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Are the children in this trial part of high risk groups? I guess I am quite surprised to hear that there are drug trials for healthy children that young. In t

Are the children in this trial part of high risk groups? I guess I am quite surprised to hear that there are drug trials for healthy children that young. In this case, the risk/reward seems very imbalanced almost to the point being unethical.

Larrikin 5y ago
There are so many shots new borns and toddlers receive. It is not unusual at all for the young to receive vaccines.
- bequanna 5y ago
  Right…Vaccines we have been using for many years.
  - creato 5y ago
    How do you propose to get to the point that a vaccine has been used for many years? They were new at some point.
    - asabjorn 5y ago
      Normally a vaccine trial lasts for 5+ years, and many vaccines do not survive the trial due to adverse effects. You can not know longer-term effects before the 5 year trial has concluded, so approving after a short trial and then inevitably mandating is one of the most reckless large-scale experiments ever done.
      - astrange 5y ago
        The vaccine trials normally last that long because it's usually much harder to get so many deaths in the control group. It's not done with the intent to show safety.
      - BTCOG 5y ago
        Absolutely. It's a live experimental trial.
        el_benhameen 5y ago
        Which trials are non-experimental? Or non-live, for that matter?
        BTCOG 5y ago
        Ah, right. I forgot to say that it was "a trial forced on the entire human populace." Better?
      - el_benhameen 5y ago
        Vaccine trials have historically been 5+ years because of the way the phases are scheduled and timed, not because long term effects present or are tracked for 5+ years.
        asabjorn 5y ago
        They are breaking vaccine approval protocol that often discover sever side-effects that lead to the vaccines not being approved. In addition to cutting down approval steps due to a shortened time frame as well as using a vaccine protocol to EUA a gene therapy based vaxx tech, they are also skipping the childhood science advisory panel after they said no the first time [1]. This is not how you do science. [1]https://www.wsj.com/articles/dangerous-push-to-give-boosters-to-teens-vacccine-covid-19-omicron-vaxx-requirement-mandate-11640107759 https://www.wsj.com/articles/dangerous-push-to-give-boosters...
  - VLM 5y ago
    Vaccines with far fewer negative side effects.
el_benhameen 5y ago
No, the kids in this study were not specifically recruited from high-risk groups. There are trials for all sorts of drugs for all ages. Generally they’ll “walk down” the age spectrum, ie start with adults, then teens, then younger kids. Pfizer is running a vaccine study for <6-month olds, too. Covid is less of a risk for little kids, but it’s not zero risk, and I’d rather my kids not be immunologically naïve when they encounter it.
- astrange 5y ago
  Very young kids won't be totally naive since some of their immune system comes from their mothers. (although the mom might need active antibodies for that)
  - el_benhameen 5y ago
    My children were born and weaned before covid came along, so this does not apply to them.
ethbr0 5y ago
We give other vaccines to children that young [0]. As far as I know, there are really only two differences vs adult vaccines. Regulatory - The FDA et al. have a higher standard for what they'll approve in young children, given their developmental stages and substantial post-vaccine expected lifespan. Biological - Early childhood immune systems work differently than adults', in that they have substantially boosted innate/naive defenses, but much poorer adaptive defenses. Consequently, whether and at what dosage a vaccine will be effective changes. (Welcome corrections if the above summary is inaccurate) [0] https://www.cdc.gov/vaccines/schedules/hcp/imz/child-adolescent.html#birth-15 https://www.cdc.gov/vaccines/schedules/hcp/imz/child-adolesc...
- bequanna 5y ago
  Right, but isn’t the main difference that children are still developing? Shouldn’t we try very hard to avoid the possibility of screwing up a growing child’s body?
  - afavour 5y ago
    > Shouldn’t we try very hard to avoid the possibility of screwing up a growing child’s body? That's why we have the vaccine trials. They're the very last step in testing a vaccine. And there really is no other option: if the end result is going to a vaccine given to small children at some point you're going to have to give it to some small children and see what happens. The only way around it is to not vaccinate children at all... which doesn't seem great from an ethical standpoint given the number of lives that have been saved by vaccines.
    - asabjorn 5y ago
      It seems reckless to me to enroll a kid in a vaccine trial where the FDA decided to skip the science advisory panel for childhood vaccines [1] because they last time denied the request. The way this is handled is unscientific, and I share the parents concern that this has no balance of risk vs reward. The FDA skipping essential vaccine approval procedures in childhood vaccines, given fewer kids died of covid in 2020 than from the flu the year before, is one of the best signs that we are in a mass formation [2]. I understand that because there is only a liability shield for vaccines given to children pharma wants it for business reasons, but the FDA science advisory panel said risk vs reward does not scientifically justify childhood covid vaxx. [1]https://www.wsj.com/articles/dangerous-push-to-give-boosters-to-teens-vacccine-covid-19-omicron-vaxx-requirement-mandate-11640107759 https://www.wsj.com/articles/dangerous-push-to-give-boosters... [2] https://www.youtube.com/watch?v=uLDpZ8daIVM https://www.youtube.com/watch?v=uLDpZ8daIVM
divbzero 5y ago
It’s interesting to read your viewpoint because I can see your logic but happen to weigh the risks differently. I am personally more concerned about the long-term risk of disease than the risk of vaccination. As a parent with children I wish could be vaccinated earlier, I have actually wondered if (a) I should have volunteered them for the trials and (b) if as a society we would be willing to start trials for children sooner in the future.
- bequanna 5y ago
  Man…that sounds like a scary future. Pharma is a business. Children are just another demographic for them to expand into. In the aggregate, they have shown that they care very little about the long term negative effects of any drug. Maybe that is OK when we’re testing MS drugs or on people with shortened life spans, but children need to be protected. They are stuck with any damage that is done for the long, long term.

