5 ms·

The problem isn't 7 out of 7 million odds. It is that it is an unknown side effect that did not come up in the original studies. We have approved vaccines with

by doikor 6y ago

The problem isn't 7 out of 7 million odds. It is that it is an unknown side effect that did not come up in the original studies. We have approved vaccines with worse side effects before. The difference is that we knew what those side effects were and weighed the risk vs reward and made the call to use it.

FunnyLookinHat 6y ago
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...
raverbashing 6y ago
> It is that it is an unknown side effect that did not come up in the original studies. Well, obviously it didn't. Exactly because it is so rare A clinical study with (I think) 30k people can't detect something that's 1 in a million case
- doikor 6y ago
  Yes. And that is why when something like this pops up we stop giving out the treatment while we look at the new data and make the decision.
  - njarboe 6y ago
    So we stop giving out treatment and an extra 1000-10000(?) people die and we delay the economy getting back on track for a week or two with the delay. No skin off the FDA bureaucrats teeth, but they are hurting a lot of people with this decision.
    - doikor 6y ago
      We don't know any of that. What if it ends up killing more than that? > FDA bureaucrats You mean doctors. These decisions are done by doctors as they should be. The current (acting) head of FDA is a physician too.
thelean12 6y ago
> side effect To be clear, we haven't determined that it's actually a side effect. That's why they've stopped, to get a better handle on what actually happened, and what to do about it. It could be related to the vaccine, it could not be. It could be 1 in a million, it could be 1 in 100k.
handmodel 6y ago
While I understand this to a degree - this still pretends the long-term risks of covid are zero or less than the Johnson & Johnson vaccine. It is a two sided equation.
- caddemon 6y ago
  For young people (it seems especially young women) I think the answer could end up going in either direction honestly. I think it's completely reasonable to redirect them to mRNA vaccine until we know more. Not sure why the J&J vaccine had to pause for older population where clearly the vaccine has a much better benefit/risk profile though. But at least in my area of the US the vaccination rate for senior citizens is quite high already.
deleted 6y ago
[deleted]
tharne 6y ago
> It is that it is an unknown side effect that did not come up in the original studies. It's not clear that this even has to do with the vaccine. If you gave 7 Million people a glass of water on the same day, I'm sure at least 7 of them would experience some sort of moderate to serious health outcome in the days that followed.
argvargc 6y ago
"Doctors For COVID Ethics" a (non anti-vax) group of 150+ medical professionals/university professors etc, warned in March about the likelihood of deaths resultant from exactly this issue. They went public with their previously private correspondence with the European Medicines Agency, as they were unsatisfied with EMA's responses. Who picked up their pleas? Conspiracy, fringe and some right-wing websites - that seems to be it.
theptip 6y ago
> an unknown side effect that did not come up in the original studies. You shouldn't expect side-effects this rare to show up in the trials. The AZ trial was based on ~32k participants (https://www.astrazeneca.com/media-centre/press-releases/2021/astrazeneca-us-vaccine-trial-met-primary-endpoint.html https://www.astrazeneca.com/media-centre/press-releases/2021...). Your probability of observing a 1/1,000,000 occurrence in 32k observations is something like 3%. It's impossible to uncover (with statistical significance) 1/1,000,000 side effects without giving millions of doses. The fact that a rare side-effect has (maybe!) shown up should not negatively impact your priors for how safe the vaccine is. If anything, the fact that we're talking about 7 / 7,000,000 cases should reassure you that we're catching extremely rare stuff, which means we would have caught anything more serious too. A more general way of putting this is that, by doing a trial you don't prove there are _no_ side-effects, you just put an upper bound on how common they can be. This is the best that science can do! Epistemologically speaking, you can never prove the non-existence of something, you can just show that it doesn't occur in the places you've taken measurements, at a frequency that your experiments would detect. (This is the "black swan fallacy", as John Stuart Mill originally formulated it.)

by doikor 6y ago

FunnyLookinHat 6y ago

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...

raverbashing 6y ago

> It is that it is an unknown side effect that did not come up in the original studies. Well, obviously it didn't. Exactly because it is so rare A clinical study with (I think) 30k people can't detect something that's 1 in a million case

doikor 6y ago
Yes. And that is why when something like this pops up we stop giving out the treatment while we look at the new data and make the decision.
- njarboe 6y ago
  So we stop giving out treatment and an extra 1000-10000(?) people die and we delay the economy getting back on track for a week or two with the delay. No skin off the FDA bureaucrats teeth, but they are hurting a lot of people with this decision.
  - doikor 6y ago
    We don't know any of that. What if it ends up killing more than that? > FDA bureaucrats You mean doctors. These decisions are done by doctors as they should be. The current (acting) head of FDA is a physician too.

thelean12 6y ago

> side effect To be clear, we haven't determined that it's actually a side effect. That's why they've stopped, to get a better handle on what actually happened, and what to do about it. It could be related to the vaccine, it could not be. It could be 1 in a million, it could be 1 in 100k.

handmodel 6y ago

While I understand this to a degree - this still pretends the long-term risks of covid are zero or less than the Johnson & Johnson vaccine. It is a two sided equation.

caddemon 6y ago
For young people (it seems especially young women) I think the answer could end up going in either direction honestly. I think it's completely reasonable to redirect them to mRNA vaccine until we know more. Not sure why the J&J vaccine had to pause for older population where clearly the vaccine has a much better benefit/risk profile though. But at least in my area of the US the vaccination rate for senior citizens is quite high already.

deleted 6y ago

[deleted]

tharne 6y ago

> It is that it is an unknown side effect that did not come up in the original studies. It's not clear that this even has to do with the vaccine. If you gave 7 Million people a glass of water on the same day, I'm sure at least 7 of them would experience some sort of moderate to serious health outcome in the days that followed.

argvargc 6y ago

"Doctors For COVID Ethics" a (non anti-vax) group of 150+ medical professionals/university professors etc, warned in March about the likelihood of deaths resultant from exactly this issue. They went public with their previously private correspondence with the European Medicines Agency, as they were unsatisfied with EMA's responses. Who picked up their pleas? Conspiracy, fringe and some right-wing websites - that seems to be it.

theptip 6y ago

> an unknown side effect that did not come up in the original studies. You shouldn't expect side-effects this rare to show up in the trials. The AZ trial was based on ~32k participants (https://www.astrazeneca.com/media-centre/press-releases/2021/astrazeneca-us-vaccine-trial-met-primary-endpoint.html https://www.astrazeneca.com/media-centre/press-releases/2021...). Your probability of observing a 1/1,000,000 occurrence in 32k observations is something like 3%. It's impossible to uncover (with statistical significance) 1/1,000,000 side effects without giving millions of doses. The fact that a rare side-effect has (maybe!) shown up should not negatively impact your priors for how safe the vaccine is. If anything, the fact that we're talking about 7 / 7,000,000 cases should reassure you that we're catching extremely rare stuff, which means we would have caught anything more serious too. A more general way of putting this is that, by doing a trial you don't prove there are _no_ side-effects, you just put an upper bound on how common they can be. This is the best that science can do! Epistemologically speaking, you can never prove the non-existence of something, you can just show that it doesn't occur in the places you've taken measurements, at a frequency that your experiments would detect. (This is the "black swan fallacy", as John Stuart Mill originally formulated it.)