FDA approves vaccine preventing common diseases in elderly
Diphtheria, pertussis and tetanus
The U.S. Food and Drug Administration (FDA) recently approved Boostrix vaccine manufactured by GlaxoSmithKline Biologicals to prevent tetanus, diphtheria, and pertussis (whooping cough) in people ages 65 and older.
Boostrix was originally approved on May 3, 2005, for use in adolescents ages 10 years through 18 years. It was subsequently approved in December 2008, to include adults 19 years through 64 years of age. There are other vaccines approved for the prevention of tetanus and diphtheria for the elderly but Boostrix, a single-dose booster shot, is the first vaccine approved to prevent all three diseases in the older people (65 years and older)
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."
According to Karen Midthun, M.D., director of FDA's Center for Biologics Evaluation and Research, "Pertussis is a highly contagious disease, and outbreaks have occurred among the elderly in nursing homes and hospitals.With this approval, adults 65 and older now have the opportunity to receive a vaccine that prevents pertussis, as well as tetanus and diphtheria."
FDA report further states that 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.
Furthermore, 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.