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Experts in the Hot Seat: Forging Ahead in Infant RSV Prevention

Burden of RSV in the Overall Population

So, looking at the burden of RSV overall, I know we'll focus much of our time together on young infants, but it's important to put this into context. We are all impacted by RSV. And data from the CDC, RSV, NAT show here the burden in all ages in the US over several seasons pre, during, and post-pandemic. And you can see there's generally what we consider the typical RSV season of October, November to February. March. And during this season, we can experience millions of outpatient visits due to RSV. Hundreds of thousands of hospitalizations and even tens of thousands of deaths. And that's not something we often think about with RSV. But when you take into account both extremes of age, and particularly adults 75 and older have very high morbidity and even mortality associated with RSV impacts all ages.

And as we talked about the seasonality, it is important to note that we can get peaks outside of this season. And I think if you're interested enough to be coming here tonight, you probably do know that the seasonality, even in majority of the US, that had quite a classic season that we didn't even look for RSV outside of it was heavily disrupted after that year with essentially no RSV in the following year.

Having that summer surge, which I think shocked us all. And we're slowly, as you can see in the graph, getting back to a kind of normal seasonality although with markedly higher peaks in these last couple seasons. And this season, many of us may still even be experiencing a tail end of a kind of low. I think like a low, slow burn, prolonged RSV this year. So we're, yeah, still seeing a lot of changes.

Estimated Annual RSV Burden in Infants and Young Children: United States

And looking at in just infants and young children. So if we look at you know, children less than a year of age, it still causes nearly 2 million infections and almost a million lower respiratory tract infections, serious infections. And still in this tens of thousands of hospitalizations and even deaths. So huge medical burden of RSV overall and hospitalizations are the easiest thing for us to count. And those of us who work in a hospital setting know that RSV is consistently year after year has been the leading cause of US infant hospitalizations. We're seeing that change now with our preventive therapeutics. But overall 10% of infant hospitalizations are from RSV. So a really huge burden of severe disease in this age group.

RSV Disease Manifestations and Associated Burden

Fortunately most cases of RSV are mild and self-limiting, but many still do require pediatrician office visits. Lost work for family members, spread throughout the household of family members, and there still are many severe cases, including ICU admissions, and it's been associated with long term complications like chronic wheezing and asthma.

Risk Factors for RSV

And classic risk factors for severe RSV have been established, such as young age, most certainly in the first three months of life or even the first season one experiences, as well as prematurity, specifically those born at 30 weeks gestation or less, as well as chronic lung disease, congenital heart disease, and certain demographic factors. But I think the most important point on this slide, and that many of you noted in your pretest, is that more than 70% of infant RSV hospitalizations don't have any of these risk factors. These are in previously healthy babies. And that is a huge talking point with families.

The Advent of Infant RSV Immunization

So with all of that, we do now have a couple different prevention strategies that first started in 2023. We now have maternal vaccination, as well as long acting monoclonal antibody. And you can see here how the uptake has been during those first two seasons. That first season was kind of a late and slow one in terms of rolling it out and operationalizing as well as having actual product available. But by last year's full season, the 24/25 season, we're seeing pretty decent uptake. So, you know, around 50% coverage.

And what we saw in that season was also around 50% decline in RSV hospitalizations for those infants, less than eight months of age who were eligible to receive these products or receive protection from these products. So huge. Pretty much a 1:1. And I know in my state in New York and we participated in this study, we saw over 70% reduction in our hospitalizations and had higher than the national average uptake as well. So it's remarkable. And the largest is seen in these very young infants, the highest risk as we went over in one of the previous slides in the zero through two months of age group and absolutely remarkable.

Profound Impact of the COVID-19 Pandemic on RSV

And as we noted earlier, there has been a profound impact on both the seasonality. And as we're seeing in the post-COVID era, the rates of RSV infections. So this is something we'll have to continue to watch as now we add in the impact of these preventive agents.

Posttest 3

All right. So now for this section's posttest. Let's see. In the United States. Most infants with RSV hospitalization occur in those with;

A. Preterm birth;

B. Lung disease;

C. Congenital heart disease; or

D. No risk factors.

All right, So look at that. We have some converts. We've done our job. Don't have too much of a post-dinner food coma here. So wonderful. Yeah. 95%. Got it. So yeah, again, this is a huge - huge point to drive home with families when you're talking about risks and benefits of infant RSV protection. So yeah, again, more than 70% occur in those with no risk factors.

Experts in the Hot Seat

All right. So now we'll have some discussion time here. Imagine a fire with the red lights. So our first question RSV infections in otherwise healthy infants are usually mild and self-limiting. We just went through that. So how should factors such as the indirect costs of mild RSV infections factor into the decision to immunize for parents and caregivers who are hesitant. Thoughts?

Dr. Michael J. Smith (Duke University School of Medicine): Well, I think as you know as we've highlighted a couple of times already, it's - it's the infants without any risk factors that are at risk. And, you know, if I had a crystal ball and could tell a parent, you know, your child is going to be exposed to this infection, you know, six months from now, that would be a different situation. But - but, you know, you never know. So just in general, talking points and a lot of people who practice general pediatrics do this, but kind of taking that seat belt approach, you know, just like buckle up now kind of while you can. And, you know, and you talked briefly, obviously we're talking about infants.

You know, we talked briefly about the impact of this disease and how it can cause death and severe disease you know, in grandparents and more elderly patients. And that - that actually seems to have resonated pretty well, at least in our - you know, in our part of the country, we have a joint ID case with PID and adult ID. And the adult ID folks like to try to trick themselves. And for them, like an RSV case is like a super exciting case. Like can - can is the - is the - is the first year adult ID fellow going to think of RSV in this differential? So I think that message is starting to get out there.

Dr. Pablo Sanchez (Ohio State University College of Medicine): No. And I think also even with milder cases, the - they still need health care visits. They go to their pediatricians. They go to urgent care. I mean, these babies, even though - even if they are saturating well and feeding okay, but they have a lot of secretions and really they have a lot of - I mean, it's a really mild. I mean, nobody wants to see your child struggling with breathing and having to do all the suctioning and - and then the feeding. So I think that - that it's - it's - it's a major impact on their lives. Yeah. And it's not just on the baby, but on the family.

Dr. Tesini: Yeah. Yeah, I completely agree. Especially with your, - we're talking about newborn babies, you know, a two month old who was, yeah, struggling to breathe. Even some nasal - nasal blockage can be incredibly scary and - and quite troubling for that.

Dr. Sanchez: And on top of that, you mentioned also the later effects and RSV early in infancy can also predispose to chronic cough and then the association with later asthma. So I think we need to bring that into play as well. So - so I think that there's a lot that we can prevent and or ameliorate by the use of these products.

Dr. Smith: Yeah. And some of those qualitative outcomes that maybe we're not studying. Right. We can look and see, okay, how many kids came into the emergency department, urgent care got admitted? But well, how much sleep did you lose? You know, things like that.

Dr. Tesini: Yeah.