Larrikin 5y ago

There are so many shots new borns and toddlers receive. It is not unusual at all for the young to receive vaccines.

bequanna 5y ago
Right…Vaccines we have been using for many years.
- creato 5y ago
  How do you propose to get to the point that a vaccine has been used for many years? They were new at some point.
  - asabjorn 5y ago
    Normally a vaccine trial lasts for 5+ years, and many vaccines do not survive the trial due to adverse effects. You can not know longer-term effects before the 5 year trial has concluded, so approving after a short trial and then inevitably mandating is one of the most reckless large-scale experiments ever done.
    - astrange 5y ago
      The vaccine trials normally last that long because it's usually much harder to get so many deaths in the control group. It's not done with the intent to show safety.
    - BTCOG 5y ago
      Absolutely. It's a live experimental trial.
      - el_benhameen 5y ago
        Which trials are non-experimental? Or non-live, for that matter?
        BTCOG 5y ago
        Ah, right. I forgot to say that it was "a trial forced on the entire human populace." Better?
    - el_benhameen 5y ago
      Vaccine trials have historically been 5+ years because of the way the phases are scheduled and timed, not because long term effects present or are tracked for 5+ years.
      - asabjorn 5y ago
        They are breaking vaccine approval protocol that often discover sever side-effects that lead to the vaccines not being approved. In addition to cutting down approval steps due to a shortened time frame as well as using a vaccine protocol to EUA a gene therapy based vaxx tech, they are also skipping the childhood science advisory panel after they said no the first time [1]. This is not how you do science. [1]https://www.wsj.com/articles/dangerous-push-to-give-boosters-to-teens-vacccine-covid-19-omicron-vaxx-requirement-mandate-11640107759 https://www.wsj.com/articles/dangerous-push-to-give-boosters...
- VLM 5y ago
  Vaccines with far fewer negative side effects.

el_benhameen 5y ago

No, the kids in this study were not specifically recruited from high-risk groups. There are trials for all sorts of drugs for all ages. Generally they’ll “walk down” the age spectrum, ie start with adults, then teens, then younger kids. Pfizer is running a vaccine study for <6-month olds, too. Covid is less of a risk for little kids, but it’s not zero risk, and I’d rather my kids not be immunologically naïve when they encounter it.

astrange 5y ago
Very young kids won't be totally naive since some of their immune system comes from their mothers. (although the mom might need active antibodies for that)
- el_benhameen 5y ago
  My children were born and weaned before covid came along, so this does not apply to them.

ethbr0 5y ago

We give other vaccines to children that young [0]. As far as I know, there are really only two differences vs adult vaccines. Regulatory - The FDA et al. have a higher standard for what they'll approve in young children, given their developmental stages and substantial post-vaccine expected lifespan. Biological - Early childhood immune systems work differently than adults', in that they have substantially boosted innate/naive defenses, but much poorer adaptive defenses. Consequently, whether and at what dosage a vaccine will be effective changes. (Welcome corrections if the above summary is inaccurate) [0] https://www.cdc.gov/vaccines/schedules/hcp/imz/child-adolescent.html#birth-15 https://www.cdc.gov/vaccines/schedules/hcp/imz/child-adolesc...

bequanna 5y ago
Right, but isn’t the main difference that children are still developing? Shouldn’t we try very hard to avoid the possibility of screwing up a growing child’s body?
- afavour 5y ago
  > Shouldn’t we try very hard to avoid the possibility of screwing up a growing child’s body? That's why we have the vaccine trials. They're the very last step in testing a vaccine. And there really is no other option: if the end result is going to a vaccine given to small children at some point you're going to have to give it to some small children and see what happens. The only way around it is to not vaccinate children at all... which doesn't seem great from an ethical standpoint given the number of lives that have been saved by vaccines.
  - asabjorn 5y ago
    It seems reckless to me to enroll a kid in a vaccine trial where the FDA decided to skip the science advisory panel for childhood vaccines [1] because they last time denied the request. The way this is handled is unscientific, and I share the parents concern that this has no balance of risk vs reward. The FDA skipping essential vaccine approval procedures in childhood vaccines, given fewer kids died of covid in 2020 than from the flu the year before, is one of the best signs that we are in a mass formation [2]. I understand that because there is only a liability shield for vaccines given to children pharma wants it for business reasons, but the FDA science advisory panel said risk vs reward does not scientifically justify childhood covid vaxx. [1]https://www.wsj.com/articles/dangerous-push-to-give-boosters-to-teens-vacccine-covid-19-omicron-vaxx-requirement-mandate-11640107759 https://www.wsj.com/articles/dangerous-push-to-give-boosters... [2] https://www.youtube.com/watch?v=uLDpZ8daIVM https://www.youtube.com/watch?v=uLDpZ8daIVM

divbzero 5y ago

It’s interesting to read your viewpoint because I can see your logic but happen to weigh the risks differently. I am personally more concerned about the long-term risk of disease than the risk of vaccination. As a parent with children I wish could be vaccinated earlier, I have actually wondered if (a) I should have volunteered them for the trials and (b) if as a society we would be willing to start trials for children sooner in the future.

bequanna 5y ago
Man…that sounds like a scary future. Pharma is a business. Children are just another demographic for them to expand into. In the aggregate, they have shown that they care very little about the long term negative effects of any drug. Maybe that is OK when we’re testing MS drugs or on people with shortened life spans, but children need to be protected. They are stuck with any damage that is done for the long, long term.