Vaccinating kids under age 12 against COVID-19 -- what to know about dosages, side effects and more
Children ages 5 to 11 are eligible for COVID-19 vaccination. Why they should be vaccinated, what sort of protection the vaccine will provide and other details for parents are explained by pediatric infectious disease specialist Joseph Domachowske, MD. He also covers possible side effects, children who have had COVID-19 infections, those who are immune compromised and what lies ahead for children younger than 5. Domachowske is a professor of pediatrics and of microbiology and immunology at Upstate and is also the principal investigator of the Pfizer COVID-19 vaccine trial underway at Upstate that was one of the first sites in the world to enroll children under 5 years of age. (Click here for a New England Journal of Medicine article about the research behind the children's vaccine; Domachowske is one of the authors.)
[00:00:00] Host Amber Smith: From Upstate Medical University in Syracuse, New York, I'm Amber Smith. This is HealthLink on Air. Now that children ages five to 11 are eligible for COVID-19 vaccination. I'm talking with a pediatric infectious disease expert, Dr. Joe Domochowske. He's a professor of pediatrics and of microbiology and immunology at Upstate. And he's also the principal investigator of the Pfizer COVID-19 vaccine trial underway at Upstate that was one of the first sites in the world to enroll children under five years of age. Welcome back to HealthLink on Air, Dr. Domachowske
[00:00:32] Joseph Domachowske, MD: Thanks, Amber. Thanks very much.
[00:00:34] Host Amber Smith: Now parents have a lot of questions, so let's make it clear that we're talking about the vaccine that would, that was authorized for use in children five to 11. So was the lower age set at five just to coincide with the age kids start school or is there a big difference in the bodies of three and four year olds versus five-year-olds?
[00:00:55] Joseph Domachowske, MD: Well, the Emergency Use Authorization vaccine that was approved as the Pfizer formulation and the clinical trials have a cutoff, a younger age cutoff of five years. That will change when we start hearing about the data coming from the clinical trials from a Moderna where the young age cutoff was at six. Both trials continue to enroll kids under the age of five and six, but we don't have those data yet for EUA (Emergency Use Authorization.)
[00:01:22] Host Amber Smith: So it's just being done differently by different vaccine makers.
[00:01:27] Joseph Domachowske, MD: It's a fairly arbitrary cutoff, but it's also based on some prior experience with age groups that do need different dosing regimens when compared to adults.
[00:01:36] Host Amber Smith: All right. So the one right now, Pfizer, that's available now, is this the same vaccine that adults have already had access to? Um, or is there a difference?
[00:01:48] Joseph Domachowske, MD: The vaccine that is Emergency Use Authorized for five to 11 is exactly the same as the one that's Emergency Use Authorized for 12 to 16 and approved now, fully approved for use at 16 and over, but the, the subtle difference is the dosing. The amount of antigen or immunizing agent in the vaccine is one third the concentration.
[00:02:14] Joseph Domachowske, MD: So the adult dose is 30 micrograms delivered as a single dose. And then a second dose is given three weeks. For the five- to 11-year olds, the first dose is 10 micrograms, one-third the adult dose. A second dose of 10 micrograms is then given three weeks later.
[00:02:31] Host Amber Smith: And it doesn't matter how large or the weight of the child? Any of any child from five to 11 gets the same 10 micrograms, is that right?
[00:02:40] Joseph Domachowske, MD: That's exactly right. The way the clinical vaccine trial was developed was the age cutoffs, not by weight. And if we look at other examples for pediatric vaccines, we do similar strategies for vaccines that we use all the time, where we use age cutoff breaks for changing the dosing formulation for other vaccines as well.
[00:03:01] Joseph Domachowske, MD: So it's, it's something that pediatricians are certainly accustomed to.
[00:03:04] Host Amber Smith: Now do you expect a Moderna and a Johnson and Johnson vaccine to be authorized for those under age 18 anytime soon?
[00:03:13] Joseph Domachowske, MD: The emergency use authorization discussion for the Moderna formulation is on a temporary hold while more safety information is being collected. That Moderna strategy clinical trial is just slightly behind the Pfizer formulation.
[00:03:30] Joseph Domachowske, MD: But I do think that ultimately we will have, uh, pediatric formulations for both Pfizer and Moderna starting at six months. For Johnson and Johnson, they have started some very early phase pediatric trials. But I'm not sure they will continue on. I think they need to see how well the market share is and how much uptake there is based on the mRNA vaccines that are several months, if not a year ahead of the efforts at J and J.