Dr. Smith: Making it more real.

Dr. Tesini: And like, several days with the sick infant, and then their toddler sibling gets it. Several more days with that child, and how many days out of work is that? And urgent care visits are not cheap. All right, let's get on to our next question. So similar, what are some key talking points for helping families understand the burden of RSV? I think we've gone through some already, but what do you both use in practice?

Dr. Sanchez: I think that - that we have to - it is - I mean, when I speak to the parents like I'm a neonatologist, so I when I'm trying to - when I recommend the use of nirsevimab or clesrovimab and a mother who has not received, or an infant who is eligible for whatever reason. I think that it is the most common cause of hospitalization and even the normal, otherwise full term baby. So I think to me, that's the biggest issue. And - and as you mentioned, they don't have to have any other risk factors. They just have to be young and - and well to get RSV and they're going to be hospitalized and they're going to be seeking health care. You know, they're going to be seeking pediatrician, pediatric care and family practice. So I think that if we can reduce it, I think there's - there's a huge benefit to the family.

Dr. Tesini: Yeah, I agree. I will sometimes say, you know, pretty much every child will get it in their first few years of life. Nearly all of them, you know, 70 something percent will get it in their first year. Do you - you know, how do you want to gamble with how that's going to go for them?

Dr. Sanchez: And I usually ask them also, I said, have you - do you know about RSV? And it's interesting because many don't which we need education. But among those parents who have heard of RSV, they say, "Oh, my sibling had it." Those parents. I mean, it's an easier. And so I tried to see what their personal experience is with RSV and in general, whoever has had a - knows of somebody of an infant who's had RSV, they want to prevent it in their baby.

Dr. Tesini: Yeah, that's such a great point and 100% true in practice.

Dr. Sanchez: And unfortunately, there are some babies who die with RSV. We had otherwise full term healthy baby who went to the PICU and I tell them about intubation, especially in the NICU. We want to prevent intubation. I tell them this baby will likely will get RSV. Will be intubated on the respirator and not just CPAP, you know. And - and then there are some deaths, even though it's rare, but there's no question. So, you know, you try to build up the fact that it can be quite severe.

Dr. Tesini: Yeah. Yeah. And I love that emphasizing their - their own personal or social circle experience with RSV. And I think as we're testing more now, even in all ages and adults, I you know, have both in my clinical life, I do med-peds. I do, but also, you know, in our personal lives, we were like, "Man, I got that RSV. Like, what is that?" So I think that's helped - helped kind of bring the message out more.

Dr. Sanchez: And I think another talking point needs to be that is their highest risk is right. As soon as they leave their the hospital, whether, you know, for a full term baby or term who has been in the newborn nursery, they could get in the next couple of days. So when they see their pediatrician or family practice or practitioner that don't wait for the two month vaccines. And we really need to stress that because that's when it's going to - if they get RSV, that's going to be the worst. And so there should not be a delay. And - and I have found that that's not only with parents, but I think the health care professionals need to be aware of that as well.

Because it's when they're seeing for their first postpartum visit, you know, the first post-birth visit. I think that we need to, as health care professionals caring for these infants to remind these parents that this is - there shouldn't be a delay.

Dr. Tesini: Yeah. Yeah. Yeah. This isn't like let me think about it for a few weeks.

Dr. Sanchez: We need the decision yesterday.

Dr. Smith: Well, yeah, I think for us, you're right for - for healthcare professionals, you know, remember, this is a universal vaccine recommendation for anyone who's been born. So yes, we have to work on how we talk about this to parents, but when we talk to each other, I think it's important to remind people that.

Dr. Sanchez: But it's an immunization, not a vaccine.

Dr. Smith: Did I say vaccine?

Dr. Sanchez: Yes. You said vaccine.

Dr. Smith: Yes. That's really embarrassing.

Dr. Sanchez: Yes.

Dr. Tesini: Yeah.

Dr. Sanchez: I actually it's funny that the Columbus newspaper, The Dispatch, also had, when it first came out, new vaccine to prevent RSV. And we actually had to write a letter to the editor saying that this is not a vaccine.

Dr. Tesini: Yeah. And - and words matter for sure when it comes to this.

Dr. Sanchez: This is important because with the vaccine hesitancy, we want to get that - that word out because - but it's the truth.

Dr. Tesini: Yeah. Yeah. Yeah. And there is-

Dr. Sanchez: It's a medication.

Dr. Tesini: Exactly. And there is a lot of acceptance, maybe jumping the gun for later parts of the talk. But even parents who refuse birth dose of hep B, I think at least a third of them will accept and want nirsevimab or clesrovimab now. So it is - it's very different in terms of acceptance.

Dr. Smith: And I mean kind of like the art of the COVID monoclonals, you know, I won't get the vaccine, but granted that was for treatment. So it's a slightly different paradigm, but kind of same idea.

Dr. Tesini: Yeah, I would say don't - don't assume based on prior experiences. All right. And I think this is our last hot seat question for this section. Did infant RSV immunizations affect the current seasonal trends or have slow uptake in the preceding COVID pandemic skewed the data too much? We showed some of these data.

Dr. Smith: Yeah, that's a great - that's a great question. We were talking up here before about kind of what did we learn at the conference so far and what I learned at the conference so far? I learned a lot, actually, but related to this question is you know, in one of the studies that the team at Yale did, they looked at kind of risk factors for infection and not being immunized was by far and away the single most important thing. So I, you know, I do think, I think since we're not quite at universal immunization yet, it's hard to know. I think the epidemiology of this disease is very different in places where you have high uptake versus low uptake. And we're going to need some more time to sort this out. But probably I don't know if you have any other thoughts.

Dr. Sanchez: No, I agree, and you already mentioned that in Rochester you saw 70% decline in RSV hospitalizations and bronchiolitis. So I think already we're seeing - we're seeing an effect at the local level, which is always important. It's not just that there was a 80% to 90% effectiveness reduction in RSV hospitalization. So I think we're seeing it. It's been really interesting this season because at least in Columbus and actually we're seeing it around the country. Where, you know, normally we start seeing RSV at the end of October, beginning of November.

And what were we seeing this past season was influenza. And I remember in December, we still were not seeing very much RSV, and I remember sending out an email and asking my colleagues, is this from nirsevimab or clesrovimab administration or maternal vaccine, or is there some viral interaction? And I don't know, but I think it probably was some viral - viral interaction because then now we're seeing a very late season. And in many states, the RSV prophylaxis has continued to be, and I know in - in Columbus, we have - we're still giving nirsevimab or clesrovimab up to - to our infants and to the high risk population.

Dr. Smith: Yeah, I think a lot of states, at least through the end of April and people are going to decide, well, what about next month?

Dr. Tesini: Yeah, it's kind of a week to week, month to month decision.

Dr. Sanchez: I think local epidemiology is really important. I think it's really important for health care professionals, pediatricians, family practice. Those who care for children - for infants and high risk children. To know what your local epidemiology is with your public health, as well as infectious disease experts at your - in your community.

