Transcription:
Should Children Get A New COVID Vaccine

Dr. John Lantos: Hi, this is John Lantos with the Pediatric Ethics Podcast coming to you from Children's Mercy Hospital in Kansas City. We discuss issues that arise in pediatric bioethics and talk to experts who give us insights about some of the emerging controversies.

We are thrilled to have with us today, Dr. Angela Myers. She is the Director of the Division of Infectious Diseases and Professor of Pediatrics at the University of Missouri Kansas City School of Medicine, and has been leading our efforts on responses to COVID-19 in children. Thanks so much for joining us today, Angie.

Dr. Angela Myers: Thank you so much. John, for having me. I'm excited to be here.

Dr. John Lantos: So we're going to talk about COVID vaccines and particularly how we should think about using them for children. Let me just start with a general question. What do we know about COVID vaccines as of today?

Dr. Angela Myers: Great question. So what we know right now is that two vaccine companies have emerged kind of as the front runners of getting data out first and what looks like very promising data. So both Pfizer and Moderna have come out with data showing that it appears that their vaccine, their individual vaccines are more than 90%, you know, close to 95% effective in preventing COVID-19 infection at least for a short period of time, the short, you know, followup period of time that they've been able to do so far. So that's very exciting news. And at the same time, these vaccines are being mass produced. So that once approved, they'll be ready to roll out to the American public.

Dr. John Lantos: So we don't know how long the immunity will last yet.

Dr. Angela Myers: That's correct. We don't. So like I said, they have early preliminary data for the first 90 days and it appears very promising. But we don't know what happens after that period of time. Now, these vaccine trials will continue to go on and most trials are expected to go on for two years. So following this study subjects out for two years to really see the effectiveness of the vaccine at preventing disease over time.

Dr. John Lantos: So have any of the studies so far included children?

Dr. Angela Myers: That's a great question. So there is one study that has included children and that was done by the Pfizer company. They started out with only adults. And then, you know, they submitted a request about partway through their study to add in another 15,000 participants, to add in children between the ages of 12 and 17. And so there is some data in children of that age group.

Dr. John Lantos: But none for children under 12.

Dr. Angela Myers: That's correct.

Dr. John Lantos: So let's assume that one or both of these companies get approval from the FDA to release these vaccines and start using them, what would you tell pediatricians or parents about younger children?

Dr. Angela Myers: So that's a great question. So at least initially, the vaccine is not going to be targeted to younger children. While it's continuing to be manufactured, there are some of the vaccines that are being manufactured now that will go globally. They're not all going to stay in the US. And of the ones that will be in the US from both of these companies, at least initially, there's going to have to be prioritization of who will get the vaccine. And so it looks like it's going to be healthcare workers who are patient facing, who are at high risk from that standpoint. And then also, you know, adults who are at high risk of getting COVID-19 infection.

The good news is that these companies intend to start pediatric vaccine trials very, very quickly. We've been contacted by one of the vaccine manufacturers, Moderna, who is gearing up to start a pediatric trial, hopefully in the next month or so. They plan to do it in two phases such at the first phase is 12 to 17, like Pfizer has done, and the second phases is below 12. And so we will get data fairly quickly and I suspect we'll have at least some pediatric data by the time we have enough vaccine that we're ready to give it to children.

Dr. John Lantos: And what do we know about the disease itself in children? Would you recommend them to get the vaccine based on what you're seeing clinically?

Dr. Angela Myers: So the disease in children continues to be much more mild than it is in adults. And the frequency of hospitalization or the frequency of severe disease is much less than it is in adults. However, we know that, especially in older kids, transmission of the virus from older child to parent or to another adult and back and forth happens both ways rather than, you know, younger children, which appear not to transmit the virus as much.

So, there's still benefit. There will be benefit for sure in vaccinating children. In addition to that, there are going to be, you know, high risk children, just like there are high risk adult and we are going to absolutely want those children vaccinated when we can, when we have enough vaccine available and after we have, you know, some pediatric data to support that.

Dr. John Lantos: So let me just push you a little bit and try to get a little more clarity on age groups. So younger children do not transmit the virus as much as older children?

