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Bill Klaproth (Host): In the latest development in the fight to end the COVID-19 pandemic, the United States has authorized the use of the Pfizer vaccine in children ages 5 to 11 years old. And the CDC has recommended vaccination for children in this age group. The pediatric experts at Le Bonheur Children's Hospital know parents want to make informed decisions when it comes to their children's health and wellbeing. So, here to answer some of parents' most frequently asked questions about the vaccine, is Le Bonheur's Chief of Pediatric Infectious Diseases and Professor at the University of Tennessee Health Science Center, Dr. Sandy Arnold.

This is the Peds Pod by Le Bonheur Children's Hospital. I'm Bill Klaproth. Dr. Arnold, thank you so much for your time. It is always so great to talk with you. So, can you start by explaining what mRNA vaccines are and why we're using them to protect against COVID-19?

Sandra Arnold, MD (Guest): Absolutely. Vaccines typically contain a weakened or dead microbe or a piece of the microbe, such as a protein or a carbohydrate that then causes your body to have an immune response. This immune response that protects you against being infected or from getting sick from this particular microbe if you are then exposed.

What an mRNA vaccine does, is that instead of giving you the whole microbe or a piece of the microbe, the vaccine actually contains the instructions to make a piece of the microbe, to make a protein. The mRNA is an instruction for making proteins. So, all of the proteins in our body are made from mRNA instructions. Just like viruses and bacteria do as well. In the case of the SARS-CoV-2 virus, the virus that causes COVID, it's the mRNA encodes for the spike protein, which is the protein that sticks off the surface of the virus. That spike protein that's made after you're injected with the mRNA, triggers your body to respond. And you make antibodies and the antibodies in other cells of your immune system protect you from getting infected or protect you from getting very sick if you do happen to get infected. But this is a new kind of vaccines. Like I said, most of the vaccines that we have all received in our childhood, contain a whole bacteria or a whole virus, or just a little piece of it. And this is the first time that people, so many people have been injected with a vaccine of this kind that contains just the instructions to make the protein, instead of the actual protein. That said, there are protein vaccines out there for COVID-19.

But they are not approved in the United States. And so none of us have received those. There are a lot of mRNA vaccines that have been studied and given to much smaller numbers of people in clinical trials, for example, for Zika virus and for influenza. And they've also been studied to be used to treat cancer for example. The reason that this type of vaccine became the vaccine that we're using, is that they can be created and manufactured very quickly.

So, the fact that they were able to, the two companies that make these, Moderna and Pfizer were able to make them and get them to market so quickly, occurred for a variety of reasons. But one of which is that it's much, much easier to create a vaccine with mRNA than it is to create a vaccine with a piece of the virus. And so these could be tested and manufactured much more quickly than other types of vaccines. And that's why they've become the dominant vaccine we're using.

Host: Right. So to be clear, this is not a live virus that we're injecting into our bodies. What this vaccine does is it just spikes the protein in our immune system, which then fights off the virus.

Dr. Arnold: Absolutely. So we do have vaccines that contain weakened live viruses like measles vaccine and the influenza vaccine that you could get in your nose every year. But this is not one of them. You can't get sick from this, because it only contains the mRNA code for one protein. Your body can't make a whole virus out of this.

Host: Right. I think that's a great distinction. So thank you for explaining that to us. So then what are the differences between the vaccine for 5 through 11 year olds and those for adolescents, teens, and adults. What's the difference?

Dr. Arnold: So the main difference between the vaccine that has just been approved and the vaccine that most of us adults have received, is that it's a lower dose. So, young children have very strong immune systems. And through testing this vaccine in younger children in the trial, they figured out that it looked like children would respond with a similarly vigorous immune response to this lower dose as older children and adults would respond to the higher dose. So, the adolescent adult vaccine contains 30 micrograms of the mRNA. And this vaccine for 5 to 11 year olds contains only 10 micrograms. So, it's a third of the dose. But it produces very similar antibody levels to the higher dose, but seems to cause less side effects. So, the idea was that if you gave that full dose vaccine to these littler kids, whose immune systems are really, really vigorous that they might have even more signs and symptoms of that reaction that you have after vaccine with fever and fatigue and all those things. They might have too much of that if they got the full dose that the adults were getting. But the good news is that the lower dose does reduce side effects a bit. And it causes a very similar immune response so they're just as protected.

