Pfizer’s depressing news for 6 months to 5 year olds

[Katy]

https://www.nbcnews.com/news/amp/rcna15730
 

[Katy]

I am so angry. Why weren’t they running multiple dose trials simultaneously? Why isn’t Moderna being considered instead? How did we get to a point that vaccines have been out for so long and they still don’t have enough data on children?

And most importantly, when is DD going to be safe so we can leave this house?

[Drama Llama]

Oh no, I am so sorry.  I know you wanted this even more than I did!

[mom2scouts]

Well, I've missed the first two years of my granddaughter's life already...😞 Her mom is very Covid cautious and keeps moving the goalposts ("as soon as you get vaccinated", "as soon as you have the booster", "as soon as they approve for under 5"). She even tried to get dgd into the trial, but the dose for that age group is so small that their doctor didn't have the right equipment to participate in the trial.

Katy, I think they're not running multiple dose trials because they had trouble getting a large enough pool of trial participants.

[KSera]

2 hours ago, Katy said:

I am so angry. Why weren’t they running multiple dose trials simultaneously? Why isn’t Moderna being considered instead? How did we get to a point that vaccines have been out for so long and they still don’t have enough data on children?

And most importantly, when is DD going to be safe so we can leave this house?

Moderna  expects to have their data out in March. I’m really crossing my fingers on that one. Pfizer did dosing trials first, where they figure out which dose has the best safety profile while still producing enough antibodies, and they went with the 3mg because the 3-5 year olds had more fevers at the next dose up. Unfortunately, when they moved on to efficacy trials with a bigger sample size, it didn’t show sufficient efficacy in that age group. It really is a bummer. Under normal vaccine development circumstances, they would’ve just gone back and tried again with a bigger dose, but they’re under such time pressure now that trying three doses instead as a faster route since they know this dosage is safe.

I’m there with you on the frustratingness  of this. I’m really wanting to see Moderna's data at this point.

[mommyoffive]

46 minutes ago, mom2scouts said:

Well, I've missed the first two years of my granddaughter's life already...😞 Her mom is very Covid cautious and keeps moving the goalposts ("as soon as you get vaccinated", "as soon as you have the booster", "as soon as they approve for under 5"). She even tried to get dgd into the trial, but the dose for that age group is so small that their doctor didn't have the right equipment to participate in the trial.

Katy, I think they're not running multiple dose trials because they had trouble getting a large enough pool of trial participants.

That is so sad, and I am so so sorry.  

She isn't even ok with meeting outside and masked?  Ever, even when rates are low?  Or even if you test and do all that? 

Edited February 12, 2022 by mommyoffive

[KSera]

5 minutes ago, mommyoffive said:

That is so sad, and I am so so sorry.  

She isn't even ok with meeting outside and masked?  Ever, even when rates are low?  Or even if you test and do all that? 

In the new mom’s defense, The virus has moved the goal posts several times. We have had this happen with a couple different family events planned at one point and then a new variant or whatever has come along and plans have had to change. It sucks. We’ve always been okay meeting outside and masked, but I can see that’s much harder for a distant grandparent to do. It would be hard to spend the money to stay somewhere to only be able to visit outside. Ugh. 

[mom2scouts]

14 minutes ago, mommyoffive said:

That is so sad, and I am so so sorry.  

She isn't even ok with meeting outside and masked?  Ever, even when rates are low?  Or even if you test and do all that? 

We've had a few outside meetings including one where we sat outside in bitter cold, masked, and unable to hold the baby. Oh, but they have a nanny who got Covid a few weeks ago.

[EKS]

4 hours ago, Katy said:

I am so angry. Why weren’t they running multiple dose trials simultaneously?

I suspect that they don't have unlimited access to young children for their studies.  

Edited February 12, 2022 by EKS

[kbutton]

1 hour ago, mom2scouts said:

We've had a few outside meetings including one where we sat outside in bitter cold, masked, and unable to hold the baby. Oh, but they have a nanny who got Covid a few weeks ago.

This really stinks. It sounds like Covid is just an excuse.

We have had luck with asking people to mask everywhere for ten days before getting together, and to just try to avoid going places. No eating in restaurants, no unmasked visits with people, etc. 

 

[Xahm]

3 hours ago, Katy said:

I am so angry. Why weren’t they running multiple dose trials simultaneously? Why isn’t Moderna being considered instead? How did we get to a point that vaccines have been out for so long and they still don’t have enough data on children?

And most importantly, when is DD going to be safe so we can leave this house?

