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GlaxoSmithKline Receives FDA Approval for BOOSTRIX® to Help Prevent Whooping Cough in Adults 65 Years and Older

Fri, 07/08/2011 - 9:33pm
Bio-Medicine.Org

NEW YORK, July 8, 2011 /PRNewswire/ -- The U.S. Food and Drug Administration (FDA) has approved BOOSTRIX® [Tetanus Toxoid, Reduced Diphtheria Toxoid, and Acellular Pertussis Vaccine, Adsorbed (Tdap)] for use in adults 65 years of age and older for active booster immunization against tetanus, diphtheria and pertussis (whooping cough). This approval makes BOOSTRIX the first Tdap vaccine approved for use in this age group.  With this expanded indication, BOOSTRIX is now approved for use as a single dose in individuals 10 years of age and older – the broadest age range for any Tdap vaccine.

See content from GlaxoSmithKline at: http://inr.synapticdigital.com/gsk/boostrix/

The approval of BOOSTRIX for use in adults 65 years of age and older was based on two clinical trials in which more than 1,100 U.S. subjects received BOOSTRIX.

"A growing segment of our population, adults aged 65 and older, can now help protect themselves from whooping cough, a serious and highly contagious respiratory disease," said Leonard Friedland, Vice President, Clinical and Medical Affairs, North America, GlaxoSmithKline Pharmaceuticals.  "Although many people may have been vaccinated against whooping cough as children, immunity can wear off over time.  Adults, including those aged 65 and older, should speak with their health-care providers to make sure their vaccinations are up to date and to discuss the Centers for Disease Control and Prevention's (CDC) recommendations for preventing tetanus, diphtheria and pertussis."

Whooping cough is one of the most commonly occurring vaccine-preventable diseases in the U.S.

In 2010, the State of California declared a whooping cough epidemic.  Several other states, including Michigan, Ohio, New York and Pennsylvania, reported increases in cases in 2010 compared to 2009.  One study estimates that pertussis may affect as many

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