5 ms·

Why did the Pfizer young kids trial fail?

32 points by chmaynard 5y ago

unmole 5y ago
> My girls were so close to getting their shot. We’ve waited so long and really needed a win. Why? I don't understand the eagerness to vaccinate young children when they are not at risk. What am I missing?
- jbd28 5y ago
  I’d rather have my kids immune system with advance notice of a virus rather than have it kill cells indiscrimately if they’re infected? Just because they probably won’t die doesn’t mean I also don’t want their disease burden lowered, not to mention helping prevent them from being an unwitting vector to sicken others around them
  - unmole 5y ago
    > Just because they probably won’t die doesn’t Forget death, even the chance of becoming seriously ill seems vanishingly small. > being an unwitting vector to sicken others around them Any sensible adult should have already gotten vaccinated by now.
  - parkingrift 5y ago
    In the Pfizer trial for children 5-11 there were zero severe cases of covid among the vaccinated group or the placebo. > not to mention helping prevent them from being an unwitting vector to sicken others around them The covid vaccines don’t stop you from getting sick or spreading covid. Combine these two facts and we have a vaccine that doesn’t appear to do anything at all for children. And before anyone says the vaccine prevents severe covid, Pfizer must prove that. Their own clinical trial provided no such evidence.
    - brnt 5y ago
      > In the Pfizer trial for children 5-11 there were zero severe cases of covid among the vaccinated group or the placebo. What's severe? being on the ventilator for a few weeks or long covid for the rest of your life? People need to stop framing death or ICU are the only shitty outcomes of Covid. Long Covid is far worse.
      - unmole 5y ago
        What is Long Covid? People need to stop framing ill-defined terms which include symptoms ranging from insomnia and loss of smell to persistent trouble breathing reported across timelines ranging from 2 weeks to several months as an singular overarching condition.
        tata71 5y ago
        This will contribute to deeper understanding of how viruses are related to chronic illness.
        brnt 5y ago
        Part of the challenge is to not mistake as-of-yet unmeasurable or ill-documented conditions for non-existence of the condition. Just because you can readily measure oxygenation levels, and not "Long Covid", does not mean the first is real and the latter is not.
        cton 5y ago
        This doesn’t help with decision making though. If long covid is worse than going to the ICU then something must’ve been measured or documented that shows this. Otherwise what’s your point?
        brnt 5y ago
        That's basically the paradox of evidence based medicine, and there's plenty of published criticism on the subject. Naturally, we haven't measured the effect of decades of Long Covid yet. Yet, we can have strong and logical suspicions that the effect is potentially much more severe than a few weeks ICU (although they probably correlate strongly). I am personally in favor of acknowledging the trap of evidence based medicine, and taking 'softer' risks into account, even without evidence. In retrospective, there are plenty of things for which some sounded early alarms, but only when the evidence was in was policy adjusted. I think we can do better.