Host: So, and I think this is understandable, many parents are worried that not enough has been studied when it comes to this vaccine in children. So, as an expert in pediatric medicine, do you think the clinical trials have been sufficient enough to recommend the vaccine in the broader population?

Dr. Arnold: So, this clinical trial that has recently been published in the 5 to 11 year age group with this Pfizer vaccine, studied just around 3000 children. That's obviously a much smaller number than were in the adult trials. But, as I said, the children who are in the study achieved very similar antibody levels in response to the vaccine to 16 to 25 year olds that were seen in the adult studies. And the expectation is that because the antibody levels were essentially the same, that the protection from the vaccine should be the same. And this is something that's done all the time with vaccine trials. If we know that a certain amount of antibody will protect against infection, then the next study that you do, if you have a new vaccine, for example, would be one where all you had to do was prove that you could produce the same amount of antibody and that's called a correlate of protection. And so, we know that if adults are protected with a certain level of antibody, that if we can get the same amount of antibody in children, that the vaccine should still be protective, but that's not the, really the question you were asking. I just wanted to make sure that people understood that, that we know that this vaccine will work in young children based on that. And that's based on years and years and years of vaccine studies that have done the exact same thing.

The question is, how do we know it's safe? Well, there were not enough children. Studying this in 3000 children is not enough children to see rare side effects, right. Even in the study of 30,000 adults, there were a lot of, well I shouldn't say a lot of, there was one rare side effect that wasn't seen at all in that study because it's occurring at a rate of you know, one in several hundred thousand and you are never going to see that in a clinical trial. So even though we didn't study 30,000 children in this trial, even if we had, we probably wouldn't have seen cases of myocarditis because the rate that myocarditis occurs is much less common than one in 30,000.

The expectation is that we'll see similar side effects in children as we do in adults. But because this vaccine is a lower dose and it is less reactogenic, that's the word that we use to say what kind of side effects you see, how much it stimulates the immune system; it's not expected that we're going to see anything different. And the expectation is actually that we're going to see less myocarditis in this age group, the 5 to 11 year old children than we did in the older children and that's one, based on it being a lower dose. And two in children over 12 who have been receiving COVID vaccine, myocarditus was less common in the younger children in that over 12 age group, compared to the older children and young adults. So 16 to 25 year olds, or up to 30 were more likely to have myocarditis than those who are closer to the 12 year age group.

So, it seemed to be lower in those kids in the sort of 12 to 15 range. So, since these 5 to 11 year olds are even younger than that, and they're receiving a lower dose, the expectation is that we will not be seeing as many reactions in these young children. Of course, we're not going to know until we see it.

And that was the same for the adult vaccine. Some parents are waiting to see what happens when other children get this vaccine. And luckily there are lots of people who have been waiting to get this vaccine for their children and have been going out in the last couple of weeks to get the vaccine. And so we will have more information. And so I hope that as that information comes in, because all we need are numbers, we just need to get a certain number vaccinated to see what's going to happen. That's what happened with adults as well. So, once we get those numbers in and we can see how safe it is, hopefully many parents will be reassured over the next couple months and will go ahead and get their kids vaccinated.

Host: Absolutely. And you mentioned myocarditis. Can you just quickly explain to us what that is? We have heard that in the news.

