Products Affected - Description

• • Beyfortus intramuscular injection, Sanofi Pasteur, 100 mg/1 mL, prefilled syringe, 5 count, NDC 49281-0574-15
  • Beyfortus intramuscular injection, Sanofi Pasteur, 50 mg/0.5 mL, prefilled syringe, 5 count, NDC 49281-0575-15

Reason for the Shortage

• • Sanofi-Pasteur has Beyfortus on shortage due to demand exceeding supply.

Available Products

• • There are no presentations available

• • Sanofi-Pasteur has Beyfortus 50 mg/0.5 mL syringes and 100 mg/1 mL syringes is no longer needed due to RSV season being over.

• • Due to the limited supply during the 2023-2024 RSV season, CDC recommends prioritizing available nirsevimab 100 mg 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 50 mg doses remain unchanged at this time. Avoid using two 50mg doses for infants weighing >5 kilograms (>11 pounds) to preserve supply of 50 mg 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.
  • This information can be found at: https://emergency.cdc.gov/han/2023/han00499.asp

• • The CDC has provided interim recommendations during this shortage. This full guidance can be found at: https://emergency.cdc.gov/han/2023/han00499.asp
  • A summary of the recommendations is as follows: 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 50 mg 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. The GSK RSVpreF3 vaccine (Arexvy) should not be used in pregnant people.