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I am with you on all of this, with one small, slightly hopeful note. My under-5 is enrolled in the Pfizer study, and they are not starting over from scratch. Th

I am with you on all of this, with one small, slightly hopeful note. My under-5 is enrolled in the Pfizer study, and they are not starting over from scratch. The existing cohort is going to receive a third dose at >2 months past their last dose (starting at the end of this month, probably), and then immunogenicity will be reassessed. I am incredibly frustrated that pfizer and the fda have been so slow to roll the vaccine out to under-5s, but at least they don’t need to re-do recruitment and phase 1, etc.

afavour 5y ago
That’s amazing news, thank you for letting folks know! Also thanks for participating in the trial, you’re doing a good deed for us all.
- el_benhameen 5y ago
  All thanks are due to the kid :). All I have to do is drive the kidmobile and enjoy my share of the ice cream bribe.
bequanna 5y ago
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.
- 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.
deleted 5y ago
[deleted]
avidphantasm 5y ago
Given that safety has been proven in 6mo to <5yo, and the dose for the 3yo and 4yo is in question (hence testing 3rd dose), I see no reason why doses one and two cannot proceed in these groups. Surely some exposure to the virus is better than none. At least give parents the option. My 3.7yo is the same weight as a median 5yo. My wife and I have had two doses of Pfizer and one Moderna booster. We would get my daughter vaccinated with one of those tomorrow if we were able to.
- el_benhameen 5y ago
  I very much agree with this. The FDA seems to have decided that there is zero urgency with regards to under-5s and that they will continue to be belatedly reactive like they have for every other question during the pandemic.
- madcaptenor 5y ago
  I had a similar thought to this (and my kid is the same age as yours) but apparently immune response isn't based on weight - see e.g. https://www.nytimes.com/2021/10/26/well/live/child-vaccine-dose-weight-age.html https://www.nytimes.com/2021/10/26/well/live/child-vaccine-d... . It's not like giving them Tylenol. That being said, after hearing about 10- and 11-year-olds pretending to be 12 so that they could get vaccinated I did have a moment where I wondered if she could pass for 5.
  - avidphantasm 5y ago
    Good point re. immune response not simply being a function of mass. However, the doses in the <5yo trial were lower. So let's roll with them for now and boost later. Sadly @el_benhameen may be correct in the FDA's complacency.
- mherdeg 5y ago
  Have you talked to a pediatrician about off-label vaccination? My understanding is that there are various barriers prohibiting this; this op-ed says there is a CDC vaccine provider agreement which forbids the practice - https://www.thehastingscenter.org/with-pediatric-hospitalizations-rising-reconsider-off-label-covid-vaccination-for-young-children/ https://www.thehastingscenter.org/with-pediatric-hospitaliza.... But I have no idea how often it's actually happening. The major downsides are that you'd be missing out on information about side effects from vaccination, and on possible clinical-trial data that might show a different, better, dosage in your kid's age range.
twofornone 5y ago
>I am incredibly frustrated that pfizer and the fda have been so slow to roll the vaccine out to under-5s Why? Is there any data to suggest that children are at risk of severe illness or complications? Isn't it a fact that children do not appreciably spread covid?
a45a33s 5y ago
>. My under-5 is enrolled in the Pfizer study, and they are not starting over from scratch. can someone please explain to me the thought process of enrolling your child in an experimental medical trial for a medicine they probably don't even need?
- el_benhameen 5y ago
  I reviewed the available data on both the vaccine and the disease and decided that given my children’s medical history and my family’s medical circumstances, the risk/benefit calculus was firmly on the side of vaccination.
  - a45a33s 5y ago
    given that your young child is literally in the trial for young children, what data was there to indicate it was safe or beneficial for them?
    - el_benhameen 5y ago
      They are in the phase 3 cohort. Phase 1 assesses safety. And while children are not just small adults, the successful and safe rollout in the adult population added to the data.
      - notch656a 5y ago
        Where did you obtain a peer reviewed study of the phase 1 safety assessment? I legitimately would like to read it, as someone else with an under 5 child.

afavour 5y ago

That’s amazing news, thank you for letting folks know! Also thanks for participating in the trial, you’re doing a good deed for us all.

el_benhameen 5y ago
All thanks are due to the kid :). All I have to do is drive the kidmobile and enjoy my share of the ice cream bribe.

bequanna 5y ago

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.
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.

deleted 5y ago

[deleted]

avidphantasm 5y ago

Given that safety has been proven in 6mo to <5yo, and the dose for the 3yo and 4yo is in question (hence testing 3rd dose), I see no reason why doses one and two cannot proceed in these groups. Surely some exposure to the virus is better than none. At least give parents the option. My 3.7yo is the same weight as a median 5yo. My wife and I have had two doses of Pfizer and one Moderna booster. We would get my daughter vaccinated with one of those tomorrow if we were able to.

el_benhameen 5y ago
I very much agree with this. The FDA seems to have decided that there is zero urgency with regards to under-5s and that they will continue to be belatedly reactive like they have for every other question during the pandemic.
madcaptenor 5y ago
I had a similar thought to this (and my kid is the same age as yours) but apparently immune response isn't based on weight - see e.g. https://www.nytimes.com/2021/10/26/well/live/child-vaccine-dose-weight-age.html https://www.nytimes.com/2021/10/26/well/live/child-vaccine-d... . It's not like giving them Tylenol. That being said, after hearing about 10- and 11-year-olds pretending to be 12 so that they could get vaccinated I did have a moment where I wondered if she could pass for 5.
- avidphantasm 5y ago
  Good point re. immune response not simply being a function of mass. However, the doses in the <5yo trial were lower. So let's roll with them for now and boost later. Sadly @el_benhameen may be correct in the FDA's complacency.
mherdeg 5y ago
Have you talked to a pediatrician about off-label vaccination? My understanding is that there are various barriers prohibiting this; this op-ed says there is a CDC vaccine provider agreement which forbids the practice - https://www.thehastingscenter.org/with-pediatric-hospitalizations-rising-reconsider-off-label-covid-vaccination-for-young-children/ https://www.thehastingscenter.org/with-pediatric-hospitaliza.... But I have no idea how often it's actually happening. The major downsides are that you'd be missing out on information about side effects from vaccination, and on possible clinical-trial data that might show a different, better, dosage in your kid's age range.

twofornone 5y ago

>I am incredibly frustrated that pfizer and the fda have been so slow to roll the vaccine out to under-5s Why? Is there any data to suggest that children are at risk of severe illness or complications? Isn't it a fact that children do not appreciably spread covid?

a45a33s 5y ago

>. My under-5 is enrolled in the Pfizer study, and they are not starting over from scratch. can someone please explain to me the thought process of enrolling your child in an experimental medical trial for a medicine they probably don't even need?

el_benhameen 5y ago
I reviewed the available data on both the vaccine and the disease and decided that given my children’s medical history and my family’s medical circumstances, the risk/benefit calculus was firmly on the side of vaccination.
- a45a33s 5y ago
  given that your young child is literally in the trial for young children, what data was there to indicate it was safe or beneficial for them?
  - el_benhameen 5y ago
    They are in the phase 3 cohort. Phase 1 assesses safety. And while children are not just small adults, the successful and safe rollout in the adult population added to the data.
    - notch656a 5y ago
      Where did you obtain a peer reviewed study of the phase 1 safety assessment? I legitimately would like to read it, as someone else with an under 5 child.