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FDA Approves Boostrix to Prevent Tetanus, Diphtheria, and Pertussis in Older People
Date:7/8/2011

SILVER SPRING, Md., July 8, 2011 /PRNewswire-USNewswire/ --The U.S. Food and Drug Administration today approved Boostrix vaccine to prevent tetanus, diphtheria, and pertussis (whooping cough) in people ages 65 and older.

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Currently, there are vaccines approved for the prevention of tetanus and diphtheria that can be used in adults 65 and older. Boostrix, which is given as a single-dose booster shot, is the first vaccine approved to prevent all three diseases in older people.

Tetanus can cause paralysis and is caused by bacteria that live in soil, dust, and manure. The bacteria usually enter the body through a deep cut. Diphtheria is a serious bacterial infection that usually causes a bad sore throat, swollen glands, fever, and chills. If not properly diagnosed and treated, serious complications such as heart failure or paralysis can result. Pertussis is a disease that causes uncontrollable coughing; the infected person makes a noise when they breathe after coughing that sounds like "whoop." The incidence of pertussis disease in the United States has been increasing since 2007, with large local outbreaks occurring in 2010 in California, Michigan, and Ohio.

"Pertussis is a highly contagious disease, and outbreaks have occurred among the elderly in nursing homes and hospitals," said Karen Midthun, M.D., director of FDA's Center for Biologics Evaluation and Research. "With this approval, adults 65 and older now have the opportunity to receive a vaccine that prevents pertussis, as well as tetanus and diphtheria."  

The safety and effectiveness of Boostrix was based on a study of about 1,300 people ages 65 and older. To demonstrate its ability to protect against pertussis, the antibody levels among participants were measured and found comparable to the levels in infants who received a closely related vacci
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SOURCE U.S. Food and Drug Administration
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