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Japan Permits Antibody Preparations to Be Used in National Immunization Program

The law change creates a legal route for an infant RSV antibody to win routine, publicly funded status with the government targeting fiscal 2027 for designation.

Overview

  • The Diet’s upper house approved the Vaccination Law revision on Friday, July 24, 2026, formally allowing antibody drugs to be used like vaccines in immunization programs.
  • The government said it will pursue discussions to make an RSV antibody product a routine, publicly funded immunization and is aiming for possible designation in fiscal 2027.
  • Antibody preparations give passive immunity by delivering ready-made antibodies into the body, which differs from vaccines that prompt the body to produce its own antibodies.
  • The 2024 launch of Beyfortus for newborns has driven calls for routine coverage because infants face higher risk of severe RSV infection such as pneumonia.
  • Officials still must decide target age groups, advisory committee recommendations, procurement and public funding rules, and this change also opens the pathway for future antibody-based prophylactics to be evaluated under the program.