A month back FDA approved the Inform Dual ISH test for breast cancer patients. Now, the U.S. Food and Drug Administration have approved Boostrix vaccine to prohibit tetanus, diphtheria, and pertussis for individuals in the age-group 65 and older.
Presently, vaccination programs for the prevention of tetanus and diphtheria in adults above the age of 65 are approved. Boostrix is administered as a single-dose booster shot and is seemingly the first vaccine approved that aims to prevent all three disorders in senior citizens. Tetanus may lead to paralysis while diphtheria is a bacterial infection that causes a bad sore throat, swollen glands, fever, and chills. Pertussis is characterized by whooping cough and its prevalence has been apparently increasing since 2007.
“Pertussis is a highly contagious disease, and outbreaks have occurred among the elderly in nursing homes and hospitals. With this approval, adults 65 and older now have the opportunity to receive a vaccine that prevents pertussis, as well as tetanus and diphtheria,†explained Karen Midthun, M.D, director of FDA’s Center for Biologics Evaluation and Research.
The approval came only after a study was conducted to gauge the safety and efficiency of Boostrix. The study enrolled 1,300 individuals who were aged 65 and older. In order to determine its capability to guard against pertussis, the levels of antibody among the participants was found. The proportion was compared to that of infants who were administered a similar vaccine that is known to prohibit whooping cough.
The antibody responsiveness to tetanus and diphtheria components was compared with a licensed tetanus and diphtheria vaccine. It was apparently found comparable. Some of the side-effects of Boostrix as reported by users were headache, tiredness and pain in the region of injection. The original approval of Boostrix traces back to May 3, 2005, for accessibility to adolescents in the age-group 10 to 18. Subsequently, it was approved in December 2008 for adults of 19 years up to age 64.
Boostrix is manufactured by GlaxoSmithKline Biologicals, based in Rixensart, Belgium.