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Any parent who waited months and months and months after getting their own vaccine before they could vaccinate their own kids against COVID-19 has first-hand ex

Any parent who waited months and months and months after getting their own vaccine before they could vaccinate their own kids against COVID-19 has first-hand experience with this. If ever there was a time to be more slightly more innovative about the approval regime, a widespread active pandemic was it. The FDA failed completely on that dimension and millions of kids paid for it in various ways, especially for a vaccine which is ex post completely safe and even at the time was obviously safe.

engineer_22 3y ago
I'm sorry I may be misinformed, I was under the belief that C19 was unlikely to be dangerous to children?
- cempaka 3y ago
  The CDC itself had language on their website to the effect that Covid posed less risk than influenza to young children. Pre 2020 freakout, would we ever have approved an influenza vaccine using a novel delivery method on the basis of less than two years of testing in humans, and less than one year in the young cohort? The FDA's "torpor" is easily overcome when incentives are aligned in that direction.
  - bozhark 3y ago
    If enough people will die the FDA can’t really reason why it took so long to react.
    - cempaka 3y ago
      The FDA played a big role in the opioid crisis by permitting manufacturers to claim for years that the narcotics being prescribed were not habit forming. "Preventing deaths" is not necessarily the incentive they're responding to.
      - lillecarl 3y ago
        There's a dramatised version of this story on Disney+ called "Dopesick", it's very good, but not great PR for the US. There's also the movie "Dark Waters" about DuPont and Teflon if you want to trust your government even less.
      - ghufran_syed 3y ago
        The government, through JCAHO, also helped create the opioid crisis, with their push for the healthcare system to treat pain as the "fifth vital sign". Note that while JCAHO is supposedly a non-profit, JCAHO accreditation is a requirement for receiving medicare and medicaid funding from the government, which makes it a pretty big stick to beat the healthcare system with. Of course, now that large amounts of patient harm are recognized as a result, the regulators and bureaucrats are extremely quick to dodge any responsibility, summarized well here with quotes from various JCAHO publications in the past: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6139759/ https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6139759/
  - deleted 3y ago
    [deleted]
cempaka 3y ago
Actually, an adolescent subject was paralyzed by the Pfizer vaccine during the trials, and children were never at any serious risk from COVID (which it was clear at that point the vaccines did not prevent anyway), so the FDA's decision to authorize it in those age groups was reckless indeed. Fortunately a solid majority of parents made the correct choice at any rate. "ex post completely safe" is your head just completely in the sand about all the myocarditis that has been inflicted?
- xp84 3y ago
  Are you disputing that Covid itself was known to cause myocarditis at an even greater rate than any vaccine was said to? Arguably, having a ton of unvaccinated kids going to school and swapping the virus back and forth constantly and then infecting their families could have been a big contributor to how long this pandemic lasted. If you’ve ever met kids, you know school is basically a series of viral infections constantly. Not to mention the stress it caused to the schools and childcare and thus to the families because exposure notices were so constant, forcing kids home constantly.
  - whimsicalism 3y ago
    > Are you disputing that Covid itself was known to cause myocarditis at an even greater rate than any vaccine was said to? I would dispute that in the context of young adolescents and children, as I do not think that is known at all. Global covid 19 myocarditis risk in the year after taking the vaccine is 0.02% and vaccine myocarditis risk for adolescents is 0.01%. If myocarditis risk is at all similar to other severe covid symptoms, then it is likely from these stats that there is higher myocarditis risk from the vaccine for young people than from the possibility of being infected with covid and getting myocarditis. That said, not all myocarditis is created equal and my understanding is vaccine associated myocarditis is generally milder. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9743686/ https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9743686/ https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9802621/#ref3 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9802621/#ref3
  - cempaka 3y ago
    > Arguably, having a ton of unvaccinated kids going to school and swapping the virus back and forth constantly and then infecting their families could have been a big contributor to how long this pandemic lasted. Vaccinated kids did this too. "The pandemic," to the extent one ever really existed, was ended by Omicron being so infectious that even the "careful" ones were forced to face Covid and see that it wasn't really that bad, and that all their assiduous efforts to avoid infection were largely for nought anyway. I got my first infection from my kids attending school during the Delta wave. We were fine (although I didn't just sit at home and do nothing which was what the treatment advice amounted to at the time). Much like school shooting drills, the stress that was caused by exposure notices, testing, and the like was all a problem of the overreaction in response to the underlying phenomenon, and not the phenomenon itself. Certainly none of it could have been reduced by a higher rate of vaccination, since the vaccines were thoroughly ineffective against transmission at that point. > Are you disputing that Covid itself was known to cause myocarditis at an even greater rate than any vaccine was said to? I do dispute this, yes, given that a huge Israeli population study found no increased risk of myocarditis in Covid-recovered subjects in 2020 pre vaccines. I also dispute that the comparison would matter at all even if it were true, because the risks of myocarditis from the shots and from the virus are cumulative, not mutually exclusive, since the shots do not prevent Covid. There is not some tidy choice to be made between mutually exclusive outcomes of "myo risk from the shots" and "myo risk from the virus." In every case where someone has developed heart issues after both vaccination and infection (including in a friend of mine who had 3 shots of Moderna), their doctors will invariably attribute it to the virus, and usually won't even report it as a potential side effect of the vaccine, so they seem to have zero confidence at all in vaccination's ability to reduce myocarditis risk from COVID infections.
BenFranklin100 3y ago
Nothing is completely ‘safe’. Even too much water can cause hyponatremia. The correct question is does the potential benefit outweigh the potential harm? For adults over the age of 40, the vaccine was a no-brainer. For very young children — where the risk was always very low — the question was more complicated. The European Medicines Agency was even more cautious than the FDA in approving the Pfizer vaccine for 5-11 year olds. I haven’t been following the story recently so I don’t which European countries, if any, have approved the vaccines for children under the age of 5.
Gibbon1 3y ago
I don't have kids but watching my friends go through that was obnoxious. I remember a comment from someone in the vaccine industry. He said the number of vaccines that don't cause problems for adults but causes problems when given to children is zero. Worse the initial trials for children underdosed the vaccine. I think the mistake being made was the FDA and vaccine companies trying to placate lunatics.
- whimsicalism 3y ago
  Sure, but given that there are adverse effects from pretty much all vaccines and covid is generally (ie. in the data not anecdotes) not really risky for children - you are potentially causing more risk from side effects than you are preventing. This neglects the second order effects of who the children might infect, which imo is the real justification for covid vaccination of children who are not immune compromised.
- crote 3y ago
  The same does not apply to drugs in general. There are plenty of medications which are fine for grown adults but a big no-no for developing children. The Covid vaccine was not just another generic influenza vaccine, it was the first-ever approved mRNA vaccine. It works in a completely novel way and although side effects in children were unlikely, there was simply not enough data to rule it out completely.
- mongol 3y ago
  Strange, since I don't work in the vaccine industry and can provide an exsmple: Pandemrix. It caused narcolepsy for some children, in a certain age. https://en.m.wikipedia.org/wiki/Pandemrix https://en.m.wikipedia.org/wiki/Pandemrix "At the end of March 2011, an MPA press release stated: 'Results from a Swedish registry based cohort study indicate a 4-fold increased risk of narcolepsy in children and adolescents below the age of 20 vaccinated with Pandemrix, compared to children of the same age that were not vaccinated.' The same study found no increased risk in adults who were vaccinated with Pandemrix"

