Triple vaccine approved for use in senior patients

The U.S. Food and Drug Administration just 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, however not a combination of all three. Boostrix®, which is given as a single-dose booster shot, is the first vaccine approved to prevent all three diseases in older people.

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The 3 diseases that it aims to prevent, as stated, are tetanus, diphtheria, and pertussis.

Tetanus (lockjaw) causes painful tightening of the muscles, usually all over the body. It can lead to “locking” of the jaw so the victim cannot open the mouth or swallow. It can cause paralysis and is caused by bacteria that live in soil, dust and manure. Tetanus leads to death in about 1 out of 10 cases. The bacteria usually enter the body through a deep cut.

Diphtheria is a serious bacterial infection that usually causes a thick coating in the nose, throat, airway, swollen glands, fever and chills. If not properly diagnosed and treated, serious complications such as breathing problems, paralysis, heart failure or death can result.

Pertussis (whooping cough) causes uncontrollable coughing so severe that it interferes with eating, drinking or breathing. The infected person makes a noise when they breathe after coughing that sounds like “whoop.” These spells can last for weeks and can lead to pneumonia, seizures (convulsions), brain damage and death.

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.

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“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.”

Leonard Friedland, Vice President, Clinical and Medical Affairs, North America of , said: “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. 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.”

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, fatigue and pain at the injection site.

Boostrix® works by exposing you to a small dose of the bacteria or a protein from the bacteria, which causes the body to develop immunity to the disease. Boostrix®  will not treat an active infection that has already developed in the body.

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.

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Boostrix® is manufactured by GlaxoSmithKline Biologicals, based in Rixensart, Belgium.

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