Duke expert explains COVID vaccine trials, takes questions about shots for kids
A Duke expert who led the first trial of COVID vaccines in children under 12 will discuss the results and take questions in a briefing Oct. 27, 2021.
dr Emmanuel chip walter. JR is chief medical officer of the Duke human vaccine institute where he directs the vaccine and trials unit. He is also a professor of pediatrics at the Duke School of Medicine dr walter. Good morning, Good morning Greg. So to start us off, can you just give us a quick overview of the trial you conducted, who the subjects were and what the results were? Sure. So um we have been working in the past year and starting I guess about March of this year on the visor pediatric covid vaccine trial. That trial did as I said, start in March of this year and it's really been conducted in in a few different phases. The trial includes Children from between the ages of six months up through 11 years of age. And um basically the trial first uh includes those groups that that age group of Children but really in three different kinds of cohorts within that age group. So it's Children between the ages of 5-11 and then Children between the ages of two and four and then Children between the ages of six months to two. Uh we really started out the trial in the first phase by trying to determine what the best dose of vaccine. And this is again, the fighter bio N. Tech vaccine is. So we really started by evaluating three different dose or doses of the vaccine. So 10, 20 and 30 microgram Doses of the vaccine. And uh in that part of the study we determined better between the ages of five and 11 that the best dose for those particular Children was really the 10 microgram dose, which is a third of the adult dose. Um and that really that those results, we're based on kind of some preliminary uh immune response. So determined that the Children developed an adequate level of protection and also that it was really the dose that was best tolerated for Children that age. So with the fewest side effects like fever and achiness and chills and things like that. So from there we went on to evaluate in larger and larger group of Children. And I'm just really concentrate on the age group that you mentioned that is approved by the FDA. We concentrated the study in Children between the ages of 5 to 11 and vaccinated Children, Children were randomized to 21 to get either 10 micrograms of the biontech vaccine or placebo. So they were twice as likely to get vaccine in that in that part of the study. And then monitored Children for were side effects and safety. And looking at their immune response as well. So, parents were given a diary to report symptoms on a daily basis for seven days after Children received each dose of vaccine, The doses of vaccine were uh given three weeks apart just as with adults. Uh and then we measured uh obtain samples from a portion of the Children, uh looking to see whether they got protection from the vaccine. So that study uh included about 4500 Children. About 3000 who received over 3000 to receive vaccine. Uh and then about 1500 who received placebo. Sure. Absolutely. Certainly lots to dig into here. And 11 thing I wanted to ask you about, you mentioned that obviously you were looking to see what those generated an adequate immune response. So how do you measure that? What do you consider to be an adequate immune response to to show that the vaccine is doing its job? Yeah. In this case this was uh, it's a good question. And what's called an immune bridging study or um, you know, bridging study where we look at levels of antibody in a comparison group and in this case, uh the comparison group was older, older Children. So adolescents who were, you know, slightly older. Um, And young adults up to age 30, and looked at their immune response in a subset of those people who were in the original fighter trial and compared the responses and these young Children to those responses. Because what we knew is that the responses in the older Children uh equated to a level of protection. Uh, so we wanted to determine whether Children, younger Children given a lower dose of vaccine had the same degree of protection as the older Children. So it's called what's called an immuno bridging study and that's often done in vaccine studies. Sure. Thank you. That makes sense. Um, we know that obviously a lot of parents have concerns about the vaccine approval process. And one thing I want to ask you about is because we're looking at emergency use authorization here. Can you talk about whether the safety requirements for that authorization or any different from the full authorization that we've now seen for the adult vaccine that we would expect down the road. Are there any differences there in the safety standards or the rigor of the safety requirements for those vaccines? I mean I think that there's no difference in the safety standards. I think the only thing that would potentially be different in this case because we're in a pandemic situation here um where you know, we're still experiencing the delta wave, although it's coming down during the course of this study, we were right in the, in the midst of of of a pandemic situation. Um, and uh in that case you really have a public health emergency. So there is a need to get the data more quickly. So I think what you see here is that enrollments are more rapid. Getting the data assembled is more rapid. Um, getting the data reviewed as more rapid. It's