What's going on with covid vaccines for kids under 5? (1 Viewer)

[Max Power]

Correct me where I'm wrong.

The two doses for toddlers didnt produce the expected results.

So we think three doses might be the magic number. 

The FDA says we need to wait on more data for three doses before approval.

Doctors send letter to FDA demanding COVID vaccines for kids under 5.

CDC directs vaccine makers to prep for shots for children below 5 by Feb. 21 prior to more data.

...

Does this not strike anyone considering getting a toddler vaccinated as odd? We're literally watching the pharmaceutical industry put the cart before the horse. For something that is less of a threat than a toddler drowning in a bathtub. 

 

[ignatiusjreilly]

I don’t really understand the FDA’s logic with this decision, but I feel like your anger here is misplaced. The FDA’s job is to determine if the vaccine is a) safe and b) effective. If so, it should approve it. Whether parents should vaccinate their children is a totally separate question, presumably for the CDC to answer

 

[Max Power]

I don’t really understand the FDA’s logic with this decision, but I feel like your anger here is misplaced. The FDA’s job is to determine if the vaccine is a) safe and b) effective. If so, it should approve it. Whether parents should vaccinate their children is a totally separate question, presumably for the CDC to answer

I'm not angry about it, just confused. The two doses didnt produce the immune response needed to justify approval. We're still figuring out how well or even if three doses works. At the same time doctors are demanding a vaccine and the CDC wants these rolled out as soon as possible once approved. 

Them not being on the same page while there is a sense of rushing this isn't reassuring to me. Especially for something that will have such a minimal impact. 

The risk vs reward doesn't seem to be there.

 

[greenmountaingoat]

I’m more skeptical about the strategy of this move than the other decisions wrt Moderna and Phizer approvals
 

The dosage used for the trial was 3 micrograms which compares to 30 for adults and 10 for 5-16. 

I was hoping for our son that the Moderna would be available soon. 
 

Our son is now 4 and a big boy. We’re taking to his doc in two weeks to figure out a plan.

 It was explained on public radio that they’re expecting that the third dose of 3 micrograms would produce the hoped for level of antibodies and that that trial would wrap up in the timeframe that any kids that start would be ready for their third shots.

I don’t think I like it. Our son weighs more than many 5 year olds / 5 times what many 6 month old babies do. 
 

I think it’s a tough age bracket due to the wide range of body size. 
 

Hoping for a better Moderna alternative to be available soon.

 

[Grace Under Pressure]

Haven't read a lot about it but it seems like they were trying to thread the needle, going for the smallest dose that would produce antibodies and they missed the mark. But I'm sure they'll figure out something, and apparently the hand-wringing will take place over it like everything else pandemic related.

I don't have a 5 year old or under, if I did I'd probably get them vaccinated a couple of months after the first million or so in that age group got vaccinated first. I could also see waiting until 5, depending on the circumstances (health of the child, involvement in activities, etc.)

 

[Max Power]

https://youtu.be/9jQTtehif34

Good video from Vinay Prasad with his concerns about the FDA flip flopping on covid vaccines for 6m-4y group.

 

[IvanKaramazov]

I continue to find it strange that "vaccination for kids" is a contentious issue, considering how small a deal covid-19 is for kids.

We're rapidly coming up on the one year anniversary of vaccination for most of us.  It's been a strange year.

 

[Ramblin Wreck]

I continue to find it strange that "vaccination for kids" is a contentious issue, considering how small a deal covid-19 is for kids.

We're rapidly coming up on the one year anniversary of vaccination for most of us.  It's been a strange year.

It's all a political sham.  Not one damn mask at the Super Bowl last night and kids in LA are masked in schools this morning.  Why?

 

[jobarules]

It's all a political sham.  Not one damn mask at the Super Bowl last night and kids in LA are masked in schools this morning.  Why?

Exactly

 

[Insein]

Countries around the world are rejecting giving the vaccine to kids and over here they're still trying to push it through. This is more about finding a place to sell your product than it is about science. 