Dr. Arnold: Absolutely. So myocarditis is inflammation of the heart muscle or the myocardium. So, that's why it's called myocarditis and ITIS at the end of a word means inflammation. And what we have seen is that mostly in males, in this young adult, late teen range has been getting heart inflammation after their second dose of vaccine, usually within a couple of days. And it's generally very mild. We can see myocarditis in people in this age group with other viral infections, and in fact COVID-19 can cause myocarditis and it's much better at causing myocarditis, than the vaccine is. And it causes a much more severe myocarditis. So, what we're seeing after vaccine is some chest pain. Maybe some shortness of breath, or heart palpitations. And when they do blood tests, they can see that there are markers of heart inflammation that you can see in the blood. And those can be abnormal for a pretty short period of time. But most people who have had this, they've only had symptoms for a couple of days. And those markers of heart inflammation go down and there does not seem to be anything, any lasting effects from this. So, even though we're seeing myocarditis and as doctors, we fear myocarditis, the kind that we see caused by other viruses, because it can cause long lasting effects on the heart.

That is not what we seem to be seeing with these vaccine induced cases. And it's probably because the inflammation that's causing the heart to be inflamed is very short-lived following the vaccine. And so now that we're giving this lower dose to these younger children, if they're getting less inflammation in their blood and in their bodies, after getting the vaccine, we should see less of this heart inflammation, or it might even be so mild that we don't even know it's happening. That is one of the main reasons that they actually lowered the dose of the vaccine. And we're going to see over the next couple months, hopefully that that worked.

Host: And again, this is rare, right? We just want to stress that as well.

Dr. Arnold: Absolutely. It is very rare and it's much, much less rare, like a hundred times less rare than it is to get heart inflammation from COVID infection. That's what people have to remember. All the things that the vaccine does, the virus does much better than the vaccine does in terms of the side effects.

Host: And speaking of side effects for us adults, it was fever, fatigue, upset stomach, not feeling well. Arm hurt a little bit after the second dose, in some cases. For me, I really didn't have any side effects at all after my second dose. But for kids, is it the same thing? Fever, fatigue. You know, their arm hurts where they got the injection, those types of things?

Dr. Arnold: It is. So the most common side effects where those injection related side effects with a sore arm, mostly just pain. Some kids had a little swelling or a little redness. The second, most common side effect was fatigue, just feeling tired. And a lot of people were really wiped out especially after their second dose. But fevers and other systemic generalized side effects were actually a little bit less common in children.

Host: So, there is still this question remaining if kids don't seem to get as sick from COVID as adults, why should they get the vaccine?

Dr. Arnold: So it is true that many fewer children have become very ill from COVID-19. But there's still plenty of children who have, and all of those cases are preventable by vaccine. So, even though we have not seen children's hospitals fill up with COVID-19 cases in the same way that adult hospitals have, we did actually see a lot more kids get sick from COVID-19 this summer with the Delta variant.

And even though, like I said, it's less likely to occur, it's pretty random. You don't know which child is going to get very sick and being in the hospital, it was very traumatic for children. Many children have died from COVID and those are with vaccine, all completely preventable deaths. These are children who had their entire lives ahead of them. Some of them had underlying conditions, but about a third of children without any underlying conditions were hospitalized with COVID.

A third of hospitalizations, I should say occurred in children with no underlying conditions. So it's all fine to say, well, my child's not going to get sick, but you don't actually know if it's going to be your child or not. If you think about all the other vaccines that we have out there, many of those are less common. The illnesses that are prevented by those vaccines are less common than COVID-19 and cause fewer hospitalizations than COVID-19. But nobody's saying let's not vaccinate against meningitis because it's rare. Right? Nobody wants their child to get meningitis and nobody wants their child to die from COVID-19, but children do, and I've seen it. And no child should die a preventable death, as far as I'm concerned. But even if you go beyond deaths, right? We talked first about hospitalizations, being in the hospital, is very traumatic for children.

We have cases of COVID-19 almost 9,000 cases in children in this age group, this newly approved age group, 5 to 11, almost 9,000 children have been hospitalized for COVID-19 in that age group. That's a lot. And an additional 2000 children in that age group have been hospitalized for multi-system inflammatory syndrome, which is this inflammatory disease that you can get after COVID and that can occur in anybody. Most of those children, when they had COVID had asymptomatic infection, many didn't even know that they were infected.

