Susan Hepworth, Bob Hopkins, Jr., MD, Jefferson Jones, MD, Karen Crowley, DNP
Susan Hepworth: Thanks, everybody, for joining. We’ve got almost everyone who RSVP’d has joined. We will get started with today’s webinar, Protecting Infants from RSV: Understanding Guidance on New Prevention Tools. My name is Susan Hepworth. I serve as executive director at the National Coalition for Infant Health, one of the hosts of today’s webinar. I am delighted to be joined by three speakers here today with us. We’re joined by Dr. Kieran Crowley of the Association of Women’s Health, Obstetric and Neonatal Nurses. We’re also joined by Dr. Jefferson Jones of the CDC and Dr. Bob Hopkins of the National Foundation for Infectious Diseases.
I want to recognize the co-hosts of today’s webinar, the Association of Women’s Health, Obstetric and Neonatal Nurses and NFIB, the National Foundation for Infectious Diseases. I also want to thank our sponsors, Merck, Pfizer, and Sanofi, who helped make today’s webinar possible. To quickly outline the objectives of today’s webinar, we will receive an overview of RSV from Dr. Bob Hopkins at NFID. Then, we will hear from Dr. Jefferson Jones about new options to prevent RSV and what the CDC guidance says about their use. Then, we will hear from Dr. Karen Crowley, who wants to talk about resources for providers, patients, and caregivers to educate about these new prevention tools.
We have reserved a few minutes at the end for Question and Answer, so feel free to send those questions as they come to your mind. With that, I will start with a concise video that the National Coalition for Infant Health produced last year, based on a surveyconducted at the end of 2022.
Video https://www.infanthealth.org/rsv#videos
Nearly every child catches RSV by age two. Respiratory Syncytial Virus affects the lungs and airways and can cause bronchiolitis, pneumonia, coughing, wheezing, or other cold-like symptoms. But for many families, that’s only the beginning. A national survey of parents and healthcare providers found that the disease also leaves an emotional, financial, and social burden. Of the 340 parents whose child caught the virus, more than two-thirds said it landed their child in the hospital. 68% of parents reported the experience affected their mental health while their child was sick. Parents felt afraid, sad, helpless, and frustrated. Many felt guilty they couldn’t do more to prevent their child’s sickness. RSV also dealt excessive financial hardships to black families, who faced medical bills, loss of potential income, childcare costs for siblings, and transportation expenses.
Meanwhile, some parents had to request paid time off, take unpaid leave, or cut back on work. Nearly 20% left their job or were fired as a result. Perhaps that’s why more than two-thirds of surveyed parents described RSV as a financial burden or financial crisis. RSV impacted families’ social balance, too. Over one-third of parents said the experience strained their relationship with their partner. They had to turn to family members and friends to help with childcare, and all the while, siblings struggled to understand what was happening. RSV’s impact is multifaceted. So, how can policymakers help? [They can help by] supporting innovation and ensuring timely and equitable access to care and preventive interventions. Surveyed healthcare providers agreed that immunization and vaccine-like interventions could help minimize the burden of RSV. 82% of parents agreed they would want their child to receive such an intervention with good policy and innovation. Families and their healthcare providers can work together to reduce the burden of RSV.
Susan Hepworth: As you can see there, the burden of RSV goes but the burden extends to the family as well, as represented in those survey results. I want to welcome Dr. Hopkins from NFID, who will give us a presentation about the overview of RSV.
Bob Hopkins: I appreciate you all inviting me to be here. I want to spend just a few minutes discussing RSV disease and epidemiology. To set the stage for those who may not know about the NFID, the National Foundation for Infectious Diseases, a 501(c)(3) organization that was founded in 1973 with the goal of healthier lives for all through effective prevention and treatment of infectious diseases, through education, engagement of the public and other partners in collaboration to improve the health of all.
