Today’s episode features Dr Michael Hochman,to discuss the newly approved FDA product to prevent RSV in children, Nirsevimab (sold under the brand name Beyfortus). Recently there have been two RSV vaccines approved for adults—one for individuals over 60 years old, and one for use in pregnancy to prevent RSV in infants. On today’s podcast, the conversation will focus on Nirsevimab, a shot that has been approved by the FDA for all babies up to 8 months old and a second shot for infants up to 19 months who are considered to be at high risk of severe RSV infection. Nirsevimab is a monoclonal antibody with activity againast respiratory syncytial virus (RSV). On today's podcast we will review the benefits and potential side effects of Nirsevimab.
Dr Michael Hochman is a Harvard Medical School graduate, a Robert Wood Johnson Clinical Scholars Fellow at UCLA where he received his masters in public health, and he is the founding editor of a book series called “ 50 studies every doctor should know”, so he has a keen interest in reviewing medical studies.
Dr Jessica Hochman is a board certified pediatrician, mom to three children, and she is very passionate about the health and well being of children. Most of her educational videos are targeted towards general pediatric topics and presented in an easy to understand manner.
Do you have a future topic you'd like Dr Jessica Hochman to discuss? Email Dr Jessica Hochman askdrjessicamd@gmail.com.
Follow her on Instagram: @AskDrJessica
Subscribe to her YouTube channel! Ask Dr Jessica
Subscribe to this podcast: Ask Dr Jessica
Subscribe to her mailing list: www.askdrjessicamd.com
The information presented in Ask Dr Jessica is for general educational purposes only. She does not diagnose medical conditions or formulate treatment plans for specific individuals. If you have a concern about your child's health, be sure to call your child's health care provider.
Today’s episode features Dr Michael Hochman,to discuss the newly approved FDA product to prevent RSV in children, Nirsevimab (sold under the brand name Beyfortus). Recently there have been two RSV vaccines approved for adults—one for individuals over 60 years old, and one for use in pregnancy to prevent RSV in infants. On today’s podcast, the conversation will focus on Nirsevimab, a shot that has been approved by the FDA for all babies up to 8 months old and a second shot for infants up to 19 months who are considered to be at high risk of severe RSV infection. Nirsevimab is a monoclonal antibody with activity againast respiratory syncytial virus (RSV). On today's podcast we will review the benefits and potential side effects of Nirsevimab.
Dr Michael Hochman is a Harvard Medical School graduate, a Robert Wood Johnson Clinical Scholars Fellow at UCLA where he received his masters in public health, and he is the founding editor of a book series called “ 50 studies every doctor should know”, so he has a keen interest in reviewing medical studies.
Dr Jessica Hochman is a board certified pediatrician, mom to three children, and she is very passionate about the health and well being of children. Most of her educational videos are targeted towards general pediatric topics and presented in an easy to understand manner.
Do you have a future topic you'd like Dr Jessica Hochman to discuss? Email Dr Jessica Hochman askdrjessicamd@gmail.com.
Follow her on Instagram: @AskDrJessica
Subscribe to her YouTube channel! Ask Dr Jessica
Subscribe to this podcast: Ask Dr Jessica
Subscribe to her mailing list: www.askdrjessicamd.com
The information presented in Ask Dr Jessica is for general educational purposes only. She does not diagnose medical conditions or formulate treatment plans for specific individuals. If you have a concern about your child's health, be sure to call your child's health care provider.
