Dear USET/USET SPF Family,
This alert is being shared to provide a critical update with information regarding preventive measures to protect infants from respiratory syncytial virus (RSV) for the 2023-2024 respiratory season. In mid-October, USET TEC published an alert with clinical recommendations from the Center for Disease Control and Prevention (CDC) highlighting nirsevimab as a preventive measure for infants and a vaccine for pregnant people. On October 23, 2023, the CDC published an update advising of a limited supply of nirsevimab. According to the Indian Health Service, nirsevimab is currently being prioritized for AI/AN children and is available through the prime vendor (McKesson), regardless of the nirsevimab shortage.
Manufacturer reports state there is a limited supply of nirsevimab, particularly the 100 mg dose (in prefilled syringes) of the medication for children over 11 pounds (5 kg) for the RSV season. In addition, there may be limited stock of 50 mg dose (prefilled syringes) during the current RSV season. The CDC has preemptively issued interim clinical recommendations to ensure that infants and young children are protected this RSV season if the shortage continues.
Nirsevimab Clinical Recommendations for Healthcare Providers
Infants weighing less than 11 pounds (5kg): ACIP recommendations remain the same
- Infants born before October 2023: one 50 mg dose of nirsevimab.
- Infants born during October 2023 and throughout the RSV season: one 50 mg dose of nirsevimab during the first week of life.
Infants weighing greater than or equal to 11 pounds (5kg):
- Prioritize using 100 mg nirsevimab doses in infants who are at highest risk for severe RSV disease. This includes but is not limited to:
- Young infants aged 6 months or less.
- American Indian and Alaskan Native infants under 8 months old
- Infants aged 6-8 months with chronic or underlying conditions such as: premature birth (birth at less than 29 weeks' gestation), chronic lung disease, significant congenital heart disease, immunocompromised conditions, severe cystic fibrosis, and pulmonary conditions that make it difficult to clear secretions (mucus).
- Do not use two 50 mg doses for infants weighing more than 11 pounds, as these doses should be reserved for infants weighing less than 11 pounds.
Palivizumab is now eligible for use when nirsevimab is not available for certain infants and children. Palivizumab, licensed in 1998, is a monoclonal antibody created for the prevention of RSV but is limited to children under 24 months of age at high risk for severe RSV disease. This medication is given once a month to eligible children during the RSV season.
Palivizumab-Eligibility Recommendations & Clinical Recommendations for Healthcare Providers
Palivizumab-eligible Infants under 8 months:
- Follow AAP recommendations when nirsevimab is unavailable.
Palivizumab-eligible Children aged 8-19 months:
- Suspend use of nirsevimab for the 2023-2024 RSV season.
- Children should instead receive palivizumab.
Palivizumab-Ineligible Children aged 8-19 months:
- American Indian and Alaska Native children living in rural and remote regions should receive nirsevimab treatment.
- American Indian and Alaska Native children living in communities with known high rates of severe RSV in older infants and toddlers should receive nirsevimab treatment.
Pregnant People between 32 and 36 weeks and 6 days’ gestation
- Pregnant people between the above gestational age should be encouraged to receive the RSVpreF vaccine (trade name Abrysvo) to prevent RSV-associated disease in infants.
- The GSK RSVpreF3 is NOT approved for pregnant people and should NOT be used.
USET TEC strongly supports the CDC’s interim clinical recommendations, especially the prioritization of American Indian and Alaskan Native infants and children to receive nirsevimab when eligible. USET TEC will continue monitoring recommendations regarding the shortage of nirsevimab. For additional information or for clinical guidance, please see the resources below. The USET TEC is available to assist with any questions or concerns. Please do not hesitate to contact us at email@example.com.
USET Programmatic Alert: RSV Recommended Treatment for Infants and Vaccine for Pregnant Individuals
Limited Availability of Nirsevimab
FDA Approves New Drug to Prevent RSV in Infants
CDC Recommends Immunization to Protect Infants
CDC Recommends Vaccine for Pregnant People
RSV Symptoms and Care
RSV Treatment for Healthcare Providers
Palivizumab Clinical Guidance