Cervarix has won FDA approval for the prevention of cervical pre-cancers and cervical cancer associated with HPV-16 and HPV-18 for use in girls and young women (ages 10-25), according to GlaxoSmithKline. In clinical trials, the vaccine was shown to be 93% effective in the prevention of cervical pre-cancers associated with HPV -16 or 18, in women without evidence of current infection with, or prior exposure to, the same HPV type at the time of vaccination.
The FDA's approval was based on data from clinical trials in more than 30 countries involving nearly 30,000 girls and young women, the company stated. In October, a UK girl died shortly after being given Cervarix as part of an immunization program, but a coroner's report determined that her death was related to malignant disease and not the vaccine (see below) .