Dr. Angela Myers: Yeah. So there've been some reports that have come from the CDC actually in the form of morbidity-mortality weekly reports that have shown that the transmission dynamics really change kind of at that age of 10 and older. And that those kids start to become more like adults in their ability to transmit the virus compared to younger children.

There's also a recent paper that came out that looked at why these younger children aren't getting as sick as, you know, as adults are. You know, unlike influenza where, you know, people tend to get sick even when they're younger. And there's some theory that it's because children have more circulating seasonal coronavirus antibody in their blood. And so they looked at young children, they looked at adults in different age groups. And what they found was that there was more antibody present in the younger children for seasonal coronaviruses.

So they hypothesized, right-- this isn't proof-- but they hypothesized that they're just not as at risk for COVID-19 because of that. That does make some biologic plausibility sense considering kids get so many more respiratory infections when they're young than you do when you're older. So it makes sense that they might have more circulating antibody at any given time in their bloodstream than say somebody who's older.

Dr. John Lantos: Do we also think children might be getting more asymptomatic infections so we're just not discovering that they have the disease because they don't come in for testing?

Dr. Angela Myers: There certainly are symptomatic infections happening in all age groups and including children, absolutely, or even mildly symptomatic where it doesn't really prompt a test. That absolutely is happening as well. And so again, it will be important to immunize all people. It's just that, you know, we really have to stratify who is at the highest risk first and kind of go from there as we continue to manufacture more vaccine to have more available, right, for our communities and as we continue to gather data on how well it works in different age groups,

Dr. John Lantos: The efforts to develop these vaccines have been unprecedentedly rapid. No vaccines have ever been developed as quickly as these COVID-19 vaccines. Do you have any worries about the long-term safety impact, particularly for children when these are only being studied so far for a couple of months?

Dr. Angela Myers: So I'm so glad you brought that up. I just wanted to briefly review a little bit about what the existing safety monitoring systems are nationally for vaccines. So we have VAERS, which is the Vaccine Adverse Event Reporting System, which is a system in which any vaccine adverse event can be reported by anyone. And when I mean anyone, I'm saying parent or the actual patient or a physician or a nurse or so on. And that data is collected by the CDC and monitored. And they look for signals, so a specific adverse event related to a specific vaccine.

There's the Vaccine Safety Datalink, which is nine healthcare organizations across the US. They actually conduct active surveillance and research to look for possible side effects. And they can use VAERS to then find what might be a signal and do active surveillance.

There's the Clinical Immunization Safety Assessment project, which is the CDC and seven medical research centers. I have personally used CISA for specific patients that I was concerned had a vaccine reaction in the past. They are very responsive and do a phenomenally thorough job. They're there for like a one-on-one kind of consult.

There are also other things, you know, as well. There's the FDA Sentinel Initiative that's in place and other FDA pieces. But specific to COVID-19 vaccine, they've actually expanded safety monitoring systems.

So there's something called CDC V-SAFE, which is a smartphone-based app for people who receive COVID vaccine to use text messaging and web survey with the CDC to check in around any potential health problems following the vaccine.

There's also the National Healthcare Safety Network. And then there's some other large databases that the FDA has to be following this as well.

Any time there's a new vaccine that comes on the market, it is continuously monitored to ensure safety and efficacy in what we call phase 4 clinical trials after it's been approved. And so I want to stress that the government has been very careful to make sure that the studies that have been done have been done very rigorously in a way that we would normally do studies to approve a vaccine. They were made very quickly, but the studies themselves have been very rigorous. I also want to stress that the government has put extra things in place to really monitor that moving forward. So I think that they're very proactive, if you will, in the approach to ensure the safety of the vaccine and the safety of the public.

Dr. John Lantos: I know you've given some thoughts to vaccine hesitancy to parents' worries or resistance to having their children immunized. What do you anticipate with Covid vaccine? And what is the best way to deal with those sorts of fears?

Dr. Angela Myers: Yeah. You know, thank you for bringing that up. I imagine there will be hesitancy around this vaccine. There are hesitancies around all vaccines and the fact that it was developed very quickly does tend to bring some worry. I think appealing to the concerns are really important and really hearing and listening to what those concerns are. And then, you know, obviously asking if you can share the information that you know about.

