Editor’s note: This month’s article was co-authored by Drs. Lori Handy, Associate Director of the Vaccine Education Center, and Kathy Filograna, Regional Medical Director in the CHOP Primary Care Network. Drs. Filograna and Handy served on the working group for implementation of nirsevimab at Children’s Hospital of Philadelphia.

Have you implemented nirsevimab in your practice? Do you have questions about how to do so? While the science is clear that nirsevimab will reduce severe disease due to RSV in young infants, how to implement the recommendations from the Centers for Disease Control and Prevention (CDC) has been less clear, especially with the availability of a second tool that is recommended during pregnancy (Abrysvo™). So, this month, we thought it would be helpful to review key concepts and best practices for implementation to consider as we move into RSV season.

Who should receive nirsevimab?

Nirsevimab is recommended for all infants younger than 8 months of age who are born during or entering their first RSV season and for infants and children between 8 and 19 months of age who are entering their second RSV season and at increased risk for severe disease. Other things to consider when determining whether an infant should get nirsevimab include:

  1. Maternal vaccination: If RSV vaccine was administered during pregnancy and at least two weeks from the baby’s birthdate, the baby does not need to get nirsevimab. As maternal vaccination dates are not always available to providers and are not easily entered in a child’s medical record, our best recommendation is a manual review of this information until recording a maternal vaccine can be standardized.
  2. Tracking patient eligibility: Create and use a database, registry or other system to track monthly coverage and to continue outreach efforts to eligible children. Inform patients through email, text messaging or written mail of the opportunity to protect their infants from RSV. Ensure that families of high-risk infants are proactively contacted to increase the likelihood these infants are protected. 
  3. Supply shortages: In the context of limited supply during this inaugural (2023-2024) season, the CDC has released interim recommendations that include prioritizing 100 mg doses for infants at highest risk of severe RSV disease, such as infants younger than 6 months of age whose weight require this dose and older infants with high-risk conditions who don’t qualify for palivizumab. Providers should utilize palivizumab for infants 8 to 19 months old who are eligible for palivizumab.
  4. Differences in eligibility between nirsevimab and palivizumab: Even when the supply of nirsevimab improves, providers will need to develop a consistent plan of approach for the small cohort of high-risk children who are eligible for palivizumab but are not considered eligible for nirsevimab, including 8- to 12-month-old children with certain congenital heart diseases and 20- to 24-month-old children who are immune compromised or have chronic lung disease. While some commercial insurance companies will provide nirsevimab to these patient populations, the Vaccines for Children (VFC) program will be abiding closely to the ACIP guidance and will only provide nirsevimab for those meeting clear ACIP criteria. In this type of situation, offices can either plan to administer both medications or work with insurance companies to request coverage for a single dose of nirsevimab instead of a palivizumab series. Practices should make a clear decision on management of these cases and ensure that all staff are consistent in their approach to managing high-risk children.

What is nirsevimab?

Nirsevimab (Beyfortus™) is an RSV monoclonal antibody. One dose of nirsevimab can protect infants for five months, the length of an average RSV season.

When describing this product to parents and caregivers, do not commonly describe it as a vaccine or a treatment. It is not a vaccine because it does not cause the infant to generate their own immunity, and it is not a treatment because it is not treating an illness. You may consider referring to it as protection against RSV, a monoclonal antibody, or an immunization. The latter speaks to the use of passive immunity, meaning the recipient will have RSV-specific immunity, but it is not self-generated and, therefore, will not last long term. For more details about passive immunity, check the link in the resources section for the previous Vaccine Update article, “News & Views: Nirsevimab Means Brushing Up on Passive Immunity Talking Points.”

Where can nirsevimab be administered?

