- young infants (age <6 months)
- infants with underlying conditions that place them at highest risk for severe RSV disease
Recommendations for using 50mg (for children <5kg) doses remain unchanged at this time. CDC further recommends that providers suspend using nirsevimab in palivizumab-eligible children aged 8–19 months for the 2023–2024 RSV season. These children should receive palivizumab per American Academy of Pediatrics (AAP) recommendations.
Nirsevimab should continue to be offered to American Indian and Alaska Native children aged 8–19 months who are not palivizumab-eligible and who live in remote regions, where transporting children with severe RSV for escalation of medical care is more challenging or in communities with known high rates of RSV among older infants and toddlers.
What is nirsevimab?
Who should get nirsevimab?
The Food and Drug Administration (FDA) has approved, and the American Academy of Pediatrics (AAP), American Academy of Family Physicians (AAFP), and Centers for Disease Control and Prevention (CDC) have all recommended nirsevimab for:
- All infants < 8 months born during or entering their first RSV season. Infants < 8 months old born outside of RSV season should receive nirsevimab starting in October unless local epidemiology suggests atypical timing of RSV season.
- High-risk children 8-19 months during their second season. See CDC guidance for additional details.
- Chronic lung disease of prematurity requiring medical support at any time during the 6-month period before the start of the second RSV season
- Children with severe immunocompromise
- Certain children with cystic fibrosis
- Native American and Alaskan Native children.
Nirsevimab can be co-administered with childhood vaccinations.
Should infants of mothers who received RSV vaccine during pregnancy receive nirsevimab?
Most infants born to mothers who received maternal RSV vaccine during pregnancy will not need a dose of nirsevimab after birth. However, nirsevimab is indicated in a few instances in infants younger than 8 months old during their first RSV season.
Too short of time interval between maternal vaccination and infant birth: Infants of vaccinated mothers should receive nirsevimab if born to mothers who received maternal RSV vaccine <14 days before the infant’s birth.
Immunocompromised mother: Infants of vaccinated mothers should receive nirsevimab if born to mothers who may not make an adequate immune response to maternal RSV vaccine (e.g., presence of immune compromising condition) or have a condition associated with reduced maternal transfer of antibody (e.g., HIV infection).
Certain infants with congenital heart disease: Infants of vaccinated mothers should receive nirsevimab if undergoing cardiopulmonary bypass potentially leading to loss of maternal antibody and/or infants with hemodynamically significant congenital heart disease or ICU admission with oxygen requirement at hospital discharge.
What is the efficacy of nirsevimab?
The New England Journal of Medicine (NEJM) study shows clinically important benefits.The randomized control trial identified efficacy of 74.5% against medically attended lower respiratory tract disease (1.2% nirsevimab vs. 5% control group).
To review Nirsevimab for Prevention of RSV in Healthy Late-Preterm and Term Infants | NEJM, visit bit.ly/nejm-nirsevimab.
Is there still a role for palivizumab in some children?
Some groups of children may still be eligible for palivizumab, including:
- High-risk children 20-24 months of age during their second RSV season
- High-risk children younger than 20 months of age without access to nirsevimab or who decline nirsevimab (which should be discouraged)
- Certain high-risk groups 8-19m of age who do not qualify for nirsevimab but qualify under previously accepted palivizumab recommendations, such as other types of chronic lung disease or neuromuscular diseases
What can I do now to prepare for nirsevimab administration to children?
- Advocate within your communities about the importance of providing nirsevimab to all eligible infants and children
- Consider posting information within your department or practice to generate awareness about nirsevimab
- Work with your institution’s pharmacy or connect directly with your state VFC representative and your AstraZeneca/Sanofi representative to obtain nirsevimab and discuss if delays are expected
- Begin talking to families about the benefits of nirsevimab and whether or not their child qualifies for treatment
Review the section on Considerations for Nirsevimab Administration According to the Healthcare Setting.
What do we know about ordering and reimbursement for nirsevimab?
Nirsevimab will be covered through the federally subsidized Vaccines for Children (VFC) program. Private payers are expected to cover nirsevimab when prescribed according to recommended indications. Billing guidance is available.
How do we ensure equitable access to nirsevimab?
The American Academy of Pediatrics (AAP) has offered recommendations for ensuring equitable access to nirsevimab. Their specific recommendations include:
- Develop a comprehensive strategy to ensure equitable access to nirsevimab in hospitals, birthing centers, and ambulatory practice settings.
- Support the continued use of palivizumab as an option for the prevention of RSV disease in high-risk infants for the upcoming season given the likely implementation.
What is the Pediatric Pandemic Network (PPN) doing to prepare for nirsevimab?
PPN stakeholders are working with public health and clinical stakeholders to actively seek answers to frequently asked questions. We will continue to provide information as we receive it. We are developing additional educational tools for providers, families, and communities to utilize and will share those when complete.
Considerations for Nirsevimab Administration According to the Healthcare Setting
| Healthcare Setting | Optimal Patient Population and Timing | Explanation and Additional Considerations | |
|---|---|---|---|
| Birthing hospitals, in newborn nurseries | Newborn infants born between October and March | > Birthing hospitals currently provide routine medications, such as Vitamin K and hepatitis B vaccine, to all infants, so operational processes are already in place. > Because nirsevimab should be given in the first week, providing nirsevimab prior to discharge from newborn nursery avoids missed opportunities to immunize infants who do not require a primary care visit within the first week of life, who do not have secure access to primary care, or who receive primary care from a site that does not provide nirsevimab. | |
| Neonatal intensive care units (NICUs) | Newborn infants born between October and March | > NICUs should administer nirsevimab during RSV season to children eligible to receive it based on chronological age and weight (those specific parameters not yet publicly available). Administering upon admission or at the earliest clinically appropriate time during the NICU stay, rather than at the time of NICU discharge, may reduce risk of healthcare-associated RSV[SJE1] . [SJE1]The mmwr uses the following language Infants with prolonged birth hospitalizations related to prematurity or other causes should receive nirsevimab shortly before or promptly after hospital discharge. | |
| Primary care offices | All infants during first RSV season, especially those born outside of RSV season High-risk infants during second RSV season | > Primary care offices can include administration for nirsevimab during well-child visits when other vaccines are given. > They can serve as the primary vaccination site for children born outside of RSV season, and can provide during newborn visits for children who were not able to receive at the birthing hospital. > For high-risk infants in their second RSV season, appointments specifically for nirsevimab will likely be needed in October of each year if they aren’t otherwise scheduled for a well visit in that time frame. | |
| Subspecialty clinics | High-risk infants during second RSV season | > Many medically complex children rely on subspecialists for a significant proportion of their medical care, and some primary care providers may defer care to those specialists depending on the degree of medical complexity. > Subspecialty clinics who provide care to children meeting the high-risk criteria per AAP guidance can ensure these infants do not miss opportunities to receive nirsevimab. | |
| Hospitals (inpatient, urgent care, and emergency department) | Eligible infants without established access to primary care | Many children who receive hospital-based care in the inpatient, urgent care, or emergency department setting may not have established access to primary care. Hospitals can provide nirsevimab to these infants and high-risk children. | |
| Public health- and/or mobile health-based clinics | Eligible infants in resource-limited communities | > Many children in resource-limited communities may not have easy access to nirsevimab and primary care. > Some populations in resource-limited settings, such as American Indian and Alaska Native children, have a higher risk of severe RSV. > To ensure equitable distribution, public health- and/or mobile health-based clinics can fill this public health gap. |