Marisa Wojcik:

I want to thank you so much for doing this today. And just want to start by asking, what have you heard from parents, if any, now that the approval of the COVID-19 vaccine has come out for kids under five?

James Conway:

Yeah, as with everything throughout the pandemic, it’s a mixed bag. There’s a large group of parents that are actually really excited, have been waiting a long time and really eager to get their kids signed up and are a little frustrated that there isn’t enough vaccine yet this week. There’s a group, pretty much the largest group, I think, that have kind of taken the wait and see attitude although it’s kind of a split group. One group basically just doesn’t want to deal with the hassle of it and trying to compete to get slots and so they’re kind of waiting and seeing mostly just to be able to get it easily. There’s another group that does want to see a little bit more data come out from larger sections of the population. And then there’s a relatively small group that are fiercely opposed and they’re never going to get it no matter what we ask them to do.

Marisa Wojcik:

Now, if there aren’t huge swaths of people getting the vaccine for their children, does that make the vaccine less effective?

James Conway:

Well, I mean, in certain settings it does. I mean, we really depend on what we used to call herd immunity or what we now call community immunity. So if you’re in a closed setting, say a school for instance and only 10 or 20 or 30% of the kids are immunized, you’re really not going to have much of an impact if the virus gets introduced and starts to spread. You really are trying to shoot for at least 70 or 80%, is where you can sort of diminish the impact of introduction. You’re really talking about being able to eradicate or prevent any spread when you get up over 90%. So that’s part of the reason that as people think about this, if we’re all in it together it really does need to be sort of a collective commitment to really doing all the same things.

Marisa Wojcik:

Are you understanding though of parents that are taking that wait and see approach?

James Conway:

Sure, I mean, with everything throughout this pandemic, it’s been a learning process and it’s been happening, pretty much at warp speed, at the speed of light. And it’s a lot to take in. I think that currently for the pediatrics population, the one thing that we had to deal with is that the vaccines were sort of purported to be coming earlier in the year and I think people got a little bit excited and then had their hopes dashed when it became apparent they just needed more study and we needed to understand how many doses and what was the right dosing. And so I think between that, and then the combination of what was perceived to be a diminishing of the pandemic, I think sort of softened the eagerness. But I think as things are kind of moving along as we’re seeing more of these variants, we’re clearly getting a lot more people that are more interested and asking a lot of questions. And I think that’s really the biggest message we’ve got is that it’s understandable that people are going to have questions, especially as this is kind of moving into this newer age group. And so we really encourage people to talk to their own providers and make sure that they’ve got all the answers before they make their final decision.

Marisa Wojcik:

Now, that’s something that surprised me, a pediatrician on the DHS Media briefing yesterday said that the most recent Omicron variant, hospitalized children at a rate five times higher than previous variants. Is this because it was more contagious or more harmful, why was that happening? And why was it not necessarily known as well to the public?

James Conway:

Yeah, I think it’s actually more complicated than people realize, I think it was a combination of things. One, it certainly was more transmissible and it was transmissible often before people even really had symptoms. So I think that there was a little bit of a limitation in how much people could do to mitigate on their own because I think when you know you’re sick, most people have been pretty responsible, but this one was a little tricky in that people were shedding before they were sick. I think that was probably one of the larger features. I think the other though, is that, compared to where we were earlier in the pandemic with the alpha, beta and even the delta strains, society was actually behaving much more of what we would consider normal. There was a lot less mitigation. Certainly masks had been dropped in many communities including a lot of schools. And then the other piece of it was that so much of the population had been vaccinated. The largest unvaccinated portion of the population was the kids. And so I think that combination of features meant that kids got hit a little bit harder with this when they were a little bit more likely to be exposed and they were one of the larger portions of the population that was still vulnerable.

Marisa Wojcik:

There’s a misconception though that kids are less vulnerable. Do children and parents of kids of this age group feel left behind?

James Conway:

Well, I think one of the things we always have to recognize is that the transmissibility is dependent on so many different things. And so certainly for the first year of the pandemic with schools closed and people terrified, and mostly staying at home, kids were really protected. We didn’t need vaccines for them in most circumstances because they were protected by all these other behavioral things. I think then as things have returned to more normalcy; we’ve started to get a better understanding of really what happens to kids. And so, compared to flu seasons, for instance, I mean, we’ve got hundreds more kids dying from COVID currently, tens of thousands being hospitalized. It’s far worse for kids than the influenza viruses are. And so I think people had kind of mistakenly either lumped these things together, or kind of convinced themselves that these really were milder and less severe illnesses. I mean, I won’t argue the fact that most kids do do fine and recover from it, but we are seeing now the same things we see in adults, we’re seeing kids with lung COVID. We’re seeing kids with permanent disabilities related to lung and heart injuries or even neurologic problems. So I think we’ve learned a lot more with this last Omicron surge, just because we had a very different dynamic as far as how behavior was, but also who was vulnerable in our communities.

