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Melanie Cole (Host): Well, the CDC has approved the FDA's emergency use authorization of the Pfizer BioEnTech COVID-19 vaccine for children ages 5 to 11. That means that all children ages 5 and older are now eligible to receive the Pfizer COVID vaccine. But many parents are still going to have questions, even if they're eager to have their children vaccinated. Welcome to MomDocs, the podcast from St. Louis Children's Hospital. I'm Melanie Cole, and I'm talking with Dr. Jason Newland today. He's a Washington University Pediatric Infectious Disease Specialist at St. Louis Children's Hospital. Dr. Newland, I'm so glad to have you with us today. This is really exciting.

This is breaking news here. Tell us the latest development for the COVID vaccine that it's now available to pediatric patients between the ages of 5 and up. So tell us about that. Yes?

Jason Newland, MD (Guest): Well, Melanie, thanks for having me. Yes, this is so, so exciting. You know, knowing now that we have another large group of individuals eligible for the vaccine and it's 28 million children, 5 to 11 are in our country. And so the Pfizer BioNTech vaccine has been now shown through a rigorous trial or study that this vaccine is safe and it's effective.

And its effectiveness is 90%. And everyone should know that when they were doing the trial in children and they were looking at the cases, it was over the summer and we all know it was the Delta variant spreading throughout the summer. So, really you could argue this vaccine is 90% effective against the Delta variant, which I think is music to all of our ears.

Host: Oh, my goodness it so is, and I hope that this is a relief for parents. So, tell us a little bit about the trials, because we're going to have a lot of questions here today, Dr. Newland. Tell us the trials that were done and which vacs are we talking about? Tell us a little bit about why it's Pfizer and not Moderna. How are they determining the safety and effectiveness of this one? How does this process work?

Dr. Newland: It's a great process. We live in a wonderful country that has a great process around developing vaccines, especially for children. So how does it work? Well, first we do the trials for the adults. We find out the adults, it's safe and effective, and that's what we did. Right. They did over 40,000 adults and a placebo, meaning they got, they didn't get the vaccine, but got some saltwater versus they got the vaccine and we learned it was effective.

Then what happens is they started doing it in children. And as you've seen, we've done it in different breakdowns. We first had it down to 16, actually with teenagers, with the adults, then we did 12 to 15 and now we have the 5 to 11. So, they just phase it in because they got to look at a couple of things.

The first thing they got to decide, well, if I have a little person, that weighs less, is not as big, is not as developed, should the dose be the same? That's what they did with this trial. They did some of the, they call open label studies to see if the safety and that what we call the immunogenicity or the ability for our bodies to make those fighting cells called the antibodies. It hit the same as the adults. And what they found was that, oh, wow, in the 5 to 11 year olds, I can actually use one third of the dose that we used in those 12 and older. Which means it's 10 micrograms, not 30 micrograms. And that means there's less side effects, but the same immune system response. And we know that's true because then what happens is they do what they call these randomized double blind placebo controlled trial.

A lot of words to mean that they basically gave kids vaccine. And then they gave some kids pretty much salt water instead of the vaccine as a shot. And when they compared that and they did over 2000 children this way, and they had 1500 who got the vaccine, about 750 who got that placebo or the saltwater injection.

And they found that, wow, those who got the vaccine, it was 90% effective. And then the most important thing, probably just besides knowing it's effective is they follow for safety. And they have to follow beyond this two month period of time. And they also follow that safety, even in some of the original groups that got the vaccine.

So in over 3000 children, we know there was no serious side effects with this vaccine and really the side effects are similar to that what Wwe got like. So I got Pfizer vaccine and I had headache and malaise. That's the same thing kids will get.

Host: Wow. This is very exciting as we're trying to get this thing under control. Really, this is exciting news for parents. So tell us a little bit about recommendations for spacing, because I guess a lot of parents are going to want to know spacing between getting this vaccine now and also it's flu time and MMR. We got other vaccines. Parents worry about getting more than one vaccine at the same time.

Dr. Newland: Definitely there is that worry. But what we have learned is that you can give this vaccine at the same time that you give your routine vaccines. So, especially right now, trying to make sure our kids get their flu shots. So, when they get their flu shots, now you can get them their COVID-19 shot at the exact same time. I actually did that myself with my booster and I think that's a great strategy going forward, but we don't have to wait to get this vaccine.

Host: Are there any kids of this now approved age group that should not get the vaccine?

Dr. Newland: Well, just like in the adults that if there's a child that has been allergic to something called polyethylene glycol, which is found in a medicine called Miralax, it's for constipation, if there's an allergic reaction to that, then they shouldn't get it. Additionally, those who have had severe reactions to other vaccines, they can still get it, but you need to let the administrators of the vaccine know as they will probably watch longer.

And then let's say like, you do get the first dose and you have what we call an anaphylactic reaction, then you wouldn't get your second dose. So, those are the main kind of the reasons not to get it.

