The manufacturer for the new vaccine to help protect infants from RSV, or respiratory syncytial virus, revealed that they are limiting availability of the drug due to its inability to keep up with the unprecedented demand.
Despite an aggressive supply plan built to outperform past pediatric vaccine launches, demand for this product, especially for the 100 mg doses used primarily for babies born before the RSV season, has been higher than anticipated, drugmaker Sanofi said in a statement.
The RSV vaccine nirsevimab, which is sold as Beyfortus, is not currently listed as being in shortage by the FDA.
Due to the high demand and limited supply, the Centers for Disease Control and Prevention announced Monday that doctors should prioritize doses of Beyfortus for infants under 6 months old and infants with underlying health conditions that put them at a higher risk for severe infection.
"RSV season is here," Dr. Buddy Creech, pediatrician at Vanderbilt University Medical Center and president of the Pediatric Infectious Disease Society, told NBC. "We are seeing a substantial increase in the amount of RSV such that in many areas, it has become the most commonly identified respiratory virus causing disease in children.
"This is one of the reasons why there's probably a lot of scrambling going on," he said, "to identify those babies at highest risk and to try to prioritize them, since it's such a limited resource right now."
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The CDC also recommended that doctors now stop providing Beyfortus to infants 8-19 months old. Instead, the agency said healthcare providers can offer palivizumab, or Synagis, which is approved only for children at high risk of severe disease with RSV due to serious lung or heart conditions. Synagis is also only available during RSV season.
We are going to protect some children from RSV this year. Were not going to be able to protect as many as wed hoped, and thats frustrating, Creech added, CNN reports.
RSV infections, which are the most common cause of bronchitis and pneumonia in children under the age of one in the U.S., typically occur in the fall and winter during flu season. These infections "primarily spread via respiratory droplets when a person coughs or sneezes, and through direct contact with a contaminated surface," according to the CDC.
Each year, the virus leads to nearly 80,000 hospitalizations and as many as 300 fatalities in the U.S. among this age demographic. Notably, an estimated 80% of children under the of age two who are hospitalized due to RSV have no pre-existing medical issues.
The CDC says in infants younger than six months, "RSV infection may result in symptoms of irritability, poor feeding, lethargy, and/or apnea with or without fever." Beyond managing the symptoms, there is currently no specific treatment for RSV infection.
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RSV Vaccine for Infants in Short Supply Due to 'Unprecedented Demand' - PEOPLE
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