Extended Use of Tdap Vaccine Receives FDA Approval

JANUARY 15, 2019
The FDA has approved Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (Tdap) use to include repeat vaccination to help protect against tetanus, diphtheria and pertussis. The vaccine is produced by Sanofi under the market name Adacel.

The approval was granted based on data from a study assessing the efficacy of the vaccine in a population of more than 1300 adults. Participants received either the Adacel vaccine or a tetanus-diptheria vaccine during a 8-12 years period following a dose of the Adacel vaccine. Results indicated that the second dose of Adacel vaccine in adults administered 8-12 years after a previous dose found no significant differences in reported adverse events between the 2 vaccine groups. In total  999 participants in the Tdap vaccine group (87.7%) and 328 participants in the Td vaccine group (88%) reported at least 1 injection-site reaction.

The approval has made the vaccine the first and only Tdap vaccine in the US approved for a repeat dose in individuals between the ages of 10 through 64 years, following 8 years or more after the first vaccination. The vaccine is also unique in that it is the only Tdap vaccine available in a syringe made without rubber latex, which may reduce the risk of the vaccine to individuals with allergies to latex.

A version of this article was originally published by our sister publication Contagion Live. View the full article at ContagionLive.com

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