done on an ongoing basis with the FDA. Um, so, so yes, there is a sense of rapidity but it really is meeting all the same safety standards. What may be slightly different is how long and the follow up is, but these Children are, you know, before you make an emergency use authorization versus a full approval because we're in a pandemic situation. But ultimately these Children are all being followed for for the same period of time as you would normally do. Sure, absolutely. Thank you. And as a follow up to that, one of the things we've seen amongst the vaccine hesitant in the adult population and probably among parents to is this whole wait and see attitude people want to wait and see. And it's not entirely clear what people are waiting for. And so I wanted to ask you, is that with previous vaccines with this vaccine? Um do we ever see effects down the line? Is there any actual wisdom in waiting to see the effect of a vaccine or if we're going to have side effects or any adverse effects, Would we expect to see those within the first couple of weeks after somebody gets a dose? Yeah, I mean, I think that that's a really good question. I think the the um, the answer there at first, I think I would look first at the experience so far with this vaccine and the millions of doses that have been administered uh two older Children uh and adults and look at the safety track record there, which has actually been quite, quite good. Um and I don't think we have any reason we've got the safety track record will be any any different in Children. So I'm I'm, you know, really, I think people can be reassured that that the safety of this vaccine and Children will be really comparable to that which is seen in adults and I feel comfortable giving their time on the vaccine. Absolutely, thank you. Just to be clear, is there any difference in the fires of bio N. Tech vaccine the Children will receive versus what adults received? Or is it just simply a difference in the size of the dose? Um The vaccine is pretty much all the same vaccine. It will be a reduced Dose as I said earlier. It's a, you know, a third of the dose. So this is a 10 microgram dose vs a 30 microgram dose when it is packaged. It will look different. Um I think that's one of the questions that has come up. It's certainly a question I had. What would what would it look like? The I think the current vaccine has a purple cap on the on the vial. This one will have an orange cap on the on the vial. Uh It will be labeled that it will be just for Children. Uh So the adult dose should not be used for Children. This is specifically for Children, but it really is the same vaccine at a reduced dose. Sure. Thank you very much. We're gonna heard opening up to questions now. Thanks to everyone who's a bit of questions in advance. You can also pose questions via the Q. And a window at any time. I see we've already got some in there. And if you'd like to ask a question in person, raise your hand in zoom and we will a mute you when your turn comes around. If you're calling in by phone you can raise your hand by pressing start nine. Thanks also to everyone watching this on youtube. So I'm gonna go through some of the many questions that we've had submitted in advance here and one of those is that obviously there's a there could be a massive difference in size and weight and physiology of a child who's five versus one who's 11. So would we expect to see kind of a better immune response among the smaller Children because proportionately it's a larger dose or are there any differences we should expect to see in reaction Among the younger Children rather than those who are 10 or 11 and larger? Yeah, I mean I think that's a really good question. And then once that's probably open for a little discussion, you know, I think you, you know, when you design studies, you kind of um at some point you have to make things practical in terms of the administration, um, and widespread use of the vaccine. So and something you have to come up with some age cut points. So that's why when I was talking about the trial design earlier we had, you know, Children in groups of six months to two years Children between the ages of two and Or and then Children between the ages of 5-11, I think what we can say is that probably uh for the most part Children and yes, there are variations in size but in terms of immune response, Children between the ages of five and 11 should respond no matter what their sizes with, with a good robust immune response uh to the vaccine at that one dose even with a big variation in in size um that that you may see. So you might as you said, have some small five year olds and some rather large uh 11 or 12 year olds. So, but I think the the immune responses will be adequate for those for those kids in terms of safety. Um you know, we did spend a range of kids within that age group, you know, 5 to 11 and the safety really didn't appear to be different across the age group. Um We did divide out the bigger part of the study. So we are looking at lower doses or lower dose actually in in the youngest Children. So sure, thank you. And yeah, later on I'd like to come back to the Children under five since that's obviously still something that's out there, but right now we're obviously focused on the uh the FDA approval for Children 5 to 11 and um you related to that yesterday um the the hearing was very much focused on risk versus benefit. You know, the benefit uh, vaccinating this population versus