3 ms·

>someone makes a claim that "AZ cuases bloog clots", I'm not sure if they ever looked into estimating and then comparing the said probabilities. I understand t

by serf 6y ago

>someone makes a claim that "AZ cuases bloog clots", I'm not sure if they ever looked into estimating and then comparing the said probabilities. I understand the stakes here regarding this discussion topic, but your tone is undeserved and unwarranted. >No, AZ does not cause blood clots. It's being investigated for it. Why is it being investigated for that specific side-effect? >You should trust the system and the process. Which system? Which process? If I'm German, French, Italian or Spanish then the system and process are at-odds with the AstraZeneca vaccine, no? Do we all just trust that our particular governing body is the all-wise entity that GotItRight, when opinions across the world and their respective governing bodies don't necessarily agree with one another? hard to blindly trust 'the system and process' at this point when 'the system and process' are fractured and dissimilar in nearly every region of the world. Some government must be making worse decisions than the rest. Blindly encouraging trust in unknown systems across the world at large isn't great for everyone. >And even if it does cause, you should take into account the probability. Absolutely agree.

aroch 6y ago
The answer to "Why are they investigating?" is simple and, in fact, driven in part by the pharmaceutical industry itself. First: The rate of thrombosis in AZ recipients is the less than it is in the general population -- Gen pop, ~.1% [1], AZ ~ 0.001% [2]. There is no evidence that the vaccine causes substantially higher risk. Also, the populations being prioritized for vaccination are a higher risk population for DVT to begin with.[1] AZ, along with effectively every pharma company out there of note, takes the reporting of adverse drug responses (ADRs) very, very seriously. Both FDA and EMA require ALL companies that produce a labeled product (aka a drug you can "buy" and isn't only available in a trial setting) to investigate and report on every instance of a reported potential ADR. Companies want to investigate because they want to be able to keep selling their drugs. Regulators want to investigate because they want to limit ADRs as much as possible. From the therapeutic point of view, it is bad if the treatment causes ADRs but also some may be unavoidable because of how the treatment works -- think chemo and cancer. The safety window for a drug is determined by balancing the therapeutic gain of treatment (usually, shorter time to recovery, increased QOL, or, in the case of cancers, increased life span/PFS) with the number and severity of known adverse effects. You might hear about cancer patients "cycling" their treatments, this is to allow time for the body to recover from known/expected ADRs. Any way, this was a long winded way of saying every entity involved -- drug manufacturer, regulators, doctors, patients -- wants reports of ADRs investigated. [1] https://www.ajmc.com/view/overview-of-venous-thromboembolism https://www.ajmc.com/view/overview-of-venous-thromboembolism "The overall incidence of VTE is 1 to 2 per 1000 person-years in the general population, which rises to 8 per 1000 person-years in people older than 85 years" [2] https://www.ema.europa.eu/en/news/covid-19-vaccine-astrazeneca-prac-investigating-cases-thromboembolic-events-vaccines-benefits https://www.ema.europa.eu/en/news/covid-19-vaccine-astrazene... 30/5,000,000
- astrange 6y ago
  > AZ, along with effectively every pharma company out there of note, takes the reporting of adverse drug responses (ADRs) very, very seriously. This is the reason that a lot of medications list the thing they're treating as a side effect. It doesn't work perfectly, so people report they're still having the condition, and that has to go on the list.

by serf 6y ago

aroch 6y ago

The answer to "Why are they investigating?" is simple and, in fact, driven in part by the pharmaceutical industry itself. First: The rate of thrombosis in AZ recipients is the less than it is in the general population -- Gen pop, ~.1% [1], AZ ~ 0.001% [2]. There is no evidence that the vaccine causes substantially higher risk. Also, the populations being prioritized for vaccination are a higher risk population for DVT to begin with.[1] AZ, along with effectively every pharma company out there of note, takes the reporting of adverse drug responses (ADRs) very, very seriously. Both FDA and EMA require ALL companies that produce a labeled product (aka a drug you can "buy" and isn't only available in a trial setting) to investigate and report on every instance of a reported potential ADR. Companies want to investigate because they want to be able to keep selling their drugs. Regulators want to investigate because they want to limit ADRs as much as possible. From the therapeutic point of view, it is bad if the treatment causes ADRs but also some may be unavoidable because of how the treatment works -- think chemo and cancer. The safety window for a drug is determined by balancing the therapeutic gain of treatment (usually, shorter time to recovery, increased QOL, or, in the case of cancers, increased life span/PFS) with the number and severity of known adverse effects. You might hear about cancer patients "cycling" their treatments, this is to allow time for the body to recover from known/expected ADRs. Any way, this was a long winded way of saying every entity involved -- drug manufacturer, regulators, doctors, patients -- wants reports of ADRs investigated. [1] https://www.ajmc.com/view/overview-of-venous-thromboembolism https://www.ajmc.com/view/overview-of-venous-thromboembolism "The overall incidence of VTE is 1 to 2 per 1000 person-years in the general population, which rises to 8 per 1000 person-years in people older than 85 years" [2] https://www.ema.europa.eu/en/news/covid-19-vaccine-astrazeneca-prac-investigating-cases-thromboembolic-events-vaccines-benefits https://www.ema.europa.eu/en/news/covid-19-vaccine-astrazene... 30/5,000,000

astrange 6y ago
> AZ, along with effectively every pharma company out there of note, takes the reporting of adverse drug responses (ADRs) very, very seriously. This is the reason that a lot of medications list the thing they're treating as a side effect. It doesn't work perfectly, so people report they're still having the condition, and that has to go on the list.