Please share the following information with providers in your jurisdiction.
Yesterday, the Centers for Disease Control and Prevention (CDC) issued a Health Alert Network (HAN) Health Advisory to discuss the limited supply of nirsevimab. For detailed information please review the CDC HAN. For your convenience, guidance from the HAN is noted below:
CDC issued a HAN Health Advisory to provide options for clinicians to protect infants from respiratory syncytial virus (RSV) in the context of a limited supply of nirsevimab, a long-acting monoclonal antibody immunization product recommended for preventing RSV-associated lower respiratory tract disease in infants. The Michigan Department of Health and Human Services (MDHHS) recommends all providers with nirsevimab follow this guidance.
In the context of limited supply during the 2023–2024 RSV season, CDC recommends prioritizing available nirsevimab 100mg doses for infants at the highest risk for severe RSV disease: young infants (age <6 months) and infants with underlying conditions that place them at highest risk for severe RSV disease. Recommendations for using 50mg doses remain unchanged at this time.
- Avoid using two 50mg doses for infants weighing ≥5 kilograms (≥11 pounds) to preserve supply of 50mg doses for infants weighing <5 kilograms (<11 pounds).
- Providers should be aware that some insurers may not cover the cost of two 50mg doses for an individual infant.
Recommendations for Healthcare Providers
These interim recommendations apply to healthcare settings with limited nirsevimab availability during the 2023–2024 RSV season. Interim recommendations are subject to change as new evidence becomes available.
- For infants weighing <5 kg, ACIP recommendations are unchanged. For infants born before October 2023, administer a 50mg dose of nirsevimab now. For infants born during October 2023 and throughout the RSV season, administer a 50mg dose of nirsevimab in the first week of life.
- For infants weighing ≥5 kg, prioritize using 100mg nirsevimab doses in infants at highest risk of severe RSV disease:
- Young infants aged <6 months.
- American Indian and Alaska Native infants aged <8 months.
- Infants aged 6 through 7 months with conditions that place them at high risk of severe RSV disease: premature birth at <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.
- In palivizumab-eligible children aged 8–19 months, suspend using nirsevimab for the 2023–2024 RSV season. These children should receive palivizumab per AAP recommendations.
- Continue offering nirsevimab to American Indian and Alaska Native children aged 8–19 months who are not palivizumab-eligible and who live in remote regions, where transporting children with severe RSV for escalation of medical care may be challenging, or in communities with known high rates of severe RSV among older infants and toddlers.
- Follow AAP recommendations for palivizumab-eligible infants aged <8 months when the appropriate dose of nirsevimab is not available.
- Avoid using two 50mg doses for infants weighing ≥5 kilograms (≥11 pounds), because 50mg doses should be reserved only for infants weighing <5 kilograms (<11 pounds), for example those born during the season who will be at increased risk for severe RSV illness because of their young age. Furthermore, providers should be aware that some insurers may not cover the cost of two 50mg doses for an individual infant.
- Providers should encourage pregnant people to receive RSVpreF vaccine (Abrysvo, Pfizer) during 32 weeks’ gestation through 36 weeks and 6 days’ gestation to prevent RSV-associated lower respiratory tract disease in infants. Only the Pfizer RSVpreF vaccine (Abrysvo) is approved and recommended for use in pregnant people. The GSK RSVpreF3 vaccine (Arexvy) should not be used in pregnant people.
- Either RSVpreF vaccination or nirsevimab immunization for infants is recommended to prevent RSV-associated lower respiratory tract disease in infants, but administration of both products is not needed for most infants.
In light of ongoing nirsevimab supply constraints, CDC also issued some additional guidance concerning nirsevimab Vaccine For Children (VFC) borrowing policies and practices for those VFC providers who have nirsevimab inventory.
- The nirsevimab supply shortage continues to evolve and is not expected to resolve soon.
- The HAN described new recommendations related to reduced age ranges for nirsevimab usage to the youngest infants, but this will not alleviate the supply challenges.
- The goal of the Vaccines for Children (VFC) program is to vaccinate VFC eligible children, and our first obligation is to VFC eligible children.
- Although the 2023-2024 VFC Operations Guide and the recently released nirsevimab addendum reiterated previous and long-standing policy for bidirectional borrowing, it is likely not practical and not feasible for awardees to allow borrowing during times of supply constraints.
- While there are supply constraints for nirsevimab, VFC supply stock should remain prioritized for VFC eligible children.
- MDHHS will continue to review nirsevimab supply and send further messages regarding its usage and prioritization.
For More Information
Additional Information for Healthcare Providers:
Thank you for all you do to protect Michiganders from vaccine preventable diseases.
MDHHS Division of Immunization
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