Boostrix Approved to Prevent Tetanus Diphtheria and Whooping Cough in Seniors
First single vaccine to prevent all 3 diseases in elderly
MONDAY, July 11, 2011 (HealthDay News) -- Approval for the Boostrix vaccine has been expanded by the U.S. Food and Drug Administration to prevent tetanus, diphtheria and pertussis (whooping cough) in people 65 and older, the agency said in a news release.
While other vaccines exist to prevent tetanus and diphtheria among seniors, this is the first single booster shot to prevent all three diseases among this age group, the FDA said.
The vaccine's safety and effectiveness were evaluated in trials involving some 1,300 people aged 65 and older. The most common adverse reactions reported were headache, fatigue and injection-site pain.
The vaccine was initially approved in May 2005 for people aged 10 through 18. Approval was widened in December 2008 to include adults aged 19 through 64.
The product is manufactured by GlaxoSmithKline Biologicals, based in Belgium.
The FDA has more about this approval.