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FDA approves Tdap vaccine in older adults
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The FDA has approved the use of the tetanus-diphtheria-pertussis vaccine in those aged at least 65 years. The vaccine is the first single-dose booster approved to prevent all three diseases in older people, according to an FDA press release.
The vaccine was originally approved in 2005 for use in those aged 10 to 18 years and was later approved in 2008 for use in those aged 19 to 64 years.
“Pertussis is a highly contagious disease, and outbreaks have occurred among the elderly in nursing homes and hospitals,” said Karen Midthun, MD, 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.”
The safety and effectiveness of the vaccine (Boostrix, GlaxoSmithKline) was based on a cohort of about 1,300 participants aged at least 65 years. Researchers measured antibody levels of participants and found them comparable to the levels in infants who received a closely related vaccine that was shown to prevent pertussis, according to the release.
Common adverse events included headache, fatigue and pain at the injection site.
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