Dr. Tesini: Yeah. Yeah, I agree. And I had another comment but has come and - come and gone. Oh, I was also going to mention, you know, we've noticed in these last few seasons, you know, proportionally now the kids that are being admitted with RSV are the slightly older, you know, the one to twos and the two to four year olds. So I think that reflects the lack of the less than one year olds. But as you kind of think about how we will consider the epidemiology of RSV or severe RSV in the future.

Dr. Smith: Yeah, I think that's going to be really interesting to see how that plays out over time is that kind of like a, you know, like a founder effect or is that going to continue? Because we talked about talked about this - this morning, you know is this, you know, one thing that we hear is this just kind of kicking things down the road? Are you all going to get RSV later? You know, for this particular disease, that's probably an acceptable outcome because you're bigger, your airways are bigger, you're more likely to have a mild infection as compared to significant bronchiolitis.

Dr. Sanchez: I agree.

Dr. Tesini: Exactly.

Audience Q&A

All right. And audience questions. I realized I hadn't left much time for that. But what do we have here. Do we have a couple questions here in our chat. Do you anticipate a gradual increase in parental hesitancy to RSV prophylaxis as hospitalizations decrease among infants and parents are less likely to have personal experience or familiarity of such hospitalizations and friends or relatives.

It's a really great and interesting question and kind of how we talk about you know, vaccine lack of acceptance these days is the lack of personal knowledge and experience with the infections that were preventing. I'm hopeful that this prophylaxis and immunization rather than vaccine may skirt around that a bit. And I think we are still seeing RSV and other age groups. So it is still around and not that people aren't having personal experience.

Dr. Smith: Yeah. And I think we as healthcare professionals kind of still have our memory of RSV. You know, it's not like what we're seeing with measles where, you know, many of us even infectious disease people that I've trained with have only seen a handful of cases. So I'm optimistic that at least in the immediate time, you know, we as pediatricians are still going to be pushing for this.

Dr. Sanchez: And I think it's also important to remember that neither the RSV vaccine nor the monoclonal antibodies will prevent infection. And so they may - and what we're doing is ameliorating the infection in these infants and children. And we as adults, and then certainly the elderly will be also be getting infected as well. And as you pointed out, the elderly and high risk individuals over age 18 can have more severe disease. So I don't think RSV is certainly not going to go away just with our current strategies. What we're trying to do and what we have accomplished is amelioration of the disease.

Dr. Tesini: Yeah. Yeah. All right. One more question. I'll do quickly. Post-COVID, RSV rise. Could it be because we are testing more? I think in some surveillance mechanisms that could be. That did start, though, even during the pandemic and in more, you know, active research where we're not relying on clinician testing that has been done both pre and post pandemic. They did also see those rises.

Dr. Sanchez: No, I agree. I think, you know, multiplex testing was done all during, if anything, during COVID, we were testing more. And  I'm very happy that it has continued because I do think I'd like to know what this this child and what this infant has. So I don't think that that's an issue.

Dr. Smith: Yeah. No, I mean, maybe in adults because adults you wouldn't necessarily historically have tested for RSV, but if it's part of a package. But, yeah, right. I mean, RSV was always on our - on our mind as pediatricians.

Infant RSV Immunizations Assessing a Growing Armamentarium

Dr. Tesini: All right.

Dr. Smith: Well, okay, great. Well, this is a great segue. Thank you. We've talked about in general RSV and we've touched on some of these products that are newly available in the last couple of years. So I just wanted to give some - some talking points and go over the data, kind of a high level view of what the options are.

Poll 4

Okay, so here's our next poll question. In your practice, approximately what percentage of RSV infant immunizations are administered in the birthing hospital during RSV season?

Wow. So I'm not surprised by the 50%. I'm glad to see that several of you or 20% of people, you know, in their practice see, you know, more than 50% of infants immunized. That's - that's great because this is - I'll say this is something that we've struggled with at our own - at our own institution.

Review of RSV Immunization Options for All Infants

Oops. Okay. So I think we already talked about this kind of the two general approaches here. There's maternal vaccination. I got that one right Pablo. Maternal vaccination and then immunization with monoclonal antibodies for infants.

Target of RSV Immunization

And really so, you know, the - the targets of RSV immunization are the pre-F glycoprotein, which is a major antigen for RSV and really necessary for viral fusion and then host cell entry. And also, as I said, it's very antigenic, elicits neutralizing antibodies, and is conserved across both subtypes A and B. I was not a molecular biologist. But there's the pretty picture on the on the right.

Maternal RSV Vaccination With RSV Vaccine

Okay, so let's talk about each product briefly. So the maternal RSV vaccine is a recombinant vaccine given as a single dose 0.5 mL IM. It's administered between 32 to 36 weeks of pregnancy and has to be given at least 14 days prior to delivery to be considered immunogenic in the infant to be protective for the infant. And we know that the vaccine induces maternal immune response, generalizes neutralizing IgG against the RSV F protein that is actively transferred across the placenta. So that's kind of why you need the 14 days to make sure you have time for that to happen. And we know that transfer increases in the third trimester. And then what happens on the infant side is the infant is born already with circulating maternal RSV specific antibodies that can neutralize RSV before cell entry and therefore reduce viral replication. And we know we were talking about this up here earlier, that protection lasts at least for the first six months of life, and we'll go over these data here.

MATISSE: Maternal RSV Vaccination With RSV Vaccine

So these are the data from the pivotal MATISSE maternal RSV vaccination with RSV vaccine study. So this was an international double blind phase three trial, including 7358 pregnant women and maternal vaccine protected against medically severe respiratory tract illness in infants, certainly within 90 days of birth. And you can kind of see let's see. Oh yeah, you're right. I can't really see that very well. But consistently, if you look at the grey line, is the cumulative incidence in the placebo group. And the orange line is the cumulative incidence in the vaccinated group. And these are looking at infants. So they weren't vaccinated. Their mothers were vaccinated. And you can see that line really doesn't tick up through those first 90 days of birth.

And so if you look at the first 90 days, the calculated vaccine efficacy, and this came up in a lot of the meetings today, the difference between efficacy and effectiveness. And just for the purpose of this talk remember, efficacy is kind of in the controlled ideal clinical - clinical trial world. How good is the product in this case the vaccine at preventing the outcome and as compared to effectiveness, which is kind of the real-world implications. So vaccine efficacy was just at 82%. And then even once you get to 100 days out, it's still fairly high at 69%. Notably, there were no safety concerns identified.

Long-Acting Monoclonal Antibodies for RSV: Nirsevimab

And then there are two long acting monoclonal antibodies for RSV. So the first one is nirsevimab, which is the first one that was FDA approved. And both of these products are approved by the FDA. I think there's really no preference for one over the other. The key thing that we're going to highlight in these slides is just to point out with nirsevimab, the dose is based on weight. And that was part of the initial pharmacokinetic studies that were done. And so there were several trials that you may have heard of the MELODY and HARMONIE studies, and then in Galicia in Spain, they did an excellent job bringing this nirsevimab to children out in the community.

