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> The EMA has said that as of March 10, a total of 30 cases of blood clotting had been reported among close to 5 million people vaccinated with the AstraZeneca

> The EMA has said that as of March 10, a total of 30 cases of blood clotting had been reported among close to 5 million people vaccinated with the AstraZeneca shot in the European Economic Area, which links 30 European countries. "The decision today is purely precautionary..." given this level of signal. We don't have details on the age groups involved and the normal rates expected but I can hazard a Fermi Estimate that the risk is minuscule compared to COVID-19 itself. I look forward to seeing the actual data in coming days/weeks. Precaution without downside is acceptable; this is not one of those cases, IMO. YMMV.

detaro 6y ago
And the press statement says that this is based on new data compared to when they looked at it on the 11th. Hope we'll see what that is.
ArkanExplorer 6y ago
Surely more people will die from COVID than from blood clotting, due to this delay? Or perhaps not, given that 2020 deaths in Germany were 985,145, only 4.85% higher than 2019, and only 3.2% higher than 2018 (and so basically in line with what we would expect from an aging society). https://www.destatis.de/DE/Themen/Gesellschaft-Umwelt/Bevoelkerung/Sterbefaelle-Lebenserwartung/Tabellen/sonderauswertung-sterbefaelle.html?nn=23768 https://www.destatis.de/DE/Themen/Gesellschaft-Umwelt/Bevoel...
- deleted 6y ago
  [deleted]
- libertine 6y ago
  You're missing the point. This is an anomaly. It's not about the "oh it's worth the risk compared to COVID 19". If it's a side effect it wasn't spotted in the trials, why was that? It's not a side effect? It was a problem in production? What problem? Was is tampered with or was an accident? What failed in QA to let that batch come to the public? Was is a storage problem that compromised the batch quality? Was it while in transport or in the local hospital? You talk about this like background noise. It's not. It should be investigated. It's good that this is happening, because it shows regulators are doing their job. This is what builds trust in vaccines, not disregarding odd occurrences because they seem to have no "statistical relevance". That's just ignorance talking.
  - freewilly1040 6y ago
    No one is saying side effects should not be investigated. The question is whether the vaccine administration should be halted in the meantime, and that would be determined by the risk/reward of preventing covid deaths.
    - libertine 6y ago
      Just like I trust the regulators for vaccine approval, I trust them in the decision of stopping the administration of a vaccine to further investigate the problem. This goes together. It's not a political decision no matter how many people try to spin this. This is the outcome of doctors reporting an anomaly to a regulator. The system is working, and this should give you reassurance, not doubt about the consequences of stopping a vaccine. I'm pretty sure they know the consequences of this setback, so for them to stop it it's because something is not right.
      - hntrader 6y ago
        "It's not a political decision" It likely is, though. From the perspective of the regulators, there are asymmetric personal consequences. If they make a decision that leads to 50 clotting deaths but saves 5000 people from COVID as a counterfactual, their head is on a chopping block because those 5000 foregone deaths are invisible but the 50 deaths are visible. If they make a decision to halt the vaccine distribution and this kills an extra 5000 people - well that's no problem because they were just being careful. Society has set up a political situation where there is literally only one choice that absolves the bureaucrats from a negative personal outcome. Of course they're going to go that route. Personal incentives are incredibly powerful drivers of behavior, whatever the publicly stated reasons for an action may happen to be. It may be the case that they've made the right decision, but we can't assume that it was for the right reasons.
        Dma54rhs 6y ago
        You could use the same arguments and mindset when you're an antivaxx. Vaccines can't be a holy cow that gets defended no matter what. It's always interesting that people who claim to not trust big business big pharma somehow defend everything vaccine related to death. Regulators halted it snd wait for new information to come in, that is how it's supposed to be.
- lm28469 6y ago
