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Melanie: The CDC has approved the FDA's Emergency Use Authorization of the Pfizer BioNTech COVID-19 vaccine for children ages five to eleven. That means that all children ages five and older are now eligible to receive the Pfizer COVID vaccine.

Welcome to UAB MedCast. I'm Melanie Cole. Joining me is Dr. David Kimberlin. He's the Co-division Director of Pediatric Infectious Disease at UAB Medicine. Dr. Kimberlin, I'm so glad to have you with us today. For other providers and pediatricians specifically, parents have so many questions now about the COVID vaccine for their five- to eleven-year-olds. Can you tell us about the latest developments and really how this came about?

Dr. David Kimberlin: This is a really good period that we're in right now. And of course, it's been good since, I guess, this whole calendar year of 2021 in terms of having vaccines initially for 16 and over, that was the Pfizer vaccine or 18 and over for Moderna. And then there was an authorization for 12 through 15 for Pfizer, that was early in the summer. And now, we have this five through eleven authorization. And so it's a really good day because as you said, five and over now, across the age spectrum, as long as your five years of age at least, you have the ability to be vaccinated now against COVID. And we've certainly seen the devastation that this pandemic has done to our country and to our world for these last almost two years. This is a period of celebration that we're in right now. Although a vaccine only works if it goes into someone's arm. It doesn't work if it's in a freezer or if it's in a refrigerator. We got to get people vaccinated.

Melanie: One hundred percent. And as the pediatric infectious disease specialist at UAB Medicine that you are, tell other providers what kind of trials were done to prove that this vaccine is safe and effective because they're answering parent's questions every single day, Dr. Kimberlin. So how did the FDA determine the safety and effectiveness of this for kids ages five through eleven?

Dr. David Kimberlin: The first thing we got to recognize is what was done from the very beginning in terms of their studies. So I'm going to focus only on Pfizer because it's the Pfizer vaccine that's authorized for five through eleven now and 12 through 15 as well. For the Pfizer vaccine, the studies were started in the middle part of 2020, and they were very large in the order of 45,000 participants. And again, it was 16 and over for that, so mostly adults but including some 16 and 17-year-olds in that particular trial, and that's the one we're so familiar with where we saw the, you know, 94% vaccine efficacy. In that particular study, we saw the very good safety profiles. They also did, and this is important, they did immunologic assessment in those studies, the very first study, the very large study. And they determined what kind of antibody responses there were, what kind of other cellular immune responses there were and so forth. And when they went down to the 12 through 15 years and now the five through eleven years, it allowed Pfizer to be able to do what are called immunobridging studies, so that they can enroll a few thousand children or adolescents depending on which one we're talking about, and they can do measurements of immune responses in those few thousand subjects and compare the immune response with the immune response seen in the very, very large trial of 45,000 or so. And that allows them to then say, "All right. We have a vaccine that in 16 and over has, you know, 94% efficacy." And, you know, there've been some mild variations to that with subsequent analyses, but essentially, you know, very excellent kind of responses. We know what sort of antibody titers, for example, correlate with that degree of protection.

Now, in the five through eleven-year-olds study, which I think had about 2,600 children in it, in that study, they also were able to measure the antibody responses in those five to eleven-year-olds. And they were able to compare those two responses and see that the five through eleven-year-old-response was very comparable, if not even a little bit better than the immune response, specifically in the 16 through 25-year-olds, that was, you know, kind of that older adolescent younger adult group is who they were comparing with.

And since we know that it works exceedingly well in preventing disease in 16 through 25-year-olds. And we know that the immune response in five to eleven-year-olds is as good, if not better than in 16 to 25-year-olds. The inference is that it also will have that degree of efficacy in the five to eleven-year-olds, even though the study was not, you know, done in 45,000 five through eleven-year-olds, which I would suggest is a very good thing. We need to get this information as quickly as possible. And it already took several months to do the 2,600 or so in that study. So it's good news that we now have evidence that the dose evaluated in this five through eleven-year-old group gives the same amount of immune response and therefore is inferred to have the same degree of protection.

Melanie: Thank you for that comprehensive answer, Dr. Kimberlin. So what is the dosing difference? Is there a difference in ingredients or dosing for this vaccine for people like 16 and older or versus people five to eleven?