This is really a real world effectiveness study that showed excellent, really clinical effectiveness. So when you look at these studies together, the efficacy for reducing RSV, lower respiratory tract infection is between 70% and 75%. Even better for hospitalization, 62% to 80%. And this is a fairly well tolerated product. It's safe. There's maybe a rash. Some very mild injection site reactions and really not much fever to speak of. Fever is very uncommon with this.

Long-Acting Monoclonal Antibodies for RSV: Clesrovimab

And then the other product that - that was newer to the market and newer to FDA is the clesrovimab. And again, the thing to remember here is it's a single dose regardless of your age. I don't know, I kind of like the names they use for these trials. They were CLEVER and SMART about it. But also, again, remember, there's no head-to-head comparison studies between these two products. So, similar to the other monoclonal, efficacy is pretty high. They use a slightly different definition for LRTI but still at about 60% and again, hospitalization. Also excellent 74% to 91%. And really, no concerns, no safety signals or adverse events of interest.

AAP Guidelines for RSV Prevention

Okay, so it's 2026. So we rely on the American Academy of Pediatrics for guidelines, for immunizations, and just make sure everyone's aware of what is recommended and hitting at this point that we've already discussed, the key thing is that infants born during RSV season should receive immunization with a monoclonal within one week of birth. I will say the prior iteration of the ACIP also had a similar recommendation. And remember, this can be given anywhere.

So we can talk maybe later about where this is going to be administered. If you are in one of those groups where people get admitted to receive nirsevimab or in the hospital, that's great. They can be given in any health care setting. I will say one thing that we're trying to figure out at our hospital is we cannot give it to inpatients, but can we kind of wheel you by our outpatient space on the way home to get it there?

And again, as Dr. Sanchez has mentioned, really this needs to be done as soon as possible. That said, if you're born outside of RSV season, that's where there is the seasonality to it that you should be immunized shortly before or during the season, which is typically October to March. So again, as we've already said, it's being extended now. And again, just to reiterate, if the infant's mother was vaccinated 14 days or longer prior to giving birth than the monoclonal is not necessary. And yes, this policy says that the recommendations for timing are flexible and clinical judgement is advised.

So for instance, if that's meaning that you can give it a little bit earlier if you're born outside of the outside of the season. It's really not that flexible because it should be given as soon as possible. But for instance, if you're born in the United States in the early spring, but you're travelling to a part of the country, or we were chatting up here, maybe Hawaii even states where there's more year-round transmission. You don't necessarily need to wait for October to March. And again, obviously the reason to do this sooner rather than later is you want to get people immunized while they're present in your office. So really taking any opportunity as a chance to immunize children.

Predictors of RSV Immunization Uptake

Okay, so we're going to talk just briefly before we open it up for questions and the fireside chat here again. This is a very efficacious product. And I've already said one of the issues though, is how can we all work together to make sure children are protected? And when you look at the factors associated with immunization uptake, there really are related to several socioeconomic factors. So what type of insurance do you have? Is it private insurance or not that's associated with - with uptake? Although interestingly, initially when this first came out, it's easier to get at least in our health system was easier to get this paid for if you were VFC eligible. Families with adult partner working in healthcare. So again, this gets back to the fact that people who are familiar with RSV are going to be more likely to immunize their infants. If you attend out-of-home child care. And again, higher income families more likely to be immunized.

Uptake of RSV Vaccine Among Pregnant Women in the US

And these are some data from the CDC looking at some racial and ethnic differences in pregnant women who are vaccinated for RSV. And again, you can just see that there's substantial variation with Black, non-Hispanic women being less likely to be vaccinated as compared to White non-Hispanic women or Asian non-Hispanic women.

Uptake of RSV Monoclonal Antibodies in Infants in the US

And then there's also, again, we already talked a lot about this spontaneously, but significant geographic variability in immunization. And certainly, as we're seeing with measles, there are pockets of under immunization everywhere. But this really gets at some of the regional differences. So similar to other quality indicators, immunization uptake is a little bit lower in the south. So Louisiana on the bottom there as compared to California, which is one of the higher states.

Combined Uptake of Maternal RSV Vaccination and RS

And you know, we're doing okay, particularly as we move through the RSV season. So these are data from the National Immunization Survey, and you can see that - that top group is probably will not or definitely will not get infant RSV monoclonal antibodies. by the time February 2026 comes around, that number is 10%. I wish it were lower than 10%, but I think the fact that it's only 10% really gets to the fact that people, at least right now, still know about RSV and are interested in prevention.

Where I think we can do a lot of work is that that next bar down, which is the blue, which is probably will get infant RSV monoclonal antibody or they're unsure. Those are the people that we need to really be talking with and convincing them with some of the talking points that we discussed in the last session. And then you can see the black is definitely will get and then the purple infant already received and  the green on the bottom, which is the mother was vaccinated. So at least based on these nationally represented data through the national survey in the United States right now, it looks like the bulk of immunization is coming from monoclonals.

Experts in the Hot Seat: Questions for Faculty

Okay. Well, thanks. We got about 12 minutes left. I'm going to come back over here. So, colleagues, this seems like a leading question to me, but I'm going to ask, do we need more birthing hospital involvement to optimize infant RSV immunization rates?

Dr. Sanchez: Absolutely. Yes. No, it's been an issue. And I know and I can only speak for our own. So I'm Nationwide Children's, the Ohio State University in Columbus and the birthing hospitals in Columbus have not been administering. We have not been able to get it into the birthing hospitals. We give it, obviously, at Nationwide Children's. And the problem that comes up is that newborn care. We give it in the NICUs of those hospitals, but not in the - in the newborn nursery. And newborn care is a bundled payment and we can give hepatitis B vaccine. They give it as part of the bundle care because it's only $13, $10, whereas these products are around $500.

So immunizing a delivery service of 6,000 8,000 babies, I think we need to also be able to increase the bundled care payment so that it will also include the, you know, the - the clesrovimab or the nirsevimab if that baby is eligible. I think also the other thing is that these hospitals could get vaccines for children because they - but I will say that - that is a very tedious. That there's a lot of regulations associated with having vaccines for children in your clinic, hospital or in the newborn nurseries, and so that has also been an issue as well.

Dr. Smith: Yeah. Sorry. Go ahead. I would say we tried to do this and we were told that we'd have to hire an immunization pharmacist to be in charge of the VFC supply. And we didn't have a budget for that. So go ahead.

Dr. Tesini: We got - no. No. It's interesting because I'll provide a counterpoint that in New York State, which I realize has a different public health infrastructure than a lot of other states. But they really actively supported and helped hospital, birthing hospitals enroll in VFC. We had already been enrolled in several of our larger hospitals have—our children's hospital is under the same entity as our birthing hospitals. So we actually, for the 24/25 season, had all of our hospitals in the region administering it.