[00:03:56] Host Amber Smith: Now you used the safety, and I think that's the main thing for parents. How do we know that these vaccines are safe for our children?
[00:04:05] Joseph Domachowske, MD: Well we have so far safety data on approximately 4,000, uh, five-to 11-year olds that have been immunized in the clinical vaccine trials and tens of thousands of those individuals 12 and older who have received the adult formulation of the vaccine, and the side effect profile that we're seeing in the five-to 11-year olds is very similar to what we see with vaccines that we use every day that we've used for decades in these kids. So, some injection site reactions, some low-grade fevers that are self-limiting. They last maybe for a day or two. Um, most of the people that have gotten the Pfizer or modern vaccines as adults have experienced similar side effects. And I can tell you that the rates of those side effects using this lower dose for the five-to 11-year-olds is a smaller percentage of the total vaccinated, so I think one of the benefits of going to the lower dose for the kids is that we're seeing a much better tolerated, uh, reaction profile. And we already know that there's no trade off in the form of how well we can induce the antibody responses in those kids. So there's no trade-off the antibody responses are just as good, even though the dose is one third.
[00:05:18] Host Amber Smith: You mentioned a lot of the temporary sort of side effects. Are there any serious side effects that were noticed or that parents should be on the lookout for?
[00:05:27] Joseph Domachowske, MD: The only serious side effect that has been noted so far with either of the mRNA vaccines, the Pfizer formulation or the Moderna formulation is this very rare side effect of myocarditis within a week or so of receiving usually the second dose. And that was noticed first in young adults, mostly young adult men. The first findings came out of Israel, where they launched a vaccine program for 7 million of their population. And what they were seeing in Israel was an uptick in the reported cases of myocarditis. So this led to some very active surveillance for myocarditis in the adult trial in the United States for the Pfizer and Moderna vaccines. And now of course there's much interest in looking to see if the side effect ever occurs in young children. So far from the clinical trials, I can tell you that in the five to 11 group, there has not been any cases of myocarditis in the vaccine trials.
[00:06:24] Joseph Domachowske, MD: Of course, we've been only vaccinating starting today (Nov. 4, 2021) in the five to 11 group. So we may see some very, very rare reports of myocarditis in that age group, going forward. In each case, those individuals that develop myocarditis from the vaccine, it's typically a very brief, mild condition. Sometimes hospitalization is necessary for some treatment, but the hospitalizations are also brief and there have been no deaths associated with vaccine-induced myocarditis. But I can tell you that the rates of myocarditis from active COVID infection are at least 10 times the rates that we see from the vaccine, and death is a known complication when it occurs from the wild type infection.
[00:07:08] Host Amber Smith: All right. Well, good to know. I want to ask you about the urgency in vaccinating children. Is it true that children are at low risk for getting seriously ill from COVID?
[00:07:19] Joseph Domachowske, MD: As a general population, if we compare the 28 million children that are age five to 11 in the United States as a group, they are at low risk for serious consequences of COVID-19 infection when we compare them to older adults, especially older adults with risk factors that we know. But I can tell you that we've seen dozens of kids hospitalized with COVID, especially the, the young teenagers or adolescents who have underlying risk factors, such as asthma or being overweight. And while those kids generally do better than the adults do, and mortality is low, uh, they end up in the hospital often for a week or longer.
[00:08:02] Joseph Domachowske, MD: There have been about on 100 reported cases of COVID deaths inchildren in the U S so far since the pandemic started, and compared to the death numbers inadults, that's an impressively low number. But a single death in a child is unacceptable, especially when we have a vaccine to prevent this infection. The other issue related to children that doesn't appear to occur in adults is that following COVID infection, even those infections that are very mild, or we don't even know about, um, a week or two later, a very small subset of those kids will end up with a post-infectious inflammatory condition that we refer to as MIS-C or multi-system inflammatory condition of childhood. This is a life-threatening inflammatory condition. We get those kids in the hospital right away, and we are challenged to quiet down their inflammation. This is a very difficult condition to treat. And I do know of one MIS-C-related death that we had locally. Um, so this, this is not something that that should be trivialized.
[00:09:06] Joseph Domachowske, MD: We really need to pay attention. Uh, while children are much less likely to suffer the severe consequences of COVID compared with adults the morbidity and even the mortality is significant enough to warrant widespread vaccination of every single person who's eligible.
[00:09:22] Host Amber Smith: Well, I've also heard that COVID-19 has become one of the top 10 causes of deaths among children, even though it's rare, that it's one of the top 10 causes among children ages five to 11 could widespread vaccination of this population changed that would it make an impact?