Dr. David Kimberlin: There is. In the authorized vaccine for 12 through 15-year-olds and the licensed vaccine for 16 and over, the dose or the amount of the mRNA in it is 30 micrograms per dose, per injection, per vaccination. For the five through eleven-year-olds, they selected 10 micrograms. So one third of the overall amount of mRNA that's in the vaccine for 12 and over is used in the five through eleven-year-olds. And they did some initial studies. I did not mention this, but they had done some dose-determining studies prior to the 2,600 or so in the immunobridging study to determine that 10 microgram dose was likely to give a good immunologic response. We now know that it does. And that it had good safety profiles. That's the reason that 10 was selected. They chose well because it worked exceptionally well in the immunobridging study.

Melanie: There are a lot of myths that pediatricians all over the country right now are having to answer for parents. Can you just tell us a little bit about things like infertility, myocarditis? Or for the parents that are asking their pediatricians while we've heard that children don't really get COVID or if they do it's very mild, but with Delta, we've seen an increase, right? And children that are hospitalized. Tell us a little bit about this. Break up some of these myths, so that pediatricians have the words to use.

Dr. David Kimberlin: That's maybe the toughest part of the situation that we're facing right now. It's frustrating. You know, I mean, I think any of us that are on the physician side or the nurse practitioners side of the conversation are kind of tired of having these conversation. But one of the most important things for pediatricians to realize, and they do, this is not, you know, surprising information that I'm about to say. The most trusted person for a parent to talk with about their child's health is their pediatrician. When the parent sits down with the pediatrician and she says to do such and such, the parent pays more attention and holds that particular piece of information to a higher level of value than any other source that the parent can go to and that includes, you know, the question and answer section of the Facebook and so forth.

So I really want pediatricians to realize the power that they have. And I think they do. I mean, I think this is something they do every single day. Now, of course, the vaccine for COVID is a new addition, a new layer that's been added here, but they know the impact that they have in children's lives. So that's why we do it. That's why we're in this

So first and foremost, know the power that you have. That does not mean that you're going to make every single person fall in line and get the vaccine. You know, that's the reality of the world we live in, but it does mean you can sway a lot of people and you can make a big difference and, you know, obviously, each person that's getting vaccinated is one less person that potentially could either spread the virus to someone else who might die or, you know, rarely for children, but still 600 plus have died, you know, die themselves. So, you know, every single person vaccinated is a win.

Now in terms of the misinformation that can be out there, the myths that are out there, what I recommend, and I draw this from, you know, the fantastic work that's done from the University of Colorado, Shauna Leary's Group and others, University of Michigan and so forth, one of the first things to do is simply ask the parents, "What are your concerns?" And listen to them because you may think you know what their issues are and it turns out they have totally different issues.

So the first thing to do is to be empathetic. You're there to help. You're there to provide information. You're the purveyor of information. You have that knowledge, but start by asking, "What are your concerns, Mrs. Smith or Mr. Jones?" And hear what they say. If they say that it's concerns about fertility, you can answer by saying there's no indication at all that these vaccines cause infertility. There is no even rationale for that. It doesn't even biologically make sense.

And it's okay to say rather than maybe like I just did where, you know, the data do not support that conclusion, you know, that kind of language isn't what a parent hears, or you know, responds to. The real answer is it does not cause infertility problems, period. And it doesn't make sense. And the animal studies didn't show it and the human studies don't show it and the vaccine is cleared from the... I mean, you can go into all the different reasons for why it's nonsense, but, you know, lead with "It does not do it" and be definitive, if you can be definitive.

For other kinds of myths, you know, "My child doesn't need it." I think there, one thing to emphasize is that more than 600 children have died of COVID since the beginning of the pandemic. So for those 600 plus families, you know, it was catastrophic. Another thing to point out is that it's the eighth leading cause of death in children in 2020. And that's an important statistic because children don't die as often as adults, you know, thank God, right? I mean, of anything, you know.