Hi everybody I'm Dr. Jessica Hochman, paediatrician, and mom of three. On this podcast I like to talk about various paediatric health topics, sharing my knowledge not only as a doctor but also as a parent. Ultimately, my hope is that when it comes to your children's health, you feel more confident, worry less, and enjoy your parenting experience as much as possible. All right, so today's guest is a repeat guest my husband, Dr. Michael Hochman, and we are going to talk about the newly approved FDA shot to prevent RSV in children. Now recently, there have been two other RSV vaccines approved for adults, one for individuals over 60 and one for use in pregnancy. But on today's podcast, our conversation will focus solely on the shot that has been approved for babies. And when a new shot gets approved, many people understandably have questions about whether or not their child should get it. So today, we are going to review the available data on the approved shot called Nazism app or its pharmaceutical name by Fortis. And to review some of my husband's qualifications just so you know why I wanted him on as today's guest. Mike is a Harvard Medical School graduate. He was a Robert Wood Johnson Clinical Scholars Fellow at UCLA, where he got his master's in public health. And he is the founding editor of a book series called 50 studies every doctor should know so he has a keen interest in reviewing medical studies. Hopefully this conversation helps make the decision easier for anyone out there who is considering the shot. And before we get started, I just wanted to say thank you to all of my listeners. I know that everyone's lives are so busy, and I appreciate the time you take to support this podcast. I'm so excited to have back on a repeat guest my husband, Dr. Michael Hochman, thank you so much for coming back on as Dr. Jessica, I was really worried whether I was gonna get invited back. So I'm very, very happy to be here. So today we're going to talk about RSV. And I am looking forward to talking about this because I've been getting a lot of questions from patients because RSV is a important virus in the world of paediatrics, and recently there's been a new vaccine, we're calling it a really what's called a monoclonal antibody, which we'll get into what that means exactly, but it was recently approved by the FDA. And patients are asking me the question, sure. Is this something that is necessary for kids? And what are the reasons why we would recommend it for children? So this is an exciting development in the world of paediatrics, and I brought on my husband because he's done some work with RSV in the past, and he loves reading studies, right? Certainly the first district. Okay, so first, just to explain to everybody why, why does RSV matter? Why are we talking about RSV? There are so many viruses out there that hit the paediatric world. Why is RSV something that we are particularly interested in making a vaccine for? So first, I'll say that RSV is honestly a significant concern for kids because it's the number one reason why paediatricians send kids to the hospital, it's the number one reason why kids require being monitored in the hospital because they get something called bronchial itis, which is a response to this virus where kids have difficulty breathing. And interestingly, most kids do get RSV by the time they're two years old. It's a very common virus. And most kids that get RSV it looks like a cold. But there are definitely a subset of kids where RSV can hit the system harder, and it can look like something like wheezing or kids have trouble breathing with cough and cold symptoms. And just to share some statistics every year RSP causes roughly 1.5 million outpatient visits, so 1.5 million visits to the doctor 500,000 Edie visits to the emergency room 60 to 80,000 hospitalizations, roughly, and about 100 to 300 deaths every year. So if there really is a medication or a vaccination to help prevent RSV, this would be incredibly helpful. And also interesting to notice that most kids that have trouble with RSV are less than one year of age, and in particular, they're less than three months of age. Okay, so hopefully, I've made the case on why finding an effective preventative treatment option would be really helpful for kids at large. Now, before we start talking about the new treatment option, Mike, will you please explain what has been used up until this point to prevent RSV and at risk babies? Yeah, well, thanks for the great introduction. And if you don't mind if I just take a minute, although I'm an adult, Dr. RSV is actually a condition that's very near and dear to my heart. It was actually the first medical condition in school that I really learned about I took a year off from medical school and did RSV epidemiology research on the Navajo reservation in New Mexico. And the reason for that was that, as you said, not only is RSV a very significant virus that causes a lot of trouble for a lot of kids, but it's particularly problematic for Native American kids, especially on the Navajo reservation. And so, you asked what was used to prevent RSV before this new medication came along. And I was actually doing research I was sort of a very background role in that first medication it was called synergis. And the reason they wanted to study it in the Navajo reservation was because exactly that there was just such a high rate of severe RSV disease among Navajo children. And so synergis is a monoclonal antibody. It's basically a synthetic antibody against the RSV virus. It's manufactured and it's given to little children, and it very significantly reduces the risk of complications to explain to people listening the