[00:09:42] Joseph Domachowske, MD: Absolutely. We know that prior to use of influenza vaccines, for example, that influenza-related mortality was in the several hundred to 500 or 600 range and a particularly bad flu season in children. And now we from year to year, if we see more than 80 or 90 deaths in children from influenza, it's an unusually severe year. So already we've identified COVID, withthese 100 cases as being more likely to cause death than something that we're much more familiar with that thankfully is also vaccine preventable.
[00:10:18] Host Amber Smith: Now, what do you say to parents who are concerned about how quickly the vaccine seemed to have been developed?
[00:10:25] Joseph Domachowske, MD: Um, it didn't seem very quick to me. I've been doing the clinical trials. But yes, I do see their point. From the outside looking in, it appears that this got rushed, but remember that the adult trials started about a year before the pediatric trials were even, um, designed to allow for early phase one enrollment. So there was substantial amount of safety data in 16 years and older that we relied on as we started immunizing in younger and younger populations in the clinical trial efforts. The efforts that we started here for the phase two-three, which are the advanced efficacy type placebo control trials, um, they started in June, and it's October. So that seems really fast compared to any other vaccine study that we do. The two differences here are that when, uh, when a new vaccine is being investigated, typically it has to go through the full phase one series of trials. Then there's a stop. The FDA looks at the phase one data and then makes a decision about allowing to go to phase two or to phase two-three.
[00:11:36] Joseph Domachowske, MD: That stop can be a year long and it can really slow the progress down. Uh, the difference here was that phase one, two, and three were all put together as part of the same protocol. And very carefully evaluating safety on a day-to-day basis as new information came in. And we were prepared to stop enrollment in the trial at a moment's notice, if there was a single event that was considered vaccine associated, that was severe, if there was a single death related to the vaccine that was going to shut everything down right away. And then there were softer criteria for the seriousness of the side effects that were being seen. And in fact, as we were dose selecting for each age group in the younger ages, we saw a little bit too much fever in the five- to 11-year-olds that got close to the adult dose.
[00:12:26] Joseph Domachowske, MD: So 20 micrograms or even 30 micrograms, they had a little too much side effect reactions. Not that it was severe, but it was so common that we thought, it doesn't make sense to provide a vaccine for a population like children, where we're going to see fever and almost every single one of them. So how can we figure out what the dose needed is that can achieve the same result with the same antibody responses and the same efficacy that we already know for adults. And that's how the 10 micrograms was decided. And I can already tell you that the dose for the six month up to the five-year-olds is three micrograms. So that's going to be one 10th of the adult dose. That's how impressive the, uh, the profiles are, when we look at them one by one. Much better safety as we get younger and younger with lower and lower doses, but without any trade-off, as far as the antibodies that are being produced in response to the vaccine.
[00:13:23] Host Amber Smith: That's good to know. Upstate's "HealthLink on Air" has to take a short break, but we'll be back shortly with more information about the COVID-19 vaccine for kids from pediatric infectious disease specialists Dr. Joe Domachowske.
[00:13:36] Host Amber Smith: You're listening to "Upstate's HealthLink on Air". I'm your host, Amber Smith talking with Dr. Joseph Domachowske. He's a professor of pediatrics and of microbiology and immunology at Upstate. And he's giving us some straight talk about how the COVID-19 vaccine works for kids ages five to 11. Let me ask you about the vaccine trials and whether they revealed any concerns about the vaccine affecting a child's development through puberty or a child's future fertility.
[00:14:05] Joseph Domachowske, MD: Yeah, that's a great point because very early on there were basic research scientists looking at animal models and proteins that are expressed on the surface of placental cells that seemed to very weakly cross-react with the antibodies that we make when we have COVID infection, or when we use a COVID vaccine.
[00:14:27] Joseph Domachowske, MD: So there was this basic science hypothesis that we could interfere with placental development if we have antibodies that are directed against those placental proteins. Well, it turns out that, -- uh, and it was important to study it --, but it turns out that those antibodies are so weakly attracted to those particular cross-reacting proteins in the placenta that they don't really bind much at all. So it ends up being a non concern. Unfortunately it got translated in some of the lay literature and some of the the social media as a indicative that we may have some problems with puberty or fertility and those types of things. Uh, if you go back to the source where the idea came from, it's easy to prove that wrong already.
[00:15:15] Host Amber Smith: Okay. Now are the vaccines appropriate for children with compromised immune systems or children who have chronic health conditions?