  > Or perhaps not, given that 2020 deaths in Germany were 985,145, only 4.85% higher than 2019, and only 3.2% higher than 2018 (and so basically in line with what we would expect from an aging society). Are we still having this debate.... Of course the overall mortality didn't change much, people stayed at home for literally 75% of the year. Do you have the split stats for accidental deaths, road deaths, disease related deaths, &c. ? Because otherwise it's meaningless. We can put everyone in an artificial coma and get as little death per year as possible, it isn't a really interesting metric without the context.
  - ArkanExplorer 6y ago
    https://www.statista.com/statistics/525353/sweden-number-of-deaths/ https://www.statista.com/statistics/525353/sweden-number-of-... Sweden, 2020 deaths only 6.2% higher than 2018, and following a weak 2019 flu season. These are entirely acceptable death figures within the context of aging European societies. COVID is basically a once-a-decade flu variant: like Swine Flu in 2009, which came and went without lockdown: https://swprs.org/wp-content/uploads/2020/10/sweden-monthly-deaths-1851.jpg https://swprs.org/wp-content/uploads/2020/10/sweden-monthly-... So COVID is dangerous enough to lock down entire societies, but not dangerous enough to justify continued vaccination when 1 in 166,666 have blood clotting? This is probably the background rate. It seems like Europe and its bureaucrats just can't let go of lockdown. Or alternatively, they wish to push the vaccines and end of lockdown into Spring/Summer, where natural seasonality will take care of COVID and give the appearance that lockdown and vaccines were a success.
    - mynameisvlad 6y ago
      > Or alternatively, they wish to push the vaccines and end of lockdown into Spring/Summer, where natural seasonality will take care of COVID and give the appearance that lockdown and vaccines were a success. Did you somehow forget that this is the second year of Covid? We've already gone through the whole "natural seasonality" cycle and the disease is very much still here.
      - leereeves 6y ago
andrewon 6y ago
Several considerations here: 1. If holding off AstraZeneca vaccine does not affect vaccination rate during the investigation period, it is a prudent thing to do. 2. If vaccine rate is expected to drop, number of expected increase in death per day due to covid vs blood clog should be compared, if we were to minimize short term death. 3. More concerning is unknown effect that could take a long time to materialize. This is a tough call to make since any effect is only theoretical at this point.
- polytely 6y ago
  don't discount trust in the vaccination process, it might be better to visible respond to anomalies to signal that the system that makes sure vaccinations are safe actually works.
  - finolex1 6y ago
    Ironically, the suspension of vaccines has now sowed far more doubt than some isolated reports of blood clots would have.
- _ph_ 6y ago
  Vaccination rate in Germany will drop considerably while the hold is in place, at least 20%, if not more. I don't know the exact numbers, but vaccination is quite blocked on vaccine supply at the moment.
  - yladiz 6y ago
    This isn't really true for the AstraZeneca vaccine, though. There's supply, but people don't seem to trust it and it's just sitting on the shelves because even when people book an appointment they don't show up. I'm sure the number of vaccinations _will_ drop, because it's one of the only few vaccines being distributed, but I doubt it will be as high as you mention here.
    - _ph_ 6y ago
      There have been some delays due to the fact that initially it was only used for people under 65 and only medical personal was qualified to be vaccinated with it - all other vaccinations were limited to 80 and above. But by now the AZ vaccine is used for all age groups and the vaccination has been offered to wider groups. Now, vaccination is mostly limited by availability.
tazjin 6y ago
> the risk is minuscule compared to COVID-19 itself You don't know this at all - we don't know what age groups are affected here, and COVID is pretty much negligible in many younger age groups. It's best to wait for more data to come in before drawing any conclusions.
- draw_down 6y ago
  There is such a discursive wall around the vaccines, there is no quarter for any idea that one of the vaccines could have risks that should give anyone pause. Covid will kill you, vaccines will save you, end of story.
- blagie 6y ago
  The risk *of death* from COVID is pretty negligible for some age groups. The biggest confusion of this whole situation is we've fixated on CFR numbers as a measure of risk. Risks of long-term consequences don't seem to be all that low.
  - tazjin 6y ago
