FDA Approves Tdap Booster for Seniors

July 08, 2011

July 8, 2011 — The tetanus toxoid/reduced diphtheria toxoid/acellular pertussis single-dose booster vaccine (Tdap; Boostrix, GlaxoSmithKline Biologicals) received approval today from the US Food and Drug Administration (FDA) for adults aged 65 years and older. The vaccine is already licensed for individuals aged 10 to 64 years.

Given as a single-dose booster shot, the vaccine is the first approved to prevent all 3 diseases in seniors. Before today's decision, only vaccines for preventing tetanus and diphtheria were approved in this age group.

Tdap booster vaccine (Boostrix)

Adding a pertussis vaccine to the mix meets a public health need, according to Karen Midthun, MD, director of the 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," said Dr. Midthun in a press release.

The vaccine's safety and effectiveness were demonstrated in a study of roughly 1300 individuals aged 65 and older, according to the FDA. Antibody responses among the participants resembled those in infants who had received a closely related pertussis vaccine. Likewise, antibody responses to the tetanus and diphtheria components matched up with those to a licensed tetanus and diphtheria vaccine.

Headache, fatigue, and pain at the injection site were the most common adverse reactions reported by seniors receiving the vaccine.

More information about today's decision is available at the FDA's Web site .


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