In season, in the birth, hospitalization and through VFC, which covers the majority, certainly well over half of our births, they were able to have separate reimbursement for the administration. So it was highly successful, and in to operationalize it, we really leveraged our neonatology group also staffs, the majority of hospital nurseries. And so they were really able to help kind of bridge into the smaller, more community hospitals and highly successful. As I mentioned, we had about 70% coverage in that first season.

Dr. Sanchez: I think the birthing hospitals that also have pediatrics would be more amenable to that because they already have or know of vaccines for children. When I say Columbus, none of those birthing hospitals have any pediatrics because it's all referred to the children's hospital. And so that's been - that has been an issue. We mentioned Connecticut earlier and actually Connecticut, the state has purchased these products. And so then they give it to all of the hospitals and clinics and what have you so that they're able to get it into birthing hospitals quite successfully.

Dr. Smith: Yeah. And we've taken kind of a middle-of-the-road approach, which is we are mixed use hospital. There are about 200 pediatric beds within a 1,000 bed hospital. So we do have a newborn nursery. We were unable to have nirsevimab administered in the nursery kind of for financial reasons. But when we kind of sat down and said, okay, these other high risk patients who - who would have received palivizumab previously you know, over several months during their NICU stays or after their congenital heart disease surgery. It was cost neutral to offer those children nirsevimab instead. So we're able to give the high risk kids nirsevimab, but not the low risk kids who was as we've already discussed, really are at the highest risk. Not the highest risk, but percentage wise, the largest - largest piece of the pie.

Dr. Sanchez: And, you know, and the recommendation is interesting because the recommendation, as you mentioned, is that if the newborn is eligible to receive the monoclonal product, that he or she should get it within the first week of age. And that actually was done knowing that we may have problems with the birthing hospital giving it. So it was to give a way out. I mean, the product is safe given in the newborn nursery. I think we need to be aware of that. And really it was only said within the first week because we recognized that many hospitals and many practices may not be able to give it in the newborn nursery.

And that's why they said, preferably in the first week of age to give people some, you know, some leeway in terms of the timing. I was on ACIP at the time that these products were approved by the FDA, and then we voted to approve and recommend them, and then we were part of the recommendations subsequently.

Dr. Smith: Okay. I think we may have touched upon this one already. What is the impact of prophylaxis on the burden of RSV during the early years of childhood? Yeah, I think we've talked about this. I don't know if you all have any other things that you thought about.

Dr. Sanchez: No. I think that we've seen the dramatic decrease in the first season, I think. And you mentioned that in the second what we're seeing is more hospitalizations in older children. And I think that that's going to be something that needs to be studied as well. But we really ultimately need an RSV vaccine because that's what's going to prevent that from occurring later. Nirsevimab or clesrovimab or maternal vaccine to protect them in the first year of age and then give them the vaccine. However, we're not there yet at all. RSV vaccination has been true vaccination in young infants and children has been a major roadblock.

Dr. Smith: It's kind of the holy grail of vaccinology. Okay. So it sounds like you are an excellent state. We talked about Connecticut. So what are the unique barriers to immunizations in states with low uptake? How can we address things? I think we've spoken about this also already is trying to get the State's Department of Health and the state to support universal immunization. And I think we already talked about Connecticut being an excellent example of that.

Audience Q&A

But I think I'm going to go ahead and skip to our last four minutes, some of the audience Q&A questions. And so there are a couple. So here's one that is a good question.

Dr. Sanchez: Oh keeps adding.

Dr. Smith: Yeah.

Dr. Sanchez: Well, that's good. That's good to keep adding questions.

Dr. Smith: Okay. Well, yes, they're jumping up. Thank you guys for all of your questions. I was going to start with this one though, because I think it's a good question since administration of the maternal RSV vaccination in '23. Do we have updated real-world data on the risk of preterm birth after maternal receipt of the bivalent RSV vaccine? Do you guys know the answer to that question?

Dr. Sanchez: So you should be aware that in the original trial of the Pfizer RSV, maternal bivalent vaccine, when it was administered to pregnant women from 24 weeks to 36 weeks. In the placebo group, compared to the vaccine group, the vaccine group had 1% increase in preterm births. Most of it was in South Africa, but it occurred in many of the other countries. Not uniformly. It was not statistically significant, but when you start thinking about vaccinating millions of women, it might show significance. So there was that concern and that's why. Although this trial did 24 to 36 weeks, the FDA in the United States said, "We're only going to recommend it or approve it for 32 to 36 weeks."

And the concern had also been because there was another vaccine, the GSK vaccine, that was given to pregnant women, also 24 to 36 weeks. And there was definitely was an increase, significant increase in preterm births among the women who received it compared to placebo. That trial was stopped early, and that vaccine is not available at all. Subsequently, the - there has been real-world evidence. The FDA also mandated that Pfizer also looked at post-marketing surveillance. And there's been several studies now looking at the safety of the maternal RSV vaccine in New York and in California.

And there has been no association with preterm births whatsoever. There has been an association with hypertensive disorders of pregnancy. And that still needs to be monitored. But in terms of preterm births, we're actually quite comfortable with it. There's been a recent study that was published from the UK, where they're giving maternal RSV vaccine as early as 28 weeks to 36 weeks, and they actually have not seen an increase in preterm births. Argentina also started their - they - the Argentina RSV recommendations is only maternal vaccination, and they also - they've shown effectiveness of 70% to 80% really highly effective. And they also have not seen an increase in preterm births.

So I think the preterm birth is really falling by the wayside with - with maternal RSV vaccination. And as we see more uptake as well, I think we'll get more answers. But so far that initial concern has not been borne out whatsoever.

Dr. Smith: Great. Thanks. So I have time for, I think, one more question, which is great because I have a hospital epidemiologist and an ecologist on each side of me. The question is, if nirsevimab should be given within the first week of life, should preterm infants still cared for in the NICU also receive it by one week of life?

Dr. Sanchez: Yeah.

Dr. Tesini: We talked about this earlier too, that if you're in a hospital like both of ours, I hope all three of ours we really don't have an issue with nosocomial or RSV spread within the hospital, so we do not give it until the infant is ready for discharge. And there are some gestational age considerations to that.

Dr. Sanchez: I will tell you that Chile in South America has a fantastic experience with nirsevimab. They've had over 95% acceptance. They have seen huge reductions in RSV hospitalization secondary to universal nirsevimab. They don't know maternal vaccination and they have seen no deaths from RSV, where they previously had seen 13 or 15 deaths. Now they are also giving it to preterm infants in their NICUs as - and 27, 28 weekers. And, however, they've had seen an increase in apnea and some of those babies.

And I will say that in terms of the studies, there has been the youngest, lowest. The lowest birth rate that has been given is about 1500g, 1600g. We really do not know the pharmacology and safety of premature babies given that early. If they're, you know, later, like, you know, 34, 36 weeks or in the NICU. Yes, it should be fine, but I would caution neonatologists to not give it in the very premature births and the premature infants, because we really don't know the optimal dose nor the safety. And like you mentioned, prevention of RSV infection, we have other ways of preventing it by preventing sick people from visiting these babies. So I do not recommend we wait until close to discharge to give it.