RSV is a widespread respiratory illness. From the scientific standpoint, it’s an enveloped negative-strand RNA virus from a family known as Pneumoviridae. There are two major subtypes of RSV known as A and B, and there are numerous different phenotypes or genetic groups, but A and B are the two that we need to consider. The symptoms of RSV overlap with other respiratory pathogens like COVID-19, influenza, the common cold, and others. In infants, RSV is the most common cause of bronchiolitis and pneumonia in children aged under one. Those at the highest risk are premature infants, those that have heart and lung disease, and all children, even children born at normal term with no other health issues less than six months of age. Most of those who are infected with RSV have a mild upper respiratory illness or cold, a classic illness that many of us in pediatric practice are used to seeing, or a child that comes in with a cough, then over a day or two develops fever or wheeze and copious nasal drainage area. RSV can cause that, but it can also cause other respiratory symptoms.
Adults, mainly those who are older age and who have chronic health conditions or those who are immunosuppressed, are also at increased risk for severe disease. Our focus is on the neonatal childhood burden, but it’s essential to recognize that there’s also significant disease in older adults.
Did you know that RSV is a common respiratory disease? In most years, RSV circulates in the fall and winter months in the U.S. It often starts earlier in the country’s southeastern part. I’ll show you some of that epidemiologic data in a moment. It’s spread through contact with others and in contact with contaminated surfaces. Unfortunately, the RSV virus can live on hard surfaces for many hours. It’s often spread through coughing, sneezing, kissing, or touching those infected surfaces and then touching your nose, mouth, or eyes. So, as I tried to teach my children and patients, keep your hands away from your face as much as possible.
Almost all children are infected by two years of age, but unfortunately, immunity following RSV infection is not durable. It’s not uncommon to see children and adults who get RSV multiple times a year. This is data from our friends at the Centers for Disease Control showing the seasonality of RSV from the 2018 season through the 2023 season (Table 1). The dark green line here with the high peak over October-November was a 2023 season. We had a very early onset and a severe RSV season in 2021, 2022, and 2023. In the following line that you see down in the panel to the left, you see it was a less severe season, less of a peak. And then, in the other colors, you see different seasons. We’ve seen a change in seasonality patterns, some early and others late; some years are more severe than others. With RSV, we see outbreaks in our population almost every year with slight differences in timing. The incubation period after exposure is typically considered 4 to 6 days, and you can transmit it to others before you develop symptoms. Generally, you can transmit the virus within three to eight days of infection. As previously mentioned, the typical symptoms are runny nose, cough, fever, and sneezing, and in small infants, you might see fussiness, wheezing, decreased appetite, irritability, and reduced feeding. It would be best to be suspicious about RSV when there’s RSV in the community or the time of year.
Table 1: Seasonality of RSV from the 2018 season through the 2023 season
We expect RSV and its symptoms not to be reliably distinguished from other respiratory viruses, which makes testing very important to distinguish between influenza, COVID-19, and other viruses. PCR or molecular testing is the most accurate way to test for RSV, although antigen tests are also reasonably accurate in children. Recovery from the illness usually takes 1 to 2 weeks. Still, it’s essential to recognize that those persons who are immunocompromised can continue to shed RSV virus, which can infect others for up to a month even after their symptoms are resolved. So, beyond thinking about taking care of yourself, you also need to think about what we can do to prevent transmission of RSV to others. COVID-19 and RSV are uncommon. COVID-19, you commonly see difficulty breathing, a little bit less so with RSV, but that’s still a common symptom that you can have on RSV. For people of all ages who have more severe diseases, fatigue is not typically a common issue with RSV. Fever can occur with any of these illnesses, although less likely in colds, and we think of loss of taste and smell as COVID-19. Sore throat is uncommon with RSV; wheezing is common in RSV patients. So again, RSV illness tends to be most severe in premature infants, infants less than six months of age, and persons with immunocompromised heart and lung diseases.
