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That's a bit of an odd argument, as no kids are vaccinated to compare, and especially no kids are vaccinated a year ago to see how well VE holds over time. The

That's a bit of an odd argument, as no kids are vaccinated to compare, and especially no kids are vaccinated a year ago to see how well VE holds over time. The point is the Pfizer's own trials failed to prove vaccine health benefits in kids, mainly because covid in kids is a minor health risk, and the trial was too small to capture any severe case. Odd that the FDA went with it, no wonder that some FDA officials are choosing to resign than to partake in the charade.

sjg007 5y ago
It’s not odd at all. And the vaccine is safe. Your only plausible argument would be that it’s useless, which we know is not true generally.
- ThunderSizzle 5y ago
  > And the vaccine is safe. Are you willing to stake liability on that? Is anyone willing to stake their liability on that point? The answer is no. No one has liability, which means theirs no incentives for honesty, accuracy, or transparency. Without the threat of lawsuits and bankruptcy, why would a vaccine company be more transparent and honest, than say Microsoft?
  - sjg007 5y ago
    Huh? I don’t get your point? No vaccine provider has ever taken liability which is why we have the vaccine National Vaccine Injury Compensation Program. The threat of lawsuits is not the only nor the best way to enforce quality. In fact we have regulations and the FDA for this reason.
    - ThunderSizzle 5y ago
      Liability isn't something to take. A liability exists as the nature that there is a cost that someone else is responsible for. E.g. if I start a fire in my kitchen, even unintentially, and it spreads to another's home (or apartment), I'm liable for the damaged of that fire to those affected by the fire. I can't just say "oh, you can't sue me. I don't take liability". But I can lobby the government to say "you can't sue him" which is what these vaccine companies did and continue to do.
      - sjg007 5y ago
        Liability is defined by the law.
        ThunderSizzle 5y ago
        Liability is a concept. If the vaccines cause you harm, then the vaccine company is liable. And as with all concepts, yes - they are defined by laws and statues so that society can function and the rules of the game can be determined. Vaccine companies changed their rules so they don't play the liability game like everyone else. Maybe fast food restaurants shouldn't be liable when they poison people too?
evandijk70 5y ago
I agree that it is a little strange - usually approval of a drug relies on direct evidence from a trial of the health benefit, rather than an indirect estimation. The FDA has estimated the health benefit from observational data for hospitalization and compared it to the health risk the riskiest side-effect, myocarditis This risk also had to be estimated from observational studies in older children. From the link above: "FDA conducted a quantitative benefit-risk analysis to evaluate predicted numbers of symptomatic COVID-19 cases, hospitalizations, ICU admissions, and deaths that would be prevented per million fully vaccinated children 5-11 years of age over a 6-month period, as compared with predicted numbers of vaccine-associated excess myocarditis cases, hospitalizations, ICU admissions and deaths per million fully vaccinated children 5-11 years of age. The model conservatively assumed that the risk of myocarditis/pericarditis associated with the 10 µg dose in children 5-11 years of age would the same as the estimated risk associated with the 30 µg dose in adolescents 12-15 years of age from Optum healthcare claims data. While benefits of vaccination were highly dependent on COVID-19 incidence, the overall analysis predicted that the numbers of clinically significant COVID-19-related outcomes prevented would clearly outweigh the numbers of vaccine-associated excess myocarditis cases over a range of assumptions for COVID-19 incidence. At the lowest evaluated COVID-19 incidence (corresponding to the June 2021 nadir), the predicted number of vaccine-associated myocarditis cases was greater than the predicted number of COVID-19 hospitalizations prevented for males and for both sexes combined. However, in consideration of the different clinical implications of hospitalization for COVID-19 versus hospitalization for vaccineassociated myocarditis, and benefits related to prevention of non-hospitalized cases of COVID19 with significant morbidity, the overall benefits of the vaccine may still outweigh the risks under this low incidence scenario. If the myocarditis/pericarditis risk in this age group is lower than the conservative assumption used in the model, the benefit-risk balance would be even more favorable."

sjg007 5y ago

It’s not odd at all. And the vaccine is safe. Your only plausible argument would be that it’s useless, which we know is not true generally.

ThunderSizzle 5y ago
> And the vaccine is safe. Are you willing to stake liability on that? Is anyone willing to stake their liability on that point? The answer is no. No one has liability, which means theirs no incentives for honesty, accuracy, or transparency. Without the threat of lawsuits and bankruptcy, why would a vaccine company be more transparent and honest, than say Microsoft?
- sjg007 5y ago
  Huh? I don’t get your point? No vaccine provider has ever taken liability which is why we have the vaccine National Vaccine Injury Compensation Program. The threat of lawsuits is not the only nor the best way to enforce quality. In fact we have regulations and the FDA for this reason.
  - ThunderSizzle 5y ago
    Liability isn't something to take. A liability exists as the nature that there is a cost that someone else is responsible for. E.g. if I start a fire in my kitchen, even unintentially, and it spreads to another's home (or apartment), I'm liable for the damaged of that fire to those affected by the fire. I can't just say "oh, you can't sue me. I don't take liability". But I can lobby the government to say "you can't sue him" which is what these vaccine companies did and continue to do.
    - sjg007 5y ago
      Liability is defined by the law.
      - ThunderSizzle 5y ago
        Liability is a concept. If the vaccines cause you harm, then the vaccine company is liable. And as with all concepts, yes - they are defined by laws and statues so that society can function and the rules of the game can be determined. Vaccine companies changed their rules so they don't play the liability game like everyone else. Maybe fast food restaurants shouldn't be liable when they poison people too?

evandijk70 5y ago

I agree that it is a little strange - usually approval of a drug relies on direct evidence from a trial of the health benefit, rather than an indirect estimation. The FDA has estimated the health benefit from observational data for hospitalization and compared it to the health risk the riskiest side-effect, myocarditis This risk also had to be estimated from observational studies in older children. From the link above: "FDA conducted a quantitative benefit-risk analysis to evaluate predicted numbers of symptomatic COVID-19 cases, hospitalizations, ICU admissions, and deaths that would be prevented per million fully vaccinated children 5-11 years of age over a 6-month period, as compared with predicted numbers of vaccine-associated excess myocarditis cases, hospitalizations, ICU admissions and deaths per million fully vaccinated children 5-11 years of age. The model conservatively assumed that the risk of myocarditis/pericarditis associated with the 10 µg dose in children 5-11 years of age would the same as the estimated risk associated with the 30 µg dose in adolescents 12-15 years of age from Optum healthcare claims data. While benefits of vaccination were highly dependent on COVID-19 incidence, the overall analysis predicted that the numbers of clinically significant COVID-19-related outcomes prevented would clearly outweigh the numbers of vaccine-associated excess myocarditis cases over a range of assumptions for COVID-19 incidence. At the lowest evaluated COVID-19 incidence (corresponding to the June 2021 nadir), the predicted number of vaccine-associated myocarditis cases was greater than the predicted number of COVID-19 hospitalizations prevented for males and for both sexes combined. However, in consideration of the different clinical implications of hospitalization for COVID-19 versus hospitalization for vaccineassociated myocarditis, and benefits related to prevention of non-hospitalized cases of COVID19 with significant morbidity, the overall benefits of the vaccine may still outweigh the risks under this low incidence scenario. If the myocarditis/pericarditis risk in this age group is lower than the conservative assumption used in the model, the benefit-risk balance would be even more favorable."