Dr. Smith: And that is what we do too. So, okay, great. Thank you. Here you go, sir. Okay. Bring us home.

Dr. Sanchez: Okay, great. Okay. Let's see.

Advanced Strategies for Infant RSV Immunizations: Special Cases

So advanced strategies for infant RSV immunizations: special cases.

Poll 5

So how often do you assess RSV immunization candidacy in children entering their second RSV season?

A. Is never;

B. Sometimes;

C. Usually;

D. Always.

Right. So you can - so, well, always 25%, usually 31%. Never 18%. Oh my gosh. Please, we all—listen, I always say we all must do better, not just with RSV prophylaxis or the care of babies or patients, but even in our own lives. So just take it. We all have to improve. Let's see. So when maternal vaccination is not adequate, so as Mike has said, when you give a vaccine, it's going to take 14 days, up to 14 days to develop the immune response, to develop your IgG antibodies that cross the placenta and get into the fetal circulation. And so actually, that is one of the advantages of maternal vaccination is because the baby, if given at the appropriate time, is born with maternal transplacentally acquired RSV antibodies that will protect him from day one even before they go home from the newborn nursery.

If the vaccine was given less than 14 days before birth, then that baby may not have received the full complement of the RSV IgG antibodies. In which case that baby then would be eligible to receive either a nirsevimab or clesrovimab. Birth outside of the RSV season. I mean, if the RSV maternal vaccine is a seasonal vaccine currently in most places in the United States, from January - from September to January. And so if that baby is born outside of the RSV season, there's really no reason for that baby to receive anything more or that mother to receive the vaccine.

Birth to mothers who were vaccinated during a previous pregnancy. So we do not know the - when a subsequent dose of RSV should be given not just to pregnant women, but even to adults the recommendation for adults is 75 years of age and over and then to high risk adults, 18 years of age and less than to 74 years. And currently the RSV vaccine given to those individuals seems to last at least two to three years. And so in pregnancy, we also don't know the safety of giving another dose of the vaccine when that mother has received it previously and the other reason that we don't recommend a second dose is because we have other products who can be given to the baby with—within a—if birth during a subsequent pregnancy.

Having said that, Argentina, I mentioned has a universal RSV vaccine program for the mother, and they are giving the vaccine in subsequent pregnancies. And I also know that Pfizer, the maker of the RSV vaccine, is doing currently studies to see how long protection is, how long these antibodies last, and whether the safety and effectiveness of giving the vaccine in a subsequent pregnancy. So we will have that data subsequently. But currently, because we have products for the mother and two products for the baby, we feel that in a subsequent pregnancy, we would opt of not to give and not to recommend the RSV vaccine to the mother in a subsequent pregnancy.

Inadequate immune response to RSV vaccination or transplacental antibody transfer. So immunocompromised individuals may not respond adequately to any vaccine. And what was also I learned that women who are HIV infected, transplacental passage of antibodies may not be adequate. And so women who are HIV infected, even if they receive the vaccine, we would give nirsevimab or clesrovimab to the baby.

Infant loss of maternal antibodies. So with cardiopulmonary bypass or the infant being on ECMO, even if the mother received the vaccine or if the baby received clesrovimab or nirsevimab before the vaccine, we would recommend redosing of that bit. We recommend dosing with nirsevimab or clesrovimab after cardiopulmonary bypass or ECMO. An increased risk of severe disease. So also remember we - to protect the infant, we rely on - on Assurance that those maternal antibodies cross the placenta into the infant and got into the fetus. And so with more severe congenital heart disease, we want to be assured that those—that infant has antibodies. So we would say, go ahead and give nirsevimab or clesrovimab them up with severe congenital heart disease to make sure that infant is protected.

Monoclonal Antibody vs Maternal Vaccination: Study Design and Baseline Characteristics

And so which one is better? Should we recommend RSV vaccine to the mother or is nirsevimab them up better? So this was an effectiveness, and this was a population-based cohort study using data from the French National Health Data System that was performed in Paris. And what you can see is the primary outcome was hospitalization for RSV associated lower respiratory tract infection identified by ICD-10 codes.

And what was seen was that the effectiveness of the nirsevimab product was actually better than with RSV maternal vaccine. But I just want to point out the hospitalization rates for nirsevimab and RSV vaccine. And they were quite low. The RSV hospitalization among infants who received nirsevimab was 1% versus RSV vaccine—the maternal RSV vaccine was 1.3%. So really quite low in both very effective. And so the - and you can see other parameters such as pediatric ICU admission, ventilatory support, and oxygen therapy that was actually lower among infants who had received nirsevimab versus the maternal vaccine.

And yes, I think we need more data. This is a single-center study. This is one cohort of French women. We need more studies to compare the two, but the fact remains that both of them are highly effective. And so it becomes to me a personal preference of the mother as to whether she would prefer to get the vaccine or have the baby receive one of the monoclonal antibodies.

And when is RSV immunization needed entering the second RSV season? So there are certain conditions. Severe, more severe chronic lung disease of prematurity or BPD, not just labelled with BPD because it was an oxygen at 36 weeks. But these are children who in the previous six weeks were in oxygen, had received medications, steroids for their BPD. Those - those children are eligible to receive currently nirsevimab during the second season.

Those with severe immunocompromise, those with cystic fibrosis who are not doing well, who have more pulmonary complications and poor growth. And then RSV is highly endemic and serious in within American Indian or Alaska Native children in those children who live in the reservations and among and in Alaska. Not the American-Indian who lives in Ohio. But in those areas, certainly RSV is very endemic. And so those children are eligible to receive it during a second season.

I say that it's nirsevimab because nirsevimab is what was studied in the second season. There are ongoing studies with clesrovimab in the second season we should be able to see those results in a future season to see whether clesrovimab should be given in a second season. The current recommendation is if the infant less than eight months of age receives clesrovimab and he or she is eligible to receive it in the second season. That second season dose should be nirsevimab, but that may - that will likely change in - in subsequent seasons.

Experts in the Hot Seat: Questions for Faculty

So questions for faculty. How can pediatricians ensure that all infants are fully protected against RSV, including those with conditions or circumstances, leading to inadequate protection from initial modalities?

Dr. Tesini: Yeah. I think we've done some great work to try and pull in. I think almost all of our birthing hospitals are on some form of epic, and so we've shared and made note templates that pull in if there was maternal vaccination or not. And then was as we have use of the monoclonals during birth hospitalization, whether that was given or not, that that all pulls into the discharge summary. And I think this is a really important point of communication between our care providers of pregnant women as well as child care providers, including inpatient and outpatient.