So one thing that I have felt very good about is that the technology used to make these vaccines was in place. People were already working on this. They were already thinking about "What if we have a pandemic? What are we going to do in that situation?"

So these scientists, these researchers that created, like, for example, the mRNAs vaccines, they're Pfizer and the Moderna vaccine, they were already working on that technology. And they were able to very quickly pivot into, "Now we need to use this technology to focus on making a vaccine for COVID-19." It could have been a vaccine for a new and different type of influenza, or it could have been a vaccine for a new and different, you know, X infection. So that may provide some reassurance.

The other piece to this is that these clinical trials are very large scale. So for an example, before rotavirus became a routine vaccine for children, it was studied in 70,000 people worldwide. The Pfizer one has been studied in 45,000 people worldwide. So not the same number, but still a huge number compared to what we historically had done for earlier childhood vaccines, where we were only around, you know, in the 10,000 range. So I feel very confident in the fact that we've studied it in so many people so quickly.

You know, this is one of the great things about science is that in a crisis situation, there are a lot of motivated people to mobilize quickly to get something done. And the safety data from those 90 days out from these two vaccines look very, very good.

Dr. John Lantos: So, if you had to guess when this might become available for children, particularly children under 12, what would be your best guess as of today?

Dr. Angela Myers: That's a great question. You know, I don't know. But I don't think before summer.

Dr. John Lantos: Okay. Summertime. And one of the situations that seems unique in vaccine development here is that it's likely I think that more than one vaccine will come onto the market at about the same time. Do you anticipate having to make decisions and discuss with parents which vaccine is best for their own child?

Dr. Angela Myers: Well, I'd like to push back a little bit on that statement. We oftentimes have more than one vaccine on the market from a different manufacturer. Look at rotavirus. We had RotaTeq and we had Rotarix, right? We've had different types of meningococcal vaccines on the market at the same time, right? There was a polysaccharide-based one that was older and then there was the new one and then there was another new one, you know, there's both Menactra and Menveo.

So it's not like we don't have other vaccine manufacturers that make the same vaccine on the market at any given time. Now, the difference is many of those have been studied and we look at whether or not they're interchangeable, so you can use the one brand for one dose and another brand for another and so on and so forth. And in some instances, we found that that doesn't really work and in some we found that it's fine.

This will be a little bit different because there may be five different manufacturers, right, with a COVID-19 vaccine on the market at the same time, which is not typical. But we do have, you know, history around having more than one vaccine on the market by more than one manufacturer covering the same disease.

You know, my thought is that-- and I just got asked this the other day by a community pediatrician, how are we going to know which one is the best one? And to be honest with you, we're not at first, right? We have really good data from two manufacturers. They look really promising. The other studies are a little bit further behind and we're just going to have to see. But I think what we need to focus on is not so much does this one work incrementally better than the other by 2% or 4%, but rather how does it work overall and what is the side effect profile of it? And is it available?

Dr. John Lantos: Well, this is very informative. Are there any other issues you've been thinking about related to vaccines that you'd like to mention before we wrap up?

Dr. Angela Myers: The only other thing that I think is worth kind of thinking about at this time of year, and I know that this time I sound like a broken record, but is really important to continue to be vigilant with your annual influenza vaccines and all the other routine vaccines that we give to children and that we give to older adults in our country.

So that includes going to get your, you know, varicella zoster vaccine that includes going and get your pneumococcal shot and things of that nature. We are trying to stay home. We are trying to stay out of the public and out of crowds. And I completely understand that, but we still do need to seek care and get care for ourselves and we need to do those preventative things.

Dr. John Lantos: Very important message. And I hope everyone takes that to heart and doesn't let COVID get in the way of all the other preventive treatments and routine care for their kids and themselves.

We've been talking to Dr. Angie Myers who's a Director of the Division of Infectious Diseases and a Professor of Pediatrics at University of Missouri Kansas City School of Medicine.

I am John Lantos and this is The Pediatric Ethics Podcast from Children's Mercy Hospital in Kansas City. Thanks for listening.