So when you compare raw numbers of pediatric deaths from whatever versus adult deaths from the same thing, you're going to obviously have many more adults, because there are many more adults in the world and adults are more likely to die because that includes the old people and so forth. So I think kind of normalizing it to, you know, rankings is helpful in this regard. And CDC has looked at this and it is the eighth leading cause of death in 2020, anyway it was or 2020 going into 2021, it was the eighth leading cause of death.

And then the other thing I think that's important to answer that particular question is by vaccinating the child, number one, you're protecting the child against what is a small likelihood of death, but it's there. You're also protecting that child against the effects of COVID, being in the hospital, perhaps from it. Or even if not hospitalized, the effects of long COVID and some studies have shown that, you know, 10% or so of children will have long COVID and we don't know what those long-term outcomes are. They may not be good. They may be okay. We don't know. But why risk it? You know, why run that risk at all when it can be preventable?

And then finally, I would point out that the other possibility is that if your seven-year-old, for instance, does not get vaccinated and does get COVID, symptomatically or asymptomatically, they can spread it to other people, including perhaps the 80-year-old grandmother who could die from it or the 65-year-old school teacher who could die from it. So, you know, this is not unlike other aspects of medicine where it truly is just one person's decision. When it comes to public health issues like a pandemic, that's not the case. What I choose to do impacts others, because if I get sick with the virus, I can spread it to others who can die from it.

Melanie: What an excellent explanation. You're a great educator, Dr. Kimberlin. I just have a few more questions for you. What can a child do after getting the COVID-19 vaccine different from adults? You know, we maybe used it as an excuse to get off work for the day. We said, "Oh, well, I see how we're going to feel," but are there any recommendations as far as returning to school extracurriculars? Are there some things we should be watching out for before sending them off to do their things?

Dr. David Kimberlin: That's a great question. And to some extent, it depends where you're living as you listen to this. You know, I mean when I talk about schools, for instance, things might look very different for Alabama schools versus Minnesota schools versus California schools versus Maine schools. And those are oftentimes driven by local realities, both realities in terms of virus spread within communities, but also obviously the political realities and the pressures that school boards are under nowadays and things that are well beyond the scope I think of your question.

I would emphasize, and I really mean this, that in the same way that adults getting vaccinated opens the door to be able to live a more normal life, it's a passport, if you will. And I think that is a good phrase to use. It allows you to be able to do more, to go to restaurants again. You know, especially if you're up in the Northeast for instance and, you know, you're obeying the rules. Down here in the Southeast, we don't really have rules, you know, that require people to show proof of vaccination, but it is peace of mind. It's knowing that you are protected against moderate to severe disease, hospitalization, and death. And that's what we now can extend, that benefit can now be extended to anyone five years of age and older. So the five to eleven-year-olds with the 10-microgram dose, the 12 through 15-year-olds with the 30-microgram dose. And of course, the approved vaccine for 16 and over.

And I think that's a big deal. That means children can go back to, you know, sleepovers. It means they can go back into the classroom with greater confidence and parents having greater confidence that, number one, they can go there safely. But number two, if and when they're exposed to the virus, they can then also maybe have a different and more truncated, a less invasive kind of response to that and not have to go quarantine for 10 days. You know, it gets our lives back. And I really think that, well, at least some of the studies so far coming out indicate that is a real driver for parents. They're not so concerned about deaths of their children because they know it's a small number and it is a small likelihood. You know, we don't, this isn't a fear campaign. This is a fact-based campaign. And they're right on the facts on that. And they might care less about, you know, the altruism of preventing spread in a community, but they do care about being able to go back to the football field, you know, going back to dance class, being able to not quarantine if you're exposed. Those are things that impact not only the child's life, but the parent's life in terms of mom or dad not being able to go to work and so forth while the child's at home. We can get beyond that now because of these vaccines.

Melanie: Wow, what an informative episode. As we're getting ready to wrap up here, and you're really telling us what's important to note for pediatricians when promoting vaccine confidence, which is, as you said, not always easy right now. Are we going to our pediatricians for this in our medical home situation? Do you think that kids are going to be going to the pharmacies? And while you're telling us about the medical home, tell us about vaccines in general, because parents are asking their pediatricians along with these questions, they're asking them, "Well, What about the flu vaccine and measles, mumps, all these other ones? I don't want my kid having all of these things at the same time." So give pediatricians your best advice here about the medical home, the COVID vaccine confidence in general.