We all need to be communicating this very clearly. And if it can follow along with that baby, what they're due for, then I think at that initial pediatrician or child care provider visit that they can figure that out for the first season as easily as possible. You know, your state immunization registries, depending on your state, could also be helpful in this. And then you can also leverage electronic flags for, you know, patients in your panel that do have the conditions listed for that second season. And so you can have, you know, a report pulled to see who's due. If you have some-

Dr. Smith: Yeah. No, exactly. Right. And you know, and we work with - we work with our high risk groups or the cardiology groups, the cardiac ICU groups. I will say, yeah, Epic is great from that perspective. Where we run into trouble is you know, we're kind of referral hospitals. So many of the mothers may not have received their prenatal care at our institution. And then sometimes you have time to sort that out and sometimes you don't. And again, one of the sessions this morning was really interesting that when they looked, it was the same group from Yale that had the test negative design, which was kind of a retrospective effectiveness study.

And I will say, similar to what you said, that the sample sizes were really too small with big confidence intervals to say any one was better than the other. But what was surprising, they had many more because as researchers, they went in and did a full chart review, which you don't really have time for in real life. What they were surprised to see was how prevalent kind of double immunization was, where the child had received immunization, but the mom had also been vaccinated.

So I think there's a lot of things to do, but I agree with everything that you're doing. You know, when that works well it's great. Where we've struggled is with well, you know, the mother is not a patient of our health system. So we don't for instance, maybe some states do. We don't have an easy way to pull in the mom's immunization registry, especially in a short period of time. Right. Oh, you know, well, three weeks ago I got this like, really, I don't see it. So I think most people are going to immunize the infant.

Dr. Sanchez: No, I absolutely agree. And it's been a big issue. It is recommended that if you don't know whether the mother received it or not, to go ahead and give nirsevimab or clesrovimab because we want the protection again today. We did a QR project in the birthing hospitals in Columbus, where we made it a point for the neonatologists and pediatricians in the newborn nurseries to actually find out from the obese at the time, and put it into the child's into the newborn chart and into the discharge summary as well, because it's really an issue. And what's also interesting is that you can ask this mother, "Did she get the vaccine?"

And then a common response was, "I got all the vaccines and my OB recommended." And I was like, "Well, do they have the RSV vaccine?" And looking through, you know, luckily, a lot of them have the MyChart and it's not there. And also, as you know, a lot of the vaccines are given in pharmacies. And so trying to get that information is really critical.

Dr. Smith: Yeah. I think that's a key - that's a key thing to remember that the monoclonals are safe. So if you're not sure - if you're not sure if the mom was vaccinated, if you're not sure, "Oh, was it 13 days? Was it 14 days?" The other situation that we've had some discussion with our practices is we had or had a case with a mom who received the other vaccine that you mentioned was the studies were done.

Dr. Sanchez: GlaxoSmithKline's.

Dr. Smith: Yeah, they received the GSK product, which is not licensed for use in pregnancy. And so what do you do there? And, you know, we weren't really sure. So we said, you know what, just to be safe and make sure the baby is protected, go ahead and give nirsevimab.

Dr. Sanchez: Yeah. No, and there's been errors in the vaccine that's been given because there's other products for the adults. And some of them have adjuvants as well. So there have been errors in administration and some babies have received the maternal vaccine because they're—so it's—yeah. And what to do with those it's always an issue.

Dr. Smith: Exactly.

Dr. Sanchez: Let's see. That's the next one. Right. Did we just do this one?

Dr. Smith: We just did that one. There we go.

Dr. Sanchez: So what are common barriers that lead to these infants falling through the cracks. I think we've talked some of this already.

Dr. Tesini: Yeah. This idea of being able to link the maternal vaccination history to the infant. At the individual level and I've had lots of discussions with our state immunization registry folks about to at the more epidemiology public health level to understand this is tricky.

Dr. Sanchez: And I think education also for the—I think the obese, really obese family practice. You know, the midwives, you know, whoever takes care of the pregnant woman, they really need to make it a point to stress the fact that it is important that you tell your, you know, your child, your infant's healthcare professional that she did or did not receive the RSV vaccine. I think that it goes beyond, you know, the pediatricians and the pediatric providers.

Dr. Tesini: I know some OB practices that have gone to the more old school method of giving the vaccine card to their patient, and then they can bring that to the pediatrician.

Dr. Smith: Yeah. And then just kind of, you know, vaccinology, public health 101 kind of trying to minimize those missed opportunities. So whatever reason a high risk patient is coming, maybe they're not seeing their general pediatrician, maybe they're seeing a subspecialist, you know, not necessarily seeing me as an infectious disease doc, but we have the opportunity in our subspecialty building to give immunization.

Dr. Sanchez: No, absolutely. And that's something else that we also - a lot of the specialty clinics were not giving any immunizations, and we have been able to get nirsevimab into all the BPD clinics, the low birthweight follow up clinics in addition, of course, to the pediatric clinics and the cardiology clinics. So I think that it really - it takes a huge effort, but I think it's really critical and really important that we really are very proactive in getting these products into individuals who need them.

Patient Cases

Poll 6

So case one. A five month old infant presents in early November for follow up. She was born at 37 weeks of gestation in June. Her mother received the RSV pre-F vaccine at 36 weeks of gestation. The infant's past medical history includes bronchopulmonary dysplasia and day care attendance starting this month. What is the next most appropriate step for RSV prevention in this infant?

A. No intervention since maternal vaccination provides sufficient protection;

B. Administered nirsevimab or clesrovimab or now due to high risk status and timing;

C. Check RSV antibody titers to guide need for prophylaxis; or

D. Wait until six months of age, then reassess eligibility for monoclonal antibody.

No. That's great. That's great. So the mother received that at 36 weeks. The baby was born at 37. So that's only a week. So insufficient time for the antibodies to have crossed the placenta and to protect the baby. So the infant definitely should get the monoclonal antibodies. And remember, it's the day that the baby receives. It has to be less than eight months of age. It's not less than eight months at the start of the RSV season. And the day that you give it, it has - that child, that infant has to be less than eight months. So it's really—the timing is important. So let's see.

Poll 7

So an 18 month old child presents in October for a well-child visit. She was born at 32 weeks gestation and required CPAP for two weeks after birth. She received nirsevimab during her first RSV season. Her parents are concerned about RSV and ask whether she should receive another dose of protection this season. Which of the following is appropriate for this patient?

A. Administer nirsevimab prior to RSV season;

B. Administer clesrovimab if RSV activity becomes high locally;

C. No RSV immunization is indicated for this season;

D. Check RSV antibody titers to determine need for prophylaxis.

Some of these songs bring back my hair. I'm ageing myself. Okay, so 28.6 would administer nirsevimab and 71%, which is the correct answer. So remember first of all, this child timed out because he's already 18 months old. So they have to be less than 18 months of age in order to receive the second dose.

On top of that, this baby—this child did not have BPD severe heart disease. Well, actually BPD severe heart disease is not a reason for a second one. No cystic fibrosis, and as far as I can tell, does not live in Alaska or an American Indian reservation. So no RSV immunization is indicated.

Posttest 1

So posttest one. If following AAP recommendations, what would you recommend for a person who received RSV vaccination during their prior pregnancy and is now at 34 weeks of gestation in her second pregnancy?

