Timely RSV Prevention in Infants: Take Infant RSV Prevention to New Heights

[01:05:53]

How to Develop “Change Ideas”

And now we're moving into the quality improvement part of the talk. I did 20 years in emergency medicine and 12 years beyond that in urgent care. If I never see another kid [inaudible]. I think we all feel that way.

And for me, we really harp on hospitalization. But for me, it wasn't just hospitalization. It was any medically attended. Because how many parents have you seen that we're sending your kid home, and the parent would look at me and say, “You've got to be kidding me. I'm going to be watching this kid take every breath all night for the next 3 nights. You got to be kidding me.”

So this is such a worthwhile like this is my dream come true in terms of prevention. So we're going to start. It would be ideal if I actually knew all of your data about each one of you about the uptake of the vaccine and the monoclonal antibody. But I don't. So I'm going to look at some national data with you. And then we'll go from there to looking at some of the barriers that were in these data sets. And then from there we'll talk about how do you overcome those barriers.

Now the real challenge is in your own settings, because your barriers may be different than the very specific barriers we're going to talk about.

[01:07:41]

RSV Immunization (Maternal Vaccination and mAb) Among Infants: Data from 3 Illustrative Sources

So we've got 3 main data sets I want to talk about. The first 1 is based from CDC. It's Immunization Information Systems. What we in the old days used to call registries. Nod your head if you know what I'm talking about, those state immunization registries where you put in information about vaccines primarily and now monoclonal antibody do.

The next 1 is a vaccine stated—Vaccine Safety Datalink. This is a group of healthcare systems that report data back to CDC. And then the third group of data that I want to talk about come from Children's Hospital of Philadelphia or CHOP. And that is 1 single healthcare system in New Jersey and Pennsylvania. And they looked at EHR and IIS data.

Now, each of these systems that we're going to be talking about are going to tell us a little bit different lessons. All of the data I'll be talking about right now are first season. And we know that first season was really different than second season because there was a shortage. The recommendations were brand new. The recommendation from ACIP only was published in October. So for mothers to get vaccinated, you know, we say mothers can start getting vaccinated in September, but ACIP didn't publish until October. So the first season was really different. It had lots of problems. So these data are different.

The other thing that I want to point out that the requirements to get into these studies were different. So for the IIS study and the VSD study, they were looking only at kids born during RSV season, not those kids that were born before. And so a little bit different.

And because the systems were different. The first 1, the IIS was from 33 states in D.C. so a wide band, but they were only looking at the data that was in the state registry systems. They weren't looking at EHRs. And so we know that a lot of hospitals weren't even reporting to the state systems yet. So different than the VSD that was both EHR and IIS and CHOP, which was EHR and IIS.

So the results were really different and all over the map. For the IIS study, it came up with 29% coverage. And when I say immunization, I mean both mother and infant. For the VSD, it was 72%. Now that was all healthcare systems. And so those kids were like automatically part of a healthcare system. So maybe it was higher, but maybe it was that the data systems were different because they were looking at EHR and IIS.

[01:10:52]

CHOP: mAb Uptake in a Single Network

And then for CHOP it was 35%. But remember that those kids were different because they were the ones born before, and so they didn't have the opportunity - well, those infants were born April 1st to September 30th, so they couldn't benefit from maternal vaccination because the mother couldn't be vaccinated during that time, and they couldn't get the monoclonal antibody in the birth hospital because it wasn't October yet.

So those kids have a sort of double whammy that it's harder. In those cases, you're totally relying on the primary care pediatric or family medicine office to get the job done.

[01:11:43]

What We Learn From These Studies

Okay. So looking at these 3 big studies, what are the big picture take-home messages to me from them? And maybe you would get different. But these are my take home messages. Number 1 is variability. There was a lot of variability.

[01:12:00]

CDC IIS Report: RSV Immunization by State

So looking just at the CDC IIS. Look at the difference from state to state. Some states the immunization rates were over 40%. Those are the ones in that kind of dark blue-ish and a dark teal. Go teal. And the ones less than 20% in that orange color. I didn't pick those colors on purpose. But you see that different states are different.

