The Centers for Disease Control and Prevention (CDC) is resuming limited ordering of nirsevimab through the Vaccines for Children (VFC) program.
The 50 milligram (mg) product is the only one available, and the CDC will use an allocation system that initially will target awardees who have not yet ordered or who ordered a small amount.
“We are taking this approach to facilitate equitable availability across all awardees and will continue to do so until the amount of product available to awardees is equitable,” the CDC said in an email.
The CDC paused ordering of the respiratory syncytial virus immunization Oct. 13, citing “high demand and limited supply.” It plans to fill back orders in the next one to two weeks as additional doses become available. It expects additional product to be made available every two to three weeks and will keep awardees updated as additional immunizations arrive at the depots, including both the 50 mg and 100 mg products. Awardees can monitor the daily shipping and backorder reports to track delivery. While allocations are in place, awardees are not able to make bulk purchases of nirsevimab.
While VFC ordering has resumed, Sanofi does not anticipate accepting new orders for the 100 mg formulation of nirsevimab this season. However, it expects to have more 100 mg doses that will be used to fill existing orders and to supply the VFC program awardees that are under contract. The company said earlier this week that demand has been higher than it anticipated. Using two 50 mg doses in place of a 100 mg dose is not approved or recommended.
For months, the AAP has been in close contact with the CDC and manufacturers advocating for measures to reduce barriers to accessing nirsevimab and will continue to do so. On Wednesday, the CDC announced VFC program providers will not be required to keep a private stock of nirsevimab or COVID-19 vaccines during the 2023-’24 respiratory virus season if they are not vaccinating privately insured patients.
This flexibility is in addition to previously announced moves, including bidirectional borrowing of VFC and private stock and allowing certain providers to offer a limited formulary of immunizations. The American Medical Association also recently approved two new Current Procedural Terminology codes related to the administration of nirsevimab, one of which accounts for the work associated with providing counseling.
Resources
- VFC operations guide addendum for nirsevimab
- AAP RSV resources, including information on ordering, dosing, coding and a visual guide for nirsevimab administration
- Information for clinicians from the CDC on 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”