[00:15:24] Joseph Domachowske, MD: Yes. So of course we want to protect those who are most at risk most carefully. So are the vaccines that we have, or the one for the Pfizer formulation for the five- to 11-year-olds that now has authorization for use, is it appropriate for those immune compromised patients who are medically complex patients? Well, in the clinical trials, those particular groups of children were excluded, particularly, because we know that in general, they respond less well to all vaccines. And we wanted a real world look at how well these vaccines did at producing antibodies in the general population.
[00:16:05] Joseph Domachowske, MD: So the, the corollary is that we expect these vaccines to work reasonably well in those medically complex patients, but they may not do what we expect them to do in otherwise healthy kids. And that is a trade-off that we always take in children and in adults. And it's one of the reasons why now, if you're following the recommendations for boosters, that booster vaccines for adults that are transplant recipients. Talk about immune compromised, right? That population, um, really has a very compromised ability to respond to things that are trying to come and infect them or two vaccines. And in that situation, it's clear that for adults with transplants, we need to re-vaccinate them with multiple boosters. Uh, currently the, the total regimen is four doses, but it won't surprise me if that goes up.
[00:16:58] Joseph Domachowske, MD: So when we talk about children who are compromised, as far as their immune system goes, or they're medically complex, maybe they have a trach or they need a ventilator at night in order to maintain their breathing. Those are among the highest risk for morbidity or death from COVID infection. So they should be first in line, for vaccination. We should be doing everything that we can to protect them, social distancing, masking, making sure that people around them are vaccinated. Especially if they have healthier immune systems, we don't want to bring the virus to those kids. And of course, vaccinating the kids in the hope that their immune systems are healthy enough to at least give them some level of protection.
[00:17:41] Host Amber Smith: So what you just said pretty much applies to adults too, that have health conditions, that they still have to take care, whether they're vaccinated or not, they still have to use common sense and the social distancing and the masking just to protect themselves, still.
[00:17:58] Joseph Domachowske, MD: Absolutely. Now, there, there are a subset of vaccines that we call live vaccines. Most of them are live viral vaccines, meaning they're weakened viruses that are very similar to the virus that causes the infection Measles is a good example. Chickenpox is another good example. Those vaccines, even though they're weakened vaccines, because they're still alive, they are not appropriate to give to our very immune compromised patients because they may not even be able to fight off that very weakened vaccine strain. But for the COVID vaccines, none of them have been developed as live vaccines. So we don't have to consider the live vaccine issue as far as a contraindication to receiving vaccines for those who have immune compromised conditions. In fact, those are the patients that should be at the top of the list and prioritized to get the vaccines themselves.
[00:18:50] Host Amber Smith: Are there any children who should not get the vaccine?
[00:18:53] Joseph Domachowske, MD: The only absolute contraindication to receiving the Pfizer formulation, 10 micrograms, is a known allergy to a vaccine component. And thankfully these mRNA vaccines are the simplest biochemically, the simplest vaccines that we use across the board. They have RNA in them and they have some cholesterol-like fatty lipid particles to protect the mRNA from being degraded before we inject it as a vaccine into an individual. That's it. The rest is just some salts and buffers that all of us are exposed to every day when we have a Gatorade or drink drink drinking water. So they're very unlikely for individuals to be allergic to one of those lipid components. Um, but there are a very, very small number of individuals who have received those types of lipids in another medication, or even who receive a single dose who have an acute, severe allergic reaction to it who should never receive another dose of that particular form of formulation. Since theformulation of the J and J (Johnson and Johnson) vaccine is quite different, it is often an alternative. If we do have someone who can't receive one of the RNA vaccines. For now, that's limited to adults, but hopefully one day it will be extended to children as.
[00:20:15] Host Amber Smith: Now, what about a child who was sick with COVID or who tested positive before? Do they still need to be vaccinated?
[00:20:22] Joseph Domachowske, MD: Absolutely, yes. And the data for this are becoming more and more clear that immunity from natural infection is nowhere as good as the immunity that's achieved following two doses of mRNA vaccines for children or for adults. And ironically, the people that are best protected, who are immunized are those who were infected with COVID before they started their vaccine series. So that's an even added incentive in my mind to say, wow, you can really be even better protected for a longer period of time if you already had COVID and now you're going to get your two-dose mRNA vaccine series -- Pfizer, or, Moderna. Um, those individuals now clearly show that their longevity or their durability of protection is going to be for many months longer than those of us weren't infected before we started the vaccine series. It's great information and it's really carefully described.