- Tagbert 5y ago
  Because they are a transmission vector and … some do get seriously ill.
  - unmole 5y ago
    We’ve waited so long and really needed a win sounded more like the author's frustration at not being able to get her daughters vaccinated. I could have misread the sentiment considering the author is an epidemiologist. But still, I find the idea of vaccinating children when they are unlikely to benefit from it uncomfortable. > some do get seriously ill. At a vanishingly small rate.
    - TechBro8615 5y ago
      > At a vanishingly small rate. And, critically, at a smaller rate than get seriously ill from the vaccine itself. As my college roommate used to say, nothing scares me more than an irrational person.
      - dpark 5y ago
        > And, critically, at a smaller rate than get seriously ill from the vaccine itself. Is this actually true? The rate of serious reactions to COVID vaccines seems to be almost astronomically small. There have been hundreds of millions of COVID-19 vaccine doses given in the US at this point and something like a few thousand total reports of significant adverse effects. https://www.cdc.gov/coronavirus/2019-ncov/vaccines/safety/adverse-events.html https://www.cdc.gov/coronavirus/2019-ncov/vaccines/safety/ad... The main concern appears to be anaphylaxis, at 2-5 cases in a million. Meanwhile there have been >8000 children ages 5-11 hospitalized, and 94 deaths, with about 2 million reported infections. (As of October) https://www.cnsnews.com/index.php/article/national/susan-jones/cdc-94-children-ages-5-11-have-died-covid-000012-all-covid-deaths https://www.cnsnews.com/index.php/article/national/susan-jon... I'm having trouble finding stats about children under 5, but I did find a CDC publication that indicates a hospitalization rate of 4.2 per 100000 population as of July for ages 2-4, and 24.8 per 100k for children <2. https://www.cdc.gov/mmwr/volumes/69/wr/mm6932e3.htm https://www.cdc.gov/mmwr/volumes/69/wr/mm6932e3.htm COVID seems higher risk than the vaccine even in this population. (Which is not to say the risk is particularly high in this population.)
xyzzy21 5y ago
Just, wow! A supposed trained Epidemiologies agrees to let her own kids be test subjects to FDA trails that don't even follow the FDA's own rules and this without the ADULT Phase 3 even being close to done (2023-2024) and already seeing VAERS indicating 10-20x higher adverse reaction and death rates than ANY OTHER VACCINE IN HISTORY. She needs to have her children taken and and face child abuse criminal charges! She's grossly irresponsible!
deleted 5y ago
[deleted]
8note 5y ago
What I'm not clear on after reading this is whether a dose that works is expected to still be safe
- rsfern 5y ago
  Unclear, but they must have published early trial data with discussion of why they didn’t go higher?
- InfiniteRand 5y ago
  My read of this article is that we don't know, because Pfizer used a dose which was safe but did not work
  - GauntletWizard 5y ago
    My understanding is that Pfizer knows what the safe dose is, and administered it, and it didn't not work
    - tata71 5y ago
      Pfizer believes they know a safe dose.