the risks. Um based on your, you know, your work with the vaccine study and your work as a pediatrician. Do you feel that approving the vaccine at this time for Children 5 to 11 is the right call? Yes, I'm absolutely confident that this was the right call. Um, you know, I think there there was a large and rightfully so and a good robust discussion yesterday about risk versus benefit uh for the vaccine, I think, you know, obviously the issue that came up was the issue about myocarditis and risk of myocardial itis, myocarditis being inflammation of the heart muscle and also pericarditis, inflammation around the heart. And um, if you look at that, you know, you have to realize that um, you know, myocarditis has been seen feeling the Covid vaccines or what's the Pfizer biontech is one of the two M. RNA Covid vaccine, the other one being the Moderna vaccine that risk really for for developing this seems to be greater after the second dose of vaccine. Uh, it's more commonly seen in males, particularly young males between the ages of 16 to 30 and the rate. And that particular group is about 40 per million doses of second doses of Covid vaccine received. I think it's really important to recognize that not all myocarditis is the same. In fact, you can develop myocarditis after developing Covid as a complication and that myocarditis from Covid actually is usually quite severe and makes people quite ill and causes a prolonged hospitalization. The myocarditis that we've been seeing after vaccine is generally fairly mild. It does often lead to hospitalizations, but it's usually very easily treated once, you know, once it's recognized. So uh you know, I think you have to weigh that risk of developing covid. So depending upon the prevalence of covid in your community versus uh you know, the risk of uh and complications from covid including myocarditis versus the risk of myocarditis from next team, which is exceedingly rare. So I think in this case everybody decided after considerable deliberation yesterday decided that, you know, the risk versus benefit much was tipped and benefit of vaccination. So sure, very quick logistical question because we've had this coming from a few people will the vaccines for this age group if approved, take the same form as adults in that they'll need two shots a few weeks apart. Or would it be one shot because their Children? No, it's again uh it will be very, very similar to the adult dancing schedule. It'll be two shots of a lower dose. I just want to emphasize that the 10 microgram dose for Children and they'll be administered three weeks apart. Sure. Thank you, couple of follow up questions to the point you just made someone asked that if there had been any cases of myocarditis in the 5 to 11 age group as a result presumably of contracting covid that you know, of a great question. You know, it was certainly in the trial. Uh, the short answer is no, there were no cases in the trial, but it was something we really, uh, because we knew that jesus and like arthritis had been reported that we really carefully looked for uh, in in the study. So if, you know, if certainly if if a child complained of any pain, chest pain or shortness of breath, that was something, you know, Children were immediately, the families were immediately called. The Children were evaluated. So it was examined for quite closely in the trial and there were no cases terrific. Thank you. Um, going back again to the hearing yesterday, there was at least one doctor on the FDA panel who expressed concern over making a decision for millions of Children based on studies that had only a few 1000 Children. What reassurances could you offer the parents who might have that same concern? Yeah, I think, um, what I would say about that is, you know, again, I think we have to look at this vaccine in total with the millions of those is that have been administered to adolescents and and adults, um, that we can be reassured by that. And then the Other factor is if you're looking for, you know, a study of 3000 Children getting the vaccine actually is a pretty good group. If you're looking for fairly common side effects. If you're looking for rare things that occur of rates in, you know, in one in a million, there's absolutely no way that you're going to be able to tell that in a study, even a study that included a fairly large number of a much larger number of Children. So, um, I don't think that we would accumulate any more data with a larger trial. So um, at some point you have to say, you know, we are confident that you know what we know about this vaccine that it's safe and comfortable giving it to Children. Sure. Thank you. You mentioned earlier also that the trial started March and that the Children were followed. Will you continue to follow the subjects from that trial? Um, you know, you continue to follow now and if so, how long will they continue to be followed to monitor for any long term side effects? Yeah, We'll continue to monitor her for two years. Excellent. Really close contact with participants Marvelous. Um, another question we had, there was a recent poll that found that almost 25% of parents don't intend to get their Children vaccinated. And another third said they would wait and see. Uh about third said they would get their kids to shop right away. Do you think that that level of uptake where we only have a third who plan to get it right away and more than waiting and seeing. Will that be enough to make a difference in the spread