Manufacturers have expanded their capacity to produce nirsevimab (Beyfortus) to protect infants and toddlers from respiratory syncytial virus (RSV) and are shipping immunizations to clinicians.
The Food and Drug Administration has approved a new filling line to expand production following supply shortages that plagued last year’s rollout. Sanofi, which works in collaboration with AstraZenecca, also implemented a reservation program.
Customers participating in the reservation program should receive reserved shipments this month and throughout the season. Those not participating in the program can order nirsevimab from October 2024 through February 2025 via http://www.vaccineshop.com.
“This upcoming season, we look forward to BEYFORTUS offering its demonstrated real-world protection to as many infants as possible,” Thomas Grenier, M.Sc., M.B.A., head of vaccines for Sanofi, North America, said in a press release.
About two-thirds of infants get RSV, and nearly all children have had it by age 2 years. The virus 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 majority of children hospitalized with RSV who are less than 2 years have no underlying medical conditions, so every young infant is at risk, which is why it’s important to protect them all,” CDC expert Katherine Fleming-Dutra, M.D., FAAP, said during a recent AAP/CDC webinar on preparing for the upcoming respiratory virus season. Dr. Fleming-Dutra leads the Vaccine Effectiveness and Policy Team in the Coronavirus and Other Respiratory Viruses Division of the CDC’s National Center for Immunization and Respiratory Diseases.
The AAP recommends all infants be protected from RSV by receiving nirsevimab or through vaccination of their gestational parent with RSVpreF (Abrysvo). Children are eligible for nirsevimab if they are under 8 months during their first RSV season or 8 months through 19 months of age and at increased risk of severe RSV disease when entering their second season.
About half of infants were protected by nirsevimab or maternal vaccination during the 2023-’24 RSV season, according to the CDC. Data from the first season show nirsevimab was 91%-98% effective at preventing RSV-associated hospitalizations.
Clinicians can learn more about nirsevimab and RSVpreF 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
- AAP/CDC webinar on preparing for the respiratory virus season
- 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