So, that's a lot of hospitalizations. And some of those children unfortunately passed away. If you just think, well, the number it's not as bad because not as many children died as adults, but, children are in the dawn of their lives. That's many, many years of lives lost and then finally long COVID. So, you may not even be that sick from COVID, but a lot of children are suffering from prolonged symptoms after COVID. Things as weird as brain fog, where they just, they can't get their schoolwork done. And that's a huge thing for children who have already suffered from education loss because of lockdowns and virtual school that they can't think and get their work done in the same way that they did before they had COVID. And we don't really understand how to make that better. And so it's taking months for these children to recover.

Some of them also have shortness of breath and chest pain. Some people don't recover their taste and smell, and it's really hard to eat. So, we have children who are out there who are losing weight and not growing and thriving because they can't eat because things either taste strangely or they can't smell things at all. And it really takes away their appetite. So, there are a lot of reasons out there not the least of which is children do die of COVID for people to want to get their children vaccinated.

Host: Absolutely. And unfortunately, there is a lot of misinformation swirling around on social media that doesn't help. And on certain cable channels, all of this can be very scary. So, can you address the concerns and we've heard a ton of them, about the vaccine. One of them is that the vaccine alters DNA and could have long-term side effects no one can predict. Can you debunk all that for us?

Dr. Arnold: Yes, that one's really easy to debunk. So the mRNA that's injected into you is broken down really quickly after it's used to make a protein. This is done in the cytoplasm of the cell and in the nucleus is where the DNA resides. So, there's mRNA, one never gets anywhere near your DNA. It disappears pretty quickly. And also our cells can't make DNA out of mRNA. Even if it did get into the nucleus, that mRNA has no way to be incorporated into the DNA. We don't have the cellular machinery to do anything like that. We don't have enzymes to make that happen. This boogeyman thing that people keep talking about that it's going to change our DNA is actually not scientifically possible at all.

The vaccine also, like I said, disappears very quickly from your body. It's not lurking in your cells. The mRNA is not hanging around waiting to cause problems years later. Any adverse effects you see from this vaccine are related to the way the immune system responds to the vaccine. Like we talked about with myocarditis, right? That it causes inflammation in the body and that can cause inflammation in different organs. And we see that with all vaccines. These are very rare adverse events, but we know that vaccines can do that because the illnesses that the vaccines are preventing, can also do that, but these all occur fairly soon after vaccination, usually within about six weeks. And so that's why in these studies, they were required to watch people for actually about two months after the vaccines were given before they could go and start analyzing the data and submit to the FDA. That two month period was actually chosen for a reason. And that was because experts said the adverse events that you're going to see with vaccines are going to occur within a couple months. Now, can those adverse events last a long time? Sure. Very rarely. We said that most of the myocarditis gets better, really, really quickly. Is there going to be an occasional person who may suffer a longer lasting effect from that? It's certainly possible. But that adverse effect is going to start within six to eight weeks. It's not going to suddenly start 2, 3, 4, 5 years later. There are all these myths out there that we all are ticking time bombs because we've gotten this vaccine and we're all going to get cancer in five years. It's just not possible because the vaccine itself is long gone from your body within a week of it being in there, within days. It's not sitting there waiting to alter your cells and cause you to have cancer. That just doesn't happen.

Host: Well, that's good to know that it just doesn't happen. It's impossible. It can't happen. So thank you for clearing that up. And more misinformation is out there about fertility. And that the vaccine can effect a woman's fertility. And on the male side, we just heard a certain NFL quarterback say he didn't want to get the vaccine because he heard that it could make him sterile. All of this misinformation. It's just crazy and it's just compounding things. So, can you talk about the vaccine and fertility and debunk that one for us?

Dr. Arnold: Right. So, the concern about fertility was raised by some physicians who thought that the spike protein, very closely resembled a protein that's involved in making the placenta in the female body. So, this has nothing to do with men at all. And they were worried that the spike protein and this protein called syncytin-1, they're both what are called fusion proteins and that because they're both fusion proteins, antibodies that the body makes against the spike protein may also bind to this placental protein and cause it to not function. Right? Because if an antibody binds to it, then it gets cleared from your body, just like with the spike protein. But everybody who has looked at these proteins, I mean, the structure of these proteins is available online. The structures are not nearly similar enough for that to happen.