of the virus or to protect that population and others? Or does more need to be done to convince hesitant parents. You know, I think, you know, vaccine hesitancy has been with us for a, you know, a long time I think um certainly it's been somewhat prevalent with covid pandemic and I think, you know, people uh uh yeah, there will be people that will uptake or you know, decided to get vaccinated or have their Children vaccinated quite quickly. There'll be some in that middle road uh that that will be kind of waiting a little bit as you pointed out. And then there will be also some that just don't want to get vaccine. I think, you know, the the issue is you're correct that without achieving a certain level of protection in the community, um, you may not get the full benefit of the vaccine to achieve what we call her protection or community protection from a vaccine. In fact, vaccination rates with this particular Or coverage with this particular vaccine. These particular vaccines with this virus actually probably has to be on the level of 80, uh to really achieve that kind of herd or community protection from from infection. Uh so, you know, with the numbers that you Are saying uh you know, that doesn't quite meet that goal. Um, but I think if you look at the population as a whole and consider that Children, you know, for roughly about 28-20, some percent of the population getting as many Children vaccinated as possible will lead to overall population protection. So sure, absolutely, thank you. And as a follow up to that, because it seems like generally anecdotally, at least the cases in Children have been lower than they have been in adults. So when it comes to vaccinating this population, how much of it is about protecting that population and how much of it is about protecting the the more elderly people and immuno suppressed people? Um ba in terms of getting Children vaccinated because of the elderly relatives they live with, for example, how much is it protecting kids and how much is protecting others? Or is it just both? Uh My my short answer would be it's both. Um you know, I think you know, we have to be able to afford Children the same protection from covid through vaccination that we afford to adults. I mean, I think that is the the right thing to do. Um we do need to realize that with this current delta surge Children now account for about 25% of reported cases of COVID that's been really a little bit different with delta than it was earlier in the pandemic. And part of that may be related to the fact that we have a larger portion of the adult population vaccinated right now. Um and then I think most importantly for kids is, you know, I think we've been kind of lulled by this thought that yes, the pandemics worth in older adults and adults with comorbidities, but Children aren't totally spared from covid. Um you know, I think when I last looked the other day, there have been 700 nearly 750 deaths from Covid and Children under the age of 1860 deaths in this age group for which we're now um considering approval or authorization for the vaccine between the ages of five and 11. Um and that's way more tests then it occurred to the influenza in a typical year. So I think if you kind of put it in that perspective in terms of health, we really do need um to get Children vaccinated other reasons uh you know, to prevent complications from covid uh in Children, I think um you know, Children can have this condition, where do they get inflammation in their multiple organs in their bodies or their heart, their lungs, kidneys, uh their G. I. Tract intestines um called multi system inflammatory syndrome of childhood. Um makes can make kids quite ill. Um there have been about 5000 or more reported cases of that with 46 deaths occurring due to due to that complication of COVID. Plus there are long term potential long term effects of covid, which we really haven't even well defined um in this population. And I guess the last point for why vaccinate Children now is really to allow kids the freedom to be kids and do all the things comfortably that kids do go to school. Um, you know, do sports activities, other after school recreational activities and just do the normal things that kids want to do. So. Sure. Absolutely. And and related to that. We had a number of questions about mask mandates. There are some school districts that starting to lift them. Do you think that's premature? Do you think that the once the vaccine is out there that that is something that could be considered? Yeah, that that issue has come up lately. I think, you know, right now, I think it's premature to do that until we get some, you know, we know we things happen have to happen when we have to get a good level of coverage of for vaccination in, in this age group of Children. So that that has to occur and um, the rate of covid and the community has to fall to a certain level I think for us to feel comfortable about really lifting mask mandates. So I think it's a little premature. We're not, we're not there yet. So maybe we can have those discussions in a few months from now, but I'm not sure we're there yet. Sure. Thank you. I'm getting through as many of the questions that we've got as we can, we have a raised hand, um, in the chat. So we'll go ahead and a mute. You you can go ahead and ask you a question. Hi, this is Judith with CBS 17. This might also be something that's a little bit premature but we're talking about boosters for older populations. Do