FDA Oks Boostrix for Senior Citizens to Prevent Tetanus, Diphtheria, and Pertussis
Whooping cough (Pertussis), increasing since 2007, is highly contagious; outbreaks among elderly in nursing homes and
hospitals
July 11, 2011 – Senior citizens – people age 65 and older – no longer have to get separate vaccinations to prevent
tetanus and diphtheria. The Food and Drug Administration on Friday approved the Boostrix vaccine, which will prevent both of these diseases,
plus pertussis (whooping cough), which is increasing among the elderly.
Boostrix, manufactured by GlaxoSmithKline Pharmaceuticals, is given as a single-dose booster shot
and becomes the first vaccine approved to prevent all three diseases in older people.
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."
“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 as 3.3 million adolescents and
adults in the U.S. each year.
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.
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:
Boostrix Product Page
FDA Consumer Inquiries: 888-INFO-FDA
The FDA, an agency within the U.S. Department of Health and Human Services, says it protects the public health by
assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and
medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements,
products that give off electronic radiation, and for regulating tobacco products.
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