engineer_22 3y ago

I'm sorry I may be misinformed, I was under the belief that C19 was unlikely to be dangerous to children?

cempaka 3y ago
The CDC itself had language on their website to the effect that Covid posed less risk than influenza to young children. Pre 2020 freakout, would we ever have approved an influenza vaccine using a novel delivery method on the basis of less than two years of testing in humans, and less than one year in the young cohort? The FDA's "torpor" is easily overcome when incentives are aligned in that direction.
- bozhark 3y ago
  If enough people will die the FDA can’t really reason why it took so long to react.
  - cempaka 3y ago
    The FDA played a big role in the opioid crisis by permitting manufacturers to claim for years that the narcotics being prescribed were not habit forming. "Preventing deaths" is not necessarily the incentive they're responding to.
    - lillecarl 3y ago
      There's a dramatised version of this story on Disney+ called "Dopesick", it's very good, but not great PR for the US. There's also the movie "Dark Waters" about DuPont and Teflon if you want to trust your government even less.
    - ghufran_syed 3y ago
      The government, through JCAHO, also helped create the opioid crisis, with their push for the healthcare system to treat pain as the "fifth vital sign". Note that while JCAHO is supposedly a non-profit, JCAHO accreditation is a requirement for receiving medicare and medicaid funding from the government, which makes it a pretty big stick to beat the healthcare system with. Of course, now that large amounts of patient harm are recognized as a result, the regulators and bureaucrats are extremely quick to dodge any responsibility, summarized well here with quotes from various JCAHO publications in the past: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6139759/ https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6139759/
- deleted 3y ago
  [deleted]

cempaka 3y ago

Actually, an adolescent subject was paralyzed by the Pfizer vaccine during the trials, and children were never at any serious risk from COVID (which it was clear at that point the vaccines did not prevent anyway), so the FDA's decision to authorize it in those age groups was reckless indeed. Fortunately a solid majority of parents made the correct choice at any rate. "ex post completely safe" is your head just completely in the sand about all the myocarditis that has been inflicted?