you anticipate that later down the line? This may be something that we start to consider for these younger age groups? Yeah, Thanks for that question. Um It's a good question. I don't think I have quite the answer for you at this time. I think it depends on, as I said, you know, where where we head with the pandemic. I think what we do know Um and adults is that the level of antibody uh over time, you know, over the period of 6-7 months or so declines. So uh that um you know, your your level of protection from vaccination kind of decreases over through vaccination decreases over time. Um And so I think uh there are a few things again that would have to happen when we would have to study uh you know, boosters and Children. Um uh and and and and do that first before we that was something we wanted to do. And two, I think you would have to have a compelling need. So, you know, there would still have to be a covid in the community um uh in order to do that. So I think a few questions have to be to be answered before we decide on on boosting, Splendid. Thank you. Uh, we've had some questions about the nature of giving vaccines to 5 to 11 year olds. Would you anticipate that people would go to their regular family pediatrician to get this rather than having the kind of vaccine centers that we've set up? Do you think that the rollout should or will be different for Children of this age group than it was for older kids and adults? Yeah, that's another good question. And I think we will see the rollout being different and maybe two tracks. Um, you know, I think when you look Children generally get vaccinated in the physician's office, whether it be a pediatrician or family practitioners office for most of their routine. That's kind of their medical home. That's where they feel comfortable. And that's truly truthfully where the vaccinators feel comfortable having those discussions with families about vaccination and and administering vaccines. Um, so, uh, the form, new form or the formulation of the vaccine for Children that will come out actually won't have as many constraints upon it as we did early in the Um, rollout of the vaccine for adults. So the vaccine on this case, it will be refrigerators able for up to 10 weeks. Um, so that will enable vaccine to be more easily administered in the practitioners office, um, than than was in the initial rollout. So I think you'll probably see, um, some larger centers still administering vaccine indicates where they feel comfortable to do so and they have the resources to do so. And also you'll see vaccine more vaccine being administered in pediatric offices which is a good thing. Sure, thank you. We've had another question about multi inflammatory syndrome syndrome in Children, which I know was a concern in some of the some of the cases that kids have had. Um And apparently this question asked that there are some concerns about undercounted cases. Multi inflammatory syndrome in Children. Do you share those concerns? Do you think that could have impacted the FDA is benefit versus risk analysis? I don't um If you're talking about multi inflammatory condition following covid um which you know, we know it occurs. I don't know that. I mean I think that was considered in all the the risk benefit analysis was it has it been undercounted um perhaps uh there are cases that aren't recognized, recognized and and reported. So that that is certainly a possibility which I think would actually if if there are cases of M. I. S. C. That were under candidate really just tips the the risk benefit into the benefit ratio of vaccination through the course of your trial. Did you have any breakthrough cases? And if so, how many did you see um you know, if you look over all in the trial in in this age group. Yes, there were some breakthrough cases of of Covid that did did occur. Um There were 16 in the placebo group that occurred in Israel and three that occurred in the vaccination group, which, you know, calculated out because it was a 2 to 1 randomization Gave us a not an estimate for 90% efficacy of the vaccine. Now, what is remarkable, I think when we set out to do this study that we we set out early on this was before the delta waves. So we were just coming down through the summer months where rates of covid were fairly low. So I think we really didn't necessarily anticipate um that we would see um be able to tell whether the vaccine was going to be effective in this in this age group. You know, unfortunately we hit the delta wave with a lot of cases um which um again enabled us to determine. Um but that the vaccine was effective against preventing preventing infection and this was really largely infection due to delta. So, um so, you know, even though it wasn't a good thing that we've had the delta wave, we were able to assess efficacy of the vaccine. Sure, there's a follow up, we know that in adults, you know, the emphasis has been that the vaccine won't necessarily stop you from getting covid, but it will stop you from developing complications that require hospitalization is it's the same thing in Children that we won't necessarily expect that it will just prevent everybody from getting it, but it should just prevent those more serious cases. I think. I don't think we would expect that things would be a lot different in Children than adults. I think, you know, early on um I think it will prevent um some infection and transmission. I I think as levels of antibody decline over a period of months that