As omicron continues to surge and pediatric hospitalizations increase, parents of children under 5—who cannot yet be vaccinated against COVID—are scared. In November, kids aged 5 to 11 became eligible for a COVID shot, and parents of the littlest kids had high hopes that the youngest age group would be next to get approved. But then November and December passed with no vaccine and no real timeline for when one might be approved. Recently, the FDA called for a couple hundred more children to be added to the Moderna vaccine trial for the under-5s, which likely means the timeline is slower and that a vaccine for little kids is even further away.
This news was frustrating, but also hard to find. Data and updates from these vaccine trials have not been widely shared. Parents of kids under 5 are disappointed at the timeline for vaccines, but also at the widespread sense that people without little kids simply don’t seem to care. On Friday’s episode of What Next: TBD, I spoke with Meg Tirrell, who covers health and science for CNBC and who is also the parent of a nonvaccinated toddler, about what’s going on with the little kids’ vaccines. Our conversation has been edited and condensed for clarity.
Lizzie O’Leary: Where do the various vaccines for kids under 5 stand now?
Meg Tirrell: Here in the United States, the main two that folks are really setting their hopes on are Pfizer and Moderna. Until recently, Pfizer really seemed to be chugging along. Then, about a month ago, they came out with an announcement saying they had the initial data, and while they looked good for 6 months to 2 years 2, for kids who are 2 to just under 5, 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. That was the standard they needed to meet in order to say “This works.”
So what they decided to do was to add a third dose to essentially all the age groups, including these young kids, and that’s going to push the trial results back. The latest we heard was from a 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 sometime in the first half of this year. That’s much later than a lot of us were expecting and hoping for. We were thinking maybe February we’re going to have a vaccine.
What do we know about Moderna’s vaccine?
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 6 for Moderna. Moderna’s CEO came on CNBC this week and also indicated that it would be coming very soon. But then, on Wednesday afternoon, Moderna put out a kind of funny press release updating the timeline, and the most concrete information they gave was that they expect to report data in kids 2 to 5 years old in March. And if those data are good, they may file for clearance in the US and other countries. We didn’t hear about kids under age 2. At this point, for both Pfizer and Moderna, March seems to be the timeframe we’re looking at.
By their very nature, clinical trials take time. Both Pfizer and Moderna have been working with researchers around the country. How do these trials really work?
There are some blood draws, you get COVID tested, and there’s a lot of entry criteria that determine whether or not you’re eligible. And then 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 since the initial data were not what they hoped, they’re presumably doing that, so calling everybody back to dose them. Then they follow up over a period of time to check safety. They also look at the immune response, so they draw blood and look at antibody levels. They are also tracking how many cases of COVID they see in the trials. And—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.
Do you feel like there’s less urgency around this? If so, why do you think that is?
I do get that sense. When the Pfizer vaccine was cleared for kids ages 5 to 11, the FDA had a press briefing and I asked them about the timeline for younger kids. Peter Marks, who’s the head 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.
You’ve spoken with the CEOs of Moderna and Pfizer recently. What sense did you get from them about where pediatric vaccinations for little kids lies in their priority list right now? Obviously, they have a lot going on.
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 uncovered population as really important, and 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 seem like we keep waiting and waiting and waiting.
Do we know what the U.S. government’s thinking is on all of this? Where does this population lie on their priority list?
Well, it’s frustrating. Every time I hear 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.” I’m like, “But some people can’t choose whether or not to be vaccinated. Kids under 5 don’t have a choice!” I know they don’t mean it that way, and they’re not talking about kids under 5 when they say this, but it’s true that the unvaccinated include kids under 5. When they’re asked about this, they say they’re working as quickly as they possibly can.
I think also when you look at the vaccination rates for 5- to 11-year-olds, there was so much excitement at the beginning for parents searching for appointments for their kids, but right now only 17 percent of kids 5 to 11 are fully vaccinated. Maybe the government is thinking, “How much do parents really want this?”
Yeah, I was looking at that data and I had the same question of whether there was a 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?”
I think they do think that there is a need for a vaccine for every potential age group, but they are just being especially careful with this age group. It’s also an ever-changing situation. Right now we’re hearing about increased pediatric hospitalizations, we’re hearing about the way omicron presents. It’s great that overall it’s less severe, but hearing that you can get infection and inflammation in the throat, that can really affect little kids.
How should we, as a society right now, make sense of this increase in pediatric hospitalization data?
That’s something I’ve really been trying to figure out. We’ve listened to the CDC director talk about it, and so far they’re not identifying anything about this variant that’s necessarily worse for kids than the previous variants. It seems that the data suggests that so many people are getting it, and so hospitalizations are going up. Even if outcomes do tend to be better, it’s scary when hospitals are so full. Right now is a really fraught time, even if we know from the data that things are likely to be OK.
Ethically, is there any concern that pushing for a vaccine for the under-5s is taking brain power, manpower away from getting vaccines to vulnerable adults in other parts of the world that don’t have access yet?
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 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 what’s been contracted in the United States, I don’t think that is something that would affect access in other countries.
What do you think is the simplest answer for why this feels like it’s taking so long?
The simplest answer is that the FDA wants to be incredibly careful when it comes to the littlest humans among us. They view the risk benefit as different for the youngest kids.
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.
Are you even willing to guess when there’s going to be one?
I’ll guess. I’ll guess by … This is going to be conservative, but by June.
Is it weird to be a journalist who reports on this professionally and then also be a mom of a toddler?
It is weird, to the extent that I have to separate out covering it from its implications for my own life. You’ve just got to separate the work from what it means for your life. I’ve been living like that for this whole time, because it would be really hard to be covering this, the whole thing, if I was personalizing it the entire time.