    I haven't seen anything that indicates that the risk of long-term consequences is significantly elevated above other viral diseases. There is a condition (which we know too little about, and which - as one of the few good outcomes of the COVID situation - is now actually getting some attention) that can lead to fatigue and other symptoms after fighting off a viral infection, but it's not unique to COVID. A year ago there was a lot of noise about things like heart issues induced by COVID, which turned out to be mostly statistical errors in the papers that made the claims. A lot of people (often people who never actually had a positive test) also claim to suffer from various mental impairments after their COVID infections, and some newspaper ran an article saying that some of these symptoms were alleviated after the people were given anxiety medication. Go figure ...
    - DanielleMolloy 6y ago
      Mh, do you really want to play down the possibility of unknown long-term consequences? Check out this: https://www.biorxiv.org/content/10.1101/2021.02.23.432474v1 https://www.biorxiv.org/content/10.1101/2021.02.23.432474v1 The Spanish Flu has led to a „sleeping sickness“ epidemic years after it ceased.
sradman 6y ago
British Columbia's Dr. Bonnie Henry discusses [1] (5min YouTube clip up until 28m37s) the decision process surrounding Adverse Events Following Immunization (AEFIs) [2] within the context of the EMA decision involving the AstraZeneca vaccine. Her explanations tend to mirror her refrain "Be Kind, Be Calm, Be Safe". For those jurisdictions like the UK, India, and Canada that continue recommending AstraZeneca, I'd suggest that COVID-19 vaccines are like beer; the best one is the one in front of you. [1] https://youtu.be/xbLJCh9XHl0?t=23m42s https://youtu.be/xbLJCh9XHl0?t=23m42s [2] https://en.wikipedia.org/wiki/Vaccine_adverse_event https://en.wikipedia.org/wiki/Vaccine_adverse_event
h3cate 6y ago
The risk of covid-19 in the majority of the population is miniscule
petre 6y ago
It's 0.0015% compared to 4%, so at least a 2.6·1e3 difference. Given less than 0.004% chance to catch the disease in my city, the odds are 10 fold in favour of not getting vaccinated. I'll still get vaccinated regardless, because I am sick and tired of this pandemic and want to go on vacation instead of into an another lockdown this year.
- theptip 6y ago
  Where are you getting 4% from? It looks to me like like 3 deaths out of 1.2m vaccinated. (I’m looking at the linked PDF https://www.pei.de/SharedDocs/Downloads/EN/newsroom-en/hp-news/faq-temporary-suspension-astrazeneca.pdf?__blob=publicationFile&v=5 https://www.pei.de/SharedDocs/Downloads/EN/newsroom-en/hp-ne...)
  - petre 6y ago
    The 4% deaths are from covid-19, not from the vaccines. 3.4% is the WHO global estimate if you want to be more precise and 2.5% in my country as of today. https://www.worldometers.info/coronavirus/coronavirus-death-rate/ https://www.worldometers.info/coronavirus/coronavirus-death-... The 0.0015% is the known rate of blood clots from all the AZ doses on the continent according to what the GP has reported and RFI has confirmed the same numbers today (30 cases in 5M doses but it's not clear how many have died and why). So 0.4 death rate times 0.004 chance to get covid in my area equals 0.0016 chanches to get covid and die which is one point higher than the chances of getting blood clots from the vaccine. Yeah, I botched the last product, so it's actually about the same risk figure, but the benefits of getting vaccinated outweigh the risks and the allegedly faulty vaccine batch has already been halted anyway. I have acquaintances that were vaccinated with the allgedly faulty batch AVB2856 before it was halted and they're doing just fine.
    - theptip 6y ago
      Got you, thanks. (Side-note, I wish it were easier to transmit simple models like this as part of discourse). The 0.0015 risk of death seems high. Where are you getting that from? https://www.reuters.com/article/us-health-coronavirus-germany-astrazenec-idUSKBN2B71UM https://www.reuters.com/article/us-health-coronavirus-german... gives "The EMA has said that as of March 10, a total of 30 cases of blood clotting had been reported among close to 5 million people vaccinated with the AstraZeneca shot in the European Economic Area, which links 30 European countries." But if you want to take the German numbers, 3 deaths out of 1.6m vaccines: 3/1,600,000 = 0.000001875 (In percent, 0.0001875%) which is 0.125 of your figure. And the OP gives a base rate of "two to five cases per 1 million individuals per year" for context; we need to subtract out the base rate from the observed deaths too (because obviously the base rate of this condition occurs regardless of whether you take the vaccine). [edit: percent conversion typo]