Some examples people have used about the similarity are things like saying that two people's phone numbers are the same because they have one digit that's the same. If you and I both have the number five in our phone numbers, you're saying, oh, those are really similar. Well, of course that doesn't make any sense. The degree of similarity between these proteins is very, very small. And the same degree of similarity is seen with lots and lots of other proteins that are much more widespread in our body and will cause us a lot bigger problems if this amount of similarity was actually enough to make this what's called this molecular mimicry, that's what it's called, to make that actually happen. There's no evidence that this actually has happened. Tons of people have gotten the vaccine.

There's no evidence that we're seeing widespread infertility. And then the most important thing is, the virus contains spike protein and people who are infected with the SARS-CoV-2 virus make antibodies against the spike protein. So, it wouldn't just be the vaccine that could cause this, it would also be the illness. And so even if you say, well, we don't know about all the vaccinated people, millions and millions of people have been both vaccinated and infected with COVID-19 and we have not seen a massive outbreak of infertility among women. And again, like I said, this has nothing to do with men at all because men don't make placentas. Now, COVID-19 itself, has there has been concerned that, the infection itself could actually cause male infertility by reducing sperm counts. Being pregnant and having COVID can also lead to miscarriage and stillbirth. So, COVID-19, once again, proves to be much, much more dangerous than the vaccine.

Host: Absolutely. So good points on all of those. All right. So let's turn to masks another you know, hotly debated topic. Do we still need to wear them?

Dr. Arnold: This is a really tough one. People are getting pretty tired of wearing masks. I'm going to agree with that. I don't want to wear a mask anymore, but of course I do, because I know it's the right thing to do. Unfortunately cases are starting to go back up again. And the issue is, that as long as we're seeing cases and people getting very sick from them and ending up in the hospital, blocking hospital beds, making it so that people who have COVID-19 or other illnesses cannot get the care that they need, as long as hospital systems are being overwhelmed, we are going to need to keep wearing masks. Now there will be lulls in between where we maybe don't have to wear masks for a little while because cases are low, but when they start going back up again, we're all going to have to start wearing masks and cases are surging all across Europe right now. The expectation is that we're going to see cases surging here. And the only way that we're going to keep that from continuing to happen is to get more and more people vaccinated. If everybody would get vaccinated, even though we'll still have cases of COVID, they will not be severe cases and we will not overwhelm the hospitals and then we'll get to stop wearing masks, but we're not there yet, unfortunately.

Host: Yes. Everyone needs to get vaccinated if we're going to really put an end to this thing or control it to the point where it becomes like a, like the flu, right?

Dr. Arnold: Exactly.

Host: We get our yearly shot and everything is okay. Obviously some people will be affected by it, but for the mass population we'll be able to manage it effectively.

Dr. Arnold: That's exactly right.

Host: So, let me ask you this then, what advice would you give to a parent who may be on the fence about whether or not to get their child vaccinated? We heard all of the information that you gave us on how the vaccine is very safe. There might be a parent that says I know it, but I'm still don't know, who should they turn to for more credible information?

Dr. Arnold: They need to speak with somebody they know and trust who actually understands vaccines and understands COVID-19. So the most important thing for them to know is that it is true that their children are less likely to get very sick from COVID. So even though I strongly encourage everybody to get vaccinated, when they do have a friend whose child contracts the illness, I still tell them, it's most likely that your child's going to be fine, so just be calm, right. Most likely your child's not going to end up in the hospital. But COVID-19, the disease is much more dangerous overall. When you look at the odds of something bad happening with illness versus vaccine, it's much, much more likely to happen with illness. And so at this point, we're not at a if I get COVID, it's going to be a when, right.