 

[jobarules]

I dont have a under 5 year old but did not get my 12 year old a vaccine. Dont see the point. If mandated for school, Ill suck it up and get him his shot but wont feel happy about being forced to do so.

 

[Insein]

I dont have a under 5 year old but did not get my 12 year old a vaccine. Dont see the point. If mandated for school, Ill suck it up and get him his shot but wont feel happy about being forced to do so.

I have 2 11 year olds and a 4 year old. None of them will take the shot. Kids are not affected by this virus statistically.

We've all had Covid now. My kids got over it in a day where I had it for 2 weeks. My wife is vaxed and had it for the same amount of time as me. There have been under 800 deaths TOTAL for kids 0-18 in over 2 years from this 95% of which had other underlying conditions. 

Giving kids this unknown drug is borderline child abuse and I question any parent that does so blindly. 

 

[Dickies]

I'm not angry about it, just confused. The two doses didnt produce the immune response needed to justify approval. We're still figuring out how well or even if three doses works. At the same time doctors are demanding a vaccine and the CDC wants these rolled out as soon as possible once approved. 

Them not being on the same page while there is a sense of rushing this isn't reassuring to me. Especially for something that will have such a minimal impact. 

The risk vs reward doesn't seem to be there.

The FDA says more data is needed before approval and your impression is that they’re rushing this?

I don’t have a kid under 5, but if I did I would absolutely get them vaccinated once approved. 

 

[Insein]

The FDA says more data is needed before approval and your impression is that they’re rushing this?

I don’t have a kid under 5, but if I did I would absolutely get them vaccinated once approved. 

My question to you would be why? What benefit is provided to the kid? 

 

[IvanKaramazov]

My question to you would be why? What benefit is provided to the kid? 

In the case of little kids, we're talking about weighing very small benefits versus very small risks.  This is the kind of topic that nobody should really care all that much about one way or the other.  

I don't have any kids under 5.  If I did, I would probably vaccinate them.  I say "probably" because I haven't actually looked into it too deeply, because I don't actually have any kids under 5, so I don't don't have to worry about it either way and so why bother to read up on the topic.  If somebody decided that they'd rather hold off for now, that's fine too and I can see why a parent might make that decision.  

This should go without saying, but I'd be happy for my vaccinated kid to play with his unvaccinated buddy.  This is probably a good test for which people who are thinking about this issue like adults and which people have had their brain melted.   

 

[Dickies]

My question to you would be why? What benefit is provided to the kid? 

To protect them from Covid and also limit them spreading it to others. 

 

[The Commish]

To the OP question, I can't think of a vaccine in my lifetime where there wasn't a tug/pull between the federal government and the big phrama companies regarding timelines.  This seems like SOP and I'd think them pushing back on big Pharma for better results would be seen as a good thing.  

 

[Manster]

My 12 y.o. got vaxxed, mainly to be able to go on an overseas trip she's been saving for.....we went back and forth on it, but she really wants to go.....so we jump thru the hoops.....we aren't getting our 9 y.o. vaxxed, as we don't really see it as necessary at this time.  I can't imagine seeing the need to vax a 5 y.o. or younger.

 

[Insein]

To protect them from Covid and also limit them spreading it to others. 

There's no statistical evidence that a shot for kids under 5 would do that. Covid still spreads and kids under 5 are statistically unaffected. 

If there was a new drug that came out and said that it could prevent your kids from getting emphyzema, something they theoretically could get but most likely will not until maybe when they're way older, would you give it to them without knowing the possible side effects?

 

[jobarules]

To protect them from Covid and also limit them spreading it to others. 

Seriously?

 

[Dickies]

Seriously?

Yes.

 

[Insein]

See to me I'm never giving my kid a drug they don't need to help some random stranger from possibly getting sick. 

 

[IvanKaramazov]

See to me I'm never giving my kid a drug they don't need to help some random stranger from possibly getting sick. 

But vaccinating and masking children helps reduce community spread, thereby making it safer for adults to go maskless at bars, nightclubs, and sports arenas.

 

[parasaurolophus]

See to me I'm never giving my kid a drug they don't need to help some random stranger from possibly getting sick. 