Now, when you think about why did different states have such hugely different uptake? Well, I mean there's different levels. There's a patient level. So our patients different in some states where maybe there's higher vaccine hesitancy in some states than other states. So it might be at the population level.

It might be at the practice level. If you're in a more rural place, you're more likely to see a family medicine physician than a pediatrician. We know that traditionally, pediatricians have much higher vaccination rates than family medicine physicians. So that's another layer of difference from state to state.

Another 1 is healthcare systems. Some healthcare systems like the hospitals may have already been VFC providers because they were providing hepatitis B vaccine, and so there might have been differences at the healthcare system level.

And then finally, some states—at the public health level, some states have more money for better IIS, more coverage through their IIS systems or more money to have public health people out detailing primary care offices about here's what's coming down the pike. Get ready. So there's lots of different reasons for possible variability, but we see a lot of variability.

[01:14:12]

CHOP: mAb Uptake by Practice

Here's a different kind of variability. So this is that Children's Hospital of Philadelphia study we talked about where they looked at kids who were born before RSV season started. And we see that in individual practices, the protection ranged from 65% down to 20%. Now again, we look at could there be differences from different practices in terms of populations that attend these different practices? Yes.

If you know anything about Pennsylvania, there's parts of Pennsylvania that are very rural and very red. We know that, for example, HPV vaccination uptake. Actually, Joe's team did a study looking at HPV uptake by voting and found that red states were much less—the kids in red states were less likely to be fully vaccinated against HPV.

And we know that in Pennsylvania that there are parts that are very red and that there are parts that are very blue. And so these practices may be - that the variability may be at the patient hesitancy level. And they can't be at the health system level because it's all the same health system. They could be different at the public health system, although even Philadelphia has a different public health system than the rest of Pennsylvania. But they're both very good.

So I think that a lot of it comes down to practice level stuff, like who has, reminder recall in place, who has standing orders in place so that the nurses know that they can give this. We'll talk more about how practices—you know, what practices can do to be on the left side of this.

[01:16:14]

What We Learn From These Studies

Okay. So variability. Birthing center involvement is important.

[01:16:18]

CDC ISS Report: Age at Receipt of mAb

This slide shows you—this is from that CDC report. This is supposed to be IIS, Immunization Information System. So this is the month that the kids were born across the bottom. And this is all the kids over the whole time. And this shows you the percent of kids vaccinated in dark blue is Days 0-3. The lighter blue is Days 4-6. In pink is Days 7 through the first month, and in orange is more than a month beyond birth.

So when you look at this column with all—and so as time went on, more and more kids that were tracked in the red in the state registry were vaccinated in the first few days of life. And overall, more than a third of the kids were vaccinated in the first 6 days of life. So what this says to me is having hospitals on board, giving this vaccine is a very important piece to this whole unified puzzle, getting that done as soon as possible.

[01:17:44]

What We Learn From These Studies

All right. My third take-home message is 2 options are better than 1. We know like when you're trying to do pertussis, you know vaccinating the mom isn't as powerful as vaccine is. Does almost nothing as opposed to vaccinating kid. Here we have 2 options. And so using both options because some parents - some moms say, “Oh, yes, give me the vaccine. I'd rather take the vaccine than have my baby get the shot.” And other moms feel like they don't want anything unnatural during their pregnancy. They would much rather have their baby get a protein injection after they're born.

And so there's different psychology. But having both options makes it that if we can get a third done this way and a third done this way, we're more likely to get it all done.

And then the other thing I do want to say is, in the study that this data is from, Murphy's law is alive and well. Anything that can go wrong will go wrong. 7% of the kids in the VSD study, the mother was given the vaccine less than 14 days before the baby was born. You know, so what Pablo said earlier about you have to not just know whether the mother was vaccinated or not. You have to know when she was vaccinated because there's a whole lot of error along the way. If it can go wrong, it will go wrong.

