Where Are the Little Kids’ Vaccines?

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S1: Late last week, I was going through Twitter looking for any crumbs of information I could find on when my kid might be able to get a COVID vaccine. He’s 18 months old. He was born in the pandemic. It’s been his entire life, even though he’s totally unaware of it. We don’t let him do much with Omicron all around us and pediatric hospitalizations increasing. I’ve honestly gotten more and more anxious both that he’ll get sick and that our finely tuned balance of child care and work will come crashing down. Back in November, kids who were five to 11 became eligible for a COVID shot.

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S2: Today is a monumental day in the course of this pandemic and one that many of us have been very eager to see for almost.

S1: It seemed like maybe the littlest kids would be next soon. And I got my hopes up. But then November turned into December and then January, which is how I found myself searching Twitter Friday night. Another parent pointed me to a news story from Wisconsin, where part of Moderna’s pediatric vaccine trial is happening. Dr. William Hartmann is leading UW Health’s Moderna vaccine trials for kids ages six months to four years old, and says it recently expanded. The FDA

S3: a couple of weeks ago had asked nationally that the population of kids be expanded by a couple of hundred kids, and so without added more participants into the trial

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S1: Pfizer. That little tidbit that the FDA had asked for more kids in the trial likely means the timeline is slower and that a vaccine for little kids is even further away. That news was devastating. But it also felt so weird that I had to go digging for this information. It felt like people without little kids just don’t care to figure out more. We called up an expert Meg Tirrell.

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S4: I cover health and science for CNBC, and for the past two years that has essentially been the covered beat. And I also co-host a biotech podcast for stat called the Readout.

S1: Loud Meg also has an unvaccinated toddler, one who has basically been at home with her for two years.

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S4: I also am a parent of a three year old, so I’m asking these questions as a reporter knowing that a lot of people really, really care about this. But I also really, really care about this personally.

S1: Today on the show. What is going on with the little kids vaccines? Why don’t they seem to be a priority for the government? The pharma companies and anyone but parents who are stressed to a breaking point? I’m Lizzie O’Leary and you’re listening to what next? TBD a show about technology, power and how the future will be determined. Stick around. I wonder if you could give me a state of play of where the various vaccines for kids under five stand now.

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S4: So the main two, I think that folks are really watching in setting their hopes on in the near term are Pfizer and Moderna here in the United States. And Pfizer really seem to be chugging along and was the frontrunner, as it has been for pretty much every age group so far. They’re cleared in kids down to age five now, and so we were waiting for the data for kids under five. And then about a month ago, they came out with an announcement saying they had the initial data. And while they looked good for six months old to two years old for kids who are two to just under five, the immune response generated by this very low dose of the vaccine was not comparable to what you see in older teenagers and young adults, and that was sort of the standard they needed to meet in order to say this works. And so what they decided to do was to add a third dose to essentially all the age groups, including these young kids. And so that’s going to push the trial results back. The latest we heard was from Pfizer representative at a CDC meeting last week, who said Probably end of March, early April, we should see those data. So they’re potentially filing for clearance, you know, sometime in the first half of this year. And that’s much later than a lot of us were expecting and hoping for. We were thinking maybe February we can have a vaccine.

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S1: And so what do we know about Moderna’s vaccine?

S4: We had been expecting based on comments made from one of the doctors leading a trial site that we could be hearing really any day now on the data for kids under age six for Moderna. And Moderna’s CEO came on CNBC this week and also indicated that it would be coming very soon. So my expectation was very soon means maybe within a couple of weeks. But then on Wednesday afternoon, Moderna put out a kind of funny press release, sort of updating the timeline for what people should expect for the vaccine for kids. And the most concrete information they gave there was that they expect to report data in kids two to five years old in March. And if those data are good, they may file for, you know, clearance in the U.S. and other countries. We didn’t hear about kids under age two, and March just seems a lot later than I think a lot of us were expecting. So at this point for both Pfizer and Moderna. March seems to be the time frame we’re looking at.

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S1: It felt like a sort of opaque communication to me, and I wonder as someone who you know, communicates with the drug companies and has a better sense of how all of this works, how you received

S4: it, I received it as this feels kind of out of nowhere where, you know, where is this coming from? And my sense is they must have just been getting a ton of incomings. But at what does seem clear is that they felt they needed to give an update. So maybe that means parents are really starting to speak up about this and the companies know they really want answers and so are trying to give a little more clarity

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S1: by their very nature. Clinical trials take time. Both Pfizer and Moderna have been working with researchers around the country, like the one you heard at the top of the show, kids get enrolled and either get a vaccine or a placebo.