You can't say, well, I'll just take my chances with getting the virus cause you will get the virus, if you have not had it, because at some point everybody's going to unmask. Right? We just talked about that. And if you're vulnerable, you will get it. Everybody needs to get vaccinated. We need to get all the children vaccinated, so that we can get back to normal. And this is not just so a lot of people say you're just scaremongering. You're just saying, you know, telling people to be worried about their children getting sick, but it's not just about preventing that illness. It's about getting ourselves back to normal so our children can live the lives that we expected them to live before this all started. We want them to live their fullest lives in the best way that they can, participate in all those great activities that kids get to do without limitations. And the only way we're going to get there is for everybody to be vaccinated.

I have said to several people who are hesitant, that if they want to wait and see for a couple months, what kind of information comes out, letting other people vaccinate their kids first, people who are willing and actually very anxious to get their kids vaccinated. And we will have that information, about more information about safety, even though I feel very secure in saying that I think that this vaccine is safe. If you need that extra layer of reassurance, give it a couple months. We'll have that information. And then please, please, please go and get your child vaccinated.

Host: Yeah. That's a good, common sense approach. And then what about children younger than five? Do you think they'll be able to get a vaccine soon?

Dr. Arnold: They will soon. It depends on what your definition of soon is. It will probably be several months before we have a vaccine for these children under five years of age approved under an emergency use authorization, unfortunately. But the best way to protect your littlest ones is to make sure that everybody around them is vaccinated. If the rest of us are vaccinated, then those kids will be much more protected. So, if you have people coming to your house, if you're having family gatherings, and you have young children, just make sure that all those people are vaccinated. It's not a hundred percent of course, because we know that vaccinated people can still be infected. And that a lot of people are saying, why bother, if I can still be infected? But of course, vaccinated people are much, much, much less likely to get very sick. And also they shed virus for a shorter period of time. And so they're less likely to infect other people. So, everybody needs to be vaccinated in order to protect those vulnerable young children and also vulnerable elderly people or immunocompromised people who may not have responded in a vigorous manner to the vaccine.

Host: Right. And with the holidays approaching, Thanksgiving and Christmas, and it's getting colder, we're all going to be indoors more often; that message is really more important now than ever about getting vaccinated and not only protecting ourselves, but the people around us. Right? Care for the common man. You know, all of our neighbors. We're all in this together.

Dr. Arnold: Right. It's not just about us. It's about everybody. And we want to get back to normal, you know, even if you're doing it, even if you're doing it for selfish reasons, it's going to make your life better by being vaccinated, because we'll be able to get back to normal.

Host: Absolutely. Well, mentally I'm vaccinated. The minute I got the second shot, I started feeling like, okay, it's going to be okay. You know what I mean? Because if I do get it, like you just said, the chances of severe illness are much less.

Dr. Arnold: Yes.

Host: It's so true and not to end with a scary story, Dr. Arnold, but I had a friend of mine who was an anti-vaxxer, if you will, I'll just say it. And he would not wear a mask. Would not get vaccinated, thought it was stupid. This is all overblown. He caught COVID and he passed away. So, I have personal experience with it. It's not worth it. Get the vaccine. It's not worth it. Like you said, you're going to take the chance. This thing has killed over 700,000 people, you never know. Get the vaccine, really, if we're ever going to end this thing, that's what we all need to do.

Dr. Arnold: Absolutely so many stories like that out there.

Host: And you've seen it firsthand as well. You even talked about children, you've seen children that have died from this. So, come on, this is real. We all need to do this. So thank you so much for your time, Dr. Arnold, you're always a wealth of information. I love talking with you. You put it in, in just great ways that we all can understand, us parents out there that we do have these questions. So thank you again for your time and your insight. We appreciate it.

Dr. Arnold: Thanks so much.

Host: And once again, that's Dr. Sandy Arnold. And to learn more, please visit LeBonheur.org/podcast and be sure to subscribe to the Peds Pod on Apple podcasts, Google podcasts, or wherever you listen to your podcasts. You can also check out LeBonheur.org/podcast to view our full podcast library. And if you found this podcast helpful, please share it on your social channels. This is the Peds Pod by Le Bonheur Children's Hospital. Thanks for listening.