Pfizer Starts COVID Vaccine Trials On Children 6 Months To 11 Years

5,037 Views | 37 Replies | Last: 4 yr ago by YouBet
Irish 2.0
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hamean02
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AG
Not my kids
Teslag
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This would make about as much sense as an Alzheimers cure for the same age group.
JP_Losman
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seems like overkill
amercer
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Schools will probably require it, so it shouldn't be a surprise that trials are being run. Expect 13 and up to be approved by summer.
Gilligan
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Which parents farm their kids out for this and for how much $$?

Duncan Idaho
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I am curious if they are going to do frequent surveillance testing during this test since so many kids are a symptomatic and so few end up in hospital. I just don t see how you would get meaningful data if you are relying on symptoms.



amercer
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My understanding is that for the kids trials they would have pretty small number (in the hundreds) and just measure antibody response. If the kids generate the same level of immune response as has been proven to be protective in adults then they ask for approval.

This should also make the kids trials really fast, which kind of makes the Pfizer timelines announced in this thread confusing.
Duncan Idaho
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I guess they still have the same time requirements for safety during the phase 3? Trials as the traditional testing method.
amercer
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Some quick Google fu answered the timeline question. For teens they just used the adult dose, but for younger kids they will do a dose escalation study. So if you add a safety break in between the doses, timelines can really stretch.

I do kind of wonder if they will get much enrollment by next fall. I could see a bunch of people being interested now (I would have no problem with my 10 year old being in the trial) but COVID is going to be a back page story by September. Once things are open no one will really give a **** about case numbers anymore
BBQ4Me
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100% effective!

https://abcnews.go.com/Health/pfizer-covid-19-vaccine-100-effective-children-ages/story?id=76779737
amercer
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That's for the 12-17 year olds. Looks like the next fight will be requiring it for schools, and schools refusing to open until kids get it.
fightingfarmer09
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BBQ4Me said:

100% effective!

https://abcnews.go.com/Health/pfizer-covid-19-vaccine-100-effective-children-ages/story?id=76779737



So is their natural immune system.
ORAggieFan
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amercer said:

That's for the 12-17 year olds. Looks like the next fight will be requiring it for schools, and schools refusing to open until kids get it.
Schools will be open and back to normal before it's approved, at least for elementary kids. Once things are fine I don't see the momentum to get kids done.
amercer
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You clearly haven't met the teachers unions in my state. They aren't ready to commit to full time school in fall yet.
tysker
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amercer said:

Schools will probably require it, so it shouldn't be a surprise that trials are being run. Expect 13 and up to be approved by summer.
I'll be interested to see if there's any push back here and if there's a push for continual virtual learning for those not willing or able to receive the vaccine.
GAC06
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They can't test against severe illness because it's too rare to be significant. Sounds like a compelling case to vaccinate kids
The_Fox
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amercer said:

You clearly haven't met the teachers unions in my state. They aren't ready to commit to full time school in fall yet.


You apparently live in the wrong state.
Windy City Ag
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Quote:

So is their natural immune system.
Kids certainly have unbelievably low risk but can still catch it and still spread it. That is the only reason I can think of for vaccination. I would think just having the at risk folks vaccinated would be enough though.
cone
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vaccinating kids under EUA doesn't seem exactly ethical
ORAggieFan
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amercer said:

You clearly haven't met the teachers unions in my state. They aren't ready to commit to full time school in fall yet.

I live in CA....
NASAg03
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amercer said:

You clearly haven't met the teachers unions in my state. They aren't ready to commit to full time school in fall yet.
What are they (teachers) afraid of if teachers get vaccines before students?
Aust Ag
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I doubt most are "afraid", they just want to milk the WFH thing as long as possible, because they can.
amercer
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cone said:

vaccinating kids under EUA doesn't seem exactly ethical


I don't know if this has changed, but previously I think they said they would go for full approval

Honestly it's just semantics at this point. Hundreds of millions of doses have been given, and the tracking has been far and above what any post marking requirements would usually be. At this point the vaccines have had way more scrutiny than any regularly approved drug.
cone
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Quote:

Honestly it's just semantics at this point.
then full approval should be a snap and demanded

i was under the mistaken impression that adult administration and outcomes with regard to safety didn't fill in the blanks for kids 12 and under with regard to full approval

https://www.nytimes.com/2021/03/31/health/pfizer-biontech-vaccine-adolescents.html

Quote:

Pfizer and BioNTech plan to request from the Food and Drug Administration an amendment to the emergency use authorization for their vaccine, in hopes of beginning immunizations of older children before the start of the next school year. The companies also are planning to submit their data for peer review and publication in a scientific journal.
Fitch
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It's been rolled out to >100M Americans and several times more globally. Either we're going to all get cancer and die or will be fine.

