Adacel indication expanded to include repeat vaccination

  • Sanofi

  • curated by Liz Scherer
  • Clinical Essentials
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Takeaway

  • The FDA has expanded the indication for tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis (Tdap, Adacel) to include repeat vaccination for persons ages 10-64 years, according to a company news release.

Why this matters

  • Expanded indication boosts protection against tetanus, diphtheria, and pertussis waning immunity and adds flexibility to existing Tdap vaccination schedule.
  • Despite current CDC recommendations, ~75% of U.S. adults have not received the Tdap vaccine.
  • Manufacturer has provided additional data to CDC’s Advisory Committee on Immunization Practices for inclusion in future vaccination updates.

Key points

  • Licensure was based on clinical data demonstrating safety of a second Tdap vs tetanus-diphtheria (TD) vaccine in >1300 adults, 8-12 years post-initial dose.
  • 86.2% (n=861/999), 88.0% (n=286/325) Tdap, TD recipients, respectively, reported >1 injection site reaction.
    • No other significant adverse events were observed.
  • Vaccine is contraindicated in persons with severe allergic reactions to any vaccine component.
    • Note that tip caps of prefilled syringes may contain natural rubber latex, leading to allergic reactions in latex-sensitive individuals.