- 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.
- 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.