difference between a monoclonal antibody and a vaccine. When we give a vaccine, the body produces its own antibodies. With a monoclonal antibody, we're actually injecting the formed antibody. So we may be referring to this RSV shot as a vaccine, but in truth, it's not a typical vaccine, right? It's more of a preventive measure. Yes. So tell everybody, what did you do in the background for RSV prevention at the Navajo? Well, like I said, I was a medical student, and I certainly was very much in the background, but one of the things I did was I was working in the paediatric clinics with the Indian Health Service in Shiprock. actually loved my time there. It was, it was actually right after you and I met I took a year off for medical school went to the Navajo reservation to do this work, but I was in the paediatric clinics. And I would take samples from little children's noses, nasal pharyngeal swabs, where you have to stick that swab back and get a sample from the very back of their their nose, which was really fun to interact with the Navajo community. But sticking a swab in the back of a little child's nose is not a lot of fun. It sounds like typical work they would give to a medical student. But the benefit was I get to live in a beautiful area in New Mexico and learn about a wonderful culture and hopefully do something to advance the health of that community. Yes, I definitely remember that time. Well, it's hard for me to believe it was over 19 years ago now. So let's talk more about synergist the current available preventative measure for RSV I think it's really helpful to understand its benefits and limitations. So that you can see why paediatricians feel that there's ever Mab or by fortis, which is the drug name, maybe such a step up from what we currently offer. So first, to explain the good about the current medication synergist synergis has been shown to reduce hospitalizations of RSV by about 50%. And the other great thing about synergis is that it's very safe, but send it just also has significant drawbacks. First, it's very expensive, it's about $1,000 a dose so the reality is most paediatricians do not carry the treatment in their office, we have to send kids elsewhere to get it. Second, it can be a pain to get it authorised by insurance companies, it often requires a lot of paperwork to be filled out. Third, it's recommended to be given as five doses total spaced once a month throughout the RSV season, which typically runs October through March. So ideally, kids get five doses total. So if you think about it, this means families have to take their kids somewhere five times to get the treatment. And the last drawback I can think of is that kids who are eligible for synergist is a really short list. It's mainly reserved for kids who are born prematurely. Yeah, that's exactly right. You know, synergists was a great medication for very high risk kids, but it just was not realistic or practical for most children, because as you said, it's just so time intensive. So I think this new antibody treatment is a real breakthrough. So it's a one time treatment, and it actually is also more effective than synergist. So I think it will essentially replace the need for synergis. Now this there's a map or by Fortis has been now added to the CDC recommended vaccines for all children under eight months of age during RSV season. So understandably, with this new recommendation, a lot of parents have questions. Many families are feeling hesitant because there's been a lot of talk about vaccines in the last few years. And a lot of parents really want to know if this is something that they should really do. So my husband, as I mentioned earlier, has a real passion for dissecting medical studies. So I thought we can actually go through the study that was published in the New England Journal of Medicine showing its benefit. So take it away Dr. Hochman, sounds good. And I will violate my rule of trying to use generic names because I can't pronounce the generic in this case I'll go with buy for this and in this case, so that was saying before buy for this really is a significant advance over synergists and there was a moderate to large size study that was published in the New England Journal that just showed how significant the benefit is. So they took 3000 Children, right the beginning of cold and flu season and they gave 2000 of them the by Fordist medication and 1000 Most of them got placebo. So a key difference from previous studies is that this one included the general paediatric population, not just at risk children, when we were studying synergis. In the Navajo population, it was really only being considered for very high risk kids, kids with lung disease, heart disease, immunodeficiencies, it was also being studied in the Navajo population, because the rates were so high there. But it wasn't really something that was considered or practical for the general paediatric population. And so the first thing to highlight is because this is a once a one time dose. This is actually something that could theoretically be used for a much broader population, maybe all kids under the age of eight months. And so that's exactly what they did. They did a comparison in general kids, most of them were not preterm, they did not have lung disease or heart disease. So very different population that synergist has historically been used in. And what they did is they took some of them, and they gave the by Fordist medication and they compared outcomes to those who who didn't, who got a placebo. And this study was focused on on young kids under eight months. And what they found was really impressed impressive results. You know, I am an adult