FDA expands indication for Tdap vaccine to include 10-year-olds

Sanofi Pasteur announced that the FDA has expanded the approved age indication for its tetanus-diphtheria-acellular pertussis vaccine for patients aged 10 to 64 years, according to a company news release.

The Tdap vaccine (Adacel) was originally licensed in the United States in 2005 to protect against pertussis in patients aged 11 to 64 years. The vaccine demonstrated protection against tetanus, diphtheria and pertussis, and its safety profile is comparable to tetanus-diphtheria vaccine.

The FDA’s latest decision to expand the age indication of the booster was based on data from a phase 4, open-label, multicenter trial comparing the safety and immunogenicity of a single Tdap dose in patients aged 10 years vs. 11 years. Results from the trial indicated that antibody responses to all of the vaccine’s antigens — tetanus, diphtheria and pertussis — were similar between both age groups, and both groups experienced similar rates of adverse events.

David P. Greenberg

“We are pleased the FDA has expanded the age indication for Adacel vaccine, especially in a time when we have seen increases in reports of pertussis …” David P. Greenberg, MD, vice president of US scientific and medical affairs at Sanofi Pasteur, said in the release. “This approval not only reinforces the safety profile of Adacel, but importantly provides an additional opportunity to vaccinate a younger age group to help prevent this highly contagious disease.”