you may see um that rates of you know being able to become infected. Um Yes, you will be able to become infected. But I think uh we can be reassured that you know, serious illness will be prevented. In fact, I don't think anybody in the pediatric study any, any of the cases, none of them were serious. Sure, thank you. Obviously last year we saw a big bump in covid cases around the holidays. There wasn't a vaccine then there is now. But how important do you think the timing is to try and get as many Children as vaccinated as possible before the holidays? Given that there will be probably more socialization, more people intermingling. Could it make a big difference if we can get a lot of Children vaccinated before the holidays this year in terms of overall cases. Yeah, I think that's another really good question. You know, I think what we do know that from some recent studies that came out of uh schools here in north Carolina is that in fact Children are more likely to acquire infection outside of the school setting than in the school setting. So there, you know contracting infection either the only thing or recreational settings and and not in the school setting. So I think what you as you suggest is people travel moreover with these um go with meat, extended family or friends that you know, their chance for acquiring infection um will potentially increase. So that really does underscore the need to try to to you know, increase vaccination coverage prior to holidays if we can. So, so with the rollout occurring um you know, it's going to happen overnight. But I think of trying to get as many many Children vaccinated, you know, it may not all happen before thanksgiving holiday but but trying to get as many kids vaccinated before winter holidays is important. Sure, thank you. Now of course in addition to being a vaccine trial administrator, you are a pediatrician. People are asking about any advice you could give for parents on how to prepare their Children for getting the shot and whether you whether the Children had difficulty with it in the trial. Um Yeah, that's a great question. I mean I think most of the kids that we um um had in the trial, they were actually at this age. Um you know um they're all verbal, they were all excited to be part of the trial and um you know, most, you know obviously Children don't, most people don't like needles. So, but but you know, I think they were all willing and excited to be part get vaccinated. Um and um you know, I think what we can tell parents um and I don't necessarily um you know, you can, depending upon the level of understanding child parents can have that discussion with their child that they may get a fever, they may feel a little piggy, do not feel as good. Um you know, the evening over the next day following vaccination. Um and that's to be, to be expected. They make, you know, as I said, get a little low grade fever, those things can be managed um pretty easily by giving, you know, if you get symptoms like that fever or achiness or headache, um it can be managed with ibuprofen or you know with some resolution of symptoms and usually the symptoms are pretty mild in most cases maybe a little bit moderate, but they resolved within a day or two. Sure, thank you very much. We getting through as many questions as we can. We've got some more raised hands. So Kristin, we're going to go to you next Euron muted. Please go ahead and ask your question. Hi, can you talk to me a little bit more about how um approving this dosage for kids is crucial to the overall population protection. Yeah, Yeah, thanks Christian for the question. Um so yeah, I mean, I think we have to realize that Children do make up about 20% of the power, a little over 20% of the population. So if you really look at needing to achieve her immunity, you probably need to get about 85% of the total population somewhere around there vaccinated depending upon how transmissible the viruses. Um and and delta we know is be transmissible. Um so that's why I'm kind of saying 85%. And I always a little tough to quote those numbers, but you really need to achieve a high level of vaccination. Well, if you're already exclude 20% of your pop 27% of your population under the age of 18 from getting vaccination, that's a significant proportion of the population. So vaccinating Children is really an important part of of um developing really professional. The other thing we I mean we do know that kids this age can age can spread infection. I think examples from influenza in fact, school age Children are probably the biggest transmitters for flu so it would not be unanticipated that that um you know, Children this age can spread covid. So it really is important to get them vaccinated for community protection. Very much dr walter will move on through the people with their hands raised and so Alice Park you are now a muted. Please go ahead and ask your question. I just wanted to ask if you could um provide a little more detail for parents, let's say of 11 year olds. You know, we do have 12 year olds authorized for the full dose of this vaccine. And we now have 11 year olds authorized at a third of the dose. Can you just tell me a little bit about the antibody levels or immunity you were seeing in this study for 11 year olds and how you might answer questions from parents who might say if I have an 11 year old, AM I better off waiting until their 12th birthday and having them get the full dose? Yeah. My answer to that is I would not