doctor, I see a lot of medications for diabetes and high blood pressure. And a lot of these studies, you know, they reduce risk of heart attacks or strokes or whatever it may be by 10% 15%. Maybe it's a Grand Slam, if it's 20%. What they found was actually an 80% reduction in RSP related hospitalizations during that first winter when a baby was born. But we also have to consider the overall context. So the first thing to say is that in the control group, the placebo group, one out of 50 of those kids actually ended up in the hospital for an RSP related hospitalisation that first winter. That's a lot I have to say. I did not realise that hospitalisation rates were so high for RSV in young children, that's probably why you're constantly getting called in the middle of the night. By the hospital. Yeah. And when we were reviewing the data, my husband said to me, is this right can really one in 50 kids be hospitalised for RSV? And I have to say that number actually could be correct because I think about my own experience as a paediatrician. And last year, I remember counting 11 kids in my practice being admitted to the hospital for RSV, which I have to say, just to further explain, of course, you never want to kid to be in the hospital. But most of the kids that I send to the hospital for RSV, they are there for a day or two and then they do come home afterwards. They're there to be monitored to make sure their breathing is okay. Meaning that they're not there for an extensive amount of time, and they do turn around and recover. But just juxtaposing that with COVID for example, a lot of parents are very nervous when their kids get a diagnosis of COVID. And in the last year, I didn't hospitalised a single kid for COVID. So by comparison, with my own experience, RSV is a much more serious virus. So one in 50 actually strikes me as a very possible realistic number. Yep, so in the control group, the hospitalisation rates were one in 50. And in the group that received the buy for this treatment, it actually was reduced to one in 250. So again, just to highlight that's a really significant difference. That's an 80% reduction, very significant decrease in the amount of, of RSP related hospitalizations. The other question always comes up is about adverse effects or side effects. Actually, I should say that would actually was a very safe medication to use, there was no major side effects except some rare allergic reactions. So as studies go, this is one of the more compelling ones I've come across recently. And I'm glad you mentioned the side effects because that's something that always I think about when we're recommending a new product, because I think it's so important when you have a healthy child. And then as a doctor, we are doing something to that healthy child, we really have to consider the side effects. So that's really nice to know that as far as side effects go, and the study was found was an addition to you know, redness and soreness over the injection site, rare rare instances of allergic reactions. But I I'm going to add a caveat. There were actually only 2000 kids who received by Fortis in the study. And what we know is that it is not unheard of, and even not uncommon in medical studies, that you don't really start seeing major side effects emerge until 10s of 1000s, or hundreds of 1000s of kids have gotten the vaccine. So while the studies are reassuring, we're not out of the woods yet and I think I would feel a lot more confident in the safety of buy for this. Five years from now when many people in the community have received it. So that begs the big question. And I'm just curious after reading the data and hearing about the burden that RSV places on families and children, would you recommend this vaccine to your patients? Right. So let me try and answer this by putting a couple other things in context. Although of course, as you said, we do not want any child ended up in the hospital with RSV infections. Most kids who do end up hospitalised end up doing pretty well maybe you could make a comment or two about your typical situation. When one of your children one of your patients with RSV ends up in the hospital, I would say they do end up doing well. It's it's scary for families, and I think nobody wants their kid to be in the hospital. Typically what we'll see with RSV is a child will have cold like symptoms. And then somewhere around the fourth fifth day, they seem to get worse, they'll have signs of difficulty breathing in the medical world. We call that to kip Nia. And so we monitor children in the hospital for a day or two till they get over that hump. And then they go home and recover. So I would say yes, most kids do. Well, despite being hospitalised definitely, yeah, I was actually reading a little bit about RSP, in preparation for the grilling I was going to get from you today. And it said that about 300 kids die a year from RSV infections. And again, I don't want to in any way suggest that it's that's not very sad and unfortunate, but three hundreds, not a lot, the entire United States and most of those kids are those with severe underlying pulmonary or cardiac disease. Just to clarify, because most people when they hear you say that they'll say we should have zero deaths and kids, which I understand that sentiment as well. But you're saying that of the kids that pass away, most already have health conditions that are difficult. That's right. And it is very, very rare unusual for a otherwise healthy child who was born at term to die of RSV infection, not unheard of, but but very, very rare. And that important. And the reason that's important is to put in into context, the pros and the cons of