It is important to remember that over 80% of children who were hospitalized with RSV before two years of age have no risk factors. RSV can affect people regardless of whether they have chronic health conditions or not. RSV is the number one cause of bronchiolitis and pneumonia in children. Every year, approximately 2.1 million outpatient visits a year in children due to RSV illness, with 58,000 to 80,000 hospitalizations a year and, unfortunately, 100 to 300 pediatric deaths in children under five a year. This doesn’t even include the significant additional burden of RSV disease in older adults. So, what’s the treatment for RSV infection? We can suction those copious nasal secretions I mentioned. Oxygen can be provided for those with low oxygen saturation; bronchodilators may help with some of the coughs but have not been shown to change the direction or the duration of illness and nutrition support. It is essential to provide nutrition to help those infected with RSV use their muscles to breathe effectively. There are no currently effective available antiviral medications for us. So that’s one of the reasons that prevention of RSV is so vital. If we can prevent somebody from getting the infection, we don’t have to worry about whether we have effective antivirals.
Regarding the prevention concepts around RSV, hand-washing, surface decontamination, and masks probably have a modest effect on reducing RSV transmission. Still, they are essential, and we should implement these in our daily lives, particularly in the clinical setting. It’s also important to remind people that if you’re sick or your child’s sick, don’t get them out around others or take a chance on transmitting the virus to others. We have selective benefits. Palivizumab is a monoclonal antibody that’s been recommended and approved. The AAP recommendations are to use it for the highest-risk infants. It has to be administered intramuscularly and once a month throughout the season it’s used. We have great potential with our new preventive tools, including honesty, vaccines, and the app, which Dr. Johns will discuss shortly.
That is my brief presentation. I look forward to answering some of your questions in the webinar.
Susan Hepworth: Thank you, Dr. Hopkins. Before I turn it over to Dr. Jones to discuss those prevention tools Dr. Hopkins just spoke about, I want to share the video of one more family who RSV impacted.
Video https://www.infanthealth.org/rsv#videos
Melanie: Life in the Rogers House is very chaotic. My name is Melanie, and this is my husband, Dan. We live in the suburbs of Chicago with our four kids. Our kids are nine, Dylan, six, Reagan, and then we have twins who are three, Austin and Holden. Reagan was four months old, and when she woke up in the morning, I could tell her breathing was not right. Those ten days in the hospital were grueling. They were exhausting.
Dan: The one word I would use to describe the RSV experience is helpless. I never even heard of RSV before. So it’s like, oh, they have RSV, and you’re like, what’s that?
Melanie: Her breathing was not right. She was breathing very deeply, very quickly, and it was really scary. It’s a waiting game. When they finally did tell us that we could go home. I’d be lying if I said I wasn’t panicking, thinking, can I do this at home by myself? It’s very frustrating because there’s nothing we can do to speed up their getting better, and you’re just stuck. As a family of six, we tried to do what we could to keep them from it. We still got it with the twins. For everyone who’s had a child or has dealt with hospitalizations, the bills are all calling at once. They start trickling in; you don’t know when they will stop. You have all the emotions flowing through when it’s happening. You feel helpless because you’re there with your child in the hospital, and then you feel guilty because you’re not at home with the other children. It can be really scary with how contagious it is. You need to trust your instinct with something like this because even though some may say it’s just a cold, these babies cannot handle it. They need supportive care and help. Be bold and call your pediatrician’s emergency line in the middle of the night. If you’re worried about their breathing, don’t be afraid to show up at the E.R. when uncomfortable with your baby’s breathing. This is not something to take lightly. It’s very scary, and you feel very helpless, and this is just something we shouldn’t have to watch our children go through.
Susan Hepworth: The good news is that hopefully, with two newly approved prevention tools available, fewer families will have to experience what the Rogers did, which was three of their four children being hospitalized with RSV. Dr. Jones, I’ll now turn it over to you.
Jefferson Jones: Thanks so much for having me today and for the other presentations. We, as general pediatricians, were undoubtedly excited about this time of being able to prevent severe disease from RSV. So today, I’ll discuss our two new immunization products and CDC recommendations for their use. First, I’ll be going over the efficacy and safety. The two products are nirsevimab and the Pfizer maternal RSV vaccine. Then, the CDC recommendations and clinical guidance for health care facilities. These are assuming a sufficient nirsevimab availability with respect to the shortage of nirsevimab and interim recommendations for healthcare facilities experiencing limited availability. Finally, there are considerations for implementing these RSV immunizations.