detaro 6y ago

And the press statement says that this is based on new data compared to when they looked at it on the 11th. Hope we'll see what that is.

ArkanExplorer 6y ago

Surely more people will die from COVID than from blood clotting, due to this delay? Or perhaps not, given that 2020 deaths in Germany were 985,145, only 4.85% higher than 2019, and only 3.2% higher than 2018 (and so basically in line with what we would expect from an aging society). https://www.destatis.de/DE/Themen/Gesellschaft-Umwelt/Bevoelkerung/Sterbefaelle-Lebenserwartung/Tabellen/sonderauswertung-sterbefaelle.html?nn=23768 https://www.destatis.de/DE/Themen/Gesellschaft-Umwelt/Bevoel...

deleted 6y ago
[deleted]
libertine 6y ago
You're missing the point. This is an anomaly. It's not about the "oh it's worth the risk compared to COVID 19". If it's a side effect it wasn't spotted in the trials, why was that? It's not a side effect? It was a problem in production? What problem? Was is tampered with or was an accident? What failed in QA to let that batch come to the public? Was is a storage problem that compromised the batch quality? Was it while in transport or in the local hospital? You talk about this like background noise. It's not. It should be investigated. It's good that this is happening, because it shows regulators are doing their job. This is what builds trust in vaccines, not disregarding odd occurrences because they seem to have no "statistical relevance". That's just ignorance talking.
- freewilly1040 6y ago
  No one is saying side effects should not be investigated. The question is whether the vaccine administration should be halted in the meantime, and that would be determined by the risk/reward of preventing covid deaths.
  - libertine 6y ago
    Just like I trust the regulators for vaccine approval, I trust them in the decision of stopping the administration of a vaccine to further investigate the problem. This goes together. It's not a political decision no matter how many people try to spin this. This is the outcome of doctors reporting an anomaly to a regulator. The system is working, and this should give you reassurance, not doubt about the consequences of stopping a vaccine. I'm pretty sure they know the consequences of this setback, so for them to stop it it's because something is not right.
    - hntrader 6y ago
      "It's not a political decision" It likely is, though. From the perspective of the regulators, there are asymmetric personal consequences. If they make a decision that leads to 50 clotting deaths but saves 5000 people from COVID as a counterfactual, their head is on a chopping block because those 5000 foregone deaths are invisible but the 50 deaths are visible. If they make a decision to halt the vaccine distribution and this kills an extra 5000 people - well that's no problem because they were just being careful. Society has set up a political situation where there is literally only one choice that absolves the bureaucrats from a negative personal outcome. Of course they're going to go that route. Personal incentives are incredibly powerful drivers of behavior, whatever the publicly stated reasons for an action may happen to be. It may be the case that they've made the right decision, but we can't assume that it was for the right reasons.
      - Dma54rhs 6y ago
        You could use the same arguments and mindset when you're an antivaxx. Vaccines can't be a holy cow that gets defended no matter what. It's always interesting that people who claim to not trust big business big pharma somehow defend everything vaccine related to death. Regulators halted it snd wait for new information to come in, that is how it's supposed to be.
lm28469 6y ago
> Or perhaps not, given that 2020 deaths in Germany were 985,145, only 4.85% higher than 2019, and only 3.2% higher than 2018 (and so basically in line with what we would expect from an aging society). Are we still having this debate.... Of course the overall mortality didn't change much, people stayed at home for literally 75% of the year. Do you have the split stats for accidental deaths, road deaths, disease related deaths, &c. ? Because otherwise it's meaningless. We can put everyone in an artificial coma and get as little death per year as possible, it isn't a really interesting metric without the context.
- ArkanExplorer 6y ago
  https://www.statista.com/statistics/525353/sweden-number-of-deaths/ https://www.statista.com/statistics/525353/sweden-number-of-... Sweden, 2020 deaths only 6.2% higher than 2018, and following a weak 2019 flu season. These are entirely acceptable death figures within the context of aging European societies. COVID is basically a once-a-decade flu variant: like Swine Flu in 2009, which came and went without lockdown: https://swprs.org/wp-content/uploads/2020/10/sweden-monthly-deaths-1851.jpg https://swprs.org/wp-content/uploads/2020/10/sweden-monthly-... So COVID is dangerous enough to lock down entire societies, but not dangerous enough to justify continued vaccination when 1 in 166,666 have blood clotting? This is probably the background rate. It seems like Europe and its bureaucrats just can't let go of lockdown. Or alternatively, they wish to push the vaccines and end of lockdown into Spring/Summer, where natural seasonality will take care of COVID and give the appearance that lockdown and vaccines were a success.
  - mynameisvlad 6y ago
    > Or alternatively, they wish to push the vaccines and end of lockdown into Spring/Summer, where natural seasonality will take care of COVID and give the appearance that lockdown and vaccines were a success. Did you somehow forget that this is the second year of Covid? We've already gone through the whole "natural seasonality" cycle and the disease is very much still here.
    - leereeves 6y ago