wait. 11 Children will develop as good in anybody response or protection. Um protected level of neutralizing antibodies in the blood. Um Mhm. 10 micrograms of vaccine as they do from 30 months. So so I'm confident that they'll have the same protection. Um So I would not wait. Fantastic. Thank you. We're gonna move on through the list. Patrick thomas. We can go ahead and a mute you and you can ask your question. Okay? It seems like we may have lost Patrick. Um Hey, I'm okay dr walter. We talked a while back about the vaccine trials for Children and um today um and in the next couple of hours I'm going to be entering into a pediatric I. C. U. And one of the things that I hear from practitioners providers and physicians um and normalized to you is how often patients are begging for the vaccine when it's too late? These are Children who can't make those decisions for themselves. So what is sort of your police for parents of Children uh in this age range who essentially um could soon get the vaccine? Yeah, I mean, I think that my my advice to parents is this is the best way to protect your child from him, serious illness and potentially death from covid uh, is to get them vaccinated. It's the best tool we have. Um and so by all means I would recommend and suggest they get vaccine. Thank you very much. We have had we're gonna be wrapping up here shortly. We've had a number of questions about the trial you perform because obviously you also had subjects who were under five and I wonder if you could talk a little bit about the responses you saw in those Children that were younger than five. What kind of dose we might look at what you think the kind of time frame might be for whether there will or should be vaccinations available for that age group as well. Yeah. So all I can say is that um, you know, after the preliminary information um, that we did in the early part of the trial of the dose of vaccine that's being evaluated in Children under five uh, is the three microgram dose, which is you have to realize that even a much smaller dose of vaccine. So it's 1/10 of the adult dose of vaccine. Um, so, um, you know, preliminary results. Look um, and it looks like, you know, that was the best dose to give again the best immune response or a comparable immune response? Um And uh with the fewest side effects and young youngest the very youngest Children. Um Now that said we have not, you know the study is really looking at evaluating that dose in a comparable population size for each of these 22 age groups. You know there'll be another like five or 6000 Children in the in the 2 to 4 age range and a similar size under under between the ages of six months to two. So there will be um data forthcoming that really you know shows whether that dose gives a comparable response. So it's it's you know we have to get wait for the confirmatory data. Likewise we have to wait, make sure that it's safe and tolerable when Children that age. Um So that those data will be forthcoming. I think we probably We'll see something sooner in the Children ages 2-4 than we do six months to uh two a gradual um uh process. So we will see that data in the upcoming months I suspect that you know probably we won't be vaccinating those Children until sometime early next year. I don't have the total timeline on this. Gotcha. Thank you very much. We're gonna wrap up here shortly. Just trying to cram in another couple of questions. Uh There were some concerns on the advisory committee yesterday about how a recent infection might impact the risk of my myocarditis. Post vaccination. Do you share those concerns or would a higher risk makes sense given the pathogenesis of myocarditis? Yeah, I think we really don't know the total pathogenesis yet of of what's causing um you know uh post vaccination, myocarditis after the M. RNA vaccines, we really don't know. So, you know, I think if I speculated there's several things you could speculate, you could I could speculate that, you know, you get a much larger immune response after having had coded and then getting a vaccination and that may be uh an issue. Um you might speculate that it's dose related. I don't think we have those answers yet to know that. So. So um you know, I don't know that. I could comment a lot farther on that, so sure, no problem at all. We're about to wrap up here, we're at time, doctor or just like to ask you as a way of reinforcing the point you've already made. If you yourself had a child between 5 to 11, would you be going to get them this vaccine once it's available? I'm too old to have Children, 5 to 11 and I said if you did, but actually I have grandchildren and um I'm hopeful that they will be uh lining up to get their vaccine shortly. So, Absolutely. Thank you very much and we are going to leave it there. Thank you everyone for joining us. Thanks to our panelists Dr Chip walter for sharing your perspective and expertise will be back on monday to discuss the Second Amendment case that will go before the Supreme Court next week case. It could have powerful effects on the carrying of concealed weapons. If you'd like to be notified about that and all our other upcoming briefings, please email Duke News at Duke dot E D. U. Or if you're watching on Youtube, please like and subscribe in the meantime, keep following public health guidelines and please remember that when doing your research, just as when seasoning your food. Always choose your sources carefully. Thank you very much and have a great day.