AAP experts are optimistic the use of nirsevimab (Beyfortus) to protect infants from respiratory syncytial virus (RSV) will be smoother in the upcoming season, although some logistical hurdles remain.
The AAP is continuing to work on the remaining challenges that plagued the rollout of the long-awaited RSV immunization last fall. It also is reminding clinicians to review the clinical guidance, which will remain the same.
RSV causes about 50,000 to 80,000 hospitalizations and 100 to 300 deaths per year in children under 5 years, according to the Centers for Disease Control and Prevention (CDC). The AAP recommends all infants be protected from RSV by receiving nirsevimab or through vaccination of their pregnant parent with RSVpreF (Abrysvo).
About half of children born during the 2023-’24 RSV season were protected, according to the CDC.
Data from the first season show nirsevimab was 91%-98% effective at preventing RSV-associated hospitalizations.
“I think if we are able to deliver this product in a timely fashion, we’re going to see a significant impact on the RSV season this coming year,” said Sean T. O’Leary, M.D., M.P.H., FAAP, chair of the AAP Committee on Infectious Diseases.
Clinical guidance
Nirsevimab is recommended for infants under 8 months during their first RSV season. They should be immunized regardless of whether they have high-risk conditions. The ideal timing is during the first week of life for those born shortly before or during the RSV season. In most of the continental U.S., the season typically runs from October through March. Infants whose pregnant parent received RSVpreF vaccine at least 14 days before giving birth do not need nirsevimab.
The AAP also recommends nirsevimab for infants and children 8 months through 19 months of age who are at increased risk of severe RSV disease when entering their second season. These children should be immunized in season two regardless of whether their pregnant parent was vaccinated or whether they received nirsevimab in their first season.
While palivizumab previously was the primary means of protection for high-risk infants, Dr. O’Leary said clinicians should prioritize nirsevimab because it can be given in a single dose and likely provides more protection. The AAP continues to recommend palivizumab if nirsevimab is not available.
Eligible infants and children can be immunized shortly before the RSV season begins if a clinician is concerned the child may not return.
Logistical hurdles
While supply shortages plagued the first season of nirsevimab use, Sanofi has implemented a reservation program it hopes will mitigate those issues.
Customers participating in the reservation program should receive reserved shipments in September and throughout the season. Those not participating in the program can order nirsevimab from October 2024 through February 2025 via http://www.vaccineshop.com.
The degree to which providers face other logistical challenges may depend on where they practice. Issues around billing and integration into immunization information systems have improved for many. Sanofi has created an immunization card hospitals can give to parents to show their baby received nirsevimab. However, clinicians in some areas may have to take extra steps to find out if a child was immunized in the hospital or if the child’s pregnant parent was vaccinated.
“For pediatricians working in primary care, it’s good to be familiar with the practices of the delivering hospitals in your area,” Dr. O’Leary said. He added that no safety concerns are expected if the pregnant parent was vaccinated and the child receives nirsevimab.
There also are ongoing issues around birthing hospitals enrolling in the Vaccines for Children (VFC) program and payment for hospital-based administration of nirsevimab.
The CDC is allowing flexibility in the VFC program regarding inventory requirements and borrowing nirsevimab from private stock through August 2025, although CDC guidance does not supersede jurisdictional policies.
The AAP is continuing to advocate for steps to ease the logistical concerns and has been working with the CDC, Sanofi and other partners.
Clinicians can learn more about nirsevimab at a webinar from the AAP and CDC on preparing for the respiratory virus season. It will be held at 11 a.m. Central on Aug. 27.
Educational opportunities also will be available during the AAP National Conference & Exhibition in Orlando, Fla. The AAP Section on Infectious Diseases and Section on Epidemiology, Public Health and Evidence will hold an H program on RSV from 1-5 p.m. EDT Sept. 28.
Resources
- AAP RSV resources, including information on ordering, dosing, coding and a visual guide for nirsevimab administration
- Information from the CDC on using nirsevimab
- VFC operations guide addendum for nirsevimab
- AAP Red Book chapter on RSV
- Information for parents from HealthyChildren.org on RSV symptoms and when to call a doctor
- Information from the American College of Obstetricians and Gynecologists on maternal RSV vaccine Abrysvo
