Demand for Infant RSV Antibody Overwhelms Supply

Ordering of the new respiratory syncytial virus (RSV) immunization nirsevimab-alip (Beyfortus™) through the Vaccines for Children (VFC) program has been suspended, according to the American Academy of Pediatrics (AAP) News on October 17, 2023.

Beyfortus is the first U.S. FDA-approved extended half-life monoclonal antibody offering passive immunization to prevent lower respiratory tract infections caused by RSV. 

The  American Medical Association has approved two new Current Procedural Terminology codes related to the administration of Beyfortus (96381), one of which accounts for the work associated with providing counseling (96380).

In a letter to state immunization managers in early October 2023, the Centers for Disease Control and Prevention (CDC) cited a "high demand and limited supply" for causing the pause in ordering.

"This approach will help us ensure equitable availability across all awardees," the CDC said to immunization managers.

"Despite an aggressive supply plan built to outperform past pediatric vaccine launches, demand for this product, especially for the 100 mg doses used primarily for babies born before the RSV season, has been higher than anticipated," Sanofi said in a recent statement.

'Our approach for distribution across the private marketplace will be similar. We are working with our Alliance partner in charge of manufacturing, AstraZeneca, to accelerate additional supply and explore several actions to extend the manufacturing network.'

In Texas, the Department of State Health Services (DSHS) recently announced it is pausing provider orders for nirsevimab in the Vaccine Allocation and Ordering System until further notice.

DSHS's understanding from the CDC is that Texas orders placed before October 9, 2023, are already being shipped. DSHS is awaiting confirmation on how the CDC will handle orders placed after October 9, 2023.

The CDC says pediatricians can continue to use the multi-dose Synagis® (Palivizumab) for eligible high-risk children.