Hopefully your kid isn't hanging out with random strangers. 

( just joking. I get your point)

 

[jobarules]

See to me I'm never giving my kid a drug they don't need to help some random stranger from possibly getting sick. 

And it doesnt even do that with the Omicron variant

 

[Max Power]

The FDA says more data is needed before approval and your impression is that they’re rushing this?

I don’t have a kid under 5, but if I did I would absolutely get them vaccinated once approved. 

I linked a couple of my reservations with it.  From the doctors demanding a vaccine link..

about 250 other doctors sent a letter to the Food and Drug Administration Thursday morning demanding children under 5 get “urgent access” to COVID-19 vaccines. The letter argues the science supports immediate vaccine access and “procedural red tape” is preventing that.

Is this True or Not?  It was reported by USA TODAY.

and the CDC telling providers to be ready to recieve the vaccine by 21FEB.  Although this now appears to be on hold since I initially posted.  It didn't make much sense.

Also from the Vinay Prasad video... most of this trial data is from Delta and the vaccines have been less effective vs Omicron, so there is no guarantee this third shot will make the cut either.  

 

[joffer]

See to me I'm never giving my kid a drug they don't need to help some random stranger from possibly getting sick. 

See sometimes your kid is the random stranger

 

[greenmountaingoat]

Our son was hospitalized on October 07, 2019 with pneumonia.  We spent the night with him there with my wife sobbing as we obsessively checked his dangerously low oxygen saturation levels. It took weeks for him to regain full functioning of his lungs. He was almost 2 at the time.

He'd never had asthma symptoms before then but developed asthma and we still struggle to keep his breathing clear when he has respiratory infections. Which have been few and far between thankfully.

As a result, my wife has been exceedingly cautious and we've been living in a bubble for 2 years. This has caused some major problems and missed time for me with my teenaged daughters that I used to get a fair amount of time with, among other major heartburn over all kinds of stuff. Not that getting him vaccinated would be to regain normalcy, but this has been a massive compounding of a problem. 

"Borderline child abuse" statement I found inappropriate and offensive. The risks of COVID are non zero, the risks of vaccine side effects are non zero. I'm pretty confident I know which side of the equation is greater for my own child. 

 

[jobarules]

Our son was hospitalized on October 07, 2019 with pneumonia.  We spent the night with him there with my wife sobbing as we obsessively checked his dangerously low oxygen saturation levels. It took weeks for him to regain full functioning of his lungs. He was almost 2 at the time.

He'd never had asthma symptoms before then but developed asthma and we still struggle to keep his breathing clear when he has respiratory infections. Which have been few and far between thankfully.

As a result, my wife has been exceedingly cautious and we've been living in a bubble for 2 years. This has caused some major problems and missed time for me with my teenaged daughters that I used to get a fair amount of time with, among other major heartburn over all kinds of stuff. Not that getting him vaccinated would be to regain normalcy, but this has been a massive compounding of a problem. 

"Borderline child abuse" statement I found inappropriate and offensive. The risks of COVID are non zero, the risks of vaccine side effects are non zero. I'm pretty confident I know which side of the equation is greater for my own child. 

I agree with this. People should not be judged for how they raise THEIR children. Best of luck to you.

 

[greenmountaingoat]

I'm glad they put this past effort on hold. I never liked the whole "it's not ready" "Oh wait maybe it is??" approach. I'm talking out my ### but maybe 3 micrograms works well for a 10 pound baby but it's not enough for a 50 pound child. I'd be curious to dig into the data. 

Just re-checked and Moderna 2-5 trials are supposed to wrap up in March.  I have more faith because 1. it's Moderna who's largely done IMO a better job of dosing and not as much waning of the effectiveness. and 2. I have a hunch that the age bracket is more closely aligned to my son's size. 

 

[Doug B]

My question to you would be why? What benefit is provided to the kid? 

To protect them from Covid and also limit them spreading it to others. 

This. The "limiting spread" is the bigger deal for small kids.