Okay. And then another thing that I get out of those studies is overall coverage doesn't tell us the whole story. There are groups of babies within that overall picture that aren't getting protected.

[01:19:54]

CHOP mAb Uptake: Results by Patient Characteristic

So this is a harder slide to see. So this is from the CHOP study. This shows both maternal vaccination or—no, because those kids weren't eligible for maternal vaccination. Never mind. This is just protection through monoclonal antibody. And the red line—so these are odds ratios. If you're on the right side of the odds ratio, it means you were more likely to be protected. So kids with low birth weight were; and if you cross the line, it means that there's no statistical difference. There can be trends. But if you cross the line, it's not statistically different.

So if you had low birth weight, you were more likely to receive the monoclonal antibody, which I think is interesting. But when you compare that with the complex chronic conditions, those kids, I mean, were close to—you know, it's not statistically significant because it crosses the red line. But it was less likely. Isn't that odd? I don't have an explanation for that.

We were talking about if you work in a BPD clinic or are a pulmonologist and that, you know, doing the work to remind the parents of kids who have chronic conditions that they - they really need this protection. So other things that were significantly, COI means Child Opportunity Index. So it's like a socioeconomic status index and very low, you are statistically less likely to get the protection than if you were very high. Kind of what you'd expect that there's access problems, maybe other problems. Public insurance. You are statistically less likely.

I'll point out to the teal team. The rest of you can ignore me right now. But the teal team, I want you to notice that public insurance was actually statistically. The age in months made a difference. And black made a difference.

Now there's some overlap. But 1 of the things I want to point out here in this study, having a Hispanic or Latina mama actually came close to being statistically significantly higher. Now, that isn't borne out in all the different studies. You know, we talked about 3 different studies. That isn't borne out in all the different studies. And 1 of the things I have to say is Hispanic isn't Hispanic isn't Hispanic. You know, like Puerto Rico is in Colombia is in Mexico, so different. But in this case, in this study it was close to significantly higher. Interesting.

[01:23:20]

Weekly Rates of RSV-Associated Hospitalization, Age <1 Yr, 3 RSV Seasons

All right. I was telling a girlfriend of mine about this whole talk, and you know, how interesting and how excited I am about RSV protection. And she said, “So what's the answer? Did all these efforts make a difference?” And I realized that I didn't put this slide in. So the answer is yes. It really is making a difference in the United States.

Here are the RSV-associated hospitalizations by season for ’22-‘23, ’24 - ’23-‘24, ’24-‘25. It's going down. So very, very exciting. And you all know that you have access to these slides. So if you want to teach this, that you can.

[01:24:06]

Poll 4

Okay. How to increase rates? I don't have time to have you to talk about this because I'm already over my time. But I want you to type in because I would like to learn from you what you're doing in - in your area to increase immunization rates?

[01:24:22]

Change Ideas

I'm going to talk about just a few. One is enhancing delivery before hospital discharge. So working with your affiliated hospital to get the job done.

[01:24:33]

Successful Implementation of mAb and Factors Influencing Uptake in Neonatal Care

And I'm just going to point out that this hospital in California did an amazing job by talking about this to staff and caregivers. We were talking, I forget who was saying, the hospital that they work with. Actually, some of the staff gave the parents wrong information about needing this. And so doing education at the hospital level seems like an important piece, but also making it so that it's part of their workflow.

[01:25:01]

Change Ideas: Collaborations

Collaborations not only with the hospital, but also with your OB/GYNs so that you hear from them not only whether they gave it, but when they gave it. Working with subspecialists, as we talked about, if you have a group who - who could potentially give the monoclonal antibody in their office when they see the complex chronic illness kids. And then, of course, enhancing delivery in primary care.

[01:25:33]

Change Ideas for Primary Care

Making sure that your office has monoclonal antibody to give as the first step. If you don't have it, you can't give it. Making sure everybody knows that this is still covered by VFC and that they are okay. And then a political word on this that if our children are losing access to Medicaid, that they won't have access to VFC. If the ACIP decides to take monoclonal antibody off of VFC that that leads to lack of access. So there are political issues involved in this too.

