Ordering of the new respiratory syncytial virus (RSV) immunization nirsevimab through the Vaccines for Children (VFC) program has been put on hold, and the 100-milligram formulation also is not available for ordering from Sanofi.
In a letter to state immunization managers, the Centers for Disease Control and Prevention (CDC) cited a “high demand and limited supply” for causing the pause in ordering. The AAP has been in communication with the CDC and Sanofi to express its concerns about equitable distribution.
“We knew there were going to be many barriers to implementation of nirsevimab that we were anticipating, and pediatricians have been working hard to overcome those barriers, but we were assured by the manufacturer that supply would not be one of the barriers,” said Sean T. O’Leary, M.D., M.P.H., FAAP, chair of the AAP Committee on Infectious Diseases.
The CDC expects VFC ordering to resume later this week with an allocation system in place. It will initially target awardees who have not yet ordered or who ordered a small amount. The doses allocated to awardees will be based on ordering history.
“This approach will help us ensure equitable availability across all awardees,” the CDC said to immunization managers.
The AAP will continue to have conversations with the CDC as it rolls out plans for this new allocation system and will communicate additional information to members as it becomes available.
In addition to the VFC ordering pause, a Sanofi spokesperson said that "while deliveries of 100 m doses continue, new orders are not being taken by Sanofi at this time."
“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 statement.
The company said it is working with manufacturing partner AstraZeneca to accelerate availability but did not provide a timeline. The AAP has requested more detailed information about how long the shortage will last. In the meantime, using two 50 mg doses in place of a 100 mg dose has not been studied and is not approved or recommended.
Dr. O’Leary encouraged pediatricians to keep trying to access nirsevimab. They also can continue to use palivizumab for eligible high-risk children and encourage pregnant women to get vaccinated between 32-36 weeks’ gestation with the new RSVpreF vaccine.
The supply issues with nirsevimab are the latest logistical challenges for the product, which can protect infants from the leading cause of hospitalization. The product costs $495 in the private sector and $395 in the VFC program. VFC participants traditionally must carry both VFC and private stock and only 10% of birthing hospitals participate in the program.
For months, the AAP has been advocating for measures to reduce these and other barriers to access. It recently celebrated the approval of two new Current Procedural Terminology codes related to the administration of nirsevimab, one of which accounts for the work associated with providing counseling.
AAP leaders also applauded recent VFC flexibilities the CDC announced for this season. Those include allowing borrowing between VFC and private stock of nirsevimab. Certain specialty providers like birthing facilities also can offer nirsevimab and hepatitis B vaccine at birth without stocking other VFC vaccines.
- AAP RSV resources, including information on ordering, dosing, coding and a visual guide for nirsevimab administration
- The AAP will hold a webinar on nirsevimab implementation strategies in outpatient practices at 7 p.m. CDT Oct. 17.
- 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”