FDA Expands Age Indication for Adacel Tdap Vaccine
Sanofi Pasteur announced that the FDA has approved the use of Adacel (tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine; adsorbed) vaccine in children as young as 10 years old. Adacel was initially approved to immunize against tetanus, diphtheria, and pertussis in patients 11–64 years old.
This recommendation was based on a recent Phase 4, open label, multi-center clinical trial designed to evaluate differences in antibody response and adverse reaction rates in cohorts of children aged 10 and 11. The safety and immunogenicity rates to the components of Adacel were similar between both age groups.
Originally licensed by the FDA in June 2005, the Adacel vaccine was intended to expand pertussis protection to individuals between the ages of 11 and 64. The combined waning immunogenicity against pertussis alongside the morbidity and mortality of the disease in younger patients spurred the shift in the standard of care to vaccine coverage including pertussis in addition to tetanus and diphtheria.
Adacel is available as a suspension in single-dose vials or prefilled pens indicated for IM injection.
For more information call (800) 822-2463 or visit Adacelvaccine.com.