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Prioritizing High-risk Infants with Nirsevimab: Essential CDC Guidelines Amidst Limited Drug Supply

The Centers for Disease Control and Prevention (CDC) provides key recommendations to healthcare providers about optimizing usage of the monoclonal antibody nirsevimab amidst growing demand and limited availability.

This drug, developed by Sanofi and AstraZeneca, has been approved by the FDA for protecting infants from severe cases of the respiratory syncytial virus (RSV), a leading cause of lower respiratory tract disease (LRTD) among infants. However, nirsevimab has been facing compromised accessibility due to an increased demand forecasted for the upcoming 2023-2024 RSV season. This has led the CDC to release a Health Alert Network Health Advisory to address such challenges and to explore alternatives for RSV prevention.

In efforts to evenly distribute available doses through the Vaccines For Children Program (VFC), the CDC urges healthcare providers to give priority to 100 mg doses of nirsevimab for infants most susceptible to severe RSV disease. The drug’s usage extends to newborns and infants aged one year or less entering their first RSV season, and children up to 24 months old who remain at risk for severe RSV during their second season. The CDC especially stresses on the vulnerability of infants under six months and those having underlying health conditions.

The CDC also maintains its guidelines for 50 mg doses of nirsevimab. For infants weighing 11 pounds or more, administrating two 50 mg doses is discouraged to maintain supply for infants weighing under 11 pounds. However, the CDC advises discontinuing nirsevimab treatment for palivizumab-eligible children aged 8 to 19 months for the 2023-2024 RSV season.

Amidst these supply shortages, Sanofi is actively collaborating with AstraZeneca to speed up additional supply and elaborate its production network. Moreover, healthcare providers are recommended to discuss Pfizer’s RSVpreF maternal vaccine to pregnant individuals to potentially reduce the need for nirsevimab for newborns during the RSV season.


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