First is efficacy and safety. Two products could protect infants in their first RSV season. The maternal vaccine for pregnant people is from Pfizer, and the trade name is Abrysvo. Then, the monoclonal antibody or nirsevimab with the brand name Beyfortus. This is given to the infant after birth. Please note that there is an additional RSV vaccine by GSK with a trade name, Arexvy, which is not approved or recommended for use in pregnant people.
To protect eligible children at increased risk in their second RSV season, the only option is nirsevimab. The efficacy of nirsevimab was initially evaluated through two multi-country trials, including preterm and term infants. Efficacy was assessed 150 days after injection in the trials, and the pooled efficacy from these two trials was 79% in preventing medically attended RSV, lower respiratory tract infection (LRTI), or allergy and then 80.6% in preventing RSV LRTI with hospitalization. Nirsevimab has an acceptable safety profile, and it’s generally well tolerated. The most commonly reported adverse reactions were injection site reactions and rash, which were present in less than 1% of recipients. In trials, the incidence of serious adverse events was not significantly different between the nirsevimab placebo arms.
The efficacy of Pfizer’s maternal RSV vaccine was also evaluated in a multi-country trial, and the vaccine was administered during 24 through 36 weeks gestation. The efficacy was assessed through 180 days of birth, and it was 51.3% in preventing medically attended RSV associate LRTI and 56.8% in preventing hospitalization for RSV-associated LRTI; the side effects tend to be mild or moderate and temporary like those experienced after other vaccinations and the most common local and systemic adverse reactions during the trials were pain at the injection site, headache, muscle pain, nausea, more preterm births, and reports of hypertension during pregnancy, including pre-eclampsia receiving the vaccine group, as well as the placebo group in the clinical trials. However, these differences were not statistically significant, and whether these were related to the vaccine or simply due to chance is unknown. So restricting vaccination to 32 to 36 weeks, as discussed in the recommendations, also reduces any potential risk of preterm birth. The Advisory Committee for Immunization Practice (ACIP) judges that the benefits of maternal RSV immunization at 32 through 36 weeks gestation outweigh any potential risk for preterm birth and hypertensive disorders of pregnancy.
Next, we’ll talk about maternal vaccine recommendations. With seasonal administration, the maternal vaccine is recommended for pregnant people during 32 to 36 weeks of gestation. This means administering from September through January in most continental United States. However, in jurisdictions with seasonality that differs from most of the continental United States, for example, Alaska, and many jurisdictions with tropical climates, a provider should follow state, local, or territorial guidance on timing of administration.
The maternal Pfizer vaccine can be simultaneously administered with other indicated vaccinations. Now, either of the two options, maternal vaccination or the use of nirsevimab in the infant, is recommended to prevent RSV LRTI. However, administration of both products is not needed for most infants. Healthcare providers of pregnant people should provide information on both products and consider patient preferences when determining whether to vaccinate the pregnant patient or not and rely on the administration of nirsevimab to the infant after birth.
Later, I will go into more detail on vaccine counseling and the importance of discussing the potential lack of nirsevimab availability as part of this conversation.
Now, we’ll talk about nirsevimab recommendations. It will first apply to healthcare settings where there’s sufficient supply. In most of the United States, the RSV season has started. Therefore, the administrator and eligible children should begin nirsevimab as soon as it is available. Nirsevimab should continue to be offered to eligible infants and children through March, and it is mainly vital for those born between October 2023 and March 2024. Infants born shortly before the RSV season or in October 2023 through March 2024 should be immunized with nirsevimab within one week of birth, and administration can occur during the birth, hospitalization, or in the outpatient setting. We encourage immunization of infants with prolonged birth hospitalization shortly before or promptly after discharge. For all other infants younger than eight months, nirsevimab should be administered as soon as it is available if the infant is younger than eight months at the time of immunization. Again, this assumes sufficient doses, and I’ll discuss the recommendations if there is a lack of dosing. And because the maternal RSV vaccine is shown to be effective, if the mother was vaccinated 14 or more days before birth year [date of birth], nirsevimab is not needed for most infants.
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