xp84 3y ago
Are you disputing that Covid itself was known to cause myocarditis at an even greater rate than any vaccine was said to? Arguably, having a ton of unvaccinated kids going to school and swapping the virus back and forth constantly and then infecting their families could have been a big contributor to how long this pandemic lasted. If you’ve ever met kids, you know school is basically a series of viral infections constantly. Not to mention the stress it caused to the schools and childcare and thus to the families because exposure notices were so constant, forcing kids home constantly.
- whimsicalism 3y ago
  > Are you disputing that Covid itself was known to cause myocarditis at an even greater rate than any vaccine was said to? I would dispute that in the context of young adolescents and children, as I do not think that is known at all. Global covid 19 myocarditis risk in the year after taking the vaccine is 0.02% and vaccine myocarditis risk for adolescents is 0.01%. If myocarditis risk is at all similar to other severe covid symptoms, then it is likely from these stats that there is higher myocarditis risk from the vaccine for young people than from the possibility of being infected with covid and getting myocarditis. That said, not all myocarditis is created equal and my understanding is vaccine associated myocarditis is generally milder. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9743686/ https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9743686/ https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9802621/#ref3 https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9802621/#ref3
- cempaka 3y ago
  > Arguably, having a ton of unvaccinated kids going to school and swapping the virus back and forth constantly and then infecting their families could have been a big contributor to how long this pandemic lasted. Vaccinated kids did this too. "The pandemic," to the extent one ever really existed, was ended by Omicron being so infectious that even the "careful" ones were forced to face Covid and see that it wasn't really that bad, and that all their assiduous efforts to avoid infection were largely for nought anyway. I got my first infection from my kids attending school during the Delta wave. We were fine (although I didn't just sit at home and do nothing which was what the treatment advice amounted to at the time). Much like school shooting drills, the stress that was caused by exposure notices, testing, and the like was all a problem of the overreaction in response to the underlying phenomenon, and not the phenomenon itself. Certainly none of it could have been reduced by a higher rate of vaccination, since the vaccines were thoroughly ineffective against transmission at that point. > Are you disputing that Covid itself was known to cause myocarditis at an even greater rate than any vaccine was said to? I do dispute this, yes, given that a huge Israeli population study found no increased risk of myocarditis in Covid-recovered subjects in 2020 pre vaccines. I also dispute that the comparison would matter at all even if it were true, because the risks of myocarditis from the shots and from the virus are cumulative, not mutually exclusive, since the shots do not prevent Covid. There is not some tidy choice to be made between mutually exclusive outcomes of "myo risk from the shots" and "myo risk from the virus." In every case where someone has developed heart issues after both vaccination and infection (including in a friend of mine who had 3 shots of Moderna), their doctors will invariably attribute it to the virus, and usually won't even report it as a potential side effect of the vaccine, so they seem to have zero confidence at all in vaccination's ability to reduce myocarditis risk from COVID infections.

BenFranklin100 3y ago

Nothing is completely ‘safe’. Even too much water can cause hyponatremia. The correct question is does the potential benefit outweigh the potential harm? For adults over the age of 40, the vaccine was a no-brainer. For very young children — where the risk was always very low — the question was more complicated. The European Medicines Agency was even more cautious than the FDA in approving the Pfizer vaccine for 5-11 year olds. I haven’t been following the story recently so I don’t which European countries, if any, have approved the vaccines for children under the age of 5.

Gibbon1 3y ago

I don't have kids but watching my friends go through that was obnoxious. I remember a comment from someone in the vaccine industry. He said the number of vaccines that don't cause problems for adults but causes problems when given to children is zero. Worse the initial trials for children underdosed the vaccine. I think the mistake being made was the FDA and vaccine companies trying to placate lunatics.

whimsicalism 3y ago
Sure, but given that there are adverse effects from pretty much all vaccines and covid is generally (ie. in the data not anecdotes) not really risky for children - you are potentially causing more risk from side effects than you are preventing. This neglects the second order effects of who the children might infect, which imo is the real justification for covid vaccination of children who are not immune compromised.
crote 3y ago
The same does not apply to drugs in general. There are plenty of medications which are fine for grown adults but a big no-no for developing children. The Covid vaccine was not just another generic influenza vaccine, it was the first-ever approved mRNA vaccine. It works in a completely novel way and although side effects in children were unlikely, there was simply not enough data to rule it out completely.
mongol 3y ago
Strange, since I don't work in the vaccine industry and can provide an exsmple: Pandemrix. It caused narcolepsy for some children, in a certain age. https://en.m.wikipedia.org/wiki/Pandemrix https://en.m.wikipedia.org/wiki/Pandemrix "At the end of March 2011, an MPA press release stated: 'Results from a Swedish registry based cohort study indicate a 4-fold increased risk of narcolepsy in children and adolescents below the age of 20 vaccinated with Pandemrix, compared to children of the same age that were not vaccinated.' The same study found no increased risk in adults who were vaccinated with Pandemrix"