Host: Okay. So what can a child do after getting the COVID vaccine? Dr. Newland, when I got my second shot, I made sure to plan nothing for that day, just in case I had the soreness or a headache or any of those symptoms and kids, as you mentioned, get milder symptoms anyway. So, as far as school and extracurriculars, if they're in sports, any of these things, what should we plan for our kids after getting the vaccine?

Dr. Newland: I think you can plan that they could be a participant in those extracurriculars or even going to school the next day, but you should also be aware that they might not feel up to it. They actually might feel kind of lousy. And in that case, you might be considering, well, maybe they're not going to do that, but I think the kids are going to tell you what they can and can't do. And let's be clear. The kids are a lot tougher than I am for sure. So I have this feeling that they might ache a little bit, but they'll be out running about not even realize it before they know it.

Host: Yeah. I mean, I am too. I'm like you, I just, you know, it wasn't really bad. And I did that sort of tick-tock arm swing to get rid of the soreness, but I was more sore with my booster. Anyway, let's bust up a few myths for parents because there's a lot of these things floating around, right? Does this cause infertility or even developmental problems? Parents of five-year-olds are going to worry about this. And then we even hear about myocarditis.

Dr. Newland: Yeah, so all great. Let's start with infertility. Cause that's come up from the get-go of these vaccines being approved. Number one, the experts in maternal health and in pregnant women, those obstetricians and gynecologists that have their national society recommend strongly that all women, and that would mean girls too, should get vaccinated.

There is no biologic possibility that there could be impact on in fertility. That has been suggested, that is not possible. We have continued to follow the safety that we're not any safety events suggesting we're having infertility. So, I think infertility is not happening. Number two is what about development?

We have been giving children vaccines and we give them a, one would say a plethora of vaccines that have really revolutionized healthcare. We don't have polio in this country because of vaccine. We don't see measles rarely, even though, that's a virus that can cause a bad infection because we've been doing that. And when we follow all of these vaccines and the safety for years upon years, there is no developmental problems. That's going to be the same thing here, too. We've also learned that if you follow vaccines beyond this two to four months, there's not these longterm impacts.

So that's why the FDA has set this as that time to follow safety. And lastly, let's talk about myocarditis, right? Because that's the one that's got us all, like what's going to happen next. So, what we have learned is that with these mRMA vaccines, both Pfizer and Moderna are the mRNA vaccines that after the second dose, there is an increased risk of having myocarditis or inflammation of the heart.

The risk seems to be the highest in young men 16 to about 30. And that risk, and I'm going to say the number so everyone think about this number, is 10 per 100,000 individuals in that age group. That's that age group. Now, the question we should all ask is what's our risk of having something impact my heart, if it's COVID.

So if I get COVID, how likely is my heart going to be impacted or something similar? Those numbers are much higher. So, if you look at myocarditis in young men and women that got COVID-19 about 600 per 100,000, right? So 600 versus 10; 600 per 100,000 who had COVID-19 got myocarditis. And then lastly, if we look at that multi-system inflammatory syndrome in children, a lot of words, which is a bad, bad complication of COVID-19 that risk is about 30 per 100,000.

So three times greater. The final point is that those who got myocarditis in association after the second dose had mild illness and recovered very quickly. So in the end, the benefit of this vaccine and its protections against some of these horrible things with natural infection with COVID-19 so far outweigh the risks.

Host: Oh, I like you so much, Dr. Newland, you just get to my questions, even some of them before I get to them. And you have so much passion and so much expertise and authority. Parents, I really hope you're listening to this man. And you share this show with all of your friends and family. So, while you're telling us those benefits of why children should receive the vaccine, which should seem obvious and why it's important to have our children vaccinated against COVID, some parents are asking, why did more children become sick with COVID this year than last year?

What changed? Can you explain that mutation and the Delta? Just a little bit for us here.

Dr. Newland: This is a great question, right? Because we did over the summer, all of a sudden we start learning about a lot more children being infected and one of the reasons for that is the Delta variant, right? So, viruses can be smart. COVID-19 is really smart and it changes and every time it makes more of itself, it might make little changes. Then all of a sudden the virus has a change that makes it stronger. And in this case, the Delta variant has become stronger in the sense that it can infect people better. And that's why all the infections currently in the United States are the Delta variant. Additionally, it showed that kids were just getting sicker more often. I think it's because of this, this Delta variant stronger thant means that it could actually infect them easier. Now it's not making them any sicker than the original strain, but it's definitely infecting them more. The other thing to note is we have to remember that we have a large group of children that are unable to be vaccinated over the summer.

So we had this group of people that were one might say susceptible or it could be like almost a sitting target if it came in because they couldn't be vaccinated. And that is another reason why children became a much greater percentage of the infections.

Host: Also, I'd like to add my own thing in here is people stopped wearing masks and started going out more and started with social situations that those kids that hadn't been vaccinated were certainly more vulnerable. How does vaccination status affect quarantine guidelines Dr. Newland?

