The US Food and Drug Administration (FDA) has approved Boostrix vaccine to prevent tetanus, diphtheria, and pertussis in people ages 65 and older.
There are other vaccines approved for the prevention of tetanus and diphtheria that can be used in adults 65 and older, but Boostrix is the first vaccine approved to prevent all three diseases in older people.
“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 the 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 3 May 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.
Source: US Food and Drug Administration