A. The mother should receive RSV vaccination now;

B. The infant should receive either clesrovimab or nirsevimab before eight months of age;

C. The mother should receive the maternal RSV vaccination; or the infant should receive either clesrovimab or nirsevimab;

D. No further immunization needed.

Great. Much better. So again, in the United States, we don't give a second a subsequent dose in a subsequent pregnancy. So the baby should receive immunoprophylaxis.

Poll 7

If following AAP recommendations, what would you recommend for a person who received RSV vaccination during their prior pregnancy and is now at 34 weeks of gestation in her second pregnancy?

Dr. Smith: Yeah, that's - I think that's the - that's the discussion.

Dr. Sanchez: I'm sorry.

Dr. Smith: Which you did. Like you did on your own. You don't need the prompt. Sorry.

Dr. Sanchez: I was like, I think I'm reading the same thing.

Key Takeaways

Key takeaways. RSV is the leading cause of infant hospitalization. 70% of hospitalized infants do not have risk factors for infection. That's really critical. Options for prevention of RSV include immunization through maternal vaccination during pregnancy, or administration of long acting monoclonal antibody during the first week of age, and these are nirsevimab or clesrovimab. Both highly effective - effective in certain high risk cases. Monoclonal antibodies should be administered during the second RSV season depends on age and health status.

Posttest 2

So posttest two, I have strategies to increase RSV protection for infants.

A. Strongly disagree;

B. Disagree;

C. Neither agree nor disagree;

D. Agree; and

E. Strongly agree.

Dr. Sanchez: Okay.

Dr. Tesini: All right.

Dr. Sanchez: Let's see.

Dr. Smith: Excellent.

Audience Q&A

Dr. Sanchez: Great. So we're going to go through some questions. So when to plan additional RSV immunization after ECMO. So I would give an additional dose before that infant is discharged. If it's still during RSV season. I wouldn't give it immediately. It depends on what the practice is, but I would wait until - until NICU discharge if you're still within the season. What do you do if the date of maternal vaccination is not 100% clear? Give infant immunization just in case it was less than 14 days.

Dr. Smith: Yeah. We talked about this, right. So yes, if you're not sure this is a very safe product, go ahead and give it.

Dr. Sanchez: Absolutely. From virtual audience, how would you counsel a mother with wanting to immunize the baby, even if she has been vaccinated greater than 14 days prior to delivery?

Dr. Tesini: Thank you for caring this much about RSV prevention in your baby.

Dr. Sanchez: Yeah, go on.

Dr. Smith: Yeah. Well, so - so I think - I think one thing I'll say this, I mean, this - this has happened to me in real life. I had you know - got an email from a colleague and she said, "Oh, by the way, I'm asking about myself." You know, but - but you know that that graph, that kind of survival, it's not survival curve, but the time series analysis that - that we showed. You know, I kind of said, look, this - this vaccine is very efficacious because this was a clinical trial at - at preventing RSV in infants and here - here you go. So I try to reassure them that it's not really needed.

Dr. Sanchez: Yeah. I think I would say by virtue of you having received the vaccine, your baby has been protected and you can further protect by breastfeeding and preventing the exposure, especially in the first couple of months of age. So don't let other - don't let people who are sick be with your child. So how do you bridge the gaps to warrant RSV immunization for every infant? Is it public policy, health professionals education, population education, or all of them?

Dr. Smith: I mean, it's all of them, right? But like, if you had to pick one word, what would you start?

Dr. Tesini: You know, I would - I would say probably the, the health professionals education under the - the context of, you know, one of the most important predictors of vaccination is a strong recommendation from your healthcare provider, your trusted health care provider. And so I think giving those people the tools to make that strong recommendation, obviously, we need the infrastructure to, to have the product available for them to also give the vaccination. But I think that is such a motivator.

Dr. Sanchez: Oh, absolutely. I think that the health - health care professional who's caring for that family is really critical. But I also think it probably depends locally and statewide what is available? Because like, as we talked with Connecticut, they already have a public policy in place. So I think that's really great. Whereas we could urge other places to do that as well. So I think it's - it becomes local issues as well.

Let's see here. We extended administering - we extended administering the RSV antibody until 4/30, April 30th. However, would it be better to recommend at this point waiting until September for better coverage during the majority of the RSV season? This is a question that actually has been discussed a lot.

Dr. Tesini: I think this is also all ID is local, all infectious disease is local. And so you know, really knowing your local epidemiology, if RSV is still circulating and you have a very young infant, you know, this is-

Dr. Sanchez: I agree.

Dr. Tesini: This is still the most problematic time for them, but it's really more or less gone in your community than - yeah.

Dr. Sanchez: I agree. Do you have any comments?

Dr. Smith: No, I was going to say. Right. This is - this is the highest risk period in the infant's life. You got to - you got to do it.

Dr. Sanchez: Next season, the baby will - the child will be older and probably may very well be-

Speaker: Second dose at six months or something.

Dr. Sanchez: It's only recommended one dose. So if that child is otherwise healthy without those risk factors that we talked about or health conditions, the question is would we give that infant or child another dose in six months? No, the recommendation is only one dose. And by that time that in the subsequent season, that infant should be older and be better able to tolerate it.

Now, the other thing is that the antibodies last at least 150 days. And actually, there are studies that show that with both clesrovimab and nirsevimab, it really probably lasts even longer. They really are long acting antibodies. So there probably will be protection, at least during the beginning of the following season. What can community pharmacists do to support infant RSV immunization? Any pharmacists in the audience?

Dr. Smith: This is a great question. I think I'm not aware of any location where you can just go down to Walgreens and - and, you know, receive one of these monoclonals. So I think when I read that question, I think just being an advocate because you're going to be seeing perhaps the mothers themselves. You're going to be seeing other family members. You're going to be seeing the grandparents. And that's really a good time to advocate, you know, advocate for them - for especially grandma or grandpa to get vaccinated if they're at high risk. And just kind of reemphasize the importance of - of RSV. So I don't know that there's a role in the administration of the monoclonals, but I think you can be an advocate and make sure that you're having discussions?

Dr. Sanchez: No. And I think these pharmacies can put up signs. I know that CVS sends me, "Oh, you're due for your flu vaccine. You're due for this or for that." So I think that they can certainly play a big role, since so many people are getting their immunizations at pharmacies and putting signs up like we would do in the postpartum areas and the newborn nurseries about it. And then the - the OB offices. Let's see, if there is too long a season or in places where there is no seasonality, would you consider two doses for infants at bulk protection for six months?

Dr. Smith: Yes, we kind of talked about that one.

Dr. Sanchez: Recommendation currently is one dose only. And by the time the infant is over six months or over eight months should be better able to tolerate it. My colleagues and I struggle with babies born at the tail end of season, such as this month. Balancing giving it early when babies are most at risk due to age versus protection through more of a season. Like we talked about, I agree. Give it now because the younger the baby, the more likely they're going to have worse disease.

Dr. Smith: Yeah. And if they truly are high risk they're still eligible for season two.

Dr. Sanchez: I think that's the last question.