I see no issue with getting the whole of the population vaccinated, probability of mortality or no.
cone
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you'd probably want to really really make sure the vaccine is safe for people expected to live another 70 years and who haven't gone through puberty yet

like really sure

like full FDA approval process sure

especially if those people aren't getting sick

using an EUA to vaccinate that population just to eliminate the human reservoir seems crazy

it would be more ethical to force-march every adult in the country before you go that route
Fitch
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Either it's safe or it isn't. Several billion people will have gotten it by years end. No going back now.
bigtruckguy3500
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I'm curious about the extreme aversion to giving this to children. Yes, they are low risk of dying or having severe complications from it, but we already give kids so many vaccines. Kids are pretty low risk from dying or having severe complications from chicken pox. Likewise, they're pretty low risk of dying from HepA. Yet we still give them the vaccine. At some point the vaccine was tested on children and proven to be safe. And it was made mandatory long before we could see the "long term" side effects.

Why do some think that expanding what appears to be a safe vaccine in adolescents and adults to children is so crazy? Is it because it's a new technology? Is it because it seems "rushed"? Is it just a gut feeling? Or is it a perception of high risk but low reward?
Infection_Ag11
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Gilligan said:

Which parents farm their kids out for this and for how much $$?




National polls show roughly a 55/45 split for/against COVID vaccines in children. It's not exactly a fringe position either way.

I think vaccinating this age group will have a negligible impact on spread, but the studies are still going to show a much lower chance of severe reactions to the vaccine than the chance of a severe case of COVID. This is just simply because the rates of truly severe vaccine reactions in children are so astronomically low.
No material on this site is intended to be a substitute for professional medical advice, diagnosis or treatment. See full Medical Disclaimer.
Infection_Ag11
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bigtruckguy3500 said:

I'm curious about the extreme aversion to giving this to children. Yes, they are low risk of dying or having severe complications from it, but we already give kids so many vaccines. Kids are pretty low risk from dying or having severe complications from chicken pox. Likewise, they're pretty low risk of dying from HepA. Yet we still give them the vaccine. At some point the vaccine was tested on children and proven to be safe. And it was made mandatory long before we could see the "long term" side effects.

Why do some think that expanding what appears to be a safe vaccine in adolescents and adults to children is so crazy? Is it because it's a new technology? Is it because it seems "rushed"? Is it just a gut feeling? Or is it a perception of high risk but low reward?


It's the naturally irrational perception of risk most humans have. Doing something is almost always perceived as being riskier than not doing something. It's why so many bemoan the small risk of taking stains while ignoring the exponentially greater risk heart disease poses them. Actively taking a medication with some small risk attached is perceived by our monkey brains as more dangerous than a greater future risk posed by inaction.

When someone has a sever vaccine reaction, EVERYONE wants to focus on it. But when someone dies of a meningitis or pneumonia that could have been prevented by a vaccine, a FAR more common occurrence, nobody focuses on that aspect. It's just the way it is and one of many examples of how our evolved instincts fight against our reason in a modern world. Our brains just aren't naturally designed to be rational, because rationality was a detriment for nearly all of evolutionary history.
No material on this site is intended to be a substitute for professional medical advice, diagnosis or treatment. See full Medical Disclaimer.
beerad12man
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Of all the selfishly perceived things people try to say, ie not social distancing, not wearing a mask, etc., the single most selfish thing in all of this would be for us to vaccine children before other countries at risk populations were taken care of.

And I'm as big of an American first type of person. But this just makes too much logical sense. I sincerely hope teachers unions don't force hands here.
cone
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Fitch said:

Either it's safe or it isn't. Several billion people will have gotten it by years end. No going back now.
um

it's not too late to not mass vaccinate children until it receives full regulatory approval

i don't understand your line of logic here, or your resignation when it comes to long-term child safety
cone
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were any of those vaccines administered without full regulatory approval?

is that too big of an ask here? if it's just a matter of semantics, then it shouldn't be an issue to get that level of approval.

otherwise, why have full approval?
amercer
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So if the FDA comes out tomorrow and says "we've decided to convert the emergency authorization to full approval" your position on this changes?
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