Health

Advisory

FDA APPROVES BOOSTRIX TO PREVENT TETANUS, DIPHTHERIA AND PERTUSSIS IN OLDER PEOPLE

The Delaware Division of Public Health is sharing the press release below from the U.S. Food and

Drug Administration (FDA).

On July 8, 2011, the U.S. Food and Drug Administration approved Boostrix vaccine to prevent tetanus, diphtheria, and pertussis (whooping

cough) in people ages 65 and older.

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 vaccine that was shown to prevent pertussis.

The antibody responses to the tetanus and diphtheria components were compared with a licensed tetanus and diphtheria vaccine, and were

found comparable. The most common adverse reactions reported by the older adults after receiving Boostrix were headache, and fatigue and

pain at the injection site.

Boostrix was originally approved on May 3, 2005, for use in adolescents ages 10 years through 18 years. It subsequently was approved in

December 2008, to include adults 19 years through 64 years of age. Boostrix is manufactured by GlaxoSmithKline Biologicals, based in

Rixensart, Belgium.

For more information, visit http://www.fda.gov/BiologicsBloodVaccines/Vaccines/ApprovedProducts/ucm172925.htm

or contact the Delaware Immunization Program at 1-800-282-8672 or (302) 744-1060, or visit DPH’s website at: http://www.dhss.delaware.gov/dph/dpc/immunize.html

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