Using reminders and recall. In that CHOP study, about a third of the kids who got the monoclonal antibody got it at nurse-only visits. Using prompts so that the kids that come in having—whether it's your EHR reminds you or your nurse staff, but ideally both remind you.

[01:26:36]

Using Standing Order Templates

There's standing order templates. And again, you have access to all these slides. So I don't expect you to memorize this, but there are standing order templates that help people know who needs what. You've gotten a lot of education tonight, but it's really hard for your nursing staff a lot of times to know who needs it and who doesn't.

[01:26:58]

Change Ideas That Have Worked for Vaccines

Share Reliable Resources: “Prebunk” Misconceptions

Other ideas that have worked in the vaccine world. One is to what they call prebunk. Instead of having to debunk misinformation after the fact, you give people information before the—you know, like when—during the pregnancy so that they know.

[01:27:19]

Additional Resources for “Prebunking” Misconceptions

And here's just a couple. AAP has healthychildren.org. There's a great website called letsgetreal.org that helps prebunk.

[01:27:28]

CHOP’s Vaccine Education Center

And Children's Hospital of Philadelphia if you're not already familiar with the Vaccine Education Center it has awesome higher reading level but awesome education information.

[01:27:40]

Use “Presumptive” Recommendations

Using presumptive recommendations like we do with HPV, where we say today your child's due for 3 things rather than saying, “So how do you feel about getting the RSV?” And that has worked; that works very well with HPV. We don't have any studies yet with RSV, but I think it would be very interesting to do that.

[01:28:07]

What Do You Think of This Approach?

What do you think of this approach? Saying, you know, using this difference in mechanism because the monoclonal antibody isn't a vaccine. It isn't. And so saying something like, “Well, we've talked about RSV. Today, it's time to give that protein shot that will improve Jason's chance of making it through this RSV season without needing help in the emergency room or the hospital.” The medicine lasts about 5 months, just long enough for 1 RSV season.

Do you think if you said it's a protein shot, not a vaccine? Does that matter? Sometimes. [Inaudible]. Yeah. [Inaudible]. Immediately.

[01:29:03]

What If a Parent Declines mAb?

If a parent declines—and we talked about this—that parent declined at the beginning of the season but then was willing to get it later. Don't shut the door.

[01:29:20]

Staff Training: How to Handle This?

Which brings up staff shutting the door by saying, “I don't want my baby to get RSV”, and the staff saying, “Okay, then we won't talk about it.” Just saying, “Oh, the doctor feels really strongly about this. Let me make sure that you talk to the doctor or the nurse practitioner.”

[01:29:37]

Improve Patient Experience

And then the last thing I want to say is that some people just don't want the owie factor—the ouch. And so there's wonderful information about addressing vaccine, anxiety and pain for infants and toddlers. And we give you the website there.

[01:29:53]

[01:33:17]

Q&A

Dr Humiston: We're going to say and do a couple of questions. If - we are officially over. So if you need to leave, don't feel bad for me. I don't have.

Dr Sanchez: So I can go with the first 1.

Dr Domachowske: Sure.

Dr Sanchez: So if an infant contracts RSV in September, they should still get the vaccine after October in the first season. They should still. Yes, they should get the monoclonal antibody if the mother had not received the RSV monoclonal yes, in the first season. So after an RSV infection, they are able - the infant is able to receive the monoclonal antibody if he's eligible at the time of the immunization.

Dr Domachowske: So the next question I have here is, can infants get monoclonal antibody, even if mom got the RSV vaccine more than 14 days before the delivery?

And the answer is usually not necessary. But the list of reasons to do that sort of sequential, from maternal vaccination to also giving long-acting monoclonal antibody is growing. Right? So we already know that - if we're not sure if mom was vaccinated, if she was vaccinated less than 14 days before delivery. If there is an indication either suspected or proven of placental insufficiency. So a low birth weight baby, for example. Placental insufficiency is also a condition that - that occurs with HIV infection. Even if the HIV infection in the mother is well controlled, we know that those babies benefit from also getting long-acting monoclonal antibody.