[00:21:18] Host Amber Smith: So how soon after a child is vaccinated, are they protected? And they need the two dose series. So that's, they're three weeks apart, right?
[00:21:26] Joseph Domachowske, MD: Correct. So if they get their first dose today, they would get their second dose right before Thanksgiving, um, three weeks from now. And then two weeks after that two-dose series they're considered protected. They're considered fully vaccinated. Whether or not boosters will be recommended based on the clinical trial data that we're continuing to, to gather, uh, is still an unanswered question, but we will have an answer for the community once we get to that point, because the clinical vaccine trials are several months ahead of the Emergency Use Authorization community availability for the five- to 11-year-olds.
[00:22:08] Host Amber Smith: Can children get the COVID-19 vaccine at the same time they get other childhood vaccines?
[00:22:14] Joseph Domachowske, MD: Yeah. So the Advisory Committee on Immunization Practices -- this is the advisory committee to the Centers for Disease Control -- this is the group that met on Nov. 2nd of this year to basically recommend that COVID vaccine be used in children five to 11 now that it was Emergency Authorized by the FDA, (Food and Drug Administration.) So the ACIP has stated that other recommended vaccines can be given, can be given, uh, safely at the same time the COVID vaccine is administered. This is based on limited amount of data because we didn't do that during the clinical vaccine trials, uh, intentionally, but some of those kids did get vaccines sort of on the side, even though they weren't supposed to in the vaccine trial. So based on what we know about, vaccinology in general, there's very few instances where all of the vaccines that an individual is due for cannot be given at that same visit. So the ACIP is using that historical information to provide this guidance, completely understanding that doing so offers a level of, um, logistical convenience, and also will improve both our immunization rates for COVID and for influenza, because spacing them out or doing them at different times means that we start losing some of those kids to having one or the other full series of vaccination. So the current recommendation is yes. COVID vaccine can be given along with influenza vaccine at the same time in a different injection spot and other vaccines that are also necessary could also be considered at the same time. The downside of doing so is that if there are moderate or severe side effects, it's unclear which of the vaccines that were given has caused the side effect.
[00:24:07] Joseph Domachowske, MD: So in children who have a history of maybe having excessive swelling or injection site reactions and response to other vaccines, it might be better to space these out and give the COVID vaccine separately and independently so that, uh, vaccine specific side-effects can be determined for the future.
[00:24:28] Host Amber Smith: Now I know we talked about the dosage of the vaccine being about a third, or 10 micrograms, for kids from age five to 11 compared with the adults that get the 30 micrograms. And we talked about size. But let me ask you this: if a person has a large 11-year-old, who's turning 12 next month, should they just wait a month to get the full dose? Or should they vaccinate now?
[00:24:56] Joseph Domachowske, MD: My recommendation in that situation is to go forward with the 10 microgram dose times two, three weeks apart. And the reason I say that is that we know the side effect profile in the 12- to 16-year-olds from the adult dose -- the 30 microgram dose that's Emergency Use Authorized for 12- to 16 -- is more reactogenic than the 10 microgram dose is for the five to 11 years, meaning it causes more side effects, injection site reactions, more fever. A higher percentage of those kids will, will end up with those things. The FDA asked both Pfizer to do an extension of the safety study for the clinical trials that we're involved with now looking specifically at a lower dose for 12- to 30-years old. So we're not just stopping in the teenage age group. These clinical trials are going from 12 up to 30, where a 10 microgram dose is now being evaluated for exactly the same reason. Can we bring that dose down to 10 micrograms without trading off how well it works and thereby reduce the, the tolerability profile, reduce the percentage of those individuals having moderate side effects? And I'm going to predict that we start soon using a 10 microgram dose as a two dose series for many individuals, at least through the teenage years. We have to wait for the formal clinical trial results, but it won't surprise me at all. And that's why I would recommend that, um, an 11 year old, soon turning 12, even if they're not a large 11 year old, uh, go ahead and get vaccinated under the current EUA 10 microgram dose regimen.
[00:26:36] Host Amber Smith: All right. Well, let's talk a little bit more about what the vaccine provides to children. If a child is vaccinated, can they still be infected with COVID-19?
[00:26:45] Joseph Domachowske, MD: Yes. There, there's no doubt that none of the vaccines that we use for anything are 100 percent effective. There's differences in immune responses for many, many different reasons. But there's always going to be a small percentage of individuals that just aren't fully protected. Now, the vaccinology tells us the science tells us and experience tells us that those who are vaccinated, if they do get a breakthrough infection, will have a much milder course and be less likely to be hospitalized for example, or have a severe complication from the infection.