Any providers of the eligible patient population can administer nirsevimab, including birth hospitals, primary care practices, children’s hospitals and subspecialists. However, the logistics of obtaining a supply and getting reimbursed are complex, often leading to the quickest progress on implementation by primary care offices. If you are located in a setting other than a primary care office, these considerations may be helpful:

  • Identify whether your patient population is eligible for VFC. Most broadly, children covered by Medicaid and those who are underinsured qualify for VFC. 
  • To offer nirsevimab to VFC-eligible patients, providers need to be enrolled in the VFC program. If you are not enrolled, work with other groups that can administer nirsevimab to ensure that your VFC patients are protected.
  • Children with commercial insurance will have coverage that depends on the specifics of their plan. Because some, but not all, commercial insurers are prepared to reimburse for nirsevimab, encourage families to check their plans prior to the visit, so they know whether nirsevimab is covered or if they will need to pay for the dose. Providers should be prepared to discuss, and potentially share, the estimated costs with families in this situation. 
  • Because inpatient settings and birthing hospitals have unique considerations related to their payment models, a multidisciplinary group of clinicians, inpatient pharmacists and the hospital finance team (at a minimum) should collaborate to work through your payment model to understand how coverage will impact your patient population.
  • As you determine which subgroups of patients are covered and which are not, be sure to communicate the plan for protecting each group. In some cases that may mean relaying proactive messaging to families with high-risk infants that do not have coverage, so you can work with them to determine a plan for them to pay directly, get the dose elsewhere, or navigate insurance appeals. Make sure your team is prepared to communicate the importance of protecting their child and how to most easily do so, given their insurance situation.

When can nirsevimab be administered?

Administration will vary based on the seasonality of RSV in your area; however, for most providers, administration will begin in the fall and should continue through RSV season, which is typically about five months. Use local epidemiology, offered by your health department, for guidance. If you are in a setting where you see patients for well-child visits, you may determine that the best course for optimal coverage is through these regularly timed visits. However, if you do not see patients for this type of visit or you will not reach a significant portion of your patients, you may want to hold a nirsevimab clinic.

Why should babies get nirsevimab?

RSV impacts all newborns and young infants. One or two of every 100 children will be hospitalized with a lower respiratory tract infection caused by RSV in the first six months of life, and virtually all children are infected with RSV at least once by the time they are 24 months of age. We finally have an effective tool for protecting all infants from RSV. By giving babies antibodies that prevent RSV infection during the period when they are most susceptible, we can reduce the number who need to see a doctor, go to the emergency room, or be hospitalized with pneumonia or bronchiolitis caused by RSV.

How do you administer nirsevimab?

While nirsevimab is not a vaccine, its administered like one. Most patients should receive a single intramuscular (IM) injection. Some patients in their second season will require two injections given at the same time. Nirsevimab can be given at the same time as all recommended vaccines. If the patient is getting two vaccines plus nirsevimab in the same leg, the doses should be separated by at least one inch, and you should ensure that your team has a consistent way to document the three doses in one limb. Likewise, in the same way that there is a Vaccine Information Statement (VIS) for vaccines, a patient information sheet for nirsevimab is also available (see “Resources” section at the end of this article). If you use an electronic health record (EHR), ensure that the nirsevimab dose can be recorded in your patients’ immunization records, so that central registries can still record receipt.

In sum

From the outset, many anticipated that there would be obstacles for implementation of nirsevimab. But we also know how hard it is to manage an influx of RSV-positive patients, so some upfront work to improve rates of receipt of nirsevimab will surely help your patients — and your team — in the long run. Because implementation challenges may disproportionately impact certain patient populations or geographic regions, we will all need to work together to quickly identify and resolve logistical barriers, so that all infants can be protected. Finally, make sure you and your team are comfortable with the science related to this new tool, so that you can communicate a clear, consistent and strong recommendation.

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Materials in this section are updated as new information and vaccines become available. The Vaccine Education Center staff regularly reviews materials for accuracy.

You should not consider the information in this site to be specific, professional medical advice for your personal health or for your family's personal health. You should not use it to replace any relationship with a physician or other qualified healthcare professional. For medical concerns, including decisions about vaccinations, medications and other treatments, you should always consult your physician or, in serious cases, seek immediate assistance from emergency personnel.