Marisa Wojcik:

Now let’s back up a little bit. So which brands of the vaccine have been approved and at what dosages?

James Conway:

So currently we’ve got Moderna and Pfizer, both with emergency use authorization for these youngest kids. Pfizer is coming in at 1/10th of the adult dose, so at three micrograms, the older kids are getting 10 micrograms and adults are getting 30 micrograms. Moderna is coming in at a quarter of the adult dose. So they’re coming in at 25 micrograms, their booster dose and their dose for the older kids is about 50 micrograms, and the initial primary doses for adults are 100 micrograms. And the goal with both of those is really to see how far they could push diminishing the side effects and still get at least decent immune response or decent immunogenicity that approximated what the adults got with those bigger doses.

Marisa Wojcik:

So kids are getting how many doses?

James Conway:

So the Pfizer kids are going to get three doses. When they originally seemed to be getting ready to submit their information back in February and March, people looked at it and said, it just doesn’t seem to be effective enough with two doses. And so they continued those studies and basically extended them and decided on three doses. Moderna’s coming in initially with just two doses at that 25 micrograms. I think most of the expectations are that these groups will eventually need boosters, the same as we’ve added boosters now for all the other age groups, including most recently the five- to 11-year-olds. So I think people have understood now that there’s a waning or a bit of an immune exhaustion that happens over time that that immunity just basically fades a little bit and needs to be reminded. And so I think the expectation is likely that both the Pfizer and Moderna kids are ultimately going to need an additional dose at some point.

Marisa Wojcik:

And that’s part of why it took so long for this emergency approval to come out, is they wanted some more data to understand the dosages.

James Conway:

Yeah, I think when you look at any new vaccine, there’s really two sides to the coin, is it safe and is it effective? And so I think that we’ve learned a lot over these years now with hundreds of millions of doses of vaccine having been provided at what it is we need to understand and study. And so for all the studies in kids, they were primarily focused on the safety and trying to figure out what’s the right dose that gets you a decent immune response and then giving it to a lot of kids to make sure that it was safe and didn’t cause any unexpected side effects. And at the same time looking at how decent was that immune response. And essentially what they’ve done is what we call bridging studies, where they basically tried to approximate what we saw with the adult response and the older kid response and shoot for a lower dose that still allowed these younger kids to get a similar immune response to what those older individuals got.

Marisa Wojcik:

Now you’ve dealt with vaccines in younger humans for quite a while. And what is your message to parents or guardians that are unsure about vaccinating their child between six months and five years old?

James Conway:

Yeah, I think there’s a couple things that are really key to remember. I mean, one is this virus is unpredictable and as much as we think we understand it, it does things and it changes that actually then leads to unexpected consequences, some of which are pretty unfortunate. And so I think that it’s a false narrative to convince ourselves that the virus is somehow getting milder or less invasive or less transmissible. I think what we’re seeing is a change in the dynamics just because more and more the population has some immunity and so it does change how it behaves once it gets into the community. But we really don’t want to leave kids vulnerable to something that really may surprise us and cause unnecessary side effects from those infections themselves. I think the other thing is that this virus keeps changing and as it keeps mutating, unfortunately people are not maintaining their immunity. And certainly we can’t trust that the immunity from a wild type infection previously is going to continue to protect kids. I think people have seen some of the data that’s come out that suggest that in some areas of the country and in some age groups, as many as three out of four kids have actually had a COVID infection at some point, but we can’t let ourselves be fooled by that predicting that then they’re going to be protected and have a milder case or have no infection when it comes around. So we’ve got a tool now that is extraordinarily safe in all of these studies that we’ve done and while it may not completely protect against all infections, and I think everybody’s gotten used to the concept of breakthrough infections, these vaccines do what we need them to do, they protect against severe disease. They protect against hospitalization, intensive care unit admission, and obviously the worst outcome being death. And so I think that’s really where we’re looking at these as being something that’s going to change how we think about this is trying to give essentially equitable protection to all age groups so that they’re protected against the worst outcomes that can happen as we continue to learn about this really sort of rapidly changing dynamic of this pandemic in front of us.

Marisa Wojcik:

Now is this kind of the last step in ensuring that the general population is protected against this virus, is this last age group of six months to five years old getting emergency approval for the vaccine? Is this kind of the last big hurdle we needed to get over and we’ll finally see a little bit of a light at the end of the tunnel?

