5 ms·

A major portion of that typical 10 year approval process is running a clinical trial where enough people get sick to have statistically significant results. Whe

A major portion of that typical 10 year approval process is running a clinical trial where enough people get sick to have statistically significant results. When the trials for all the EUA vaccines were run last year, COVID was extremely widespread. That dramatically shortened how long trials needed to run to prove effectiveness.

chitowneats 5y ago
If the trials were comprehensive enough to prove both efficacy and safety, why did they not catch the AZ & JnJ blood clotting issues? One theory is that these problems primarily afflict those under 40 and this population was not adequately represented in the clinical trials.
- bawolff 5y ago
  Blood clots happen at a rate of something like 1 in 100,000 people, the trial had something like 20,000 people getting the vaccine in it. Statistically its not surprising it wasn't caught. That the risk is probably not equally distributed just furthers that. For the trial to pick up the blood clots, it would probably have to administer the vaccine to at least half a million people if not more (and you would need other people for the placebo arm). If the size of your trial is a significant portion of a medium sized country, you are not really running a trial but just giving out a vaccine. The trial established it works, and any safety concerns are rare enough that the risk of not just getting covid but getting covid and having severe illness or dying from covid, is higher for most people. There is no 100% garuntees in life, the best we can hope for is showing that the risk is less than the alternative.
  - chitowneats 5y ago
    Many of us have preexisting immunity. For that population, the marginal benefit of vaccination is zero. People should be informed about the risks.
    - adrianN 5y ago
      People are informed about the risks.
      - deleted 5y ago
        [deleted]
    - Pyramus 5y ago
      Not really. If you are talking about pre-existing immunity from prior infection, the benefit may be less, and in fact it is recommended not to vaccinate within 6 months of infection. If you are talking about innate immunity or cross-immunity from SARS-Cov-1 it's super rare and hasn't been shown to be relevant in most Western countries. To see the (reduced) benefit even with prior infection just look at the numerous reports of re-infection, be it with a mutated version or otherwise, as well as the numerous reports of prior infected subjects with no or very little antibodies after a couple of months (not the full picture but still). > People should be informed about the risks. Show me one vaccine/medication where people were more informed than about the current Covid vaccines. We are at the point that for most folks it's riskier to drive to the vaccination appointment by car then the actual vaccination.
      - chitowneats 5y ago
        It's also riskier for most folks to drive a car than to catch Covid. I agree that people should look at their specific case and do honest risk/benefit analysis. Most of what I've seen, however, feels more like herd mentality behavior based on one's political leanings. Or people feeling they genuinely don't have a choice, given impending requirements and restrictions from their local governments and employers. Edit: not sure why I'm being downvoted. It should be common knowledge at this point that people in their 20's, 30's, and 40's have a higher risk of automobile accident, suicide, drug overdose, etc, than of covid death.
        Pyramus 5y ago
        As a European I do not understand what vaccination has to do with political leaning. It's even stranger that in the US pro-life (abortion) seems to correlate with pro-choice (vaccines)? I do understand however that society as a whole says "if you are not willing to take a negligible risk for us, we are not taking risks for you".

chitowneats 5y ago

If the trials were comprehensive enough to prove both efficacy and safety, why did they not catch the AZ & JnJ blood clotting issues? One theory is that these problems primarily afflict those under 40 and this population was not adequately represented in the clinical trials.

bawolff 5y ago
Blood clots happen at a rate of something like 1 in 100,000 people, the trial had something like 20,000 people getting the vaccine in it. Statistically its not surprising it wasn't caught. That the risk is probably not equally distributed just furthers that. For the trial to pick up the blood clots, it would probably have to administer the vaccine to at least half a million people if not more (and you would need other people for the placebo arm). If the size of your trial is a significant portion of a medium sized country, you are not really running a trial but just giving out a vaccine. The trial established it works, and any safety concerns are rare enough that the risk of not just getting covid but getting covid and having severe illness or dying from covid, is higher for most people. There is no 100% garuntees in life, the best we can hope for is showing that the risk is less than the alternative.
- chitowneats 5y ago
  Many of us have preexisting immunity. For that population, the marginal benefit of vaccination is zero. People should be informed about the risks.
  - adrianN 5y ago
    People are informed about the risks.
    - deleted 5y ago
      [deleted]
  - Pyramus 5y ago
    Not really. If you are talking about pre-existing immunity from prior infection, the benefit may be less, and in fact it is recommended not to vaccinate within 6 months of infection. If you are talking about innate immunity or cross-immunity from SARS-Cov-1 it's super rare and hasn't been shown to be relevant in most Western countries. To see the (reduced) benefit even with prior infection just look at the numerous reports of re-infection, be it with a mutated version or otherwise, as well as the numerous reports of prior infected subjects with no or very little antibodies after a couple of months (not the full picture but still). > People should be informed about the risks. Show me one vaccine/medication where people were more informed than about the current Covid vaccines. We are at the point that for most folks it's riskier to drive to the vaccination appointment by car then the actual vaccination.
    - chitowneats 5y ago
      It's also riskier for most folks to drive a car than to catch Covid. I agree that people should look at their specific case and do honest risk/benefit analysis. Most of what I've seen, however, feels more like herd mentality behavior based on one's political leanings. Or people feeling they genuinely don't have a choice, given impending requirements and restrictions from their local governments and employers. Edit: not sure why I'm being downvoted. It should be common knowledge at this point that people in their 20's, 30's, and 40's have a higher risk of automobile accident, suicide, drug overdose, etc, than of covid death.
      - Pyramus 5y ago
        As a European I do not understand what vaccination has to do with political leaning. It's even stranger that in the US pro-life (abortion) seems to correlate with pro-choice (vaccines)? I do understand however that society as a whole says "if you are not willing to take a negligible risk for us, we are not taking risks for you".