Limited Availability of Nirsevimab in the United States

  NewsEditor      Pharmacy

The Centers for Disease Control and Prevention (CDC) is issuing this Health Alert Network (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.

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.

CDC further recommends that providers suspend using nirsevimab in palivizumab-eligible children aged 8–19 months for the 2023–2024 RSV season. These children should receive palivizumab per American Academy of Pediatrics (AAP) recommendations. Nirsevimab should continue to be offered 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 is more challenging or in communities with known high rates of RSV among older infants and toddlers. Prenatal care providers should discuss potential nirsevimab supply concerns when counseling pregnant people about RSVpreF vaccine (Abrysvo, Pfizer) as maternal vaccination is effective and will reduce the number of infants requiring nirsevimab during the RSV season.

Read more about the background and recommendations for healthcare providers: Health Alert Network (HAN) – 00499 | Limited Availability of Nirsevimab in the United States—Interim CDC Recommendations to Protect Infants from Respiratory Syncytial Virus (RSV) during the 2023–2024 Respiratory Virus Season