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FDA Panel Greenlights New Injection To Prevent Respiratory Virus in Infants

  • An advisory committee to the FDA recommended approval of an injectable drug called nirsevimab to protect infants up to 2 years old from RSV, a leading cause of hospitalization among infants.
  • The injection, delivered in a single shot, was found to lower the risk of developing respiratory disease from RSV that required doctors' visits by around 70-75% for at least five months.
  • The company estimated that its injection could prevent up to 500,000 medical visits per year, including up to 60,000 hospital admissions
  • Nirsevimab is a monoclonal antibody developed by AstraZeneca and Sanofi to protect infants and young toddlers from RSV
  • This vote comes shortly after the FDA approved the first RSV vaccine for use among older adults
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