[00:27:18] Host Amber Smith: Well for children who get vaccinated, for most children who get vaccinated, if they are exposed to COVID-19 does the fact that they're vaccinated, is that going to prevent them from spreading the virus to other people?
[00:27:32] Joseph Domachowske, MD: Well, the, the clinical trial data that we have so far -- so the purest data, um, for the clinical trial participants -- one third of them got placebo, meaning they didn't get active vaccine at all. Two-thirds of them got vaccine. At three months after their second dose in the clinical trial, there were 16 total cases of COVID infection documented in the placebo group, which is, again , one third of the total enrolled. And in the vaccinated group there were only three. So 91%, almost 91% efficacy at preventing infection altogether. And if you don't get infected, you're not going to spread it to someone else. Will those few that do have breakthrough infections, um, have enough virus replication and have sort of respiratory hygiene that's a sloppy enough if you will, uh, that they can be transmitting that infection? Sure. But it's much less likely than a child, who's never been vaccinated, who's replicating very, very high amounts of virus and you know, coughing or sneezing. And those individuals are going to easily transmit, especially the Delta variant.
[00:28:44] Host Amber Smith: Do we know how well this vaccine is going to protect against future variants?
[00:28:49] Joseph Domachowske, MD: We don't because we don't know what variants are going to emerge. Um, this virus is, um, you know, kind of tricky. We have to try to keep up with it and watch it very carefully. The, the virologic testing that's being done is molecular, and it's being followed and tracked to try to predict what variants might emerge, especially variants that could evade the protection provided by the current vaccine strategies.
[00:29:16] Joseph Domachowske, MD: Luckily the mRNA vaccine production process is simple enough compared to every other vaccine that's being made for other reasons that changing the mRNA in that vaccine is fairly straightforward and simple so that we can use a change or a mutation in our vaccine to change the way our antibodies are made, so that it's directed specifically against a mutant that we can't currently provide protection for. So it won't be done over the course of two or three years like we would expect for a different type of vaccine strategy, but we're talking about within a couple of months, we could have a, a new formulation or an added mRNA subgroup of subspecies in the vaccine to provide that extra protection on top of the current antibodies that we're already making from the widespread Delta variant.
[00:30:13] Host Amber Smith: That's good to know. Now, kids who get vaccinated, once they're fully vaccinated, can they safely interact with grandparents? Can they go out and sort of start living life again?
[00:30:25] Joseph Domachowske, MD: We have to look at both sides. So we need to make sure that those grandparents are also vaccinated. And if those family members are now vaccinated, I say, let those families come together, as long as nobody is feeling ill. You know, if anybody's feeling sick, it's not a good idea to be hanging around with, uh, folks who are older, especially the more frail elderly who have, um, comorbidities, other medical conditions underlying. And that's just good, common sense even before the pandemic, right.
[00:30:54] Joseph Domachowske, MD: I would say that the, the way this vaccine works, especially in kids, that we can finally let those kids unmask and spend time with the grandparents, as long as everyone in that group has been, uh, fully immunized.
[00:31:06] Host Amber Smith: Well, before we wrap up, can you tell us where things stand with the vaccine for children under the age of five? I know you're involved in trials for that, but can you predict how soon things might wrap up?
[00:31:17] Joseph Domachowske, MD: Yes, it's very exciting. So we have been involved in recruiting and enrolling children in the clinical vaccine trial down to age 6 months. The total trial enrollment has been completed, but we're now waiting for the rest of the antibody response data from the blood testing that's done in those immunized to be finished and analyzed. And once that's done, um, in Pfizer, we'll certainly be pulling together an Emergency Use Authorization packet for submission to the FDA. It's likely that will first happen for the two- to five-year-old group, just because that group is really a good four to six weeks ahead of the six month- to two-year-old group in the clinical trials.
[00:31:59] Joseph Domachowske, MD: And then to follow in a wave, sort of, is the data for the younger kids. And as we as we gain more information about the safety profile and the immunogenicity profile of that three microgram dose, right? This is one 10th of the adult dose we're studying in the under five-year-olds. Then I think that the FDA will be eager to evaluate its safety profile and how well it's working.
[00:32:25] Host Amber Smith: Thank you for taking time to talk about this. My guest has been Dr. Joe Domachowske, a professor of pediatrics and microbiology and immunology at Upstate. I'm Amber Smith for Upstate's "HealthLink on Air."