andrewon 6y ago

Several considerations here: 1. If holding off AstraZeneca vaccine does not affect vaccination rate during the investigation period, it is a prudent thing to do. 2. If vaccine rate is expected to drop, number of expected increase in death per day due to covid vs blood clog should be compared, if we were to minimize short term death. 3. More concerning is unknown effect that could take a long time to materialize. This is a tough call to make since any effect is only theoretical at this point.

polytely 6y ago
don't discount trust in the vaccination process, it might be better to visible respond to anomalies to signal that the system that makes sure vaccinations are safe actually works.
- finolex1 6y ago
  Ironically, the suspension of vaccines has now sowed far more doubt than some isolated reports of blood clots would have.
_ph_ 6y ago
Vaccination rate in Germany will drop considerably while the hold is in place, at least 20%, if not more. I don't know the exact numbers, but vaccination is quite blocked on vaccine supply at the moment.
- yladiz 6y ago
  This isn't really true for the AstraZeneca vaccine, though. There's supply, but people don't seem to trust it and it's just sitting on the shelves because even when people book an appointment they don't show up. I'm sure the number of vaccinations _will_ drop, because it's one of the only few vaccines being distributed, but I doubt it will be as high as you mention here.
  - _ph_ 6y ago
    There have been some delays due to the fact that initially it was only used for people under 65 and only medical personal was qualified to be vaccinated with it - all other vaccinations were limited to 80 and above. But by now the AZ vaccine is used for all age groups and the vaccination has been offered to wider groups. Now, vaccination is mostly limited by availability.

tazjin 6y ago

> the risk is minuscule compared to COVID-19 itself You don't know this at all - we don't know what age groups are affected here, and COVID is pretty much negligible in many younger age groups. It's best to wait for more data to come in before drawing any conclusions.

draw_down 6y ago
There is such a discursive wall around the vaccines, there is no quarter for any idea that one of the vaccines could have risks that should give anyone pause. Covid will kill you, vaccines will save you, end of story.
blagie 6y ago
The risk *of death* from COVID is pretty negligible for some age groups. The biggest confusion of this whole situation is we've fixated on CFR numbers as a measure of risk. Risks of long-term consequences don't seem to be all that low.
- tazjin 6y ago
  I haven't seen anything that indicates that the risk of long-term consequences is significantly elevated above other viral diseases. There is a condition (which we know too little about, and which - as one of the few good outcomes of the COVID situation - is now actually getting some attention) that can lead to fatigue and other symptoms after fighting off a viral infection, but it's not unique to COVID. A year ago there was a lot of noise about things like heart issues induced by COVID, which turned out to be mostly statistical errors in the papers that made the claims. A lot of people (often people who never actually had a positive test) also claim to suffer from various mental impairments after their COVID infections, and some newspaper ran an article saying that some of these symptoms were alleviated after the people were given anxiety medication. Go figure ...
  - DanielleMolloy 6y ago
    Mh, do you really want to play down the possibility of unknown long-term consequences? Check out this: https://www.biorxiv.org/content/10.1101/2021.02.23.432474v1 https://www.biorxiv.org/content/10.1101/2021.02.23.432474v1 The Spanish Flu has led to a „sleeping sickness“ epidemic years after it ceased.

