FDA Approves Expanded Use of Sanofi’s Tdap Vaccine

January 15, 2019

Sanofi’s Adacel (tetanus toxoid, reduced diphtheria toxoid and acellular pertussis [Tdap] vaccine adsorbed) is approved for a repeat dose in people 10 through 64 years of age, 8 years or more after the first vaccination.

On Jan. 14, 2019, Sanofi announced that FDA approved the expanded use of Adacel (tetanus toxoid, reduced diphtheria toxoid and acellular pertussis [Tdap] vaccine adsorbed) to include repeat vaccination to help protect against tetanus (lockjaw), diphtheria, and pertussis (whooping cough).

The company reports that Adacel is the first Tdap vaccine in the United States approved for a repeat dose in people 10 through 64 years of age, 8 years or more after the first vaccination. 

The vaccine was initially approved by FDA in February 2015. In September 2017, the vaccine was also approved to be administered as a pre-filled syringe tip cap that is not made with natural rubber latex.

"While strong vaccination programs are in place for young adolescents, a single Tdap immunization does not offer lifetime protection against pertussis due to waning immunity," said David P. Greenberg, MD, regional medical head North America at Sanofi Pasteur, in a company press release. "The licensure of Adacel as the first Tdap vaccine in the US for repeat vaccination is an important step for eligible patients and offers flexibility for health care providers to help manage their immunization schedules."

Source: Sanofi