Pediatricians will be able to reserve doses of respiratory syncytial virus (RSV) immunization nirsevimab (Beyfortus) for the 2024-’25 season.
Sanofi is expanding its nirsevimab manufacturing network and rolling out a new reservation program Monday in hopes of mitigating the supply issues that plagued this season's launch. The program will apply to private purchases of the monoclonal antibody, which protects infants and high-risk toddlers from RSV.
From Feb. 5 through April 30, clinicians can work with Sanofi (via their representative or Beyfortus.com) to forecast their needs for the 2024-’25 season, which typically runs from October through March in most of the U.S. The manufacturer’s forecast tool will consider the estimated number of newborns a practice sees monthly, anticipated immunization rates for those births and the percentage of publicly insured patients.
During July and August, program participants will be able to reserve doses and will be eligible for priority shipping, preferred monthly shipping schedules, 90-day payment terms and cancellation up to 14 days prior to scheduled shipments. Returns will be accepted on expired products.
There is no minimum order to participate in the reservation program. Orders placed during the reservation period cannot exceed more than 10% above what was forecasted and submitted for each dose (50 milligram and 100 milligram). Customers would receive their reserved shipments beginning in late August or early September and throughout the season.
Clinicians are not required to participate in the reservation program. The normal ordering window for nonparticipants will be September 2024 through February 2025 via vaccineshop.com. Clinicians ordering during this time would have payment terms of 60 days and no ability to schedule future shipments.
Announcement of the reservation program comes on the heels of a difficult launch for the long-awaited product. It received approval from the Centers for Disease Control and Prevention (CDC) in August 2023 and quickly saw demand outpace supply.
Sanofi has said it had to finalize its launch supply in March 2023 and aimed to provide enough immunization for 30% of the birth cohort within six months of launch, which was higher than the initial uptake of rotavirus and pneumococcal conjugate vaccines. The company noted implementation barriers like commercial payer coverage and coding issues resolved more quickly than expected, and orders quickly exceeded planned available doses.
The AAP has been working diligently with Sanofi and health officials on supply issues. In December, Sanofi announced it would be releasing 230,000 doses from supply originally intended for the Southern Hemisphere. Those doses are now available for ordering without an allocation on a first-come, first-served basis. Customers with questions about supplies for this season or next season can contact their representative, or call 855-BEYFORTUS.
- Information from the CDC on using nirsevimab
- AAP RSV resources, including information on ordering, dosing, coding and a visual guide for nirsevimab administration
- AAP News article “How to use new CPT codes for administration of RSV immunizations”
- VFC operations guide addendum for nirsevimab
- Information for parents from HealthyChildren.org on RSV symptoms and when to call a doctor
- Pediatrics in Review article “Implications of Food and Drug Administration Approval of Respiratory Syncytial Virus Prophylactic Medications”