They are still working on Moderna, and based on my observations of the very small number of kids I know in that study who were heavily exposed to Covid and came through either positive without any symptoms at all (1/3) or consistently negative over multiple tests (2/3), I'm optimistic.

[Ausmumof3]

7 hours ago, KSera said:

In the new mom’s defense, The virus has moved the goal posts several times. We have had this happen with a couple different family events planned at one point and then a new variant or whatever has come along and plans have had to change. It sucks. We’ve always been okay meeting outside and masked, but I can see that’s much harder for a distant grandparent to do. It would be hard to spend the money to stay somewhere to only be able to visit outside. Ugh. 

Yeah I feel like I’ve moved the goalposts a bit but that’s because the vaccines didn’t quite perform as hoped and the roll out has been so slow for kids. And then new variants etc etc. it’s really hard to set a target date with a constantly changing situation. 
 

It kinda reminds me of the day we had the fire and were meant to be at someone’s house. They wanted to know when we were coming, what time etc. You just can’t make those decisions with any certainty.  So much depends on the situation at the time.

Edited February 12, 2022 by Ausmumof3

[Clarita]

On 2/11/2022 at 3:37 PM, mom2scouts said:

Well, I've missed the first two years of my granddaughter's life already...😞

I'm so bummed for you. My kids have not seen my mom in person for going on 4 years now. They see her online but it's not the same interaction. WE *don't really have a choice in our case because my mom lives across an ocean from us. (*I know we technically do but everyone involved thinks it's too irresponsible.)However I totally feel like they don't know her, and she doesn't know them at all and it saddens me.

[mommyoffive]

On 2/11/2022 at 6:32 PM, KSera said:

In the new mom’s defense, The virus has moved the goal posts several times. We have had this happen with a couple different family events planned at one point and then a new variant or whatever has come along and plans have had to change. It sucks. We’ve always been okay meeting outside and masked, but I can see that’s much harder for a distant grandparent to do. It would be hard to spend the money to stay somewhere to only be able to visit outside. Ugh. 

Oh for sure it has.  But I also think there has been a lot more information about what is safer and advances in prevention with vaccines and at home testing.  I am sure if I had a newborn I would have rules set up in place.  And I know their isn't a vaccine for the 2 year old, but they can wear a mask.  I have seen so many little kids that age wearing masks. 

[KSera]

31 minutes ago, mommyoffive said:

Oh for sure it has.  But I also think there has been a lot more information about what is safer and advances in prevention with vaccines and at home testing.  I am sure if I had a newborn I would have rules set up in place.  And I know their isn't a vaccine for the 2 year old, but they can wear a mask.  I have seen so many little kids that age wearing masks. 

Omicron changed the game with at home testing. We used that for grandparent and friend visits October and November but then by December Omicron arrived and the tests were no longer cutting it (meaning we had to cancel our long anticipated finally having a whole big family get together that we had all planned to do with tests). There isn’t an N95 for a 2 year old, so an indoor meetup would require grandparents to be willing to wear well fitted N95s. If I knew they had ones that fit really well and I trusted them to wear it the whole time, that might be a doable solution that would make me feel okay about going indoors. Good hepa filters could be run as well. 

[Terabith]

On 2/11/2022 at 8:58 PM, Xahm said:

They are still working on Moderna, and based on my observations of the very small number of kids I know in that study who were heavily exposed to Covid and came through either positive without any symptoms at all (1/3) or consistently negative over multiple tests (2/3), I'm optimistic.

So, my concern about Moderna is that they don't "jump age groups," and Moderna isn't approved for anyone under 18 yet?  

[KSera]

3 minutes ago, Terabith said:

So, my concern about Moderna is that they don't "jump age groups," and Moderna isn't approved for anyone under 18 yet?  

In what context do they not jump age groups? I haven’t yet heard any concerns that that would be a barrier to approval, but I’ll have to go looking since I am really hoping that this one might come through before Pfizer. I don’t know if this is relevant, but I recall with one of my kids, they missed a window for their dtap booster and had to wait a year or so to be old enough for the age group the next one was approved for. They could have gotten it off label if there were a specific medical indication like an injury, but without that, they were certain ages that there wasn’t an approved shot for. I feel like it was somewhere in the middle elementary school years. So that seems like a case where age groups were skipped in approval.

[Terabith]

Just now, KSera said:

In what context do they not jump age groups? I haven’t yet heard any concerns that that would be a barrier to approval, but I’ll have to go looking since I am really hoping that this one might come through before Pfizer. I don’t know if this is relevant, but I recall with one of my kids, they missed a window for their dtap booster and had to wait a year or so to be old enough for the age group the next one was approved for. They could have gotten it off label if there were a specific medical indication like an injury, but without that, they were certain ages that there wasn’t an approved shot for. I feel like it was somewhere in the middle elementary school years. So that seems like a case where age groups were skipped in approval.