I'll another reason for small kids to get vaccinated: I'd want my small kids to have lifelong memory B cell and T cell protection primed by a safe early childhood exposure to a SARS-CoV-2 analog (viz, the spike proteins elicited by the mRNA vaccines).
 

 

[Max Power]

A review of the trial data.  This is really bad.  More kids were getting covid who took the vaccine vs the placebo.  

Everyone should watch this video. It should be required viewing for any parent who is considering vaccinating their child.

Here is the report Pfizer submitted to the FDA referenced in her video. You can see the numbers on page 39 (look in the column headings for the N= numbers).

 

[PinkydaPimp]

Some other links:

FDA meeting for <5 COVID vaccine: Q&A

COVID-19 vaccine info for trusted messengers: Kids <5 years

 

[shader]

To protect them from Covid and also limit them spreading it to others. 

I’m as pro vaccine as they come (been vaccinated twice, have a booster, teenagers both vaccinated), but the vaccine doesn’t really do this. It doesn’t keep you from getting it or spreading it. 

 

[shader]

This. The "limiting spread" is the bigger deal for small kids.

I'll another reason for small kids to get vaccinated: I'd want my small kids to have lifelong memory B cell and T cell protection primed by a safe early childhood exposure to a SARS-CoV-2 analog (viz, the spike proteins elicited by the mRNA vaccines).
 

How does it limit the spread? I literally just got covid from my nieces who are under 8 and were vaccinated a few months ago. 
 

Vaccines are a major protection against severe cases and death, but I don’t think they are limiting the spread to a significant degree.

 

[Dickies]

I’m as pro vaccine as they come (been vaccinated twice, have a booster, teenagers both vaccinated), but the vaccine doesn’t really do this. It doesn’t keep you from getting it or spreading it. 

The vaccines absolutely do protect from Covid.  As for catching/spreading Covid, the vaccines do limit it, but they're obviously nowhere near 100% effective at it.

 

[jobarules]

The vaccines absolutely do protect from Covid.  As for catching/spreading Covid, the vaccines do limit it, but they're obviously nowhere near 100% effective at it.

Theyre closer to 0% than 100%

 

[Doug B]

How does it limit the spread? I literally just got covid from my nieces who are under 8 and were vaccinated a few months ago. 
 

Vaccines are a major protection against severe cases and death, but I don’t think they are limiting the spread to a significant degree.

You're quoting me from four months ago? Little if any data specific to Omicron was yet published.

I generally agree with you now depending on how we define "significant degree" and whether or not we account for the time element (vaccination protection against spread, whatever it is, wanes rapidly after several weeks).

 

[jobarules]

You're quoting me from four months ago? Little if any data specific to Omicron was yet published.

I generally agree with you now depending on how we define "significant degree" and whether or not we account for the time element (vaccination protection against spread, whatever it is, wanes rapidly after several weeks).

By the middle of February we kind of knew this already.

I even responded as such in this thread.

 

[Doug B]

By the middle of February we kind of knew this already.

I even responded as such in this thread.

We're kind of dancing around a matter of degree here. IMHO, even a 25% reduction for a month, then 10-15% for another month, and then tapering away <5% for another month ... that's still worthwhile icing on the cake for the near-hammerlock that upon infection you won't be hospitalized (depending on baseline health) for a long while.

 

[GordonGekko]

Does this not strike anyone considering getting a toddler vaccinated as odd?

2024 POTUS might end up as "The Battle Of The Governors" i.e. DeSantis Versus Newsom. The natural argument will be COVID19 response. Florida had infant/child COVID related deaths. DeSantis also kept the state "open" and got kids back into school.

Suburban women voters. This is one area that Newsom has an advantage over all the other Team Blue candidates. In short, lots of middle aged women think he's good looking. And frankly that might the only reason he won Mayor of SF eons ago.

Team Blue is looking at staggering losses with suburban women voters and needs some kind of counter to the Baby Formula Crisis and natural cover from Newsom's infidelities. DeSantis' wife had cancer and he stood by her. Newsom has had multiple affairs with his own staffers. Also there's the Big Blue Governors who turned nursing homes into COVID19 death camps that ended up as a way to protect the bottom line for Big Medicine / Big Pharma corporate donors, and the Democrats want that narrative suppressed as well.