Dr. David Kimberlin: It's a broad question, an excellent question, but with multiple kinds of facets to it. Medical home is valuable. And I do not want to minimize that. I also think we are in particularly stressful period right now, and I think pediatrician's offices many times are also feeling that stress to a pretty significant degree, you know, we're at the end of 2021 right now and many offices have fewer staff working there because people have quit or retired over the course of the pandemic. So, you know, a lot of pediatricians are nervous about the influx of all the kids that might be coming in to get COVID vaccine. And I think the most important thing we can do right now, same as with the adult rollout, you know, in the spring and over the summer, the most important thing we can do is to get as many people vaccinated as quickly as possible. If that's in the pediatrician's office, fantastic. If that's in a family practice doc's office, fantastic. If it's at the CVS or the Walgreens, fantastic. Get them vaccinated.

And for many of the pediatricians' families, you know, the ones that are fine getting it, go on and go to CVS. Those that have questions and want input, guidance from their pediatrician, that they're the ones coming in to have those conversations. And all of those are contributing toward the greater good or the greater goal of getting as many children vaccinated as quickly as possible. So that, you know, some extent does minimize or at least take away some from the medical home, but I just don't see how we can get this many children vaccinated this quickly without having some pop-up valve. And those pharmacies, for example, or, you know, hospital-based areas to go get vaccinated and so forth, those are the pop-up valves

Now, in terms of concomitant administration of vaccines, it is now recommended that if you need to get, you know, flu and COVID, get them both. If you need to get MMR and COVID, get them boats. If you need to get HPV and COVID, get them both. Or if you need to get HPV, meninge, Tdap and COVID, get them. The human immune system is extremely robust. When we get infected with a common cold virus, we are exposed to 30,000 antigens with just the cold virus. When we get, let's say, I'm going to use MMR, Tdap, meninge, and COVID, I'm having to do the math in my head here pretty quick, that's like 12 or so. You know, so 30,000 and we survive the cold, we can handle 12. And so, you know, don't get them in the same arm if you can avoid it, but don't miss the opportunity obviously to get the COVID vaccine. But also recognize, and pediatricians know this, we are way behind looking statistically or numbers across the country, we are way behind on adolescent and childhood vaccines, regular vaccines, pre-pandemic vaccines, mainly because people didn't go to the doctor last year, because they were told not to. They were told to hunker down at home. But now, we're playing catch up now and we got to do it fast.

I'm the editor of the American Academy of Pediatrics Red Book which pediatricians will know. And it's sometimes referred to as the Bible of Pediatric Infectious Diseases. It's the work product of the AAP's Committee on Infectious Diseases. And it has input from CDC and FDA and NIH. I mean, it is group think in the best sense of the word, brilliant people contributing to this. And I am collating all of their guidance. I want pediatricians to know that everyone at the American Academy of Pediatrics and the pediatricians that are members of the American Academy of Pediatrics are so grateful to what each individual pediatrician is doing in her practice or his practice every single day.

The conversations are tedious. Sometimes they're exhilarating, especially when it ends with the vaccine being administered, but know that the work you're doing every day in and day out is making a difference. And on those days, at least like me, maybe you have those times when you go, "Well, I'm exhausted. How can I keep going?" You just keep doing it. You know, that's what we're here to do. We're here to look in the eyes of the child, sitting across from us. And to know that we are doing everything we can to help have that child be as healthy as possible and grow up to be a happy and productive adult. What you're doing is making that kind of difference every single day. And I personally want to extend my gratitude to your commitment and to your passion. Thank you.

Melanie: So very well said, Dr. Kimberlin, as a parent myself, I can tell you that our pediatricians are helping us to raise our children and you guys are the gold standard helping us to do that safely, which is really what it's all about. Thank you so much for such an informative episode today. And a physician can refer a patient to UAB Medicine by calling the MIST line at 1-800-UAB-MIST or by visiting our website at uabmedicine.org/physician. That concludes this episode of UAB MedCast. I'm Melanie Cole. Thanks so much for listening.