If mom has an immune compromising condition and her response to a vaccine is suspected to be not as robust as an otherwise healthy individual, because in the clinical trial that showed that this works, the maternal vaccination, they had to be perfectly healthy singleton pregnancies. And so, you know, we can't translate that to every instance. So yes, it is possible to go sequentially after maternal vaccination. Also give long-acting monoclonal antibody.

If you're going to do that, I would make sure that for claims reasons that you document it in the chart exactly why you're doing that.

Dr Humiston: I want to say a question that has come up. You know, the Murphy's law thing about everything that can go wrong will go wrong. We've had instances where the baby got the vaccine. Like the real –

Dr Domachowske: Yeah, yeah.

Dr Humiston: Got Abrysvo.

Dr Domachowske: Yeah. We've had pregnant women getting monoclonal antibodies.

Dr Humiston: Yeah. And so what do you - so do you guys want to talk about what do you do if the baby got the vaccine?

Dr Sanchez: Well, first of all report it to the VAERS, so that we do have a reporting system. And we have no data on whether that baby will actually have an immune response. So I would go ahead and give the monoclonal antibody to the baby if he's eligible to receive the monoclonal antibody.

So yeah. And there's also been instances where the mother has received the other RSV vaccine. And so that's also of concern. So you have to be really careful about checking which - which preparation is actually being given to whom?

Dr Domachowske: Yes. Good point. Right. There's 3 formulations of RSV vaccine approved for adults, depending on the context, but only the Abrysvo, the Pfizer vaccine PreF formulation is approved for use during pregnancy. The GSK vaccine is adjuvanted and it's not recommended to be given during pregnancy. And the RNA vaccine is not studied and recognized to be safe and effective during pregnancy. So you have to use the PreF bivalent Pfizer vaccine during pregnancy if you're vaccinating pregnant women.

Dr Sanchez: And the whole issue with the 32 to 36 weeks in pregnancy for the maternal vaccination, a lot of that came out of the GlaxoSmithKline, the GSK vaccine, the - which in pregnancy was not adjuvant. But in that study, given at 24 to 36 weeks, the study was stopped early because of prematurity. And so there was concern as to when the PreF Pfizer vaccine was being evaluated by FDA and CDC as to whether that could happen.

And so in the randomized study, when given at 24 to 36 weeks, there was an imbalance in preterm births. So in other words, it was 4% vs 5%, 1% difference, more so in the vaccinated group. Most of them occurred after third - the preterm births occurred after 30 days and - and mostly in South Africa. But it was really seen in many different countries because those multinational. But because of that, it was recommended then to only give the vaccine to pregnant women at 32 to 36 weeks, not to go down to 24 weeks.

I will tell you, the UK is doing 28 weeks and over. And however there's been post-marketing studies. The FDA require these companies to do post-marketing study in the Pfizer vaccine. And so far, there's been a couple of large studies that have not shown an association with the - with prematurity. So we're comfortable with saying that it is not associated with prematurity.

There has been an - an association with hypertensive disorders in pregnancy in women who've received the vaccine, even at 32 to 36 weeks. That was seen in the trial and it's been seen in post-marketing surveillance. But -

Dr Humiston: Are we allowed to take a question from the room? Go ahead.

Speaker: Can you comment on the situation. A premature baby born, let's say, [inaudible] They are not 9 months old until November. So how do we handle that situation for second season? [Inaudible] the second year after 9 months. But we're entering the season and we delivered about 7.5 months away.

Dr Domachowske: Can you repeat that for the online audience?

Dr Sanchez: Yeah, sure. So the question was a premature baby who received the monoclonal - RSV monoclonal in March.

Speaker: But was born in November. It was not 9 months until [inaudible].

Dr Sanchez: We received it at nursery discharge during the RSV season, as is appropriate. And now you're seeing the baby in October or November. And that baby is still - and is healthy or has –

Speaker: The baby is having lung disease [inaudible].