sradman 6y ago

British Columbia's Dr. Bonnie Henry discusses [1] (5min YouTube clip up until 28m37s) the decision process surrounding Adverse Events Following Immunization (AEFIs) [2] within the context of the EMA decision involving the AstraZeneca vaccine. Her explanations tend to mirror her refrain "Be Kind, Be Calm, Be Safe". For those jurisdictions like the UK, India, and Canada that continue recommending AstraZeneca, I'd suggest that COVID-19 vaccines are like beer; the best one is the one in front of you. [1] https://youtu.be/xbLJCh9XHl0?t=23m42s https://youtu.be/xbLJCh9XHl0?t=23m42s [2] https://en.wikipedia.org/wiki/Vaccine_adverse_event https://en.wikipedia.org/wiki/Vaccine_adverse_event

h3cate 6y ago

The risk of covid-19 in the majority of the population is miniscule

petre 6y ago

It's 0.0015% compared to 4%, so at least a 2.6·1e3 difference. Given less than 0.004% chance to catch the disease in my city, the odds are 10 fold in favour of not getting vaccinated. I'll still get vaccinated regardless, because I am sick and tired of this pandemic and want to go on vacation instead of into an another lockdown this year.

theptip 6y ago
Where are you getting 4% from? It looks to me like like 3 deaths out of 1.2m vaccinated. (I’m looking at the linked PDF https://www.pei.de/SharedDocs/Downloads/EN/newsroom-en/hp-news/faq-temporary-suspension-astrazeneca.pdf?__blob=publicationFile&v=5 https://www.pei.de/SharedDocs/Downloads/EN/newsroom-en/hp-ne...)
- petre 6y ago
  The 4% deaths are from covid-19, not from the vaccines. 3.4% is the WHO global estimate if you want to be more precise and 2.5% in my country as of today. https://www.worldometers.info/coronavirus/coronavirus-death-rate/ https://www.worldometers.info/coronavirus/coronavirus-death-... The 0.0015% is the known rate of blood clots from all the AZ doses on the continent according to what the GP has reported and RFI has confirmed the same numbers today (30 cases in 5M doses but it's not clear how many have died and why). So 0.4 death rate times 0.004 chance to get covid in my area equals 0.0016 chanches to get covid and die which is one point higher than the chances of getting blood clots from the vaccine. Yeah, I botched the last product, so it's actually about the same risk figure, but the benefits of getting vaccinated outweigh the risks and the allegedly faulty vaccine batch has already been halted anyway. I have acquaintances that were vaccinated with the allgedly faulty batch AVB2856 before it was halted and they're doing just fine.
  - theptip 6y ago
    Got you, thanks. (Side-note, I wish it were easier to transmit simple models like this as part of discourse). The 0.0015 risk of death seems high. Where are you getting that from? https://www.reuters.com/article/us-health-coronavirus-germany-astrazenec-idUSKBN2B71UM https://www.reuters.com/article/us-health-coronavirus-german... gives "The EMA has said that as of March 10, a total of 30 cases of blood clotting had been reported among close to 5 million people vaccinated with the AstraZeneca shot in the European Economic Area, which links 30 European countries." But if you want to take the German numbers, 3 deaths out of 1.6m vaccines: 3/1,600,000 = 0.000001875 (In percent, 0.0001875%) which is 0.125 of your figure. And the OP gives a base rate of "two to five cases per 1 million individuals per year" for context; we need to subtract out the base rate from the observed deaths too (because obviously the base rate of this condition occurs regardless of whether you take the vaccine). [edit: percent conversion typo]