I read an article that said that Pfizer's two shot regimen was effective for the 6 month - 2 year olds, but they wouldn't approve for them without the 2-5 year olds because they don't jump age groups.  The article said that approval companies will only approve for next age group down at a time.  So I think it's unlikely that Moderna would be approved for the preschool set when it's not approved for teens.  

[Farrar]

My understanding after reading about the data back in December was that they just lowballed the dose too much and were basically going to have to start over. I was shocked they went ahead looking for authorization in the first place.

[KSera]

4 minutes ago, Terabith said:

I read an article that said that Pfizer's two shot regimen was effective for the 6 month - 2 year olds, but they wouldn't approve for them without the 2-5 year olds because they don't jump age groups.  The article said that approval companies will only approve for next age group down at a time.  So I think it's unlikely that Moderna would be approved for the preschool set when it's not approved for teens.  

Oh that’s a good point; now that you say it I recall reading that that was why they weren’t approving the younger one as well. Moderna did submit their data for the older age groups a pediatric vaccine a while back and was expected in January to have the expanded data that was requested by the FDA at that time. The FDA wanted them to enroll more kids to ensure the myocarditis risk wasn’t unacceptably high compared to Pfizer. Data for 6 to 11-year-olds was supposed to be nearly complete as well. I’ll have to go track down when that is supposed to be available. I’m still unsure if their decision not to skip age groups is something they’re not actually allowed to do, or just that they hadn’t planned to do so but could change their minds. Because it seems entirely possible that it would be decided that the Moderna shot wasn’t a good choice for adolescents but was for young children, since the Myocarditis risk is is totally different in those two groups.

I’m curious about the whole thing now, because obviously there are other shots which are given to babies but not older kids. There are certain shots to drop off the schedule entirely with kids don’t get them as infants because they are no longer needed. And then the issue with the various iterations of DTP shots that I mentioned above, where there is (or was) an age gap where nothing was approved.

[KSera]

3 minutes ago, Farrar said:

My understanding after reading about the data back in December was that they just lowballed the dose too much and were basically going to have to start over. I was shocked they went ahead looking for authorization in the first place.

They weren’t going to start over with a new dose, but were going to add a third dose (and are already doing that and should have the data in March). It would take too long to go back and start over at the beginning with dosing trials. They have decided to go ahead and see if they could get the first two shots authorized so that kids could have them underway already without waiting for third shot data to come in. It seems that it was scrapped due to concern if it turned out the third shot didn’t do enough, then what would they do with kids who had already started the series with too low of a dose. 

[KSera]

This piece I thought did a good job of explaining the background of things leading to Pfizer initially submitting for approval in late January:

Here comes the under 5 vaccine! But I have questions...

And this one is a decent short summary of why they withdrew:

https://www.nbcnews.com/health/health-news/pfizer-covid-vaccine-kids-fda-authorization-postponed-rcna15730

[Paige]

Why isn't moderna being approved for anyone under 18? Is it politics or is it something substantially different/dangerous about their vaccine? I don't think the safety profiles have seemed super different. 

[Terabith]

5 minutes ago, Paige said:

Why isn't moderna being approved for anyone under 18? Is it politics or is it something substantially different/dangerous about their vaccine? I don't think the safety profiles have seemed super different. 

I think the ostensible reason is the myocarditis risk.  The main difference is that Pfizer's philosophy has been the lowest dose that is efficacious and Moderna's approach has been the highest dose that doesn't cause too many side effects.  

[ktgrok]

On 2/11/2022 at 7:32 PM, KSera said:

In the new mom’s defense, The virus has moved the goal posts several times. We have had this happen with a couple different family events planned at one point and then a new variant or whatever has come along and plans have had to change. It sucks. We’ve always been okay meeting outside and masked, but I can see that’s much harder for a distant grandparent to do. It would be hard to spend the money to stay somewhere to only be able to visit outside. Ugh. 

Yeah, we've had "ok to meet outside" then "no meet ups" then "okay if we all test first" back to "no meet ups" with my parents. (at their insistence as well as my own comfort)

12 hours ago, KSera said:

Omicron changed the game with at home testing. We used that for grandparent and friend visits October and November but then by December Omicron arrived and the tests were no longer cutting it (meaning we had to cancel our long anticipated finally having a whole big family get together that we had all planned to do with tests). There isn’t an N95 for a 2 year old, so an indoor meetup would require grandparents to be willing to wear well fitted N95s. If I knew they had ones that fit really well and I trusted them to wear it the whole time, that might be a doable solution that would make me feel okay about going indoors. Good hepa filters could be run as well. 