Dr Sanchez: So if that infant is less than 8 months of age as of the start of the RSV season, and he already received - and he's healthy. So no BPD that has required medical therapy for the previous 6 weeks. No severe cystic fibrosis, no immunocompromise. That infant does not get a second dose of RSV monoclonal.

Speaker: [Inaudible] at 7 months old. Premature. It's October 1st. What do I do?

Dr Sanchez: The baby is what? I'm sorry.

Speaker: The baby is 7 months old October 1st.

Dr Sanchez: Okay.

Speaker: Has chronic lung disease.

Dr Humiston: Chronic lung disease.

Speaker: [Inaudible].

Dr Sanchez: If - if that - no, no, no. If that infant is - has BPD or chronic lung disease and requiring medical therapy, then that infant in the second season, yes, can get it. Yes. But yes, it's recommended that it be done from - actually it's less than 8 months and 8 months to 19 months. It's not 9 months.

Dr Domachowske: So the way we handle this in the –

Dr Sanchez: So it's fine. That baby will - should get it. Yes.

Dr Domachowske: The way we handle this in the clinical trial is that the infant that you're describing would be eligible to receive a 200-mg dose at the start of their second RSV season, even if they were less than –

Speaker: [Inaudible].

Dr Domachowske: Yes, yes.

Dr Humiston: Okay. Do we have more questions from this thing?

Dr Domachowske: We talked a bit about using nirsevimab or clesrovimab in babies born to moms that were vaccinated but delivered before 14 days from the time the vaccine was delivered. The question relates to when does RSV vaccine given to pregnant mom have maximum transfer of immunity? I think that's a very insightful question.

The - the clinical trials make this very clear that it takes about 5 weeks for the maximum - from the time of vaccination for maximum transfer of antibody. So that minimum of 2 weeks is to provide some transfer, but it doesn't optimize it. That's why the recommendation is really 30 - 32 weeks to 36 weeks. We should be immunizing these pregnant women between 32 and 33 weeks to improve the - to optimize the benefit to the baby, assuming the pregnancy goes to term.

Speaker: Going on what you just said, are OBs actually sticking to that, the numbers, are they actually recommended between 32 and 36 [inaudible].

Dr Sanchez: The OBs are - so the recommendation is - that the question is whether OBs are sticking to the 32 to 36 weeks? Yes, they are, and they should be. Now –

Speaker: I have my - my baby come in with a discharge note. They don't tell me the time, so I should assume unless they're briefed.

Dr Sanchez: No, you cannot assume. You have to find out what day that mother received it. Because if –

Dr Humiston: Right.

Dr Domachowske: If it’s been –

Dr Sanchez: Now, if you know that the mother received it at 33 weeks and you're taking care of a term baby, then yes, you.

Speaker: [Inaudible] They got it. The only thing is a term baby. I would - that's what I'm saying. I would hope –

Dr Humiston: Hope that it was.

Dr Sanchez: Yeah.

Dr Domachowske: But I would also caution taking maternal history about which vaccines did you get? Did you get the RSV vaccine? Because there's a fair amount of confusion, I think during pregnancy because we give COVID vaccine, we give Tdap vaccine.

Dr Humiston: We give flu vaccine.

Dr Domachowske: We give flu vaccine. So we want to make absolutely sure that it was the RSV.

Dr Sanchez: I had a mother who told me she received all the vaccines that her OB recommended, and I said, please call your OB and find out. And then she - she called me and then she goes, “My OB does not give RSV vaccine.” So it wasn't even mentioned. So I think you really have to know. And I have them check their MyChart.

Dr Humiston: Yeah.

Dr Sanchez: And yeah. And I think OBs really need to help us with that.

Dr Humiston: Yes, sir.

Speaker: If a child has a RSV infection, we can give the antibody. But how soon after [inaudible].

Dr Sanchez: Yeah. So like - so if the - so if –

Dr Humiston: The question - the question is how long after you've had an RSV infection can you give the monoclonal antibody?

