The newly approved RSV (Respiratory Syncytial Virus) therapy, Nirsevimab, is facing a shortage and high costs, leading to frustration among parents, particularly for infants whose pediatricians have recommended it.
The dilemma: Emily Bendt, a new mother and pediatric home health nurse, struggled to find Nirsevimab for her two-week-old baby, despite it beginning to ship in September.
* By mid-October, pharmaceutical company Sanofi reported that demand for Nirsevimab had already surpassed supply, causing the CDC to issue interim guidance on prioritizing the limited doses for high-risk infants.
Understanding RSV: RSV is the leading cause for hospitalization among infants under 12 months, with an estimated mortality rate of 100-300 infants annually in the U.S.
* Nirsevimab, a monoclonal antibody, along with a new RSV vaccine from Pfizer, hold the potential to significantly lower the risk of lung infections for infants.
* The CDC also approved the Pfizer RSV vaccine for use in pregnant individuals to confer immunity to their infants.
Behind Nirsevimab: In clinical trials, Nirsevimab reduced RSV hospitalizations and health care visits by nearly 80% among infants.
* The treatment lasts about five months, enough to get infants through their first RSV season.
The obstacles: High costs and bureaucratic issues slow Nirsevimab distribution, putting infants at unnecessary risk of hospitalization.
* Hospitals are hesitant to order the treatment due to its initial price, at $495 per dose, and uncertainty about reimbursement by insurers.
* Distribution challenges also arise from the structure of the government program Vaccines for Children (VFC), which makes it difficult to administer Nirsevimab to newborns right after birth. Most hospitals are not part of VFC, posing a challenge for equitable and fast distribution.
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