James Conway:

Well, I wish I could say it was. And I know you were trying to lead me into saying that, but unfortunately I think there are still a number of steps that are going to need to still come forward before we can really consider ourselves getting this under control. I think one is getting full licensure for all these vaccines so that they can be at least in the younger age groups, getting into that situation where we may see benefit from mixing and matching. So while these are under emergency use authorization you really need to kind of stick with where you started. The other big thing though, and I think the thing we’re all really watching most carefully, is the ability to develop vaccines in a real time, rather quick response to these new Omicron variants as they keep coming, and ultimately, to whatever new variants may come. A lot of the companies now are working on these variant boosters and we hope that those are going to go forward very quickly for a review and eventually approval so that those will ultimately then become the boosters at least for the high-risk populations, the older individuals and people with underlying medical and immune conditions. But I think ultimately, depending on how things turn out, we very well may end up with a booster program similar to what we see with influenza where people periodically get doses of these vaccines, but they’re going to have to be better and more responsive to what is currently circulating and not continue to go back to the original strains that started this whole thing out.

Marisa Wojcik:

Do you foresee kids getting this regularly like they would when they’re six months on getting other immunizations, is it going to be normalized?

James Conway:

I mean, I’m still an optimist at heart, and so I do still hope that we will be able to get this under control in a way that doesn’t mean that this is going to be an inevitable persistent thing, but I also won’t be surprised if we end up in that setting. I mean, this is clearly starting to look more like an endemic virus that’s going to hang around and continue to circulate for quite some time. So I do foresee that we’re going to end up continuing to add boosters as we have a second booster for all these high-risk populations. We’re on first boosters for the healthy, younger populations, but I think ultimately we’ll add probably a booster for these younger kids, especially if the Omicron variants continue to circulate. And then I think time will tell, I think we’re really going to need to understand, does this virus continue to mutate and require updates the way we have to update the flu vaccines or is this something that we only give to select populations? I think we’re gathering that information; we’ve got the right people sort of thinking about this and I think from a regulatory and policy standpoint, I think everybody’s kind of looking at that. I think we’ve gotten really good at looking in real time at data as it emerges now, processing that and even messaging it better than we did early on. And so I think ultimately we’re going to be able to make pretty clear decisions and get people to understand what it is we all need to be doing.

Marisa Wojcik:

So if a parent or a guardian is out there listening to this and they are really eager to get their child vaccinated, can they just go to the pharmacy, like so many of us have to get our COVID shot or is there a different procedure for this really younger group?

James Conway:

Yeah, not quite yet. I think that currently the supplies are just starting to roll out and they’re just shipping from the federal government to the state government and then being allocated out. So at this point, I think everybody’s going to have to be looking for appointments, whether it’s through pharmacies, whether it’s through public health or whether it’s through health systems until there is much more supply available. I think most of us learned our lesson early on in this pandemic, that we didn’t want to offer appointment slots until we actually had vaccine in hand. So I think that people are going to have to play that game a little bit until there’s more supply available. I think ultimately once we have plenty of supply, then it’ll be more like it’s been for the adults where you can basically just show up and get them. But I think for the time being, at least certainly for the next couple weeks and probably even the next month or two. The other thing I think we’re going to see though, is that we’ve probably at some level, depended on the centralization of delivery of these vaccines for quite some time where we’ve instead of giving them in people’s routine, medical offices and places like that, have sort of kind of channeled people into select places, just to be able to manage the supply and the workforce. But I do think that there’s going to be more of an effort now to move the vaccines now out into primary care offices to make it both easier for people, but also to do it in a place where they’re more familiar and comfortable and where they can actually talk to people and get their answers that people that they’ve been working with and have dealt with for many, many years. So I think that’s going to be the biggest change that we’re going to see probably over the next three to four months, but at least initially I think it’s still going to be an appointment only thing until we get a lot more supply.

Marisa Wojcik:

And does Wisconsin law say that children three and under do have to get it from a physician or need a prescription? I thought I heard something about that.

James Conway:

Yeah, it’s been complicated. Basically the state legislature has gradually moved the age down for when pharmacies can provide vaccine, but between the emergency use authorization statutes as well as the state statutes, underage three kids do need a prescription from a provider. And so most of the providers are gearing up to be able to do that, but that’s another reason and I’m glad you reminded me, why people need to make an appointment because then the pharmacy can reach out to your primary care provider, and we’re working on pretty nimble ways to provide those electronically over the phone so that people don’t actually have to go seek and get a written prescription. But yeah, under age three, people do need something that’s been provided to the pharmacy that a provider has prescribed it.

Marisa Wojcik:

All right, Dr. James Conway, thank you so much for this information.

James Conway:

Thanks for having me.