Dr Sanchez: We have given it at the time of discharge after the first - during - so when the – the baby who is eligible to receive the monoclonal has an RSV infection is hospitalized. At discharge, we will give them their monoclonal. We don't wait for - you know, for them to get clinically, you know, they're fine to go to be home. Question?

Speaker: Can you please clarify what shortly before RSV season means? Because the antibodies [inaudible] and I want to have the chance that it's quite covered by the insurance if it's not before October.

Dr Domachowske: Yeah. So yeah. So that's a - the - the question is asking for clarification about when is the start of RSV season essentially. To clarify, the optimal timing for administering the long-acting monoclonal antibody is just before or at the start of RSV season. You have to know your local epidemiology and your regional epidemiology, because the definition of RSV season from the CDC is when 3% or more of samples that are tested test positive for RSV. And that's very different from region to region across the US. So you really need to work with your - your local laboratories, your local public health folks to really understand when is the typical timing for the start of RSV season.

For most of the continental US, it's in early October. That's why we start recommending long-acting monoclonals.

Dr Humiston: On Wednesday.

Dr Domachowske: On October 1st.

Dr Humiston: On Wednesday.

Dr Sanchez: I actually - no, but –

Dr Domachowske: But it differs.

Dr Sanchez: Getting back to others, I - I state that RSV season in in Columbus is November 1st and so we give it as of October in anticipation of the RSV season. So I measure all these ages as of November 1st, but we follow the sequence to see.

Speaker: [Inaudible] 33 week baby who had a chronic pneumothorax in the ICU. And then, last week of September, I saw him. And so I gave the [inaudible] to 1st October.

Dr Sanchez: Yeah. Yeah. You know. So the question is the - so a 33 week preterm infant who had a pneumothorax or lung disease and was seen at the end of September before October 1st, when it's generally given. You know, at some point there has to be a start. So there's always going to be a baby who should have gotten it the day - could have gotten it the day before. So at some point you have to say, this is it.

Now I just actually got that question today. And I said, “Fine, you can give him the day before”, you know. So I think some of this we - you know, there's a little bit of a leeway, but at some point we start and before then we don't.

Dr Domachowske: Every baby is entitled to 1 dose, right, entering the RSV season. So you just won't be able to repeat the dose. That's all.

Speaker: [Inaudible].

Dr Domachowske: Yeah. VFC won't care. And the claims data for most departments of insurance are going to accept that because they know they would have to pay it next week anyways.

Dr Humiston: We'll take 1 more question.

Speaker: I had the same issue with the backwards. So I had a baby who was born late March but didn't get to me until April 1st or April 2nd, and I gave it to them and then my, at first they were my clinic was refusing to let me and I was like, well, mom wants it. It's just 2 days. But they're like, we have to - and they let me give it to them in the end. I don't know what to do with that baby when she came back. I assume it should be fine, right?

Dr Sanchez: So this baby who – that - who was seen in the clinic at the beginning of April, and the question was whether to give the monoclonal antibody or not because it was after the season. So it's - we stopped giving it as of March 31st. And sometimes it - and I think going back to Joe's point, the local epidemiology in Texas by the end of February, it's done. The season is done.

Dr Humiston: And in Hawaii, they give it all year.

Dr Sanchez: And year round. And yeah.

Dr Domachowske: In Florida, the RSV season goes into April or even into May.

Dr Sanchez: In Southern Florida, they give it year round. You can give the monoclonal then. But I will tell you then that he won't get it the following season. And you really need to see how much is circulating. I actually had a preemie baby who had - went home, just like you said, 2 weeks in like the second week in April and actually got RSV, was in the ICU and had not gotten the monoclonal, was in the ICU, was still on high flow nasal cannula 3 weeks afterwards was in the NICU.

You know, so, you know, we need - we need protection year round because there is RSV that we see at all times. But I think for that we'll need a vaccine.

Dr Humiston: Thank you guys so much.

Dr Domachowske: Thanks everybody.

Dr Humiston: If you have more questions come on up. But thank you so much.

Dr Sanchez: Thank you.

[END OF TRANSCRIPT]