Because now there are breakthrough cases. And parents do need to know that some kids with the vaccination might get COVID, although it will be so much less than it would have been had they not been vaccinated, but what's the quarantine situation so that they know about school and activities?

Dr. Newland: Well, that's one of the beauties of vaccination. So, if you are vaccinated and you come in contact with someone who is sick with COVID-19, you don't have to quarantine. Now you need to watch for symptoms that if you develop some symptoms, you get tested because if you happen to be one of these breakthrough cases with a mild infection you'll need to isolate, which you know, is in another way of being quarantined, right? You have to stay away from people, but really one of the great benefits of being vaccinated is the fact that you don't have to quarantine when you come in contact with people that are COVID-19 positive.

Host: But you do, if you test positive for COVID-19, then definitely the quarantine, the isolation, whatever it is, 10 days at this point that you do have to do.

Dr. Newland: That is correct. So yeah, it's, that terminology right when you're infected and you have to stay away from people, we call it isolation, but it's the same thing as quarantine, right? Like you've got to stay away. You gotta be in house and be away from people, even if you've been vaccinated.

Host: I only have a couple more questions for you, Dr. Newland, we're almost done, but this is really such an important bit of breaking news. Since these vaccines for kids are now available, do we go to our pediatrician, our medical homes so that it's in their records there. Do you expect, it will be large registration events, like pharmacies like we've had for adults, where do you see this happening? What do you hope will happen and what is happening?

Dr. Newland: Well, I think that it depends on what's going to be available to you. So some of the medical homes will have gotten Pfizer and are set up to do give Pfizer. Some won't because of additional things that they have to do in their offices to make sure they're ready and some of the waiting periods. So, I think the first step is you can check to see if your medical home is offering the vaccine. We also know that some of the retail pharmacies have gotten vaccine and are able to give this to 5 to 11 year olds. So another easy thing to do. Additionally, healthcare systems like BJC Healthcare, as well as other healthcare systems in St. Louis are also set up to give the vaccines with different pop-up clinics occurring at St. Louis Children's Hospital, as well as occurring at other of the local healthcare systems. And finally we have our public health departments and the public health departments have come together and they will be offering appointments to give vaccine to the 5 to 11 year olds.

I think in the St. Louis region, we are so, so fortunate that we have the pandemic task force and a lot of dedicated committed people who have been preparing over the last month to be able to give and offer enough vaccine so that we can get these 5 to 11 year olds vaccinated really quickly. And I should say, and I shouldn't forget this is that check your school districts.

Local school districts are also partnering with a lot of great folks. They might have some vaccine clinics as well. You can trust me in this is that this region, especially St. Louis and probably in most regions across the country are even more prepared this time to give vaccines. Cause we're all ready to be out of this pandemic. And this is the next step forward by vaccinating this age group.

Host: 100%. I mean, as long as they're making it that easy for parents, there's no excuse. There's no reason. This can help us to all get through this and get to the other side where we don't feel this little cloud hanging over us. As the last question, Dr. Newland, what's the most important thing you want parents to know about this new COVID vaccine approval for kids 5 and up and for the parents that are nervous at the thought of getting this vaccine, or they're getting misinformation from Uncle Facebook, whatever it is, they're getting all this information and they don't know what to do with it. What do you tell them? What can you tell them so that they hear it so that we can all get back vaccinated.

Dr. Newland: The studies that have been done with these vaccines specifically Pfizer from the very get-go, including the adults have really shown us that being vaccinated protects people more so than we believe getting the disease. But more importantly protects people from ending up in the hospital and suffering some of the most severe consequences, including death.

The studies done in children are showing the same things. This vaccine is safe. It is effective, and it is the way that we get out of the pandemic. And I do understand there's going to be people still, getting a lot of different information from Uncle Facebook, maybe we'll call it Aunt Instagram, these different places, but go to your trusted sources, go to your healthcare systems, go to your medical home and have those conversations.

And I can tell you that we are blessed to live in a place, in a country where we have great safety monitoring and after giving a billion doses of Pfizer throughout the world, and over 180 million doses of Pfizer vaccine, we don't have the serious safety events that makes us think that the risk of this vaccine outweighs the benefit because the benefit is tremendous.

Host: So informative. You just answered every question so well, and with such expertise and passion, Dr. Newland, what a great educator you are. Thank you so very much for joining us today. And that concludes another episode of MomDocs with St. Louis Children's Hospital. For more advice and articles, check out the MomDocs website at childrensmd.org and parents, please, I said it before, and I'll say it again, share this show with your friends, on your social channels, because that way we're getting this quality information that you can trust. And we're getting it from the experts at St. Louis Children's Hospital together. We're all learning together and it's all about helping us to raise our children safely.

So please share this show far and wide. Get your kids vaccinated. This is Melanie Cole. Thanks so much for listening.