives. Taking a pause to consider the issues and perhaps make adjustments in suitable patient profiles and/or adjust follow up observation and early intervention treatment protocols for the issue makes sense. Don't know if it matters to anyone, but the "FDA has suggested that health care providers pause the use of the vaccine while the side effects are being studied. However, providers are not prohibited from using the vaccine if they feel the benefits to an individual patient outweigh the risks." [1] 1. https://www.npr.org/sections/health-shots/2021/04/13/986767069/johnson-johnson-vaccine-and-blood-clots-what-you-need-to-know https://www.npr.org/sections/health-shots/2021/04/13/9867670...

lamontcg 6y ago

> so it's fair to say that the risk will likely grow beyond that. not really. that's not how statistics work. it could grow, it could shrink.

kube-system 6y ago
In this case, the numerator lags the denominator. > All six cases were in women aged between 18 and 48, with symptoms appearing six to 13 days after vaccination. Presumably, some of the 7 million people who have gotten the vaccine did so in the prior 5-12 days. It is reasonable to expect to see more cases over the next 6-13 days from the moment we pause J&J vaccination.
- caddemon 6y ago
  Also, if the effected group is only young women, the denominator isn't really the same as the total number vaccinated. Not saying it isn't still very rare, but in young people COVID deaths are also very rare. We have alternative vaccines, it makes perfect sense to advise young women against J&J for the time being while this is sorted out. And for anyone that thinks this is just normal incidence of blood clots being blamed on the vaccine - that's what was said about AstraZeneca originally, and if these clots are anything like those it is absolutely not the case. Those are serious clots that are very rare to see period, let alone in young people, and require different treatment than normal clots (they have surprisingly low platelet count). I suspect US agencies had good reason to want to pause J&J given all of that - the AZ vaccine issues were also disproportionately affecting women interestingly.
joshjdr 6y ago
Provided a larger sample size, doesn’t an increasing rate of an outcome suggest existence a confounding variable that the smaller previously tested sample failed to identify, and (not absolutely- but more likely than not) would apply increasingly at the larger scale? Not a statistician here- and honestly asking.
FunnyLookinHat 6y ago
I guess I wasn't being specific - good correction. Reporting medical side effects can easily lag with new treatments, especially when we're not sure what we're looking for. I suspect that, as soon as we start looking for blood clotting post-vaccine, then you'll find more cases that may have not been caught otherwise due to their not being severe enough to be noticed.
- AndrewBissell 6y ago
  This exact thing happened with the AstraZeneca vaccine, which works very similarly to J&J. The EMA is now recognizing thrombocytopenia (not the same fatal issue but possibly related) as a "common" side effect, i.e. somewhere between 1 in 10 to 1 in 100. https://twitter.com/HamidMerchant/status/1381797044495466504 https://twitter.com/HamidMerchant/status/1381797044495466504

doikor 6y ago

Lets say these side effects only happen in certain populations. If that is the case we could then target this vaccine to the rest and have it be much safer while giving out the Pfizer-BioNTech or Moderna vaccines to this group. End result is everyone still getting their vaccine fast but less side effects (and possibly deaths due to worst case side effects). This is why we need more data or the time to study the data in this case most likely

lghh 6y ago

> but it would be unwise to not give people an educated choice between vaccines if there are known risks They are not giving people an educated choice, they are taking that choice away until they deem it okay to give it back. Education is knowing that 7/7,000,000 had a blood clot + the other tests that were done leading up to its release. We know that now. We're educated.

FunnyLookinHat 6y ago
Sorry you are correct - I should have been more specific in my wording. We should give people an educated choice. With unknown side effects we are not doing that. Thank you for pointing that out.
- lghh 6y ago
  It is impossible to rule out unknown side effects. The blood clots are now known. Any side effect that is unknown will always remain unknown. You could always be the first person to experience a symptom, whether it's Tylenol or this vaccine.
- 8note 6y ago
  We should be very specific though: If you take this vaccine, there's a 1 in 10 billion chance that a meteor strikes the pharmacy while you're in it. Make sure you cover every possible thing, no matter how unlikely.
fspeech 6y ago
It is CVST not just blood clots. There are a lot more blood clots with or without the vaccine. CVST is rare so is the proverbial canary in the coal mine here. The CVST incidents give a lower bound on risk. The trial data give a rough upper bound on risk (rough due to the small sample size). Knowledge is being refined here. We can't make educated choices without knowledge.
josefx 6y ago
> They are not giving people an educated choice Hard to give people an educated choice without looking into the issue first. Once they know what is going on it will most likely be back to normal. There was a similar issue in Europe, but that neatly overlapped with a delivery shortage of the affected vaccine.

dev_tty01 6y ago

Agreed. Another unknown is how many people may have had some clotting issues that were mild and unreported. As you note, even though the 7/7M odds are compelling, the effect is still unexpected and there are two other vaccine alternatives. Taking a pause to consider the issues and perhaps make adjustments in suitable patient profiles and/or adjust follow up observation and early intervention treatment protocols for the issue makes sense. Don't know if it matters to anyone, but the "FDA has suggested that health care providers pause the use of the vaccine while the side effects are being studied. However, providers are not prohibited from using the vaccine if they feel the benefits to an individual patient outweigh the risks." [1] 1. https://www.npr.org/sections/health-shots/2021/04/13/986767069/johnson-johnson-vaccine-and-blood-clots-what-you-need-to-know https://www.npr.org/sections/health-shots/2021/04/13/9867670...