32 points by chmaynard 5y ago

> My girls were so close to getting their shot. We’ve waited so long and really needed a win. Why? I don't understand the eagerness to vaccinate young children when they are not at risk. What am I missing?

jbd28 5y ago
I’d rather have my kids immune system with advance notice of a virus rather than have it kill cells indiscrimately if they’re infected? Just because they probably won’t die doesn’t mean I also don’t want their disease burden lowered, not to mention helping prevent them from being an unwitting vector to sicken others around them
- unmole 5y ago
  > Just because they probably won’t die doesn’t Forget death, even the chance of becoming seriously ill seems vanishingly small. > being an unwitting vector to sicken others around them Any sensible adult should have already gotten vaccinated by now.
- parkingrift 5y ago
  In the Pfizer trial for children 5-11 there were zero severe cases of covid among the vaccinated group or the placebo. > not to mention helping prevent them from being an unwitting vector to sicken others around them The covid vaccines don’t stop you from getting sick or spreading covid. Combine these two facts and we have a vaccine that doesn’t appear to do anything at all for children. And before anyone says the vaccine prevents severe covid, Pfizer must prove that. Their own clinical trial provided no such evidence.
  - brnt 5y ago
    > In the Pfizer trial for children 5-11 there were zero severe cases of covid among the vaccinated group or the placebo. What's severe? being on the ventilator for a few weeks or long covid for the rest of your life? People need to stop framing death or ICU are the only shitty outcomes of Covid. Long Covid is far worse.
    - unmole 5y ago
      What is Long Covid? People need to stop framing ill-defined terms which include symptoms ranging from insomnia and loss of smell to persistent trouble breathing reported across timelines ranging from 2 weeks to several months as an singular overarching condition.
      - tata71 5y ago
        This will contribute to deeper understanding of how viruses are related to chronic illness.
      - brnt 5y ago
        Part of the challenge is to not mistake as-of-yet unmeasurable or ill-documented conditions for non-existence of the condition. Just because you can readily measure oxygenation levels, and not "Long Covid", does not mean the first is real and the latter is not.
        cton 5y ago
        This doesn’t help with decision making though. If long covid is worse than going to the ICU then something must’ve been measured or documented that shows this. Otherwise what’s your point?
        brnt 5y ago
        That's basically the paradox of evidence based medicine, and there's plenty of published criticism on the subject. Naturally, we haven't measured the effect of decades of Long Covid yet. Yet, we can have strong and logical suspicions that the effect is potentially much more severe than a few weeks ICU (although they probably correlate strongly). I am personally in favor of acknowledging the trap of evidence based medicine, and taking 'softer' risks into account, even without evidence. In retrospective, there are plenty of things for which some sounded early alarms, but only when the evidence was in was policy adjusted. I think we can do better.
Tagbert 5y ago
Because they are a transmission vector and … some do get seriously ill.
- unmole 5y ago
  We’ve waited so long and really needed a win sounded more like the author's frustration at not being able to get her daughters vaccinated. I could have misread the sentiment considering the author is an epidemiologist. But still, I find the idea of vaccinating children when they are unlikely to benefit from it uncomfortable. > some do get seriously ill. At a vanishingly small rate.
  - TechBro8615 5y ago
    > At a vanishingly small rate. And, critically, at a smaller rate than get seriously ill from the vaccine itself. As my college roommate used to say, nothing scares me more than an irrational person.
    - dpark 5y ago
      > And, critically, at a smaller rate than get seriously ill from the vaccine itself. Is this actually true? The rate of serious reactions to COVID vaccines seems to be almost astronomically small. There have been hundreds of millions of COVID-19 vaccine doses given in the US at this point and something like a few thousand total reports of significant adverse effects. https://www.cdc.gov/coronavirus/2019-ncov/vaccines/safety/adverse-events.html https://www.cdc.gov/coronavirus/2019-ncov/vaccines/safety/ad... The main concern appears to be anaphylaxis, at 2-5 cases in a million. Meanwhile there have been >8000 children ages 5-11 hospitalized, and 94 deaths, with about 2 million reported infections. (As of October) https://www.cnsnews.com/index.php/article/national/susan-jones/cdc-94-children-ages-5-11-have-died-covid-000012-all-covid-deaths https://www.cnsnews.com/index.php/article/national/susan-jon... I'm having trouble finding stats about children under 5, but I did find a CDC publication that indicates a hospitalization rate of 4.2 per 100000 population as of July for ages 2-4, and 24.8 per 100k for children <2. https://www.cdc.gov/mmwr/volumes/69/wr/mm6932e3.htm https://www.cdc.gov/mmwr/volumes/69/wr/mm6932e3.htm COVID seems higher risk than the vaccine even in this population. (Which is not to say the risk is particularly high in this population.)

xyzzy21 5y ago

Just, wow! A supposed trained Epidemiologies agrees to let her own kids be test subjects to FDA trails that don't even follow the FDA's own rules and this without the ADULT Phase 3 even being close to done (2023-2024) and already seeing VAERS indicating 10-20x higher adverse reaction and death rates than ANY OTHER VACCINE IN HISTORY. She needs to have her children taken and and face child abuse criminal charges! She's grossly irresponsible!

deleted 5y ago

[deleted]

8note 5y ago

What I'm not clear on after reading this is whether a dose that works is expected to still be safe

rsfern 5y ago
Unclear, but they must have published early trial data with discussion of why they didn’t go higher?
InfiniteRand 5y ago
My read of this article is that we don't know, because Pfizer used a dose which was safe but did not work
- GauntletWizard 5y ago
  My understanding is that Pfizer knows what the safe dose is, and administered it, and it didn't not work
  - tata71 5y ago
    Pfizer believes they know a safe dose.