FDA Expands Age Indication for Boostrix
The vaccine is now licensed for use in people 65 and older
THURSDAY, Sept. 22 (HealthDay News) -- The U.S. Food and Drug Administration has expanded the age indications for Boostrix, the tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine (Tdap), to include people 65 and older, according to an article published in the Sept. 23 issue of the U.S. Centers for Disease Control and Prevention's Morbidity and Mortality Weekly Report.
Boostrix was originally licensed for use in people 10 to 18 years of age, an indication that was expanded by the FDA in 2008 to include people up to age 64. In October of 2010, however, the Advisory Committee on Immunization Practices (ACIP) received data on the safety and immunogenicity of Boostrix in those 65 and older; they went on to review data from two clinical trials analyzing the safety and immunogenicity of the vaccine in this age cohort.
The committee determined that Boostrix's safety and immunogenicity profiles were similar to those of currently available tetanus and diphtheria toxoids vaccine.
"With the recent FDA expanded licensure for use of Boostrix, ACIP will be reviewing the current recommendations on use of Tdap in persons aged 65 years and older. At this time, either Tdap product [Boostrix or Adacel] may be used in persons aged 65 years and older," the researchers write.