S4: There’s some blood draws, you know, you get COVID tested, and there’s a lot of entry criteria that determine whether or not you’re eligible. And then, you know, you get dosed, you either get sorted into placebo or the vaccine group and you get your first dose and then a few weeks later, you get your next one. Now, because Pfizer’s adding a third dose because the initial data were not what they hoped, they’re presumably doing that. So calling everybody back to dose them. And then they follow up over a period of time to check a, of course, predominantly safety. They also look at the immune response so they draw blood and look at antibody levels. And then they are also tracking how many cases of COVID they see in the trials. We would see this less with the pediatric trials just because they tend to go to the hospital less, but they would also be looking at severe outcomes of COVID as well. And the goal, of course, is that you see very few or none of them in the vaccine arm and you might see a few in the placebo arm.

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S1: I wonder if it feels to you like there’s less urgency around this and and if so, why do you think that is?

S4: I do get that sense. And when the Pfizer vaccine was cleared for kids ages five to 11, the FDA had a press briefing and I asked them about the timeline for younger kids. And this was before the Pfizer setback. And Peter Marks, who’s the head essentially of the unit within FDA that oversees vaccines, said that the benefit risk analysis was different for younger kids because they do seem to have better outcomes generally than older age groups. If they get COVID, if they get COVID, exactly. And you know, the younger you get them, the more careful you want to be. Of course, you want them to be careful all the time, and I think they are. But that definitely made me feel like, OK, they’re being especially careful with this age group, and they weren’t saying it was going to be imminent. And they said at the time, maybe be a few more months, and that was October.

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S1: You’ve spoken with the CEOs of Moderna and Pfizer recently. I wonder what sense you got from them about where the pediatric vaccinations for little kids lies in their sort of priority list right now? Obviously, they have a lot going on.

S4: Yeah, yeah. There is just so much happening with the Omicron variant, with figuring out boosters and waning immunity and vaccine inequity around the world. So they’ve got a lot to think about and the same goes for the FDA. I think they do see this, you know, uncovered population as really important. And so I think the companies are working as quickly as they can within the confines of what the FDA says is appropriate to get these vaccines out. But it does just seem like we keep waiting and waiting and waiting.

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S1: Do we know what the U.S. government’s thinking is on all of this on on where this kind of population bucket lives on their priority list?

S4: Well, it’s frustrating. I don’t know if you feel this way, but every time I hear, you know, Dr. Fauci or another one of the officials say this is a pandemic of the unvaccinated and some of the unvaccinated are going to get severely ill and die. It’s like. But some people can’t choose whether or not to be vaccinated. Kids under five don’t have a choice. And so just hearing that is really frustrating, and I know they don’t mean it that way. And they’re not talking about kids under five when they see this. But it’s true that the unvaccinated include kids under five when they’re asked about this. You know, there was a hearing this week in the Senate Health Committee. They say they’re working as quickly as they possibly can. But you know, folks like Acting FDA Commissioner Janet Woodcock, she was asked about it on Tuesday of this week. And, you know, she just can’t say very much because there’s so much sort of confidential information between companies and the FDA. And so she always just kind of leans on that and doesn’t really give a lot of information. But I think also when you look at the vaccination rates for five to 11 year olds, there was so much excitement at the beginning for parents searching for appointments for their kids. And if you look at the curves, they do go pretty straight up right away. But then they level off. And right now, only 17 percent of kids five to 11 are fully vaccinated. And so there is some thought, you know, maybe the government is thinking, how much do parents really want this? But of course there are, you know, maybe 17 percent of parents that really want this for their kids under five or maybe more.

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S1: Yeah, I was looking at that data, and I sort of had the same question of of whether there was a even not fully articulated sense among people at the FDA or maybe in the White House that, well, if the parents aren’t clamoring for this for the already eligible school age kids, do we really need to step on the gas with the little, little kids?

S4: I think they do think that there is a need for a vaccine for, you know, every potential age group, but they are just being especially careful with this age group. But it’s also there’s it’s an ever changing situation, right? Because right now we’re hearing about increased pediatric hospitalizations. We’re hearing about the way Omicron presents. It’s great that overall kids, it’s less severe. But you hearing that if you can get infection and inflammation in the throat, that that can really affect little kids. You know, we know how much even just getting any of the coronavirus cold viruses can affect the little kids. My son was in the E.R. several times with things like that when he was in daycare. So, you know, it’s scary and especially now when EHRs are so overwhelmed.

S1: How should we as a society right now, do you think make sense of this increase in in pediatric hospitalization data?

S4: That’s something I’ve really been trying to figure out. I’ve listened to a lot of, you know, hospital press briefings about this. We’ve listened to the CDC director talk about it. And so far they are not identifying anything about this variant that’s necessarily worse for kids than the previous variants. It seems so far that the data suggest it’s just that so many people are getting it and so hospitalizations are going up. And it’s it’s scary to hear about that, even if outcomes do tend to be better. It’s scary when hospitals are so full. I think it’s scary for everybody. But, you know, just thinking about the time I had to spend in the E.R. with our little. A guy, you know, and he was less than a year old, you know, in daycare, that would have been so much worse if we were sitting in the hallway for hours and hours just waiting to see somebody. And so right now is just a really fraught time, even if we know from the data that things are likely to be OK.

