Update Oct. 24, 2023: This story has been updated to note that while the CDC will allow bidirectional borrowing between Vaccines for Children (VFC) and private stock this season, it may not be practical during times of supply constraints. During this time, VFC supply should be prioritized for VFC-eligible children.
Health officials are offering guidance on how to prioritize infants and toddlers for nirsevimab (Beyfortus) while the new respiratory syncytial virus (RSV) immunization is in short supply.
The interim recommendations from the Centers for Disease Control and Prevention (CDC) focus on the youngest children and those most at risk of severe RSV disease. They apply only to the 2023-’24 season.
- Recommendations have not changed for children weighing less than 5 kilograms (kg). Those born before October 2023 should get a 50 mg dose now, and those born in October 2023 and throughout the RSV season should receive a 50 mg dose in the first week of life.
- For infants weighing 5 kg or more, prioritize using 100 mg doses in those at highest risk of severe disease:
- infants under 6 months of age,
- American Indian/Alaska Native (AI/AN) infants under 8 months of age and
- infants 6 to less than 8 months of age with certain conditions that put them at high risk of severe RSV disease such as premature birth at less than 29 weeks’ gestation, chronic lung disease of prematurity, hemodynamically significant congenital heart disease, severe immunocompromise, severe cystic fibrosis (either manifestations of severe lung disease or weight-for-length less than 10th percentile), neuromuscular disease or congenital pulmonary abnormalities that impair the ability to clear secretions.
- Give palivizumab instead of nirsevimab to children ages 8-19 months who are eligible for palivizumab per AAP recommendations.
- Offer nirsevimab to AI/AN children ages 8-19 months who are not eligible for palivizumab and who live in areas that are remote or have high rates of severe RSV among older infants and toddlers.
- Follow AAP recommendations for palivizumab-eligible infants under 8 months when the appropriate dose of nirsevimab is not available.
- Avoid using two 50 mg doses of nirsevimab for infants weighing more than 5 kg. It may not be covered by insurance and could exacerbate supply issues.
- Encourage pregnant people to receive the new RSVpreF vaccine at 32-36 weeks’ gestation. Most infants do not need protection from both nirsevimab and RSVpreF.
The recommendations come amid high demand for the monoclonal antibody immunization that received CDC approval in August. Earlier this month, the CDC paused ordering through the Vaccines for Children (VFC) program. While ordering has resumed, the 50 mg prefilled syringes are the only ones 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. 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 syringes.
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 state VFC programs.
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. Last week, 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. Borrowed stock must be repaid dose-for-dose within one month or after five doses are borrowed (for small practices at the discretion of the awardee) and administered to the appropriate population. However, borrowing may not be practical during times of supply constraints. During this time, the CDC recommends that VFC supply is prioritized for VFC-eligible children.
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.
- CDC guidance on use of nirsevimab while supply is limited during the 2023-’24 season
- The CDC will hold a webinar on protecting infants from RSV at 2 p.m. EDT Oct. 26.
- AAP RSV resources, including information on ordering, dosing, coding and a visual guide for nirsevimab administration
- VFC operations guide addendum for nirsevimab
- Information for clinicians from the CDC on nirsevimab
- Information for parents from HealthyChildren.org on RSV immunization availability
- 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”