Yup. We met up last time with testing by everyone right before we got together, but now that really isn't even worth bothering with as you can be contagious for days before it shows positive. Blergh. 

That said, if it was a new grandchild, I'd think that having the grandparents isolate for 2 weeks before visiting would work, assuming they don't need to travel by plane, etc. We will likely do that at some point to see my parents again,if cases stay high. 

[ktgrok]

Agree this is really upsetting. I'd already seen this coming, and had already decided to wait even if it was approved, and let DD4 get the 5 and up version when she turns 5 late March, rather than start a series that is unlikely to be protective a few weeks earlier. But I can do that given how close she is to her birthday anyway. I feel so badly for the people with say, 3 yr olds. 

[KSera]

30 minutes ago, Paige said:

Why isn't moderna being approved for anyone under 18? Is it politics or is it something substantially different/dangerous about their vaccine? I don't think the safety profiles have seemed super different. 

I do think some of the Moderna shots will be approved, and I think their pediatric one would have been already if Pfizer wasn’t available. Since Pfizer is available and has a lower incidence of myocarditis, I can see why they’re deciding that’s the better shot for that age group. I prefer Moderna for most of us, but for my teen son I probably still would’ve stuck with Pfizer if I had a choice. That hasn’t been an issue with the little kids though, so it will be interesting what they do. The dosage difference was huge. 3 mg for Pfizer in the 2 to 5 year olds versus 25 mg for Moderna. That’s more than twice what even the 5 to 11 year olds are getting in Pfizer. Like Terabith said, the two companies seem to be approaching the problem from opposite directions. For myself, I was glad to have a higher dose Moderna for a little bit stronger protection.

[Danae]

Spam reported.

[KSera]

On 2/15/2022 at 10:06 AM, Terabith said:

I read an article that said that Pfizer's two shot regimen was effective for the 6 month - 2 year olds, but they wouldn't approve for them without the 2-5 year olds because they don't jump age groups.  The article said that approval companies will only approve for next age group down at a time.  So I think it's unlikely that Moderna would be approved for the preschool set when it's not approved for teens.  

I read this article the other day and remembered this conversation but didn’t know where it went. This addressed age de-escalation:

https://www.propublica.org/article/whats-holding-up-the-covid-vaccines-for-children-under-5
 

“But when it comes to authorizing vaccines, that doesn’t apply. ‘There’s no such policy, and we would have been happy to skip an age group,’ the FDA official told me.”

 

[Guest]

On 2/11/2022 at 7:40 PM, mom2scouts said:

We've had a few outside meetings including one where we sat outside in bitter cold, masked, and unable to hold the baby. Oh, but they have a nanny who got Covid a few weeks ago.

I can hardly express how sad this is to read. I really only have two people in my life whom I consider fanatical about avoiding Covid. But thanks fully those two people don’t hold the keys to anything as important as grandchildren. 

[KSera]

15 minutes ago, Quill said:

I can hardly express how sad this is to read. I really only have two people in my life whom I consider fanatical about avoiding Covid. But thanks fully those two people don’t hold the keys to anything as important as grandchildren. 

As a parent on the other side of this, it makes me a bit bristly. We have one set of grandparents that will do whatever necessary to ensure their grandkids stay healthy and they have done all visits outdoors with us since this started, for their health and ours (except for once last summer during that period of time when vaccines were preventing transmission and delta hadn’t gotten going here). The other is clearly put out that we are still protecting the too-young-to-be-vaccinated. Now that mask and other protections are being lifted, they think COVID’s over and they should be able to fly in and have a normal visit, despite the fact they live a lifestyle with way, way more exposure than we do. Nobody is entitled to expose our kid we have worked so hard to protect for this long. We are very much wanting to do what we can to not have any of us contract Covid without the protection of a vaccine in place. I’m still very uncomfortable about the potential long term ramifications of a Covid infection in a child considering all the damage that can be found throughout the body from it. I know the other grandparent finds this unreasonable, but our kid’s long term health has to take precedence. He may get it anyway, but it won’t be because we gave up before he was vaccinated. Hopefully that will be able to happen soon, and hopefully grandparent in question will be willing to lay low for awhile and then N95 for the trip here in the interest of not getting their grandkids or us sick.

It’s been a very frustrating time for parents of kids in this age group. And more than ever now, as we hear daily that protections are being removed because “everyone who wants to be vaccinated has been.”