"See we as Team Blue want toddlers vaccinated, to keep them safe, Ron DeSantis didn't and look, those infant deaths are blood on his hands, so don't vote for him"

Given what happened to the elderly in nursing homes during the worst parts of COVID19, I don't think any of this is odd at all. If people have to die to hold onto corporate donor goodwill and profit and salvaged votes, then apparently so be it.

 

[Max Power]

The vaccines absolutely do protect from Covid.  As for catching/spreading Covid, the vaccines do limit it, but they're obviously nowhere near 100% effective at it.

In the Pfizer study, more vaccinated kids caught covid, caught covid twice and went to the hospital for covid. 

 

[shader]

The vaccines absolutely do protect from Covid.  As for catching/spreading Covid, the vaccines do limit it, but they're obviously nowhere near 100% effective at it.

We may be talking past each other here.  I never said that vaccines don't protect from covid.  They do a great job of stopping severe illness and death.  But they don't seem to be effective at stopping transmission.  Which is fine - they've turned it from a huge concern to a mostly harmless cold/flu type of event.  But it's important to understand what vaccines are good for.

 

[shader]

You're quoting me from four months ago? Little if any data specific to Omicron was yet published.

I generally agree with you now depending on how we define "significant degree" and whether or not we account for the time element (vaccination protection against spread, whatever it is, wanes rapidly after several weeks).

Sorry Doug, was on my phone and didn't notice the date.

 

[Doug B]

A review of the trial data.  This is really bad.  More kids were getting covid who took the vaccine vs the placebo.  

Looking at page 39 of your second link, as your source suggests: This is true only between doses 1 and 2 and only in this particular trial**. It's a three-dose regimen.

The under-5 vaccine got approval based on the bottom right-hand-corner figure on that page 39 chart: 75% efficacy starting at seven days past the third dose for 6-23 month-olds, and 82% for 2-5 year olds.

EDIT: I explained it poorly -- that page 39 has two similar charts, one for 6-23 month-olds and the other for 2-5 year-olds. But both "money shots" are at the bottom right of each chart.


** IOW, that result may not necessarily be replicated in subsequent trials/tests/surveys.

 

[NorvilleBarnes]

Voted Absolutely Not. I pulled my son out of school over mask mandates so the "vaccine" wasn't even a question.

 

[Max Power]

Looking at page 39 of your second link, as your source suggests: This is true only between doses 1 and 2 and only in this particular trial**. It's a three-dose regimen.

The under-5 vaccine got approval based on the bottom right-hand-corner figure on that page 39 chart: 75% efficacy starting at seven days past the third dose.


** IOW, that result may not necessarily be replicated in subsequent trials/tests/surveys.

With a -375 confidence interval. Which is so bad it shouldnt even be considered science. 

Eta: after recrunching the numbers, covid ranks about the 9th leading cause of death in that age group. 

The vaccine at best delays kids from catching covid, but there is no proof it prevents severe outcomes at this point and it does come with unknown risks.

 

[NorvilleBarnes]

Giving kids this unknown drug is borderline child abuse and I question any parent that does so blindly. 

This

 

[Doug B]

With a -375 confidence interval. Which is so bad it shouldnt even be considered science. 

I don't see that particular confidence interval on those charts.

The way the confidence interval is given is not familiar to me (two figures within a set of parentheses). I will ask around and see what's up (unless @Terminalxylem, @gianmarco, @ProstheticRGK, or @growlers wants to take a crack at it).
 

 

[Doug B]

By Max's source:

Everyone should watch this video. It should be required viewing for any parent who is considering vaccinating their child.

Here is the report Pfizer submitted to the FDA referenced in her video. You can see the numbers on page 39 (look in the column headings for the N= numbers).

It might be nothing, but I'm having trouble finding that particular PDF on the FDA website.

The email address of that link is https://www.fda.gov/media/159195/download . However, there is no page https://www.fda.gov/media . Again, might be nothing, might be a strange website organization thing on the FDA's end ... but at the moment I am suspicious.