the vaccine. So certainly a really good thing to reduce by 80% hospitalisation rates. But in terms of more serious complications, deaths, for example, or severe permanent disability, those are already very rare. So I would consider that in the decision making if I were making this about my child. The second thing to consider and I started to allude to this before, although it was very reassuring the safety data, often serious adverse effects don't become apparent until several 100,000 people have received a treatment. And that just hasn't been done yet for by Fortis. So we have a situation where there's some very encouraging data very significant reductions in RSV related hospitalisation. On the other hand, the risk of life threatening complications from RSV is very low to begin with. And although the safety data looks reassuring, we still have more to learn about the safety before we can conclude it really is a safe treatment, which is a long winded way of saying it's going to come down to a personal decision. And if you're willing to accept that uncertain risk, that there may be some serious risks that emerge with this treatment over time. Maybe it is worth it to give that treatment before it is to your your child to reduce the hospitalisation risk. But to answer your question, specifically, I tend to err on the conservative or cautious side. And what I really think what I give this to my child at this stage, I think the answer is probably no that that I would be more concerned about those rare but serious side effects than I would about the benefits. With that said, I also want to say to everybody listening that I, you do have a bias towards being conservative, as you mentioned. So my husband's what he calls himself a healthy sceptic, that whenever there's a new product on the market, where we're doing something to somebody or offering a treatment, he tends to take the cautious route before going all in correct. I'm definitely a less is more person and I, you know, big believer that sometimes you can get just as good outcomes with with doing less in medicine. With that said, if I had a friend or colleague or family member who really did want to give their child by fortis, I think that's a very reasonable decision. The data are very compelling. There's no as yet identified major adverse effects. The Centres for Disease Control is now recommending it even in in healthy infants. And I think it actually would be very reasonable to give it to a child. I also think it's worth noting, while you can't predict which child will have difficulty with RSV, or difficulty breathing in the wheezing, there are certain risk factors and I tend to feel like maybe that's something we should communicate to families. For example, kids that are approaching RSV season and they're less than three months of age. Kids that are born into RSV season with older siblings that are in daycare, kids that have lung issues, heart issues, kids that are born premature, so any kid that's Forehand younger than 36 weeks of age, all of those, I think are considerations that may make me as a paediatrician, encourage the vaccine at this time. That's exactly right. And that is absolutely something important to consider when making this decision. If I did have a baby who was born, maybe not premature, but maybe a month or six weeks earlier than term that is a risk factor for RSV infection. And that might push me to be a little more willing and open to taking the treatment. Similarly, as I mentioned before, on the Navajo reservation, if I were a public health official, and I knew that there was such a high rate of severe complications there, I might push, push it a little more in that in that population. All right, well, this has certainly been helpful. And now we really provided some details about the new monoclonal antibody, there's ever Mab or by fortis, and thank you so much for coming on and explaining the data to everybody listening. Hopefully, you got something out of it. It gave you something to think about. And hopefully we didn't confuse you more. Hopefully, I'll earn myself a third trip on the Ask Dr. Jessica podcast. Absolutely. Absolutely. Before we wrap up, do you have any final takeaways or advice for parents listening? Well, the other thing I read a lot about in preparing for this was how much simple hygiene can make a difference with RSV. So this is one of those situations where washing your hands actually can make a really big difference. And maybe you know, if there's a little sibling to keep them away, if there's a lot of friends coming over during RSV season, some simple basic things can help protect your child. I know it's interesting because it by a certain age, part of me thinks why even try because they say almost every kid will get inevitably by the time they're two years old. But you're right, especially in those younger months, it's worth the effort to take time to be careful, wash your hands, stay away from other kids that are sick. And if you yourself are sick, stay home. Yeah, that's fair, I did see that. Virtually every child by the age of one year had acquired it, but maybe in those first really vulnerable few months of life, to be a little cautious about the hygiene with your child. Absolutely. Well, thank you so much for coming on. And until next time, thank you for having me. Thank you for listening and I hope you enjoyed this week's episode of Ask Dr. Jessica. Also, if you could take a moment and leave a five star review wherever it is you listen to podcasts, I would greatly appreciate it. It really makes a difference to help this podcast grow. You can also follow me on Instagram at ask Dr. Jessica See you next Monday.