FDA approved Cervarix, GlaxoSmithKline’s cervical cancer vaccine

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On Oct. 16, 2009, GlaxoSmithKline announced the U.S. Food and Drug Administration (FDA) had approved Cervarix [Human papillomavirus bivalent (types 16 and 18) vaccine, recombinant] for the prevention of cervical pre-cancers and cervical cancer associated with oncogenic human papillomavirus (HPV) types 16 and 18 for use in girls and young women (aged 10-25).

Cervarix was shown to be 93 percent efficacious in the prevention of cervical pre-cancers (cervical intraepithelial neoplasia 2+/ CIN 2+ or adenocarcinoma in situ) 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 majority (approximately 75 percent) of cervical cancers in North America are caused by HPV types 16 and 18.

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Source: GlaxoSmithKline
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