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S1: I sent out a tweet asking parents of kids under five kind of how they felt right now. And I heard from people saying they felt abandoned. Others felt resigned. Some said, Look, they’re fine. Their kids had gotten it. It wasn’t that bad. I got like at least half a dozen of the not great Bob Jeff from Mad Men. I lost count. But the overall sense that I got was, Gee, it may not be that dangerous to my child, but I’m living such a finely tuned balance right now of work. Whatever tenuous child care situation might still be functioning as as daycares and preschools are are decimated by COVID or staff issues that you know, one piece of that pyramid comes out and it all falls apart. And I. I wonder why you think this crescendo seems to be happening right now? It feels that complaint feels louder than it’s ever felt before.

S4: Hmm. I mean, I do wonder there’s just been a crescendo of Omicron of everything. Right? So maybe that’s part of it. And maybe it’s the confluence of this massive push that we’re going through and kind of hearing, OK, we just have to get through this surge with the fact that we’re all just kind of on this island waiting for the vaccines and not really knowing when they’re going to come. And the sense I get from talking to other parents of young kids is, is that we just feel like it keeps getting pushed out that we thought it was going to be February. And yes, I think people understand setbacks in data and things like that, but not understanding. Are the goalposts moving in terms of how much safety follow up is wanted, then the study’s getting bigger. And can somebody just spell this out for us and make us feel like we can stand on solid ground and know what to expect? Because I think for two years, we’ve all just been living from this period to a period of like. We just have to get through the next few months and things will be OK. We just have to get through the warm weather or whatever it is. And for us, we’ve just had this very long period of we just have to get to a vaccine or, you know, and we just don’t know when that’s going to be as a parent.

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S1: Obviously, I want my child vaccinated. Ethically, is there is there any concern that pushing for a vaccine for the under fives is taking brainpower manpower away from getting vaccines to vulnerable adults in other parts of the world that don’t have access yet?

S4: That’s a good question. At this point, what we’ve heard is that supply is actually improving globally. So it’s not so much the vaccine material itself, but it’s the ability to administer those vaccines in low and middle income countries. That seems to be the current problem. That doesn’t mean that if we start to update the vaccines or we need annual boosters, that supply is not going to again become a problem. This inequity we’ve seen is unfortunately chronic, but right now, providing vaccine doses to kids, at least from, you know, what’s been contracted in the United States, I don’t think that is something that would affect access in other countries.

S1: What do you think is the simplest answer for why this feels like it’s taking so long?

S4: Yeah, I think the simplest answer is the FDA wants to be incredibly careful when it comes to the littlest humans among us. They’ve made that pretty clear that they view the risk benefit as different for for the youngest kids. I do wonder if through what’s happening with Omicron, they see that as different because we are seeing so many kids get hospitalized. But at the same time, it’s not clear more kids are dying. And you know, there’s really a lot more severe disease as a proportion of the number of cases. And at this point, we are in the middle of this surge, hopefully coming to the peak of it and we probably aren’t going to have a vaccine to stop this surge. But you have to hope that we are going to be working toward a place where we get a vaccine pretty soon for younger kids because as much as we are all just waiting to get through Omicron, it does not seem like this is going to be the last of COVID for us to deal with.

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S1: Are you even willing to guess when there’s going to be one?

S4: I guess I’ll guess by. There’s going to be conservative, but by June. Oh, yeah, sorry. It’s not it’s not what anybody is hoping for.

S1: Is it weird to to be a, you know, journalist who reports on this professionally and is so kind of dug in on the data and then also be a mom of a toddler?

S4: Yeah, it is weird to the extent I I kind of have to separate out covering it from its implications for my own life. I was I was in New York City when I had actually missed the announcement from Pfizer about the kids data because they did it at this like this analyst’s call they were having. And then they put out a press release a little bit later. And so they sent me the press release and I was reading it. I was like, Oh crap, like they just delayed their their kid’s vaccine. Like, This is huge news. And you know, you get into that reporter mindset of like, OK, this is huge news. I’ve got to deal with this. I’m sending headlines, I’m doing what I need to do. And then I had a second to think about it, and I was like saying to my husband like, Oh, this is really bad, you know, and you just you just kind of separate the work from what it what it means for your life. And I feel like I’ve kind of been living like that for this whole time because it would be really hard to be covering this, you know, the whole thing if I was personalizing it the entire time.

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S1: Meg Tirrell Thank you very much. Thank you. All right, that is our show today. This episode of What Next TBD was produced by Benjamin Frisch were edited by Troy Boche and Alison Benedict. Alicia Montgomery is the executive producer for Slate Podcast, and TBD is part of the larger What Next family. We’re also part of Future Tense, a partnership of Slate, Arizona State University and New America. And I want to take a moment and recommend you go back and listen to Mondays. What next? Which helped me understand the Senate campaign and transformation of J.D. Vance? All right. I’m Lizzie O’Leary. Thanks for listening.